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G goad gdrnrd ga sBoddoe dadded axad ga 4 Scawe The Gazette of the Democratic Socialist Republic of Sri Lanka EXTRAORDINARY 3878/3 — 185 agen OAS 02 Op egg — 1985.12.02 Mo, 78/3 — MONDAY, DECEMBER 02, 1086 (Published by Authority) PART I: SECTION (I) GENERAL Government Notifications COSMETICS, DEVICES AND DRUGS ACI, No. 27 OF 1980 REGULATIONS made by tho Minister of Health, under section 38 of the Cosmetics, Devices and Drugs Act, ‘No. 27 of 1980, as amended by Act, No. 38 of 1984 aud approved by Parliament. DR, RANIIDE. aTaParre, Golombo, 14. 11.1985. Minister of Health. Regulations. 1. ‘These regulations may be ited as the Cosmetics Regulations No. 38 of 1984 and shall como into operation on Ist January 1986, (hereinafter reforred to as!“ tho date of operation ”), 2. For the purposes of these regulations every cosmetic undor tho Cosmetics, Devices and Drugs Act, No. 27 of 1980, aa amended by Act, No. 38 of 1984 (hereinafter referred to as “the Act") sbsll be eallod “ss registered conmetio.” Pany I Reorsrearion oF Cosaetios. i 3. Onor after the expiry of a period of threo months from the date éf operation the Cosmneties, Devices aad Drugs Authority, (heroinafter referred to as “the Authority") shall preparo @ rogister of overy rogistered cosmotiec and shall enter or eauso to be entered theroin the following partioulars relating to such vegistered cosmetie : (a) tho name of the cosmetic ; . (®) tho name of tho manufacturer ; (©) the country of manufacture ; (@) the registration numbor assigned to it ; (©) the name and addroes of the holder of the certifioate bf rogistratic (A) whothor ho is an importer or manufacturer ; and (9) tho number of the liconoe issued to him, 4, (1) Every porson desirous of registering o oosmotio with the Authority shall make an application in that behalf to the Authority. 1A 2A Toms : (1) exga—9 cum gehmatga aGsitht Endtied 6S Boaw 0,0 og4—1985.12.02 Pant I:Szo(I)—QAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA—1986.12.09 ” (2) A soparate application shall be made in respect of each cosmetic intended to be registered. (8) Every applicant for registration of any cosmetic shall along with his application, furnish to the Auth: all such information as may be required and epecifiod in Form A of Schedule I hereto for the purpose of enabling tho Authority to dispose of such application. (4) Every application made by en importer for o certificate of registration of a cosmetic shall be substan. tially in form B of Schedule T horeto. (5) Bvery application made by a manufacturer for a certificate of registration of @ cosmotio shall be sub- stantially in Form C of Schedule I horeto. (8) The fee payable in respect of a certificate of registration of a cosmetic shall he 08 specified in Schedalo IT hereto. 5. (1) Onreecipt of an application for a certificate of registration of a oosinetic the Authority shall forward such application to the Sub-Committes on Cosmetics of the Cosmetics, Devices and Drugs Technical Advisory Committee for ndviee and report. (2) Having considored tho report of the Sub Committoo on Cosmetics, if the Authority is satinfied thet if a certifieate of registration is granted, the conditions of such certificato of registration will be observed, the Authority shall, on payment of tho specified fee, register or causo to bo registered such cosmetic and issue a certificate of registration substantially in Form A of Schedule IIT hereto in respect of that eosmetio, 6. (1) The certificate of registration of a cosmetic shall, unless it is earlier suspended or cancelled, be valid for a period of five years from the date of issue of such certificate, (2) Every application for renewal of the cortificato of registration of a cosmotie shall bo substantially ia form B of Behedule IIL beroto. (3) Whero an application for a renewal of a certificate of registration is made six raontha bofore the date of expiry of the poriod of validity of the current certificate of registration, such certificato of registration shall be Acomed to continue in force until an order is mado in respect of the application for its renewal. 7. ‘The holder of e certifioate of registration of e cosmetic shall forthwith inform or notify the Authority of —~ (a) any material changos that havo boon made or that aro proposed to be made in the particulars main- ‘tained in or furnished in connection with his application, in rolation to any cosmetic to which ‘the certificate of registration relates ; (8) any information by him that oasta doubt on the continued validity of the data which was rubmitted with, or in somnection with the application for the zezistraton of the ecemeti, for the purcoso of assessing the tafety, quality or efficacy of the cosmet (c) any decision to withdraw the cosmetic from tho register end shall etate the reason for such decision ; ‘and (@) any decision to terminate his aotivities os an iraporter or manufacturer of the said cosmetic. 8. (1) If the holder of ths certifioato of rogistration of a cosmetio fails to comply with any of the conditions of the registration of such cosmetic, the Authority may, after giving such holder of the certificate of registration of such cosmetic an opportunity to show causo why such an order should not be made, remove the namo of the soametio from the register of cosmetics by an ordor in writing and state the reasons therefor. (2) Any person aggrieved by the order for such removal of the namo of the cosmotic from the register of coumoties may, within three months from the date of such order, appeal to the Authority against such order. (8) Tho Authority shall, on the advice of the Sub Committos on Cosmetios remove the name of a eosmetio from tho registet of cosmetics and inform the holdor of tho certificate of registration of that cosmotio of the reasons therefor. Teasdes () ouqa—G cx guvaraigms WOuDif dndded 44 Bowe awd 6ye—1085-12.02 «3 A Pant 16t0, (1)—GAZETTE EXTRAORDINARY OF TAR DEMOGRATIO SOCIALIST REFUBLIO OF SRI LANKA. 1985.12.02 Pane I Jacensrxa o¥ Iirontres oF Cosmurtes 9, On or after the expiry of a period of three months frow the date of operation vo person shall import a segietored cosmetic except under authority of a licence tssucd under regulation II, Every person to whom a licenco 4s issued under regulation IL shall hereinafter be referied to as a " Tieensed irmpenter af eoemeties.” 10, (1) Every person desitous of obtaining « licence to inport any registered costnetio shall make a soparato application to the Authority in respect of each stch cosimetio which ho intends to import, Every euch application hall be substantially in Form A of Schedule IV hereto. (2) Evety applicant for « licence to import a registaxod cosmetic shall furnish to the Abthority all such information as inay bo required for the purpose of cnabling the Authority to dispose of such appli (8) The fee payablo in respect of a licence to import a registered cosmetic shall be ae specied in Schedule T hereto, LL. (1) On receipt of an application for a licence to import » registered cosmetio shall, on being satistied. ' the conditions of the licence will bo observed if the Ticence is issued, issue euch licence to the applicant, 2) Brery liconco iesued by the Authority ender this segulation shall be enbstantially in Form B of Schedule WV hereto. (B) The foo payable in rospect of a licenee to impart a registered cosmetic eball bo ceified in Schedule I hereto, Cospimtoxa oF 4 Licexce 70 Import a Cosuenic 12, Every ficouce issued under regulation IT shall contain the following conditions : (a) the liooncod importer of cosmetics shall allow any officer authorised by the Authority to enter with or without notice, any premises where tho imported cosmetio is stored, fos the jrarpoee of inspecting sand if neveseary teking eomplos for test, examination or aualysis, @) tho licensed importer of cosmetics shall furnish to the Avthority such samples as the Authority may consider adequate from every batch of each cosmotic imnported under a licence, for teet, exomination or analytis. Tho Jicopscd importer of cosmetics eball, if eo roquired, furnich fall particulars of the quality control tests eattied out by the mapufactuter of thot posticular bateh of cosmetics () the licensed importer of eostnotice thall, on being informed by the Authority that any part of any batch of the cosmoties imported bas been found by tho Anttority not to be in conformaity with the standard epecifiod by the Authority, withdraw the batch from eale ; (2) tho lieonsed importer of cosmetics shall maintain a record of all particulars of import, sale and supply of any cosmetic by him and such rocords shall be open to inspection by any officer authorised in that bchalf by the Authority. 13, (2) The licence to import a cosmetic chall wiless itis catlior suepondod ur cancelled be valid for a period, of ons year from the date of issus of such licence, (2) Where an application for renewal of such licence fo mado three months before'the expiry of the poriod of validity of the eurront licence, such licence shall be deemed to continuo in forco untill am order is inade in respect, ‘of euch application. 14, (1) If the lioonsed importer of consmeties fails to comply with eny of the conditions of the Vivenca to import such cosmetics the Authority unay, after giving euch liceneed importer of coemeties an opportunity to show cause Why ech ap order should not be made, by an order in writing stating the roasone therefor, euspend suclt ligonee for euch petiod ns the Authority thinks fit, or cancel it either in respect of all or eome of the cosmetics to wsbich it relates, (2) Any person who is aggrieved by an order mado under paragraph (1) eveponding or cancelling hie licence ‘may, within threo months from the date of such order, make an appeal to the Authority againet euch ordor. 16 No peteon shall impoit except for the purpose of test, examination, analysis or olinical trial, any cosmetic under the same name or under avy other name if the manufacture, sale or distribution of such coametic is prohibited in the country of monufacture. 4A Lemdee! () oxa—§ Crm gurmmalgjin wodOY derdiied gd Seaw aed ega—1085.12.02 ‘Panel: Seo.()- GAZETTE EX3P. \ORDINARY OF THE DEMOCRATIO SOCIALIST REPUBLIO OF SRI LANKA—1988.12.02 16, Every licensed. inaporter of cosmetics shall exhibit the licence issued to him under regulation 11 in a conspicuous place in the premisos at which ho aclls, stores or distributes the cosmetics imported under that licence, 17, The Authority shall keep a register of all licensed importers of cosmetics and shall enter or caitse to be centered therein tho following particulars rolating to each stich liconsed importer of cosmotio : (@) the name of the licensed importer of cosmetic (©) the addrees of tho promises in respoct of which tho liconce has been istuod ; (©) the date of issue of tho licence ; and (@) tho number ond date of the cortficate of registration if any issued to Ordinance (Chapter 149). ‘Tho nazo of the licensed importer of cosmetics sholl be published in the Gazette, under tho Business Names 18, (1) Every liconsed importer of cosmeties shall forthwith inform the Authority in writing of any cir- cumstances or event which may occur which affeets theaccuracy of any particulars stated by such licensed importer of costnetics in the application for a licence to import cosmoties andshall at the samo time forward his licence to ‘tho Authority. (2) Upon the receipt of any juformation furnished by s licensed importer of cosmotios under paragraph (1) the Authority may make or eauso to bo made such appropriate alterations in the register and in the licence of thot importer as may be necessary and shall rotusn the licence to the liscensed iimporter of cosmetics. 19, The Authority may revoke any Hieenoe to import a cosmetio issued under regulation 11, if the authority is satisfied that the licensed imparter of cosmetics has acted in contravention of any regulation ooatained in this port or any other regulation pertaining to importation and distribution of eosmeties made under the Act. Pama UT Jacuxen to Maxuracrone Cosmencs. 20, Ou or after the expiry of a period of threo months from tho dato of operation no person shall manu- facture any cosmetic except under the authority of w licence issued under regulation 24. Every person to whom @ Jioenoe is issued under regulation 24, shall hereinafter Lo referred to as a “Licensed manufacturer of eosmotice”. 21, No cosmetic other than any registered cosmetic referred to in regulation 2, shall bo manufactured ia S11 Lanka, 22, Every petson desirous of obtaining « Hoenee to manufacture any registered cosmetic shall make separato application to the Authority in respoot of each cosmetic he intends to manufaetuze, Every euch application shall be in Form @ of Schedule IV hereto, 23. Every applicant for a licence ty manufactuce a registered cosmetic shall furnish fo the Authority all such information as may be required for the purpose of enabling the Authority to dispose of such application. 24, (1) Tho Anthority eball, on receipt of an application for a licence to manufacture a registered cosmetio cause tho premises whero such manufacture is to be carricd out to be inspected and on being satisfied that such ‘premises ato suitablo for the manufacture of cosuieties and that allthe conditions for issuing a Licence for the manus facture of cosmetics havo been complied with, issue 2 Foence to tho applicant. (2) Tho feo payable in rospect of stch licence shall be az specified in Schedule II hereto. (8) Any manufacturer of cosmetics who has been given approval to manufacture cosmeties beforo the coming into operation of tite Act may continuo with the manufacture of a vosmetic in xeapect of which he has already obtained. approval ponding the issue of a Licence in accordanco with tho regulations contained in this Part, Conprmons oF 4 LicuNon 10 Maxuvacrors Cosmmnics. 26, Every applicant for o licenco to manufacture cosmetics shall comply with the following sonditions :— (2) the licensed manufacturer of coemetics shall provide aud maintain such staff, promises and plant as azo considered by the Authority to bo necessary for the manufacture of cosmetice undertaken by such licensed manufacturer, and ho shall not oarry out any such manufacture except at the eemises specified in his Licance ; Temd0 : () odgs—B crm geomalgea OOD? Undded 98 Boas od oya—1085.12.02 SA Pant I: Seo, ()GAZETTE EXTRAORDINARY O¥ ‘THE DEMOORA1IC SOCTALIST REPUBIUO OF SRI LANKA-1086.12.02 (@) the licensed manufacturer of coamtles shall provide and maintain such staff, promises, equipment ‘and facilitios for the handling and storago of such materials sud conmotios as aro eonsidored nocoosary by tho Authority to avoid deterforation and ho shall not use tor such purposes, premieos other than thove apecified in the lieenco or premises which may be approved from tims ta time by tho Authority 5 (© the lioonsed manufacturer of eosin shall carry ont all manufacture of cosmetios in such a way as to ‘ensure that tho cosmetics conform to the standards applicable to tim as specified by tho Auth. rity 5 (A the licensed manufacturer of cosmetics shall provide such information as may bo required by the Authority in teapoct of the eosmotica currently being manufactured and of the operations being corried out in relation to such manufacture ; 40) the licensed manufacturer of cosrnotica shall inform tho Authority before making any materia! alter- tions in the premises, plant or machinery used wsvler his License, or ip the operations for which they aro used, and he shall inform the Authority of any ohange he intends to take in any personnel ‘named in th licence as :~ (i) responsible for supervising the production operations ; or 8) responsible for quality cxsttol of the products manufsctured ; (J) the Hicensed manufscturer of coameties shall keep roedily available for inspection by the Authority or hy any potson euthorised by the Authority, tho reeords of details of manufacture of each batch of every cosmetic. which is being manufactured under ths nuthority of suck Hieonce, and tho teste carried out in respect of thoreof, iu such form that the records will be easily identifiable from the number of the batch as shown un ec container in which the cosmetics re sold, supplied or exported and the Liconsed mannfaoturer of cosnictice shall allow the petson authorised to take copies or mako extracts from such reverds. Such records shall not be destroyed for a period of five years from the dato of manufsctito of the televant batch, withou the oonsont of the Autho- () the licensed snanufacturer of cosmetics shall keep such dooumonts which wilt facilitate the with. rawal or revall from alo, supply or exportation of any cosmactio to which the licence rclates ; () tho licensed manufacturer of cosmetics shall allow the Authority or any otficer authorised by the Authority to enter with or-without motive any premises where the manufuoturo of any cosmetic is carried oxt under tho licence or any pr ‘here the raw matetinls and other substances used in tho manufacture ato stored or where tho memufectured coametio is stored, sold or supplied, ‘or tho purpose of inepeoting and sf nooosaary taking samples for test, examination, analaysis ot clinical teak (i) where the licensed manufacturer of cosmetios haa boen informed by the Authority that any batch of any cosmetio in reepect of whicb the Vicenco ig iseued hae been found not te ba in conformity with the specifications a togards strength, quality or purity of the relevant cosinetic, of with the provisions of tho Act or of any regulation made thereundsr that are applicable to cosmetics, such Vicensed manufacturer of oosmotics shail if so directed withhold such bateh, from aslo, supply oF exportation eo far az may bo rearonatly practicable, for eueh period az may be specified by the Authority 5 (j) the licensed manufooturer of cosmetics shall comply with euch further requirements if any, applicable toliconsed manufacturers f cosmotice ae may be specified m any regulations made under the Act. 26. Every Viounce ieeued by the Authority under regdlation 24 shal] bo in Worm D of Schedule IV hereto and bo valid only for the promises in respect of which itis issued. 27. Tho foo payable in respect of a licono izeued undor regulation 24 shall be 2a wpecitied in Schedule 14. hereto. 28,(L) The licence to manufacture a registered cosm valid for a period of one year fiom the date of issue of such li (2) Whore tho application for ronowal of such licenco is made three months before the exyiny of the period of validity of the current licence, such ligenea shall be deemed to continue in fora wutil an onda ig wade in reapent of the application for renowal. shall, unless it is eatlior suspended ox cancelled be 6A Lorss08 : () otige—9 cam ptrorstha HBstdak dindded ¢8 Baaw 0100 eye 1085.12.08 Pant I: Se0.(1)—GAZETTE EXTRAORDINARY OF THE DEMOORATIO SOOIALISY REPUBLIO OF SRI LANKA—1085.12.02 (3) Any application for renewal of such licence shall be substantially in Form C of Schedule IV hereto. 20.(1) If the licensed mapufsoturor of cosmetics fails to comply with any of the conditions of a Ticonce to manufacture a registered cosmetic, the Authority may, after giving the licensed manufacturer an opportunity to show causo why such an order should not bo made, by an order in writing stating the reasons therofor, suspend. the cone for stich period as the Authority thinks fit, or cancel it, either in respect of all or coms of the cosmetica ta which it relates. (2) Any person who is aggrioved by an order mado under puragraph (1) suspending or cancelling his ceos 1may, within three months of the date of such order, make an appeal to the Authority against euch order, 30, Every licensed manufacturer uf oosmetice shall exhibit the ooneo issued to him in a conepieuous place in the premises at which he manufactures the cosmetics. 31, ‘Tho Authority shall oop a register of every licensed manufacturer of cosmetics and shall enter or cance to be entered therein the following particulars relating to cach such licensed manufacturer : (@ the name of sucb licensed manufacturer ; ©) the adress of tho premises at whioh he is authorised to manufacture the ecsmetio in reepeot of whfob the liceneo has been issued {©) the number of the licenoe 5 (d) the dato of issue of the licenve ; und (©) the number and date of the certificate of registration if any, issued to him under the Business Names Ordinaneo (Chapter 149), 82, (1) Every licenrod manufacturer of cormetics shall forthwith inform the Authority in writing of any circumstances or events which affecte the accuracy of any partioulars stated by euch licensed mauufeeturer in the application for a licence to manufacture cosmotiee and shall together with euoh information. furnish to the Authority his liconce. (2) Upon the receipt of any information furnished by a licensed manufacturer of cosmetics under paragraph (1) the Authority may mnke or eause to be madé such appropriate alterations in the regieter and in the cence of that Ticensed manufecturer as may be nevessery and shall return tho licence to the licensed manufacturer. 23. Tho Authority may revoko any licence issued under regulation 24, to monufacutre cosmetics, if he is satisfied that tho licensed manufacturer of cosmetics has acted in contravention of any regulations conteined in thie Part or any other regulation made under the Act pertaining to the wmanufacture of cosmetios. Pan IV Coxprmtoxs ror Sice or Cosmetios (Rurart axp WaoLesae) 34. On or after the date of oxpiry of u period of threo months from the date of operation no person hall eell any cosmotios othor than @ cosmotio registered with Uw Authority, 36. Every porson who is engaged in eolling any registered cosmetio (by rotail or wholesale) hereinafter Yeforred to as “the dealer ” shall comply with tho following conditions :— (a) tho dealer shall allow any ofiicer authorized by tho Authority in that bebalf to onter with or without notice, any promises whore retail or wholesale trado of cosmetics is being oarriod out for tho purpose of inspocting and taking sainples of the cosmetios for test, examination, analysis or lincial trial ; (6) the dealer shall, on request and on payment, of the relevant fee furnish to the Authority from any batch of each cosmetic, such sample as the Authority may consider neoossary for any test, exami- nation, analysis or olincial trial ; (0) if the Authority so directs, the dealer shall not soll or offer for sale any batoh of a cosmotio in roapeot of which samples aro furnished under paragraph (b) until a certificate authorizing the sale of that batch of the acsmotio has boon issued to him, by of on behalf of the Authority ; Tovmx08s : (1) ossgo—G Cras gurareiien WEE Sendded o8 Sous wed &yc— 1985.12.02 7A Pane I: Seo, (1) GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOOIALIST REPUBLIC OF SRI LANKA~1085.12.02 (@) tho doaler shall, on being informed by the Authority that any part of any batoh of a cosmetic has been found by the Authority not to be in conformity with the standard specified in regard to quality and purity of the cosmetic and on being directed to do s0, withdraw the remainder of that batch from sale, and, s0 far as is practicable in the particular oiroumstances of the oase recall the issues already made from that batch. Pant V ‘Desravorion 36. Any cosmotic which fails to conform to the standards required or the storage life of which has expited shell bo destroyed. ‘Tho destruction shall be carried out under the supervision of an officer authorised by the Authority. Part VE Lavztixe 87. The containers of all cosmoties imported, manufactured, processed or packed locally or sold or exposed 0t salo shall havo lobols bearing the following information clearly indicating :— (a) the brand name, (@) the weight oF volumo of contents, (©) warnings or precautions thet may be neces (@) the dato of mannfooture, (¢) the bateh or lot number assigned by the mannfacturer, an (f) the name end address of the manufacturer, Pase VIL Apvsamsnie of Cosuprcs 38. On or after the dato of expiry of e period of three months from the date of operation no person hall advertiso any cosmetie in contravention of tho provisions of tho Avt or any regulation made thercunder. 39, No porson shall advertise any eosmetio which is not rogistored with the Authority, 40. No person shall import into Sri Lanka— (@) advertising material of any cosmetic which is not registered with the Authority 5 () advertising material of any cosmotic registered in Sri Lanke in contravention of the provisions of the Act or regulations made thers under. 41, No person shell make any falso or exaggerated claim for any cosmetic or misuse research results or ‘quotations from eciontifo literature to support such claim, 42, Tho Authority may after giving the advertiser an opportunity of being heard, prohibit the publication of eny advertisement which is in contravention of the provisions of tho Act or regulations made thereunder. Form &. ‘Regulation 4 (3) Scaxpons 1 Tyvormatioy Requieep vor Regisrxatioy oy 4 Cosweric 1, Namo of epplicant : 2. Address 8. Status of applicant : Manufacturor Importer : 4, Namo and Address of Manufscturer 8A 1 erm100: (I) oxgs—Q Cums yurastigin GOrUDse Unddad 48 Boae axed oye—1985.12.02 ‘Pass I: Beo(1) GAZETTE BXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIO OF SRI LANKA-1936.12,9, 5. Namo of tho Coametio : (1) Brand name (if any) :....-. (2) Official or approved namo nv. 0. Typo of Cosmoti Hair Lotion, Face Powder, Toilet Soap 7. Formulation and Package size : eg. Powder, Cream, Lotion, oto. 8. Composition : ‘Tho ingredients should be listed by their chomies! name and should include thoir oxact quantities, 9. A certificate from tha hoalth authorities of tho country in which tho commetfo is prodveed, confirming that th cosmotio ia in uso thera and tho poriod of uso und if not, rearons for not marketing it in tho country of manufacture. 10, Certificate of analysia and full information concerning analytical assessment and other control mothods ty censure strength, qualtiy and stability, 11. List of countries in which the cosmetic is approved or registerod for sale 12, Fully packed samyle of tho cosmetio in the form that will ba offered for sale should lso bo sont. 13. A sample of the label (s) used in the containers and package insort (if auy) should be suppliod. 14. All data should be submitted in English, in a, hard fto cover, in duplicate. Applications mails without these requirements will not be accept. Sonepunn I Form B Rogulation 4 (4) Areyioamion Form Yor Certieicare oF Rxoist#aTion o¥ 4 Cositrrio BY aw InvonTER. {to bo filled in triplionto by applicant) TWo oes . hereby apply for togistration of the cosmetic namely... dotails of ‘which are ‘enclosed herowith. Signetstto ison Dato AAAROBS Zc Designation of applicant FOR OFFICIAL USB ONLY. Application No. : Decision: Regis Registration No, Fees Paid :... Dato tosses red Not rogiatored. Authority, Sompuzz I Form Regulation 4 (6) Arrrioariox Fou ron Czetmmicars on Reoistaanion oF 4 Cosuztio s¥ 4 Maxusacrounn, (Zo bo filled in triplioato by Applicant) I/We .. Of snnsnsnwe hereby apply for registration of the cosmetic und formulation for manufacture namely .....0 details of which are enclosed herowiths, Signature e Ditto boone Addreas: Designation of applicant Toma : (D oxto—9 Gans gurariga aestOid Uaddod gd Boaw oud ONS—1985.12.02 A Pane. 8r0.(1) OAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA-1086 12.03 FOR OFFICIAL USE ONLY Application No. :. Dated 5 Docision : Registered Not registered Dates Registration No. . Dated ‘Fees paid Receipt No. :.. Authority ‘Regulations 4(6), 10(9),11(3), 24(2), 27 Sonzpucx IT vars 1, Certificate of Registration—Tho fee for the Cortificate of Registration shall be as follows -—~ (a) rupees five hundred for registration of a cosmetio. (0) rupees two hundred and fifty for the renowal of registration of a cosmeti Provided that the appliostion, or the renewal of registrati validity of the Oortificate of Registre (c} A feo of rupers fifty shall be made for n duplionte copy of thy Czrtificate of Registratio damaged oF lost and such copy of the cortificate shall bear the words “Duplicate Copy”. 1.13 mado six months before the expiry of tho ho orlginal i8 2. Licence to Import Cosmetica—Feo for a licence to import a registored cosmetic is Rs. 1,000/- (Thousand, 3. Licence to Manufacture Cosmetic —The feo for licence to manufacture a cosmetic is Rs. 1,000/- (Thousand) Form A Regulation 542) Somers TIT Caprimoars oy Rrotsrnariox ‘The following cosmetic is hereby registored under tho Coemetics, Devioes and Drugs Act, No.27 of 1980 -— Name of cosmetics... ‘Type of cosmetio :, Namo of manufacturer: Country of manufacture ‘Namo of importer i. Registration No. Date of registration ‘Fyperof registration: Full rogistratio Provisional registration :. Period : Bchodale! Full registratip sill be valid for a period af 8 years unlegs earlier suspended or oancelled. Provisional rogistration shall bo valied for the poriod stipulated. Date of issue’ AoA 051816 1A — Lems00: ) avga—g cum gdimrt ga G@sdrk Undded gH Donw 0,80 09¢—1985.12.08 Pant I:Ste, (I)-GAZETTE EXTRAORDINARY OP THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA-1986.12 5, Form B Regulation a3, Scurpure Tit Avriication Fors yor Rewswat. or Rxcisrration ov 4 Cosmetic. We. ne horoby apply for renewal of registration of the cosmetio for import/manufactury, ‘Registration No. :. * Expiry date of last registration Dato fone Designation of applicant . Form A Regulation 10(1) Sommpute IV APPLIOATION FoR LiczNoz 70 Iron 4 Recisremep Cosunni0. hereby apply for the import of a cosmetic registered by the Authority. Date iarsesnsnne Designation of applicant :. Form B Regulation 11(2) Souzpute IV Licexox ro Iurorr 4 Reoisrenmp Cosmeri ‘Ligonco number Mp. of. {sare hereby licenced to import into Sri Lanka during the period for which this in force tho cosmetio specified below manufactured by This licence is subject to the conditions prescribed in regulation 12 of the Cosmoties Regulations mado under tho Cosmotics, Devices and Drugs Act No. 27 of 1980 as amended by Act No.38 of 1984 and shall be in force for one year from the date of iseue unless its earlier suspended or cancelled. ‘Namo of cosmetio tu which this liconco is applicable. L . Authority. Form 6 . Regulation 22 Soazpurz IV Arruoation ror Issvz/Rewzwat oF 4 LiczNoz To Muyvracrun® A CosMErio By way oF Barso. Maxvrscrone/Smsa-Basto Masruraorons /FouMvzaTiox /Rerackrxa We, of on promises situated at ‘Name of Cosmetio hereby appl, for an issue /renewal of a licence to manufacture by way of Lomdes : () edge cams gtoretgin UestOak Undded g8 Doae oD oys—1085.12.02 1A ‘Pant Veo, ()-GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA.1986.12.02 ‘Details of the fem required to be registered are given in the enclosed from, Bignature Address : Date : Designation of Applicant tonne Form D Regulation 26 Somxputz IV ‘Lroexoz To MaxuracrcnE 4 Qossirrr0 ‘Liconeo Number : Bie. situated at is/are horeby licenced to manufacturo the cosmetic specified below at the premises This tioenco is subject to the conditions proseribed in regulation 25 of tho Cosmetics Regulations mad» undor the Cosmetics, Devices and Drugs Aot No. 27 of 1980 asamended by Aut No. 38 of 1984 and.shall bo in foros for ono year from the date of issue unless it is earlier suspended or cancelled. 7 ‘Name of cosmetio to which this licence is applicable. COSMETICS, DEVICES AND DRUGS ACT, No. 27 OF 1980 REGULATIONS made by the Minister of Health, under section 38 of the Cosmetics, Dovieos and Drugs Act, ‘No, 27 of 1080, as amended by Act No. 88 of 1984 and approved by Parliament, Dr. Ransrrw Avaparru, Colombo, 14.11.1985. ‘Minister of Health. ‘Regulations : 1, ‘Theso regulations may be cited as the Devices Regulations, No. 38 of 1084 and shall como into operation on (horoinafter referred to as “' the dato of operation ”) 01.01.1986, 2. For the purposes of theso rogulations every dovica registered undor tho Cosmetics, Dovices and Drags Act, No. 27 of 1980 as amended by Act No. 38 of 1984 (hereinafter referred to as “thé Act") shall be called “a registered device Part I ‘Reowreanio oy Deviczs _ 3. On or after the expiry of a period of threo months from the date of operation, the Cosmetios, Devices and Drugs Authority, (hereinafter referred to as “the Authority") shall prepare a rogister of every registered dovico and shall entor or causa to be entered therein the following particulare relating to such registered device : (2) the name of the device’; @) the namo of the manufacturer’ (©) the country of manufacture 5 (@) the registration number assignod to it; 2A — Temda: @) exge—§ cm gurasige u8rd0r? dndded (8 Boas ord &y.s—1985.12.02 Pant Lito, ()-GAZETIB EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLICOF SRX LANKA-1985.12.02 (¢) tho namo and address of tho holdor of tho certificate of registration and whether he is an importer or manufacturer ; and {f) the number of the licence issued to him, 4. (1) Every parson desi behalf to the Authority, (2) A coparate application shall be made in respect of cach device intended to be registered. (8) Evory applicant for registration of a device shall along with his application furnish to tho Authority al such information as may be roquired and specified in Form A of Schedule T hereto for the purpose of enabling the Authority to dispose of such application. (4) Every application msde by an importer for a Certificate of Registration of in Form B of Schedulo T hereto. (6) Every application made by a manufacturer for a Cortifieato of Registration of a devico sball be substan. tially in Form € of Schedule I hereto. (6) The foo payablo in respoct of a Certificate of Registration of a device shall be as specified in Schodule TE hereto, jus of registering a devico with the Authority shall make an application in thas “c:c0 shall bo substantially 5. (1) On receipt of an application for a Certificate of Registration of a devico the Authority shall forward such application to the Sub-Committee on Derices of the Cosmetics devices and Drugs Technical Advisory Committes for advice and report. (2) Having considered tho report of the Sub-Committee on Devices, if tho Authority fe catisfied that if Cortificate of Registration is granted the conditions of euch certificate of registration will be observed, tho Authority shall, on payment of the epecified foo, register or cause to bo rogistered such device and issue a Certificate of Regis- tration in Form A of Schedule ILT hereto in respect of that device, 6. (1) Tho Cortificato of Resistration of a dovice shall, unless it is easlior susporded or cancolled, bo valid for a poriod of five years from the date of issuo of such certificate. (2) Whoto an application for a ronowal of a Cortifieate of Registration is made six months bofore the date of oxpiry of the poriod of validity of the current Certificate of Rogirtretion, such Certificate of Registration chall, be doomed to continue jn force until an order is made in respect of the application for its renewal, (3) Every application for renewal of a registration of a dovico shall be substantially in Form B of Schedule ‘Ul hereto. 7, Tha bolder of a Cortificate of Registration of a device shall forthwith inform or notify the Authority of {a) any material changes that have boon made or that are proposed to be made in the particular® contained in or furnished in connection with his application, in relation to any device to which tho certificate of revistration relate (©) any information rocoived by him that casts doubt on the continued validity of the.data which ‘was submitted with, or in connection with tho application for the registration of the device, for the purpose of assessing the safety, quality. or «fticacy of the device 5 (@) any decision to withdraw the devico from the register and shall stato the roasons for. such decision ; and (@) ony docision to torminato his activitios-aé-an importer or manufacturer of the said devioe. 8. (1) Ifthe holder of a Certificate of Hégistiation’of & device fails to comply with any of the conditions of registration of sich’ dovico, tho-Authority’‘may, aftor-giving such holder of the Certificate of Registration of such dovieo an opportunity to chow cause. why such an order should not be made, romovo the namo of. the deviée from -tho register of devicos,-by-an order in writiig:and-stato tho roaséns.therofon. (2) Any person aggrieved by the order for such removal of the name of th device from the.rogistor of devices, may, within threo months from tho dato of such order, appoal to the. Authority. against, such order. 2) The Authority ehall, on the advico of tho Sub-Committee on Devices remove the namg of a device from the ropistar of dovices and inform tho holder of ths Certificate of Registration of the dovioe of the reasons theiefx- Toms: () oi¢s- § cum guiantgin woont Sndved 4S Denv O10 B94-1985.12.02 13 A Pawr 1iSro. ()-GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA.1086.12.02 Pant IL Licenstxo or Iuporrens oF Dzvices 9. On or after the expiry of a period of three months from the date of operation, no person shall import « registered. device excopt under the authority of a licence issued under regulation II. Every person to whom a Licence is issued under regulation IE shall hereinafter bo roforred to as a“ licensed importer of devices.” 10. (1) Evary porson desirous of obtaining a licence to import any rogistered dovico shall make a separate application to the Authority in respect of each suck device which he intends to import. Every such application shall be substantially in Form A of of Schedvlo IV hereto. (2) Every applicant for a licence to import any registered dovico shall furnish to the Authority all such information as may be required for the purpose of enabling the Authority to dispoze of such application. 11, (1) On receipt of an application for a lieonco to import a registered dovieo under rogulation 30, tho Authority chall, on being eatisfied that tho conditions of the licence will be satistiod if the licence is iseued, issue such liconce to tho applicant, (2) Every licence issued by the Authorit IV hereto. 3) The feo payable in respect of « licence to import @ registered dovico shall bo as specified in Schodulo Whereto, ‘under this regulation shall be substantially in Form B of Schedule Coxprrions or Licnos 10 Invonr Devices 12, Every licence iseued under regulation 11 to import a device shall contain the following conditions : (a) the licensed importer of devices shall allow any officer authorisod in that behalf by tho Authority, to enter with or without notice any. premises whore tho im orted device is stored for the purpose of inspecting and if nocessary taking samples for test, examiontion, analysis or clinica tr (6) the licensed importer of dovices shell furnish to the Authority euch samples as the Authority may consider adequate from every batch of each dovice imported under a licence, for test, examination, analysis or clinical trial (6) the licensed importer of devices shall on being informed by the Authority that any part of any batch of the device imported has been found by the Authority not to be in conformity with the standard specified by the Authority, withdraw the batch from sale ; (@) the licensed importer of devicce shall maintain a record of all particulars of import, sale and supply of such device by him and such record shall be open for inspection by any officer authorised in ‘that behalf by the Authority. 1 13.” (1) The licence to import a device shall unless it is earlier suspended or cancelled be valid fora period of one year from the date of iesuo of suck licence, (2) Where the application for renewal of such lioereo is made throo months before tHe expity of the period of validity of the current Jicence, such licotce shall be deamed to continue in force untit un order is made in respect of such opplication. 14, (1) Ifthe Jicorsed importer of doviece fails to comply with any of tho conditions ofa licence to import doviree tho Autherity may, after giving such liconsed importer of devices an opportunity to show cause Why such an order should not be made, by an order in writingetating the reasons therefor, euepend such licence for ‘such period ae the Authority thinks fit, or cancel it, either in reepeet of all or some of the deviees to which it relates, (2) Any porson who is aggrieved by the order made under paragraph (1) euepending or cancelling hie icence may, within threo monthe from the dato of such order, make an appeal to the Authority, 15 No person shalt import except for the purpose of test, examination, analyrie or clinical trial, any device under the samo name or under any othet namic if the manufacture, eale of distribution of such dovice is prohibited in the country of manufacture. UA —_ Tamme: (1) oxtta—§ comms gurmat gan oeiddik endued 4B Deas od eye 1985.12,02 Pant ESro, (1)-GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA.1985.12.09 10. Every licensed importer of devices shall exhibit tho licence iesued to him under regalation 11 in a cong. Picuous place in the premises at which he eelle, stores or ditributes tho devices imported under that licence, 17, ‘The Authority shall keep a register of all Hceneed importers of devices and chall enter ot cause to he entered tncrein the following particulars relating to each such licensed importer of devices : (@) tho name of euch licensed importer of devices ; (®) the address of the premises in respect of which tho licence has been issued ; (©) the dato of issue of the licenco 5 and (@ the number and date of the certifieato of regiatraticn, if any, iseusd to him under the Busi ‘Names Ordinance (Chapter 149). ‘Tho name of the licensed impotter of dovicos sball be published in tho Gazette, 18. (1) Evory licensed importer of devicee shall forthwith inform the Authority in writing of any cireumstances or event which may occur which affects the accuracy of any particulars stated by such licensod importer of devices in the application for a licence to import dovioes and shall at tho samo timo forward his licence to the Authority. (2) Upon the receipt of any information furnished by a licensed importer of devices under paragraph (1), ‘tho Authority may make or cause to be made such appropriate alterations in the register and in the licence of that, importer as may bo necessary and shall return the Licence to tho licensed importer of devices, 19, Tho Authority may revoke any licence to import a device issued under regulation 11 if tho Authority i satisfod that tho licensed importor of devices has acted. in contravention of any rogulation contained in this Vart or any other regulatior made under the Act pertaining to importation and distribution of devices, Inport oF Devices vor Test, Exaumvatioy, Disteinorios as Samptes, AwaLysts on Cuistoat, TRIAL 20. Every applicant for a liconco to import dovices for test, examination, distribution as samplos, analysis of clinical trial shall comply with tho following conditions : (@) ho shall mako a separate application to tho Authority in respect of each such dovice as he intonds to import. 5 (6) Evory sucb application shall bo substantially in Form © of Schedule IV hereto. 21. (1) On receipt of an application for a licence to import any device for test, examination, distribution fas samples, a or clinical trial, the Authority shail, on being satisfied tha the conditions of the licence will ‘bo obeerved if such licence is issued, igsue such licenco to the applicant 5 (2) Every linnco issued by tho Authority under this regulation shall be in form D of; Schedule IV hereto (3) The licence feo shall be as specified in Schedule II hereto, . Inport or Dzvices ror Punsonat Use 22 (1) Any device imported for personal use by sny person shall be inéended for the exclusive personal uso of that person, (2) Any device imported for personal uso, may be allowed to be imported subject to the following conditions : (2) that the Authority is eatisfied on on application made to euch Authority by avy person in Form E of Schednle IV hereto that the device is for bona fide personal tse (©) that a licence has been issued in respect of the said device in Form F of Schedule IV hereto. Parr TT Lscenoz 10 Manursorune Drvices 23, On or after the expiry of a period of three months from the dato of operation no person shall manufac ture any dovice except under tho authority of s licencs issued under regulation 27, Every person to whom 4 Liconce is isqued under regulation 27 ehall hereineftor bo roforrod to as a “ liconsed manufacturer of devices ". Tomo: () edca—§ C20) surat Ga woudl sadted 9 Boa¥ med woe 19851202 15 A vant ESxo, (1)-GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA-1986.12.02 24, No devico other than a rogistored devico referred to in regulation 2 ehal! be manufactured in Sri Lanka, 25, Every person desirous of obtaining a licence to manufacture any registered device shall make a separate ‘application to the Authority in respect of each dovice he intends to manufacture. Every such application shall be in Form G of Schedule IV hereto. 26, Every applicant for a licence to manufacture a registered dovico shall furnish to the Authority all such Informastion as may be required for the purpots of enabling the Authority to dispose of such application, 27. (1) The Authority shall, upon receipt of an application for a licence to manufacture any registered device cause the premises whore such manufecture is to be carried out to be inspectod and on being satisfied that such premises are suitable for the manufacture of devices and that all the conditions for iseuing a licence for tho manufacture of devices havo been complied with, issue a licence to the applicant, (2) ‘The foe payable in reapoct of such licence shall be as epecified in Schedule IT hereto, Conprriows oy a Licencz to Manuracrone Dayzoxs 28. Every applicant for a licence to manufacturo a device shall comply with the following conditions (a) tho licensed manufacturer of devices shall provide and maintain such staff, promises and plant as are considored by the Authority, to be necessary for the manufacture of devices undertaken hy him and fo shall not carry out any such manufacture except at the premises specified in his cence ; (®) the licensed manufacturer of dovices shell provide and maintain such staff,premisce, equipment and facilities for the handling and storage of the raw materials and devices as are considered necessary to avoid deterioration and he shall not use for such purposes premises other than those specified in the licence or premises which may be approved from time to time by tho Authority ; {(c) tho licensed manufacturer of devices shall carry out all manufacture of dovices in such e way as 19 ensure that the dovices conform to the standards applicable to them as specified by the Anchority ; (3) tho licensed manufacturer of devices shall provide euch information as may bo required by the Authority in rospoct of the devices currently being manufactured and of the operations being cerried out in relation to suchmanufacture ; (©) the licensed manufacturer of devices wiiall inform the Authority before making any material altora- tions in the premises, plant or machinery used under his licence, or in the operations for which they aro used, and he shall inform the Authority of any change he proposes to make in any personnel named in the licence as— (i) responsible for supervising the production operations or ; (ii) responsible for quality control of the products manufactured ; ) the liconsod manufacturer of devices shall keep readily availabloifor inspection by the Authority or by any porson authorized by the Authority, the records of details of manufacture of each batch of every device which is boing manufactured under the authority of such licence, and tho testa carricd out in respect thereof, in such form that the records will be easily identifiable from the number of the batch ax shown on cach container in which the device is sold, supptied or exported. ‘Tho liconsed manufacturer of devices shall allow the person authorised to take copies oF make extracts from such records. Such records shall not be destroyed for a period of five years from tho dato of manufacture of the relevant batch without the consent of the Authority ; (9) thi licensod manufacturer of devices shall keep such documents which will facilitate the withdrawal ‘or recall from ale, supply or exportation of any device to which the licence rolates ; (J) the ticensed manufacturer of devices shall allow the Authority or any officer authorised by tho Authority to enter with or without notice, any prentises where the manufacture of any device under the licenco is carried out or any premises where the raw material and other substances ‘ugod in ite manufacture are stored or whore the manufactured device is stored, sold or supplied for the purpose of inapooting and if necessary taking samples for test, examination, analysis or linical trial 5 IGA Tomes: () oa crm gtioret gn werdOr? tnddad 9 Boas 0130 oys— 1985.12.02 Pane Ise. 1)-GAZETTE EXTRAORDINARY OF THE DEMOORATIC SOCIALIST REPUBLIC OF SRI LANKA-1986.12.02 {t) whore the licensed manufacturer of devicos has been informed by the Authority that any batch of of any device in respoct of which the licenco is issued has been found not to be in conformity with the specifications as regards the quality of the relevant device, or with the provisions of the Act or of any regulations made thereunder, that are applicable to devices, he shall, if so directed withhold such batch from sale, supply or exportation 60 far as may be reasonably practicable for such period as may be specified by the Authority ; (4) tho licensed mennfacturer of devices, shall comply with such further requirements if any, applicable to liconsod manufacturers of dovices as may bo speciffed in any regulations made under the Act. 29. Every licence isaned by the Authority undor regulation 27 shall be in Form Hof Schedule IV heroto and Le valid only for the premises in respect of which it is issued. 30. Tho feo payablo in respoct of a licence issued under regulation 27 shall bo as epecified in Schedule 11 hereto, B1.(1) The licence to manufacture a rogistered devico shall, unless it is earlier suspended or cancelled, bo valid for @ period of one year from the date of issue of such liconce. (2) Where the application for a renewal of such licence is made throe months before the oxpiry of the period of validity of tho current liconce sucht tienes shall be deemed to continue in force until an order is made in respect of tho application for enowal. (2) Any application for renewal of such licence shall be substantially in Form G of Schodule TV horeto, 32, (1) If the licensed mannfacturor of devices fails to comply with any of tho conditions of a licence to manufacture # registered device, the Authority may, after giving such licensed manufacturer an opportunity to show cause why such an order should not be mado, by an order in writing stating the reasons therefor, suspend tho liconee for such period as he thinks fit or eancol it, either in respect of all or some of tho devices to which it relates, (2) Any porson who is aggrieved by the order made undor paragraph (1) suspending or eancelling hi licenge may, within threo months of the date of such order make an appeal to the Authority, against such order. 33, Every licensed manufacturer of devices shall exhi conspicuous place in the premises at whi 34, The Authority shall keep a register of all licensed manufacturers and shall enter or cause to be entered therein the following particulars relating to each such licensed manufactur (a) the name of such licensed manufacture! it the licence issued to him under regulation 27, in a bo manufactures the device, (2) tho address of the premisos at which be is authorised to manufacture the devices in respect of which the liconse has been isstod ; () the number of the licene (@) the dato of issue of the licence ; and (e) the number and the date of the Certifioato of Registration, if any, issued to him under the Businoss ‘Namos Ordinaneo (Chapter 149), . 85. (1) Every licensed manufacturer of devico shall forthwith inform tho Authority in writing of any circumstances or event which affect the accuracy of any particulars stated by such licensed manufacturer in the anntication for a licence to manufacture devises and shall, together with euch information, furnish to the Authority. ius licenco. ; (2) Upon the receipt of any information furnished by « licensed manufacturer of dovices under paragraph (1), the Authority may make or cause to be made stich appropriate alterations in the register and in the licence of that matanfacturor as may be necessary and shall return the licence to the licensed manufacturer, 36, The Authority may rovoke any liceneo issued under regulation 27 to manufacture devices, if ho is satisfied that the licensed mannfacturor of devices has acted in contravention of any regulations contained in this Part or any other regulation made andor the Act pertaining to the manufacture of devices. Lom: : () odgs— § Cwm ytinnt Ga HOW? doddod GG Beas 40 oS 1995.12.02 ITA Pane J 8x0. (}-GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA.1086.12.02 Panr IV Coxpimioxs oF Satu or Devioxs (Reratt axp Wxorzss.z} 37, Onor after the date of expiry of @ period of three montis from the date of operation no person shall sit any device other than a device reyistored with the Authority, 38, Every porson who is engaged in solling any rogistered device (by retail or wholesale) hereinafter referred to a8 tho doslor ” shall comply with the following conditions :— (a) the dealor shall allow any cfficer Authorised by tho Authority in thet bohalf to enter with or without notice, any premises where retail or wholesale trade of dovices is boing carried out, for the purposes of inspecting and if necessary taking samples of tho dovice for test, examination, ‘analysis or clinical trial ; (0) tho doalor shall, on request and on payment of the relevant feo furnish to the Authority from any batch of each dovice, such samples as the Authority may consi.er necessary for any test, oxomination, analysis or clinical t (6) if the Authority so directs, the doalor shall not sell or offer for salo any batch of each device in respect of which eamples aro furnished under paragraph (6) until a cortificato authorising the sale of that batch of the dovice, has been issued to him, by or on behalf of the Authority ; {a) the dealer shall, on being informed by the Authority that any part of any batch of a device has beon found by the Authority not to be in conformity with the standard specified in regard to the quality of the device and on being directed to do #0, withdraw the remoinder of that batch from sale, and, so far as is practicable in the particular circumstances of the case, recall the issues already mado from that batch. Pant V Destavertow 80, Any dovice which fails to conform to the standards roquired or the storage lifo of which has expired, shall be destroyed. ‘Tho destruction shell be carried out under tho supervision of an officer authorized by the Authority. Pant VI ‘Lapenuine of evory device imported, manufactured, processed or packed locally or sold or exposed for sale shall have labels bearing the following information clearly indicating :—~ (a) tho brand namo 5 {b) any special storage conditions that may be necessary 5 (¢) any warning and precautions that may be necessary ; (@) the date of manufacture ; (©) the date of expiry whore applicable ; (f) the batch or lot number assigned by tho manufacturer 5 (0) tho name and address of the manufacturer ; and (#) adequate directions for use of the device. 18 A Terme: (1) evga § crear gusmintgin HOrt:8 emddiod gS Bons O50 SyG~ 1985.12.02 Pant 1.Sse. (I- GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA-1085.12.02 Pan VIL ApvERTisIna oF Daviors. 41. On or after the date of expiry of a period of three months from the date of operation no porson shall advertise any deviee in contravention of tho provisions of the Act or regulations made thereunder. 42, No porson shall advertise any device which is not rogistered with the Authority. 43, No person shall import into Sri Lanka (a) advertising material of any dovico which is not rogistorea with the Authority j @) advertising material of any device registered in Sri Lanko, in contravention of the provisions of the ‘Act or regulations made thoreunder. 44, No person shall sond any advertising material about any devico to tho modical, dental, pharmaceutical of allied professions, which is faleo, misloading or inconsistent with the particulars contained in the application ctiginally submitted with the application for the rogistration of the devieo or particulars submitted eubsequently. 45. No porson shall make any falso or oxaggerated claim for any dovice or misuse research results or =, ‘quotations from scientific literature to support euch claim, 46, Tho Authority may, after giving the advertiser an opportunity of being heard, prohibit the publication of any advertisemont which is in contravention of the provisions of the Act or regulations made thereunder. Form : A Regulation 4 (8) Scumpute I Inronarions Ruquiney Yon Rrowsreation or 4 Davie 1, Namo of Applicant : 2. Address 3. Status of applicant Official or approved namo :. 5. Accortificate from the health authorities of the country in which itis produced, confirming that the device ja in use thero and the potiod of use and if not, reasons for uot marketing it in the country of manufacture. jt of countries in which the devico is approved or registered for sale. ‘7, Fully packed samples of tho device in the form that will be offered for salo should also be sont fo enable atudy of the product (if requested). 8. A sample of the lable (a) used on tho containers should be supplied. ). All data should be submitted in English, in a'hard filo cover, in duplicate. Applications made without these requirements will not be accepled, Temds: (0) esta § cans gtirmutgn nasil ended 4S Boas O20 ODa- 1985.12.02 19 A ‘Pant 1x0, (I)-GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA.1986.12.02 Form :B Regulation 4 (4) Sousputn I Aprrication Fors ror Cenriricare ov Rrorsrrarion or a Deion By AN Tatrourzn (To be Filled In Triplicate by Applicant) We snags of . oT hereby apply for registration of the dovico namely, details of which are enclosed herewith. Signature Addres Designation of Applicant Da ‘For Official use only Application No ee Dated Decision : Registered Not registered Dated : Rogietration No : ES Dated: ear Fees Paid Receipt No Da Signatur (Authority) Form : 0 Regulation 4 (6) Souzpurx I Arrucariox Fort For Centirtoats or Rucistaarioy or A Davicx by a Manuractonen (To be Filled In Triplicate by Applicant) - Of on «hereby apply for registration of the device and formulation for local manufacture nomely = sims va dtaile Of which aro enolosed herewith, Signature : ‘Address: Dato eo ‘Designation of Applicant = For Oficial use only Decision : Registered Not regiatored Registration No eos paid Date 20 A Lewd: (l) ouge—9 Crem girarat gen HOnlOsk Umdued 48 Dade O18 &E— 1985.12.02 Pant I: Sto, ({)-GAZBTTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SII LANKA-1986.19,09 Rogulation 4(6) 10 (8), 11(3), 21(8), 27(2), 30 Scnsputn IT FEES 1. Carlificate of Registration — Who feo for tho Certificato of Registration shall be as follows : (@) rupees five hundred for rogistration of a dovieo; (©) rupees tivo hundred and fifty for the renowal of registration of a devioo : Provided that the application for tho ronowal of registration is mado six months before the oxpiry of the _yilidity of tho Cortificato cf Registration, (©) 9 foo of rupoos fifty shall bo paid for a duplicate copy of tho Certificate of Registration if the origins! is damaged or lost and such copy of tho cortificato shall bear the words “Duplicate Oo; y”. 2. Licence to Import a Device 'Tho feo for a licence to import a registered dovice is Rs. 1,000. Licence to Manufacture a Decice.— Tho foo for a liconce to manufacture a dovieo is Rs, 1,000. Form A Rogulation 5 (2) Sonzpute III Cenrmercare oF Reotstrarion ‘he follewing dovice is hereby registered undor tho Cosmetics, Dovioes and Drugs Act, No.27 of 1980, :— Name of devico ‘Typo of dovic ‘Namo of manufacturer Country of manufacture Dato of Registration : ‘Typo of Registration :.. sue Perior Provisional Registration Schedule Full registration shall be valid for a period of 5 years unloss earlier ausponded or cancelled. Provisional registration shall be valid for the poriod stipulated. Dato of isgue ———. ‘Authority. Teer00 ! () osqa—§ Cam guimel gn oOrtOst danddod 68 Boaw O00 wye—1085.12.02 21 A Pant LSe0, (]—GAZETTE EXTRAORDINARY OFTHE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA-1089 12.02 Form B ‘Regulation 6(8) Sonepurs Iit Avriigation Fon ron Resewat or Rrorstration or a Davie Me... hereby apply for ronowal of rogistration of the device for import/local mantfaatare. Rogiatration No. « Expiry date of last Rogistratio: Signature Address Designation of Applicant. = Form A Regulation 10(1) Scuxpune IV Avriigamiox zor Licxsce ro Inport 4 Reorersxzp Drvicz|s- I/We, heroby apply fer tho import cf a device js rogistared by the Authority. ‘Signaturo Address :. Designation of applicant: Form B Regulation 11(2) Sonspuuz IV Licexcs ro Import 4 Reoisrssxp Daviox/s is/are hereby licensed to import into Sri Lanka during the period for which this Voence is in foree the devive/s specified below, manufactured by ‘This Liconce is subject to the conditions pressribed in regulation 12.of the Devices Regulations made under the Cosmetics, Devioos and Drugs Act, No.27 of 1980, as amended ‘by Act No. 38 of 1984 and shall bein force for ‘one year fkém the date of ssto unlossit ig eatller eiiapended or. énticélled. ‘Name of devive/s to which this Jiconce applies. — L 2 3. 2A — Tormdes: () ott § errs gthmslgn UOUO.k Undded GS Soav 0150 99a—1085.12.02 ‘Panr 1Se0. (I)-GAZBTTE EXTRAORDINARY OF THE DEMOCRATIO SOCIALIST REPUBLIO OF SRY LANKA-1085.12,02 Form ‘Regulation 20(6) Sonxpots IV Arrtio/ tion FoR Intron? oF A Deviox/s rou Test, Exammation, Distarsuriox 43 SaurLxs, Avatysis om CLINIoaL TataL WM Gprnensrnie OF herby apply for a licence to import from M/s. epecified below for the purpose of test Name of devico/s.— 1 OF winner’ the dovicn/s jexumination, distribution us samples, analysis or clinical trial . rf 2. 3 Signature Address ‘Designation of applicant : orm D ‘Regulation 21 (2) Sonepmz IV LioeNcn 10 Inronr A Devior/s yon Txsr, Exawmvaxtox, Disrarpomion 4s SaurLzs, ANALYSTS on Cunmoan Ria, Liconce Number : My. /aro hereby licensed to import from purpose of test, examination, distribution as samples, analyeis or oli . the doviee/s specified below for tho ical trial, ‘This cence is subject to the conditidns prescribed in regulation 20 of the Devices Regulations made under tho Cosmetics, Dovicos and Drugs Act, No.27 of 1980 as amended hy Act No. 38 of 1984. ‘Tho liconce shall bo valid for importation of ono batoh only and shall be valid for one yoar from tho date of issue. ‘Namo/s of devioo/s with quantities which may be imported :— % 3. 1 Dato of iseuo / Authority. Form E ‘Regulation 22 (2) (a) Soxspoum TV AvpLicatioy ror Licexox 70 Intron 4 Device/s rom Punsoxat Use I, .. ———— of . « hereby apply for a licence to import the devico/e specified below solely for my personal use. Tattach a prescription from a registered medioal practitioner in regard to the nood for the said devive. ‘Name of devico/s and quantity : Signature Address : Lome: ota—§ Cums gurat Gn BOO’ cmdded gH Seav 0150 69e—1985.12.02 23 A Pans I: Seo, (I)-GAZETTE BXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OP SRI LANKA-1085.12.02 Form F Bogulation 22 (2) (&) Souzpuue IV Liozxox ro Iurour Drvioz/s rox Pensoxat, Use Liconoe Number :... M/s. of Iimgort tho following devico/e in the quantities specified. in hereby licensed to Devicels Quantity ‘This licence js subject to the conditions presoribed in paragraph (2) of regulation 22 of the Devices Regulations made under the Cosmetics, Devices and Drugs Act, No. 27 of 1980, us amended by Act No. 38 of 1984. Date of Issuo :... Authority. Form: Regulation 25 Souzpure 1V AvpLioarton yon Issux/Renzwan ov 4 Lromsce 10 Manvractons Davicx/s by WAY OF Bast Maxoracrons/Smn-Basto Maxuractont/FoRMULATION/REPAGKING I/We, an jseuofronowal ofa license to manufacture by Way of « of hereby apply for “on premises eituated at .. ‘Namo of device/s : Details of the firm requiring to be registered oro given in the enclosed form. Date Form H Someputy IV Licexos To Maxuraorons Dzviox/s Licence Number is/are hereby licensed to manufacture the device/s specified below at tho This licence is subject to the conditions prescribed in regulation 28 of the Devices Regulations, mado under the Cosmetics, Dovices and Druge Act, No, 27 of 1080, as amended by Act No, 38 of 1984 and shall be in forco for one year from the date of issue unless it is earlier suspended or cancelled. ‘Name/e of dovioo/s to which this licence is applicable — L Authority. Date of iseuo = 32522 BMA Tema: () ovga—y com gurarstfin Huds Senddiod 8 Deas oO Hy4—1985.12.02 Panz [:6r0. (I)-GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SR1 LANKA.1085.19.02 COSMETICS, DEVICES AND DRUGS ACT, No. 27 OF 1980 REGULATIONS made by the Minister of Hoalth, under seotion 38 of the Cosmetics, Devices and Drugs Act, No. 27 of 1980 as amended by Act, No. 38 of 1984 and approved by Parliament. Dr. Rangrra Avararray, Colombo, 14.11.1985. Minister of Health, Reovtanions 1. ‘Theso regulations may be eited as the Drags Regulations, No. 38 of 1984 and shall come into operation on 01.01.1986, (hereinafter. referred to as “tho dato of operation”). 2, For the purposes of these regulations every drug registered under tho Cosmetics, Doviees and Drugs Act, No. 27 of 1980 as amended by Act, No. 38 of 1984. (hereinafter roforred to aa ‘‘tho Act”) shall be called “a regis. tered drug.” 3. (1) Nolicence is required under theso regulations, tosell any registered drug, specified in Schedule Thereto* ‘ond such durg shall be gold only in the original unopened containers or packs of the manufacturer and shall not contain any substance specified in Group B of Schedule IT horeto and Schedule ITT hereto. (2) No person shall, unless ho'is a holdet of a liconce issued in that behalf, sell without a preseviption, any registered drug specified in Group A of Schedule II hereto, (8) No porson shall, unless he ir a holder of a licence iseued in that bohalf, sell withont a prescription, any registered drug that may be specified from time to timo in Group B of Schedule 1 hereto. (4) No porson shall, unless ho is a hodor of a licence issued in that behalf, éell without » proscription, any registered drug spocified in Schedule III heroto. Pane T Rearsraariox or Daves 4. On or after the dato of expiry of a period of three months from tho dato of operation, the Coemetias, Devices and Drags Authority (hereinafter referred to as “the Authority”) shall prepare a rogister of overy rogistored ddrug and shall entor oF causo to be entered therein the following particulars relating to such registored drug : (a) the approved offical name and brand name of the drug ; (6) the namo of the manufacturer ; (0) the country of manufacture 5 (@) tho registration number aseigned to it; (0) the name and address of the holder of the Certificate of Registration 5 (J) whether he is an importer or manufacturer ; and (9) the number of the licence issued to him. 5. (1) Every person desirous of fegiatering a drug with the Aithority shall make an application in that behalf to the Authority. (2) A seperate application shall be made:in-respeot of each drug intended to bo registered. (3) Bvory applicant for registration of any drug shall furnish along with his application to the Authority all such iriformation as may.be tequired asspecfied in Form A of Schedule TV hereto, for the purpose of «enabling the Anthotity to.dispcse of guch spplieation:: (A) Every application miadé by an imipartar' for a Certificate of Registration of a diug shall be substantially in Form B of Schedule IV hereto. (5) Every application made by a manufscturer for-a Certificate of Registration of a drug shall be substant- ially in Form C af Schedulo TV hereto, (8) The feo payablo in respect of a Certificate of Registration shall be as specified in Schcdulo-XT hereto. 8." (1) Onrecetpt of an application for a Certificate of Registration of a drag the Authority shall forward ‘such application to the Bub-Commitéee on Drugs of the Cosmetics devices and Drugs Technical Advisory Comn.itteo foradviea and report, Lomds: 1) odge— 9 orm yorarga woud’ dndted 4G Doo o2d oys—1085,12,09 AS A Pant I: Sto. (1)—GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRILANKA-1985.12.02 (2) Having considered the report of the Sub-Committeo on Druge, if the Authority is satisfied that if a Corti- floato of Registration is granted the conditions of such Cortificate of Rogiatration will bo observed, the Authority shall, on payment of the spovified fee, rogister or causo to be registored tuch drug ana issue a certificate of regis« tration substantially in Form D of Schedule IV hereto, in respeot of such drug. (8) Every drug registered under paragraph (2) shall be assigned a number. (4) Tho feo payable in respect of a Certificate of Registration of a drug chall beasspocified in Schedule XI hereto, (6) Where the Authority is not satisfied with the eilicaoy, safety or quality of a drug in respeot of which on application for a Certificate of Registration is made, the Authority may reject sucb applicatior and inform tho appli- ‘cant in writing of tho reasons for such rejection. (6) Tho rejection of any application for a Certificate of Registration of @ drag shail not debar an applicant from submitting a fresh application if new data is vailable which moots the requirements for registration. 7. (1) Tho Certiffeste of Registration of a drug shall, unleae it is eatlior suspended or eancelled, be valid for a period of five years from the date of issue of euch certificato. (2) Where an application for a renewal of such Certificate of Registration is mado six months before the date of expiry of the period of validity of the ourrent Certificate of Registration, such certificate of registration shall, be deomod to continue fn foreo until an order ig mado in respoct of the applisation for its renewal. (8) Bvery application for renewal of registration of drug sball be substantially in Form E of Schedule TV hereto, 8. The holder of a Certificate of Registration of a drug shall forthwith inform or notify the Authority -— (@) of any matorial changes that have been made or that ae proposed to be made in the following parti- culars contained in or furnished in connection with his application, in relation to any drug to which the Certificate of Registration relates :— (i) tho specification of the drug ; (it) tho specification of any of the constituents of tho drug ; (ii) the composition of the drug or any of the constitutente of the drug; (iv) tho mothods of manufacture of the drug ; (v) the methods and procedures described in the application for ensuring compliance with such specifications ; and (vi) tho exrangements described in the application for storage of the drug. \ (®) of any information received by him that casts doubt on the continued validity of the data which was submitted with, or in connection with the application for the registration of tho drug, for the purposo of assessing the safety, quality or efficacy of the drug 5 : (0) of any deoision to withdraw the drug om the register and shall stato the reason for such decision ; and (@) of any decision to terminato his activities as ap importer or manufacturer of the said drug. 9. (I) If the holder of the Certificate of Registration of a drug fails to comply with any of the conditions of registration of such drug, the Authority may, after giving such holder of the Certificate of Rogistration of such drog an opportunity to show cause why such an order should not be mda, remove the name of the drug from the register of drugs by an order in writing and state tho reasons therefor. (2) Any person aggrioved by tho order for such removal of the nano of the drug from the register of drugs may, within threo months from the date of euch order, appeal to the Authority against sueb order. 10,: The Authority shall, on the advice of the Sub-Committee on Drugs remove the name of a drug from the register of durgs and inform the holder of the Certificate of Registration of such drug of the reson therefor, A 10--A 081616 286A Lame: (D acige—@ cum guamaifin W080i Unddied gS Dene and oys-—1083.12.02 ‘Pant :6r0,(I) GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIO OF SRI LANKA-1986.12.02 Pant IL ‘Laoexsnxa oF Inponrers or Davos 11, On or after tho date of expiry of a poriod of throo months trom the date of operation no person siall iraport any rogistored drug except under tho authoirty of a licence issued under regulation 14. Every person to whom a Hoonce is issued under rogulation 14 shall hereinafter be referred to as @ “‘Iiconsed importer of drugs”. 12, (1) Every person desirous of obtaining a licence to import any registered drug shall make a separate application to the Authority in respect of cach drug he intends to import. Every such application shall be substan- fially in Form A of Scheduly V hereto. (2) Every applicant for a Jiconoo to import any registered drug shall furnish to the Authority all such infor. mation as the Authority zmay roquire for the purposo of enabling the Authority to dispose of auch application. 13, Every applicant for 4 Licence to import a registered drug other than an applicant for a licence to import ‘a drug for test examination, distribution as samples, analysis or olinioal trial and an applicant for a drug for personal ‘uso shall be a registered pharmacist or any person authorised by him in that bebelf, acting under the supervision of a registered pharmacist, 14.(1) The Authority sball, upon reesipt of an application for a licence to import any registered drug, cause the premises where such drug is to be stored to be inspected, and on being satisfied that, such premises are suitable for the storags of drugs, and that: all the conditions for issuing a licence for the importation of drugs have heon com. plied with, issue a licence to the applicant. (2) Tho Authority may, at his disoretion refuse to issue a licence to.— (a) minor ; (8) & montally doticient person ; (©) a person addicted to narcotio drugs. 15. (1) Every licence issued hy the Authority, to import a drug under regulation 14 shall be in Form B of Schedule V hereto, and be valid only in respect of tho premises where such drugs are stored. (2) The foo payable in respect ofa licenco to import a drug shall be as specified in Schedule XI horeto. Coxprmions oF Licexcx ro Inrour Davas 16, Every licence issued under regulation 14 to import a drug shall contain the following conditions : (@) the licensed importer of drugs shall allow any officer authorizdd in that behalf by tho Authority, to onter with or without notice any promises where the imported drug is storod, for the purpose cl" inspecting and if necestary taking samples of such drug for test, examination or analysis 5 (6) tho liconsed importer of drugs shall furnish to the Authority suck samples os tho Authority may consider adequate, from every botch of a drug ianported under a licence, for test, exomination or anulysis, ‘Tho licontod itaporter of drugs shall, if so required, furnish full particulars of the quality control tests eartied out by the manufacturer of that. particular batch of divs ; (©) the licensed importer cf drugs sball provide and maintain such staff, premises, oquipinent and facilities for the handling, storago and distribution of any drug which he may import under bis licenco, as are necessary to avoid deterioration of such drug and shall not use for such purposes any ‘premises other than the premises specified in tho licence or promises which may be approved from ‘time to time by the Authority ; (@) tho licomsed importer of drugs shell, on boing informed by the Authority thot any part of any butch of the drug iniported has boon found by tho Authority to be not in conformity with tho standards specified by the Authority, withdraw the batch from sale ; (6) the liconsed importer of drugs shall maintain » rocord of all particulars of import, salo and supply of drugs by him and such record shall bo opon to the inspection of any officer authorized in that: behalf by the Authority. Lomsd8: ©) as¢o—g =m yoo tGe WOO condcod GS Dome asd UgC—1085.12.02 TA ' pant: Szc.(I)—GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA-1985.12.02 17, (1) Tho Ticenco to import » drug ehall, unless it is sooner suspended or cancolled, be valid for a period of ‘one year from the dato of issue of such liconce. (2) Where an application for renewal of such licence is mado three months befare tho expiry of the period of -volidity cf the current licence, such current licence shall bo deomed to continue in force untilen orders mado in respoct of the application for renewal. 18, (1) If the licensed importer of drugs fails to comply with any of the conditions of a licenco te imyort drugs, tho Authority may, after giving such licensed importer of drugs an eppcrtunity te show cause why such an. order should not be made, by an order in writirg stating the reasons therefer, suapend sch licence for such period as tho Authority thinks fit or caneol it, either in respect of all or some of the drugs to which it relates, (2) Any person who is aggrieved by the order mado under paragraph (1), suspending oF cancelling his licence ‘may, within throe months from the date of such order, make en appoal te the Authority against such order. 19, No person shal] import any biological or other spccial drug spocified in Group B of Schedule IT hereto, “after the dato shown on the label, wrapper cr container cf evch drug ns the dato until which tho drug may be oxpeeted {fe retain potency not less tham or to acquite toxicity grvator that: that whieb is permitted by the specified test. 20, Evory licensed imperter of drugs elu] exhibit tho licence isstod fo him under roguletion 14 together with the original of tho Cextifceto of Regietzation of the pharmaciet issued by the Ccylen Medical Council ine conspi- ctious place in the promisos et which be eolle, stores or cistributes tir imported druge, 21. ‘The Avtbority shal) keop o regicter of ell Ticonsed importers of drugs and sholl enter oF cate to be entered theroin tho following particulars relating to each Jiconsed importer of drugs -— (@) the namo of such licensed importor of drags ; (©) the address of tho promises in respect of which the Ticence has boon issued ; (6) tho date of insuo of tho licence iasted under regulation 14 ; and (d) the number and dato of the Certificato of Registraticn if issued (o him under tho Business Names Ordinance (Chop. 149). ‘The name of the licensed importer of drugs sboll be published in the Gazette. 22, (1) Bory liconsed importer of drugs sball forthwith inform the Authority in writing of any circumstances cer event which may ocour which affects tho accuracy of any particulars stated by atch licensed importar ef drags in the applicaticn fcr a licenca to imyert drugs and shall at the sotne tits forward his licence to the Authority. (2) Upen tho receipt cf any information furnished Ly e liconscé importer of drugs under paragraph (1), tho Authority may make or cause to bo mado such appropriate alterations in the register avd in the ficence of that importer as may be necessary and shall return the licence to such Heonsed importer of drugs. 23. Tho Authority may rovoke any licence issued under regulation 14 to import a drug if bo ie satisfied that tho liconsed importer of drugs his acted in contravention of any rogulation contained in this Patt or any ether regulation mado undor the Act yortaining to importation and distribution of druga. Twrorr oF Davos yor Txst, Exawywamiox, Disrarmurron 4s Samrixs, Awanysis ann Cumiear, Tataz. 24, (1) Every person desirous of obtaining o licence to import emall quantities of any drug fer tost, oxamai- nation, distribution as samples or clinical trial, chall make a soparato application to the Authority in respect of each rug ho intends to import. Every such application shall be substantially in Ferm C of Schedule V heroto. (©) No person shell import samples of any drug speoified in Schedule LIT hereto. (3) Every applicant for a licence to import any registered druig shall furnish to the Authority all sueh in- formation as the Authority may require for the purpose of enabling the Authority to dispose of such application. 25, (1) On receipt of an application for a licence to import any drug under regulation 24,the Authority shall, on being satisfied that the conditions of the licence will be observed if suoh licence is issued, issue such Licence to tho applicant, : (2) Everylicence insued under this regulation to import a drug, shall be substantially in Forza D of Schedule V hereto, and shall be valid for ono year from the date of issue. BA — Lomde: () esga—9 cum germatgin HOUR daddad GG Beas O80 S94~1985.12.02 Pane iSxe.(1)—GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA-1984.22.02 (8) The fee payable in respect of a licence to import a drug for test, examination, distribution as sample, analysis or clinical trial shall be as spocified in Sohedufe XI hereto. Conprrrons oF Licexox ro Imront Davos ron Test, EXAMINATION, DisTainuvion aS Sawpuxs, ANALYSIS on Cunmioat Tatar, 26, Every licence to import drugs issued under regulation 25 shall contain the following conditions :— (a) tho holder of such licence shall use the drugs for distribution as samples, imported under the licence ‘exclusively for the purposes of test, examination, anolysis or clinical triad and shall carry on such test, exaunination, distribution as samples, analysis or efinfeal trial in the premises syocified in the licence or in such other placo as the Authority may from time to time authorise (0) the holder of the licence shall allow any officer authorized by the Authority in that behalf to enter with or without notice, any premises where such drugs aro kept, for the purpose of inaposting the premises and investigating tho manner in which tho drugs aro used and if necessary, toking samples thereof ; (6) tho holder of the licence shall koep a record of, and shall report to the Authority on, the drugs imported under the licence, together with the quantities imported, the date of importation and the name of tho manufacturer 5 (a) tho holder of the licence shat! comply with any such further requirements if any, as aro applicable to such holders of licences to import a drug for test, examination distribution as samples, analysis or clinical trial, as may be specified in any regulation mado under the Act. 27, Onreceipt of an application for alicence toimport any drug under regulation 25, tho Authority shall, on boing satisfied that the conditins of the licence will be observed if such licenco is issued, jesue such licence a8 epecified in form D of Schedule V hereto. 28. (1) Aliconce issued under regulation 25 to import n dng, may be cancelled by the Authority for breach of any condition subject to which a licence was fesued, (2) The holder of o ficence, whose licence has been cancelled under paragraph (1) may appeal to the Authority against such order, Istonr of Darvas ror Parsoxat, Use 29. (1) Any drug imported for personal use by any person shall bo intended for the exclusive personal use of that person, (2) The quantity of any single drug so imported shall not exceed one hundred average doses 5 Provided that the Authority may, if he deems necessary in the circumstances, permit the import of « larger quantity ; Provided further that, any drug imported for personal use may bo'allowed to be imported subject to the following conditions -— {a) that the Authority is satistied on an application made to the Authority by atty person in Form E of Schedule V, that such diug is for personal use ; a (8) thot tho quantity to be Imported is reasonable in the opinion of the Anthority and is covered by 6 prescription from a medical practitioner or a dental surycon registered under the Medical Ordi- nance (Chapter 105) ; (€) that a Licence has beon insued by the Authority in Form F of Schedule V hereto, in respect of the said drug. Pan I Jaorxes 10 Maxvsacroun Davos 30. (2) Onor after the date of oxpiry of a period of thtee months from the date of operation, no person shall mannfacture any drug except under tho authority of a licence issued under regulation 32. Every petson to whom a licence ia granted under regulation 32 shall hereinafter be referred to as “a licensed manufacturer of drugs”. Temds : © dqe—§ orm gtinaiga cOnbl dnddod ¢4 Beau asd vge—1085.12.02 29 A Pant I:850.(1)—GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OP SRI LANKA.1095.12.02 (2) No drug other than registered drug referred to in ropulation 2 shail be manufactured in Sri Lanka. 81, (1) Every person desirous of obtaining « licoxce to manufacture any registered drug shall make a separate application to tho Authority in respect of each drug he intends to manufacture, Every such application shall be substantially in Form A of Schedul: VI. (2) Every applicant for a licence to saanufacture w registered drug shall furaish to the Authority all such information as may be required for the purpose of encbling the Authority to dispose of such application, 32, (1) The Authority shall, upon receipt of an application for a licence to manufacture any registered drug, cause the premises where such drug is to be stored to be inspected, and on being satisfied that such premises are suitable for the storoge of drugs, and that all the conditions for issuing a licence for the monnfacture of drugs have been complica with, issue a licence to the applicant. (2) The Authority may, at his discretion refuse to iseue a licence to a — (@) minor ; (8) mentally deficient person 5 oF (©) person addicted to narcotic drugs. 88. (1) Every licence to mauufictare a drug isqued by the Authority under regulation 32 shall— (@) bo substontistly in Form B of Schodule VI hereto ; and (6) bo valid only in respect of tho promises for whick it is issued. (2) The foo payable in respect of @ licence to manufacture 6 drug sholl he as spocified in Schedule XT hereto. Coxpmmtons oF Jacexcz 10 Maxursorups Davos 34, Every Iiconco to manufacture a drug iseued under regulaticn 82 shall contain the following conditions: (2) tho licensed manufacturer of dregs sholl provite and maintain such staff, premises ond plant a are considered by tho Authority to be nocossary for the manufacture of » drug undertoken by such licensed manufacturer ong he sholl not carry out suck manufseture except at the premises specified in his liconco ; () the liconsed manvfacturor of dregs sali provide and maintain such staff, promises, oquipment and facilities for tho havdling and storago of the rew materials and dregs as are considered nocessary by the Authority to avoid deterioration and hs shail not use for such purposes premises cther tion those specified in the licence or premises which may bo appreved from time to time ky the . Authority, (c) the Yiconsed manufacturer of drugs shall carry out off marufacturo of such drug in stick @ way #8 to ensuro that the drug conforms to the standards of strength, quality and purity agplicable to them aa specified by the Authority. (d) the licensed manufacturer of drugs shall provide such information as may be required by the Autho- in rospoct cf a drug currently being menufactured and ef the oporations being carried out in relotion tc such manufacture. (@) tho liconsed manufacturer of drugs shall inform the Authority before making any material alterations in tho promises, plont or machinery used under his licence, or in the operations for which they aro used and ho shall inferm the Authority of any change he intends to make of any personne! ‘named in the Vieence as : () respovsible for supervising the production operatio (Gi) responsihie for quality control of the products manufactured. U) the licensed manvfacturor of dregs shall koop readily available for inspoction by the Avtherity or by avy person authorised by the Authcrity, the rocords of the details of manufocturo of each batch of evory drug which is being manufactured under the authority of such licence, and the tests carried out in respect thereof, in such form thet the records will be easily identifiable from the number of the batch as shown on each container in which the drug is sold, supplied or exported. 30A Tamsds : () oxga—§ crm gthomt Gn GOs? ended gH Beas 0189 Sys —1985.12.02 Pane: 820,(1)-GAZBTTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLICOF SRILANKA-1980.12.02 The Ticensod manvfacturor of drugs shell allow the person authorised, to take copies or make oxtracts from such rocords. Svel records shall not bo destroyed for a period of five years from the date of manufacture of tho relovant batch of drugs without the consent of the Avthority. (9) tho liccusod manufacturer of drugs sholl keep alll documents which would facilitato the withdrawal cr recall from gale, supply of exportation of any drug to which the liconce relates, (f) tho licensed manufacturer cf drugs shell allow the Authority or any oflicor authorised by him, to enter with or without notice, any premises where the manufacture of any drug is carried oxt under a licence, or avy pretisos whore tho raw materials and other substavoos used in its manu. facturo are stored, or whore tho manufactured dcug is stored, supplied or sold, for the purpose of inspecting and if nocessary, taking eamples for tost, examinatien or analysis ot tlineal trial, (i) whore the Jiconsed manufacturor of drugs has been inforimed by the Authority that any batch of any drug in rompoct cf which tho liconeo is issued has been found to be not. in conformity with the specifications of the relevant drug as regards strength, quality, purity or with the provisions of the Act or of any rogulation made thereunder. Such licensed manufacturer shall, if co directed withhold such hatch from sale, supply or exportation so far as may bs reasonable, practicable, for such peried as moy be specified by the Authority. . (J) the liconsed manufacturer of drugs shall comply with such farther requiroments if auy, applicable to the licensed monvfacturer of crugs os may bo specified in any rogulation made under the Act 85. (2) The ficonco to inanufacture any registered drug shall, unless earlier suspended cr cancelled be valid for « period of one year from the dato of ismue of such lieenco. (2) Where the appliootion for a renewal of such licenco is made thrco months before the expiry of the porlod of validity cf the current licence, ench licenco shall be deemed to continue in force, until an order is made in respect ef such application. (3) Any application for renews] of such licence shall be substantially in Ferm A of Schedale VI hereto, 36. (1) If the licensed mazufacturer cf drugs fails to comply with any of the conditiens of licence to manufactury any rogistered drug, the Authority may, after giving him an apportunity to show cause why such on order should not be made by en order in writing stating the reasons thervfor, suspend such licence for such period 8 o thinks fit or eancel it, either in respect cf all or some of the drugs to which it relates. @) Any porson wie is aggrieved by an ordor under paragraph (1) suspending ct cancelling his licer:ee may within three months of the date of such order, make an sppeol to the Avthority. 87. Every liconsed manufacturer of drugs shal) exhibit the licence i conspicuous place in the premises ab whieh he manufactures the drug. vod to him undor regulation 32, ina 38. ‘Tho Authority shall keep a register of every licensed manufacturer of drage, aud shall evtor or catise to bo entered theroin the following particulans relating to ench such licensed manufacturer :— (@) the namae of such licensed monufaeturer 5 @) tho address of tho premisos at which ho is authorised to manufacture the driigs in respect of which ‘tho licence has boom issued : 5 © the number of the licence ; (@) tho date of issue of the licence ; and (©) tho number and dato of the Certificate of Registration ifiesed to him under the Busine: Ordinovoe (Chapter 149). Names 39. (1) Bvory liconsed manufacturer of drugs shall forthwith inform the Authority in writing of any cir. cumstances or event which may oocur which affects the accuracy of any particulars stated by sch licensed manu- facturer in the application for a licence to manufacture drugs and shal, togethor with euch information furnish his liconce to the Authority. 2) Upon the receipt of any information furnished by a licensed manufocturer of drugs under peragraph (1), ‘the Antkority may mako or cause to be mado such appropriate alterations ax may be nocessary in the register and in tho licence of that manufacturer and shall roturn the licence to the licensed manufacturer. Tommds : (D odee—§ cms gusantgio oOiutnt dnddod gS Seav oud ege—1084.19.02 SLA aux I: Se0(1)-GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF 6RI LANKA-1986,12.02 40, The Authority may revoke auy licence iseuod under regulation 32 to manufacture drugs, if ho is satisfied ‘hat the licensed manufacturer of drugs has acted in contravention of any regulations contained in this Part or any other regilation mede under the Act pertaining to the manufacture of drugs. Panr IV Lrorxsrxo os Reran, Deatens mv Davas 41, On or after the date of expity of a period of three months from the date of operation, no person shall rel] any registered drug other than a drug specified in Schedule I hereto, except under the authority of a licence isoued under regulation 44. Every person to whom a liconoo is issued under regulation 44 to sell (by retail) any drug thall hereinafter be referred to. 8 a “licensed retail dealer ” 42, (1) Every person desirous of obtaining a licence to sell (by retail) any registered drug shall make separate application in verpoot of each such drug to the Authority. Every such application shall be substantinly in Vorm A of Schedule VII hereto. (2) Every applicant for a licence to sell (by retail) any registered drug shall furnish to the Authority all such information as may be required for the purpose of enabling the Authority to dispose of such application. 43. Every applicant for 4 lisenoe to sell drugs (by retail) shall comply with the following conditions -— (@) he shall be a registered pharmacist or a person employed by a registered pharmacist to transact ‘business in tho premises ; (0) tho premises in which the sale uf drugs is to be carried out shall be adequate and equipped with proper storage facilities for preserving the properties of the drugs in respect of which the licence is issued and shall be in cbarge of a registered pharmacist ; (c) where any arug is to be sold or stored by the somo person for salo at moro than one promises, separate application ehall be made and a separate licence shall bo issued in respect of each such promises 44. (1) The Authority shall upon receipt of an application for a licence to sell any drug (by retail) cause the premises in which such drug is to be sold tp be inspected before issuing a licence to the applicant Provided, howover, thet the Authority may refuse to issue @ Hoence to any person whose previous licence tas been revoked under regulation 54. (2) The Authovity shall, on being satisfied that all the conditions for issuing a licence for the sale of druge (by retail) have been complied with, issue a licence to the applicant. (3) The Authority may rofuse to issue a licence to— (@) a minor ; (®) a mentally deficient person ; (0) & person addioted to narootie drugs 45. (1) Every licence issued by the Authority under rogulation 44 shal (a) be substantially in Form B of Scheawo VII hereto ; and ) shall be valid only in respect of the premises for which itis issued. (2) Tho fee payable in rospect of a lioanco to sell drugs (by retail) shall be as specified in Schedule XI hereto. Coxprrtoss ox Licexce ro Smut, Davos (sx Buran) 46, Every licence to soll drugs (by retail) issued under regulation 44 shall contain the following conditions : (a) no Licensed retail dealer shall expose or offer for sale or sell any drug bearing the State mark or any other mark indicating State property ; (0) no drug specified in Sohedulo II hereto shall be sold after expiry of tho date specified as the date of expiry on the label, wrapper or container of such drug ; (6) the liconsed retail dealer shall allow any officor authorised in that bebalf by the Authority to onter with or without notice during business hours, any premises where drugs ato sold (by rotail) for the purpose of inspooting and taking samples of drugs for test, examination, analysis or clinical ‘rial. 3A Lemde : ) odge—§ cxas guamatfen BODE Unddad GS Boow oO Sye—1085.12.03 Pant I; Sto, (1)—GAZETTE EXTRAORDINARY OF THB DEMOCRATICSOCIALIST REPUBLIOOF SRILANKA-1086.12.02 (@) the licensed retail desler shall comply with such further requirements if any, applicable to any holder of a licence to soll (by retail) any such drug as moy be spevified in any regulation mado under the Act. 47, (1) The lioenoe for the salo of drugs (by rotail) shall, unless it is sooner suspended or cancelled, be valid, for @ period of one year from the date of issue of stich licenoo. (2) Where the application for a renewal of such licence is mado threo months before the date of expiry of the period of validity of the eurrent licence, such licence shall be deemed to continuo in foreo wntil en order is made in respect of the application for such renewal. (3) Ax application for renowal of such licence shall be substantially in Form C of Schedule VIII hereto. 48. (1) If the licensed retail dealer fails to comply with any of tho conditions of the licence the Authority may, after giving him an opportunity to show cause why such order should not be made, by an order in writing stating the reasons therefor sent by registered post, suspend such licence for such period as the Authority thinks fit or cancel it either in respect of all or somo of the drugs to which such licence relates. (2) Any person who is agurioved by an order mado undor paragraph (1) may, within three months from the ddote of euch order, moko an appeal to tho Authority. 49, ivory licensed retail dealer shall exhibit the licenco issued to him under regulation 44, together vith tho original of the Certificate of Registration of the pharmacist sssued by tho Ceylon Medical Council, in conspicuous placo in the premises at which he sells drugs. 50. ‘The Authority shall koep a register of all licensed rotail dealers and shall enter or cause to be entered therein the following particulars in respect of each such dealer : (a) tho name of the licensed dealer ; (®) the addross of the premises at which ho is authorised to sell drugs : (c) the schedule of drugs in respoct of which a licence has been issued ; (d) the dato of issue of such licences and (e) thenumber and dato of the Cortificate of Registration, ifany, iseued to him undor the Business Nemes Ordinaneo (Chapter 149). 51. (1) Every liconsed retail dealer shall forthwith inform the Authority in writing of any circumstances or event which may affect the accuracy of any particulars stated by such licensed retail dealer in the application for a Licence to soll drugs (by retail) and chall at the same time forward his licenco to the Authority. (2) Upon the receipt of any information furnished by a licensed retail dealer under paragraph (1), the Autho- rity may make or eauso to be made such appropriate alterations as may be necessary in the register of druge and the Licence of that desler and shall roturn the licence to suck licensed retail dealer. 52. Any licensed retail desler who has under his control any shop or any other placo of business shall soll any registered drug specified in Schedule I1(B) and Schedule IIT only to the following persons : (a) a medical practitioner, dental sugeon or pharmacist registered under tho Medical Ordinance (Chapter (8) a veterinary surgeon rogistered under the Veterinary Surgeons and Practitioners Act No. 46 af 1956, or ° {€) any person who produces @ prescription from a registered medical practitioner, dental surgeon or ‘veterinary surgeon. 53. A liconced rotail desler shall maintain a register of drugs specified in Gorup B of Schedule I hereto which may be sold only on prescription (by retail). 54. ‘Th Authority may revoke any licence to sell drugs if the Authority is satisfied that the licensed dealer hhas acted in contravention of any regulation conteined in this Part or any other regulation pertaining to sale of drags (by retail). Toads : (1) oxigo—§ crema yuvaaad in O08 ended 48 Doae 00 03s—1985.1.03 33 A Pant It S20, (1)-GAZETTE EXTRAORDINARY OF THE DEMOCRATIO SOCIALIST REPUBLIC OF SRI LANKA-1085.12.02 Panr'V Licensma ov Waoursate Dratzns rx Davos 55. On or after the date of expiry of a period of threo months from the date of operation no person shall sell (by wholosale) any registered drug except under the authority of a licence iseued in that bebalf, under regulation 5 Every porson to whom & licence is issued under regulation 68 to ell (by wholesale) any registered drug shall horei after be referred to as a “liconsed wholesale desler."* 5G. (1) Every person desirous of obtaining a licence to soll (by wholoealo) any registered drug specified in Group A and Group B of Schedule II hereto, shall make a soperate application to the Authority in respect of the rugs so specified. Every such application shall substantially be in Form A of Schedule VIII hereto, (2) Every applicant for a licence to sell (by wholesale) any rogistered drug shell furnish to the Authority such information as may be required for the purpose of enabling him to dispoze of such application. 57. Every applicant for a licence to sell drugs (by wholesale) shall comply with the following conditions : (a) he shall be a registered pharmacist or a person employed by a registered pharmacist to transact ‘business in tho premises ; (®) tho premises in which tho salo of drugs is to be carried out shall be edequate and equipped with proper storage facilitios for proserving the properties of the drugs in reepect of which the licence is iesued and shall be in chargo of a rogistorod pharmacis (c) whore any drug is to be sold or stored by tho same person for sale at moro than ono promises, soparate application shall be made and a seperate licence shall be issued in reepeet of each euch premisce. 58, (1) Tho Authority shall, upon rocoipt of en application for a licence to sell any drug (by wholesale) cause the promises where such salo is to be carried out, to bo inspected before issuing a licence to the applicant : Provided, however that, the Authority may refuse to issue a licence to any person whore previous license ‘was revoked under rogulation 67. (2) The Authority at his diecrotion may refuse to issue a licence to a— (a) minor; (8) mentally deficient porson ; or (¢) person aadicated to narcotio drugs. (3) Tho Authority shall, on being satisfied that all the conditions for the issuing of a Licence for the sale of drugs (by wholesale) havo been complied with, issue a Ticonce to tho applicant. 59, (1) Every licence to soll any drug (by wholesale) issued by the Authority under regulation 58 shall be substantially in Form B of Schedulo VIII heroto and be valid only in respect of the premises for which it is issued. (2) Tho feo payable in respect of a licence to sell drugs (by wholesale) shall be as epecified in Schedule XT hereto. Coxorrtons or Liomxce 10 Sxut, Davos (sx Wanna) 60. Every licence to soll drugs (by wholesale) issued under regulation 57 shall contain the following conditions: (a) n6 licensed wholosalo dealer shall exposo or offer for sale or sell any drug bearing the Stote mark or any mark indicating State property ; (®) tho wholesale Ieonsod dealer sholl allow any officer authorised in that behalf by the Authority to center with or without notice during business hours, any premises where drugs are sold (by wholo- sale) for the puxpose of inspocting and tolking samples for test, examination or analysis ; (c) the licensed wholesalo dealer shall, on a request made in that behalf and on payment of the relevant foo, furnich to the Authority, from any batch of cach drug semplo of such amountas the Authority muy consider adequate for any teet, examination or anelseia to be mada (d) if the Authority s0 direots, the wholesale dealor shall not sell or offer for ale}any batch of a drug in respoot of which samples are furnished under paragraph (c) until a cartiBoate authorising tho salo of such drugs cf that bateh, bas been issued to him, by or on behalf of tho Authority ; ALMA os1616 Tomds : @ exga— cams stirs gen OreiOsl Uddod gS Boas ats 694—1985.12.02 20. (1}-GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA-1096.12.02 (©) the wholesale licensed dealor “sball, on being informed by the Authority that any part of any batch of a drug has been found by tho Authority to be not Ja conformity with the specified etandara of strength, quality and purity-and on being directed to do so, withdraw tho remainder of that batch from sale, and, s0 far as is practicable in the particular circumstances of the easo, recall tbe issues alresdy mado from that bateh ; (f) the licensed wholesale dealer ehall maintain a record of all porticulars of colo made by him and euch records shall bo open to inepection by any officer authorised by the Authority, 61. (1) Tho licence for the eale of drugs (by wholesale) shall, unloss 1t is earlier eusperded or cancelled, be valid for a poriod of one year from the dato of isste of stch Ticonce. (2) Whero an application for a renewal of sve licence is made three moxthe before the date of expiry of the validity of the oorrent liconce, such licence ehall, be deemed to continuo iu force until an order is mnado in respect of such application. (8) An application for renewal of suck licence shall bo substantiolly in Form C of Scheduly VITT hereto. 62, (1) If tho licensed wholesale dealer fails to comply with any of the conditions of the fivenco for the ale of drugs (by wholeeale) the Authority may, after giving him an opportunity to show cause why such an order shoud not: bo made, by an order in writing, etating the reasons therefor, suspend such licence for such period as the Authority thinks fit, or cancel it in respect of cither all or come of tle drugs to which such licence relates. (2) Any person who is aggrieved by an order under paragraph (1) suspending or cancelling his lisence may, within tbroe mouths from the date of euch order make an aypeal to the Authority. 63. Evory liconeed wholesale desler shall exhibit. the licence issued to hin under regulation 68 in a conapi- ‘ouots place in the premises at which he sclls drugs, together with the original of the Certifcate of Registration of tho pharmacist issued by the Coylon Medical Council, G4, ‘Tho Authority shall keop a rogister of overy licensed wholesale desler of drngs and shall enter or cause to bo entered therein tho following particulars reloting to coch such licensed wholesele dealer, nately :— (a) the nome of sveh licensed wholesale daeler ; () the address of the premises at which he is authorised to sell tho drugs specified in Schedule TI hereto, and in respect of which a licenco bas boen issued ; (0) the dato of issue of the licenco; and (d@) the number and date ofthe Certificate of Registration, ifany, issued to him under the Bueiness ‘Names Ordinance (Chapter 149.) 65, (1) Every liconsed wholesale dealer sball forthwith inform the Authority in writing of ary efreumnstanoes or gvont which may occur which may affect the accuracy of any particulars cteted by sch licenéod wholesale dealer in the appl'cation for a licenco to soll drugs (by wholesale) and shall at thd same time forward his licence to the Authority, @) Upon recoipt of eny information furnished by « esnsed wholesale deolor ynder paragraph (1), tho Autho- tity may moko or eauso to be made euoh appropriate olterations in the register and in the licence of that dealer as may be negessary and shall return tho licenes to suoh licensed wholesale dealer. 66, Any licensed wholotole dealor who bas under his control any shop, premises, vehicle cr any other place of business used for deloing in drugs shall eell any registered drug specified in Schedule 1LB only to tho following persons :—~ i ° {a) 2 medice] practitioner, dental eurgcon or pharmacist registered under the Medical Ordinance, (Chap- ter 105); () to # veterinary eurgoon registered under tho Veterinary Surgcons end Practitioners Act, No. 46 of 1956 ; (©) toe reteil licensed delact who holds a valid licence under tho Act ; or (@) to a peison authoriced by the Authority. Lome: oxe—9 crm guioigen oOrdOsk Undded G8 Boa osd oyG—1085.12.02 SFA Pane: S20, I)-GAZETIE EXTRAORDINARY OF THS DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA-1086.12.02 67. Tho Authority may revoke any Heenoe to sell any drug (by wholesale) if the Authority is satiefed that the licenred wholeeaJe dealer hae acted in contravention of any regulation contained in this Part or any other regulas tion made under the Act pertaining to exposing for sale, sale or distribution of any drugs (by wholesale), Pant VI Licuxons vor Transront or Davas srectriep mv ScreDULES 1 AND TIT 68. (1) Where any licensed rotail or wholesalo desler, importer or manufacturer of druge under, theso regu- lations desires to transport any registered drugs epécificd ix Schedules IT and J1 hereto for the specific purpose of distribution through an agent to medical practitioners, dental surgeons or te Ycterinary surgeons or to a licensed, retail or wholesale dealer, such licensed retail or wholesalo dealer, importer or manufacturer shall obtain a licence for such agent from the Authority. (2) Every such application shall be substantially in Form A ef Schedule IX hereto, 69. (1) Every applicant for a licenco to transport any registered drug specified in Schedules IT and TIL hereto, shall furnish to the Authority all such information as the Authority may require for the purpose of enabling ‘tho Authority to dispose of such application, @) The Authority shall, on being satisfied that all the conditions for issuing a lioones havo beon complied with, wsste a licence to the applicant. Cosprmioxs oF LicxxcE to Traxsrort Davos Srrowiep ry Scunpuxes II av TIT 70, very licence to transport a drug spocified in Schedules II & IIT shall contain the following conditions :— {a) tho vehiclo in which tho drug ia to bo transported shall be adequately equipped with proper storage facilities to proserve the properties of the drug to be transported. (B) the agent of tho licensed retafl or wholesalo dealer, importer or manufacturer shall be a competent ‘person in the opinion of the Authority to superviso and control the distribution and preservation of the drug under his charge, 71. Every licence issued by the Authority under regulation 69 shall be substantially in Form B of Schedule IX hereto, Par VIL Destaucriox 72. Any drug which fails to conform to the specified standards or the storage life of which has expited stall bo destroyed, ‘The destruction shall be carried out under the supervision of an officer, authorised by the Authority, Pang VIL LABELLING 73. Tho container of overy drug imported, manufactured, processed or packed locally or sold ar exposed for sale shall havo a label bearing the following information clearly indicated thereon : (@) the approved namo found in official pharmacopoeias or formularies, (The source should be stated in abbroviations ; o.g. B.P., USP. ote.) (6) tho brand namo ; (6) list of the activo ingrodionts showing : (@) the amount of each present in each dosage unit (e.g. per 5 ml. eto.) ; (b) a statement of the nett contents (o.g. number of dosage unite, weight or volume) ; (@) any special storage conditions that may be necessary ; (c) warnings and precautions that may be novessary ; (f) the date of manufacture ; (g) the date of expiry whero applicable : S0A — Lomda: () oxqu—g cum gurmrat ga aOr0st enddad gG Dane 0130 eya—1085.12.03, Pant I no, ()-GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OP 8RI LANKA-1085.12.02 (A) the batch or lot number assigned by the manufacturer ; and (@ the namo and address of the manufacturer, 74, (1) Tho container of every drug, specified in Schedule IT horoto shall bo accompanied by a printed insert ‘which shall contain all the particulars spocified in Schedulo X horoto, (2) Whore a presoription contains a drug which haa to be prepared or has to he taken out of tho original labelled container for dispensing, tho licensed retail dealer shall dispense the drug in a suitable container labelled clearly with tho following partioulars : (a) name of the pationt ; (H) name and quantity of the drug dispensed (0) the dose prescribed ana directions for us (@) the name and address of tho dispenser/chomist, (8) Drugs for oxtornal application should bo labolled— “OR EXTERNAL USE ONLY". Pant IX Apvznrisnxe or Davos 78, On or after tho dato of expiry of a poriod of threo months from the dato of operation no person ehall advertise any drug in contravention of the provisions of the Aot or regulations made thereunder. 76. No person shall advertise any drug which is not registorea with the Authority. 71. No person shall import into Sri Lanka : (a) any advertising material of any drug which is not registered with the Authority ; (®) any advertising material of any drug registered in Sri Lanka which is in contravention of the provisions of th Act or any regulation made thereunder. 78. No person shall sond any advertising material about any drug to the Medical, Dental, Veterinary, Pharmaceutical and alliod professions which is false, misleading or inconsistent with the particulars contained in the data sheet originally submitted with tho application for the registration of the drug or particulars submitted subsequently. : 19. (1) No porson shall advortise any drug spooified in Group B of Schedule II and Schedule III hereto except through professional journals and publications which aro inlendod for circulation among tho members of the Medical, Dental, Veterinary, Pharmaceutical and alliod professions or in magazines for studenta of theso professions. (2) Any drug referred to in paragraph (1) may only be advertised through the media of the Press if itis merely intended to inform the publio of its availability or ite price. 80.- No person shall make any false or exaggerated claim for any drug or misuse research results or quotations from soiontific literature to support such claim. . 81. Noporsonshall advertiseany drugtotho public asatreatment, preventive or cure for any of the diseases, disorders or abnormal physioal states sot out in Schedule F of the Act. 82, Every advertisement of any drug shall contain the genetic or official name of such drug. Where no official namo is availablo asin some drug combinations, the official names of the important constituents hall be given, 83, ‘Tho Authority may, after giving tho advertiser an opportunity of being heard, prohibit. the publioa- tion of any advertisement which is in contravention of the provisions of the Act or regulations made thereunder. Teemde : (1) esga— § cram guimat§in sG:dds? Unddod A Domw oys0 Ors—1985.12.02 STA Pant I: 820, (1)-GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA-1985.12.02 Pane X DistarsonioN o# Dave SAMELns 84. Samples of rogistered drugs epecitied in Schedule IT may bo distributed only to tho registered medical practitioners or dental surgeons registered under the Modical Ordinaneo (Chapter 106), or veterinary surgeons regis- tered under the Veterinary Surgeons and Practitioners Act, No. 46 of 1956. Such samples shall bo labelled “ Frea medical samples, Not for sale”. Pasr XT PROEDURE FoR TAKING o SameLES FoR ‘Tusy, EXAMINATION, ANALYSIS OR CLINIOAL TRIAL 85, Anofficer who obtains or takes a sample of any drug under Section 22(1)(a) of the Act, for test, examina. tion, analysis or clinical trial shall, after procuring a suitable quantity according to his opinion, of the drogin question, notify tho porson from whom the samples wero obtained of his intention to submit a sample thereof to an Approved Analyst for examination. 86, fin the opinion of the Authorised Officer, division of the procured quantity would not interfore with the test, examination, analysis or clinical trial- {a) ho chall divide tho sample into three parts (6) seal tho three parts separately with his seal (¢) permit the person or owner from whom the sample was procured to place his seal or thumb impression, if ho 0 desires (@) deliver one part of tho sample to the person or owner from whom the sample was procured ; (e) retain one part of the samplo and if a Inbel is present on the sample procured, retain the part that contains the label for producing it in court undor Section 32(1) of the Act ; and (J) forward one part of tho sample to the Approved Analyst with a description of such sample and an extract of the relevant portion of the label, for test, examination, analysis or clinical tri 87, If in the opinion of the Authorised Officer, division of the procured quantity would interfere with tho test, examination, analysis or clinical trial, he shall seal the entire quantity and permit the porson or owner from whom tho sample was obtained to place his seul or thumb impression if he desires to do so and forward the same to tho Approved Analyst with a notification as to the method, for test, examination, analysis or clinical trial. 88, An Authorised Officor purchasing any quantity of a samplo for test, examination, analysis or clinical trial, except in instances where the Authority has specifically authorised a purchase shall tondor’ the cost of the sample to the person or owner from whom the sample was obtained. 80, (1) An Authorised Officor who obtains or takes a sample of vaceine or scrum for test, examination analysis or olinical trial, under Section 22(1)(a) of the Act shall notify the person or owncr from whom the eample ‘was obtained of his intention to submit the sample to an Approved Analyst for tost, oxamination, analysis or clinical trlal. 2) The Authorised Officer shall— (a) obtain and forward a single sample to the Approved Analyst ) collect the samplo under sterile conditions whero the ssimplo is collected from bulk or from an opened package + (c) permit the person or ownor of the vaccine or serum from whom the sample was obtained to place his seal of thumb impression, if he ¢0 desires, together with the seal of the Authorised Officer. (@ despatch the sample to roach tho Approved Analyst under suitable storage during transport, 90. ‘The Regulations mado under the Food and Drugs Act (Chapter 210) are hereby resoinded. A12-A.081616 Scmpuie I Aspirin and soluble aspirin tablots Paracetamol in tablet and liquid form Analgesic balms/plasters Antacid preparations Antiseptios and disinfectants for household uso Compound effervescent salts for purgation. Magneshun Lemds : (1) edga—G Crt gusmalgen OOO Senddod GH Boas 030 vgs—1085.12.02 |-GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA-1688.12.02 Regulation (1) hydroxide mixture, Magnesium sulphate, Castor oil. Fish liver oil and vitamins for oral uee. Propotations of iron and calcium for oral use. Simplo cough preparations and throat lozenges not containing any antibiotics. Soumpuus Ii Rogulation 3(2) auour & Aone acid cream BG Phos Actal Bisooodyl Adezotin Biumal Forte with vitamin © Agarol Bonate Air Salonpas Bonjela Alka Seltzer Calberon © capsules Algipan Caletlac Almacard Calcium gluconate, oral preperations Aloxiprin Calofum lactate Aludrowe Caloiun with vitamin D Aluminium hydroxide and Dimethioone, oral pre- Calcium Sandoz syrup parations Caldeferrum Aluminium hydroxide, oral preparations Calpot Adeolan Carbaryl lotion Antistin Privine Caripeptic Liquid Andrew's liver salt OB Anusol econ Anuseol HC Cetin Arobon Corationia seed powder Ascabiol Cetapyrin “Ascorbic acid Getaoton, Asilone Cotrimide cream Aspirin tablets Ge-Vi-Sol drops Arovit, oral preparations Charcoal tablets Asmae Cheatorub Aspirin and Codeine Chlorhexidine Aspirin Chlorhexidine and Cetrimide Auuralgicin Ohlorphenesin Avomine Choline salicylate compound gel ‘B—All Leo, oral preparations Cieatrin powdot and cream Bagferron Clearasit Be Grunovit Cobadex capsules Becadex Codis Becoforal O Codopyrin Beconen Cod liver oil Becosules Collomack Beooryme Forte orat preparations Core D Becozyme Forte with O oral preparations Coskin Becozyme tablets and eyrup Gosome Beminal Cxotomiton oream Benoral oral preparations Cytacon Benorylate, oral preparations Bonzalkonium and chlorbutol coaking solution Benzyl benzoate application Berocea Betabion Cytexin, oral preparation @-Vitam orol preparations Vitam Forts oral preparations Decavitamin capsules Dequadin Tomo: +) aga—9 cum gurartgen HOO Undued GB Dome oysd oyO—1085.12.02 30 A ane 1:88. (I)CAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA.1085.12.02 Dettol Dextromethorphan eyrup and tablets Diethylamine salicylate cream Digene Dimethicone compound cream Dioctyle sodium sulfoeuccivate Disprin Drapolene Duleolax Dumasules Duofitm Durot Duvit Beoo oral preparations Duvit 0 Ephedrine naval drops Ephedrine oral preparations Ephedsine-Tpocac compound tablots Ephedrine compound tablets Ephynal Hskameb Estone vitamin tablets Biking Eurax Evion Fame! Fergon Fer-In-Sol Ferradol Ferromyn Ferromyn-B Forrous fumarate Ferrous gluconate Ferrous sulphate Fereamal Fersolate Fersovite ‘Flurocscain Fluorescite Folic decid, oral preparations Folie acid and iron, orel preparations Folvron Fortibes Franol Gamma benzene hexachloride preparations Garlic cupules and pills Getusit plain Gelusil MPS Genatosan multivitamin plain tablets Gencitosan junior vitamin tablets Genasprin Glucose Powder Giycorin Suppositories (Adult size) Glycerin Suppositories (Infant size) Gripe water Gripo mixture Guardian liquid sweetener Hacks original flavour tublets Hacks Menthol and Eucalyptus tablets Haliborange ‘Hexachlorophane Hexavitamin tablets Hibitane Hydrogen poroxide solution Lberot Ipesandrine Jai Baolin compound poultioe Kaolin and Pectin Kaopex Kaomagma plain suspension Kaomagma with Pectin suspension Ehasinol syrup Krushen salt Ewell cream and lotion Lactio acid compound lotion Listerin antiseptic Lorezane Loxene Liquor Diastos Taumagel tablete Maalox suspension Maaloz tablets Magnesium hydroxide - ‘Magnesium sulphate ‘Magnesium sulphate compound powder Magnesium sulphato effervescent granules Marvita Mecluzin Menthol compound rub ‘Menthol compound spray Metamucil ‘Methyluicotinate compound cream ‘Methylsalicylate compound ointment ‘Mothylsalieylate compound spray Minades ‘Milton antiseptic Multibay Multibionta Multi-Sanostol Syrup Multivitamin oral preparations Multivitamin-mineral syrup ‘Multivitamin-minieral tablets Multivitaples Moltivitaplex Forte ‘Naphazolino compound eye drops Natalins Nataling Mf 404: Terms0es : (0) exige—§ oss gaat gin oOdO8 Undded ga Dome o12 o——1085.12.02 ‘Pant 1See. (1)-VAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIO OF SRI LANKA.10¢ Neopolazine Sil eream Neurogrunovit Tedral oral preparations Now Hopevit aycup Tempra ‘Nola ‘etrahydrozoline solution Numolisine Theragran M: tablets Nutri Higuia ‘Thermogene medicated rut) Nutroferot Pew ‘thimerosal leaning solution Nyat toothache drops Tokukon medicated spray tron Ponos 7 ayrup Ominibeta Tea Uncle Optrex eye lotion Pranevasin Optves eye drops Tympalgin Orheptat Ulirapret Oronine Goi Ossvie adn: syrup Ontccaltvm Vasa espound syrup Veganin Mada ee pee Vick’s inhaler Viek's medicated cough syrup Pantoryme Paracotainol Phenylephrine nasal drops Phillipe gripe molieine igoron tonic Prilie ml of magni cine crap ae nin Aan Dora parton ; ; itamin B complex table ee Vitamin B complex with vitamin C ora! prepaations : ; Vitamin B complex strong oral preparations nee oral preparation Vitamnin B complex and Iron syrup eee Vitamin B, oral preparations Vitamin Bye syrup Polyvinyl alcoho! wetting solotion Vitamin Orel peparstloms Simeco Vitamin E oral preparations ‘Siopel cream Vitanorm ‘Sloan's liniment Vitece Sloan's massage Waterbury's compound Sodium hypochlorice Waterbury's vapoour rub Soluble Aspirin tablete Waterbury’s vitamin tonic Strepeils Wintogeno Sweet Woodward's grize wotee ‘Swwestex Zocsirin Somwpuuz m—axour » Regulation 313) Drugs that fall into this Schedule will be Listed a8 snd when the} are forwarded to the ‘Authority’ for xogiatration. SouxpuLe I Regulation 3(4) Opium Cooa plant Hemp plant ‘Any produce obtained from any of the phenanthrene alkaloid of opium or from the Hognonine alkaloid of tthe coca leaf not being a product which was in use on or before the 13th dey of July 1931, for medical oF scientiio purposes. Any extract or tincture of the Hemp plant ‘Morphine and its salts ‘Cocaine (including synthetio cocaine) cagonin and their respective salte, Any solution or dilution of morphine or cocaine or their salts in au inert substance whether Higuids or solids containing suy proportion of morphine or cocaine and any proparation, admixture,’ extract Loade : (D) outa —§ Gums yuri gn 0900.8 Undviad gS Boas 030 oge—1988.12.02 aA Pane I: S20, (I) GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIO OF SRI LANKA-1086.12.02 or other substances (not being such 9 solution or dilution as aforesaid) containing not less thon 1/5 Poreentum of morphine or 1/10 peroontum of cocaine or ecgomine Acotorphine. Acetylmethadot Allylprodino Alphncetylmethado! Alphameprodine Alpharethadol Alphaprodine Amphetamine Anileridino Beuzethidine Betacetylmethadot Detameprodine Botamethado! ‘Botaprodine Beritramide Cannabis and Cannabis resin Clonitazene Cocaino (methyl ester of benwzeytoogonine Codeine (Mothyl morphine} Codoxime ‘Desomorphine Det Desomphetamine Dextromoramide Diampromide Viethylthiambutene Vifenoxin Dimenoxadol Wimepheptano Dimethylthiancbutine Dioxaphetyl butyrate Diphenoxylate Dipipanone pe nT Drotebanot Hogonine, its estors and derivatives which are conver tible to ecgonine and cooaine thy] methyl thiambutene Btonitazone Etorphine Etoxeridine Fentanyl Furethidino Heroin (diacoty! morphine) Hydrocodone Hydromorphinol Hydromorphone Hydroxypethidine Isomethadone Kotobemidove Levomethorphan Levomoramide Levophenaeylmorphan Levorphanol +) — Lysergide *¥fescaline Metazocine Methadone *Mothadone-Intermediate (4-oyono-2 dimethyl amino- 4-diphenylbutanc) ‘Mfethamphotamine Methy! desorphine Methlydinydro morphine *Methyl phenidate ‘Metopon Moramide-Intermediate (2-methy]-3-morpholino-}, iphonsIpropmne carboxylic acid) Morpheriaine Morphine Morphine-N-oxide Myrophine ‘Nioomorphine ‘Noracymethadol Notlevorphanol Normethadone ‘Normorphine ‘Norpipanone Oxyeodone Oxymorphone Porahoxy! Pothidine Pethidine-Intermediate-A (4-eyano-L-methy)-4ephenyl piperidine) Pethidino-Intormediate-B ‘doxylie acid ethyl ester) Pethidine-Intermediate-C (1- methy 1t-phenyl _piperi dine-4-carboxylie acid) Phouodoxone Phenampromide Phenazocine *Phenoyelidine *Phonnetrazine Phonomorphan Phenoperidine Pholeodine Piminodine Piritramide Proheptazine Properidine Pailocine Pailotein Pailoey bine Racomethorphan Rocemoramide ‘Racemorphan “SIP, DOM Snfentanit ‘Thebacon ae ‘Trimeperidine (4-phenylpiperidine-4-cnr- 2A Lowndes: (1) exes —§ cums ytinatgn GOUOLR Uandded ¢8 Beaw a0 ogs—1985.12.02 Pant I: Suo, (I}-GAZETTE BXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC “IP SRI LANKA-1985.12.02 Form A Regulation 5(3) Sonzputz IV Isronsarron Regummep ron Reoisraamon op a Dnva 1, Name of applicant 2 Address 7 3. Status of applicant... Manufacturer Importer : 4, Namo of the drug (1) Brand Name (if any) : (2) Oficial or approved name indicating the official body that hos given this nome. (whether BP USP. ete.) lb 5, Dosage form of the drug. eg. tablet, syrup, injectio 6. Composition—The ingradients should be listed by their officinl or approved names and should include their exact quantities as por unit dose or if it is not practicable as percentage of their total formulation. 7. Main pharmacological group to which the drug belongs : (e. g. diuretic eto). #8, A cortificate from the hoalth authorities of tho country in which it is produced, confirming that the drug is in use thore and the period of tse ond if not, reasons for not marketing it in the country of origin. 9. Certificate of analysis and full information concerning analytical assay and other control methods to censure identity, strength, quality ond stability. #10. Published reports of controlled clinical trials—establishing the therapeutic efficaty of the drug. (Une controlled studies would be accopted only if controlled clinical trials aro not necessary to prove efficacy), Tn the caso of drug combinations, evidence must be provided to justify the inclusion of all the active constituents in the formulation. *11. Summary of toxicity tests ond tests for teratogenicity indicating the safety of the drug. 12, Data eheet giving the following information : (@) Pharmacology— Pharmacological actions ‘Mochaniem of action (if known) Relevant Pharmacokinotio dato (8) Clinical Information Indications Contraindications Precautions Warnings Adverso effects Drug interactions Dosage regimen Lemos : D odgs—Q rm guraaign a@suds’ Undded 4B Seae 10 o9—1985.12.02 BA ‘Pane I: 8x0. (I)-GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA.1086,12.02 Average dose and dso range for adults and children ‘Dosing interval Average duration of treatment. ‘Dosage in speoial situations e.g. renal, hepatic and cardiac insufficiency. Overdosage : Briof clinioal description of symptoms, Treatment of overdosage (€) Pharmaceutical Information— Dosage forms and strengths of different dosage forms. Storago conditions and shelf life (expiration date) Package sizes Description of produot e.g. tablet size, colour, markings ete. Namo ond address of manufaoturer (if not given earlier). "13. List of countries in which the drug is approved or registered for sale. #14, Fully packed samples of the drug in the form that will be offered for sale should lao be sent, to enable enalysia of the product. 15. A sample of the label (s) used on the containers should be supplied. 16, All data should be submitted in English, in o hard file oover, in duplicate. 17, Information marked with an astorisk* is not required in the onso of drugs that havo been already approved for import or local manufacture. In the oase of drugs approved for import, the names should be in tho Government gazcttes published on July 18, 1980 and thereafter. APPLICATIONS MADE WITHOUT THESE REQUIREMENTS WILL NOT BE ACCEPTED Form B Regulation 5(a) Soumpone IV ApriicaTioN Form ror Crztrvicarn or RecisTRaTion oF 4 Drug zy aN IMPORTER (Co tn filled in triplicate by applicant) soe OF sn --hereby details Ife ... apply for registration of the drug namely ... . sve of which are enclosed herewith. Sr Adress: ‘Designation of applicant : For official Use only Application No. Decision : Registered /Not registered. Registration No i... Fees paid : . Date fcccncie Signature :.. AA Lemsdes: (1) osqs—§ crm yeiarstgen WOOs7 tadded 4S Doaw asd ep—1985.12.02 ‘Pant 1820, (1)-GAZETTE EXTRAORDINARY OF THE DEMOCRATIO SOCIALIST REPUBLIC OF SRI LANKA-1986.12.02, Form 0 Regulation 5(5) Soumpote IV Avricamion Foust xo Canzmoare or Reatsreation oF A Dava px 4 Maxvraoronen (Zo be filled én triplicate by applicant) I/We ... amen Of . hereby apply for registration of the drug and formulation for local manufacture namely... . es s-onnsnnu detaile of which are enclosed herewith, a Addr €28 tonensnenne Date : Deeignation of applicant For official use only Application No : = Dated : Decision : Registened /Not registored., Dated :. Rogietration No, Dated Fees pai Receipt No. : . Signature becencn ne Authority Form D Regulation 6(2) Somepuim IV Crmnmoar: or Rroismantox Certified that the following drug is hereby registered under tho Cosmetics, Devioes and Drugs Act No. 27 of 1980. Namo of Drug tnenne + Dosage form fvnnennnee Nome of manufacturer Country of manufacture Name of Importer Registration No. Dato of Registration ‘Typo of Registration Full Registration : Provisional Registration -—- Period : Schedule : ull registration ehall be valid for a period of 6 yoars unless carlior suspended or cancelled. Provisional registration shall be valid for the period stipulaod. Date of issue : ‘bakery. Tomde : () edga—§ cums gtransi§ia c880il Undded G6 Beas asd oys—1085.12.02 45 A Pane I: Syo (1)-GAZETTE EXTRAORDINARY OF TH® DEMOCRATIO SOCIALIST REPUDLIC OF SRI LANKA-108.12.02 orm E Regulation 7(3): Soumpune IV Areuicarion Form ror Ruwnwat, or Ruoisraanios ov a Dave von Zurour/Manoracroan IWe . . . of ee apply for renowal of registration of the drug for import/manufueture, Registration : Expiry date of Just registration Signed: 3 Address: Date : Designation of applicant Form A Regulation 12(1) Senmpure V Appiucarion fon Licewor 70 Inceort Davos I/We ss vmnnsene orehy apply for the import of ‘the drug(s) registered hy the authority. Signed : Adare : Date : ; Designation of applicant : Form B Regulatfon 16(1) Sounsorn ¥ Laoxsox ro Inront Daves Mys. .. ' sonnei OF ae es {are hereby lleensod to import into Sri Lanka during the period for which this licenco igin foree, the drugs spocitied below, manafactured by . ‘This Koonce is subject to the conditions prescribed in regulation 16 of tho Drugs Regulations made undorthe Cosmoties, Dovioes and Drugs Act, No, 27 of 1980 as amended by Act, No. 38 of 1984 ond shall be in foroe for one year from the date of iaeuo, wnlers itis earlier susponded or eatoolled. ‘Namoe of drug(s) and dosnge forms to which this licence is applied -— L % Dato of issue : WA Lemda: @ exga—9 crm gusaasifin o8,40i2 dndded oF Baas ws0 ogs—1085.12.02, Par 8:0. (1)-OAZBTTH EXTRAORDINARY OP TRE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA. 8.42.02 24) Form ¢ Rogul Sourputn V Avpuicamon so 4 Liozxon ro Tapons' 4 Lotoren Quantity op any Dava(s) ror Txsr, Exaxmnvati0n, Dismeroriox as Swnrues, ANALYSIS on CiiNtoaL, TRIAL ayWe Eat apply for a licence to import from M/s... : ss vw.» the drug(a) specified below for the purpose of test, examination, distribution as ‘samples, analysis or clinical trial, Namo(e) of drag(a) and dosage forms : 1 a whereby, Fe attestation OR Signed ABALO0 2 oooiene Date :. : Designation of applicant Form D Regulation 26(2) Souspuun V Jacuwer ro Lirorr Daves rox Teor, Exaxncunion, Dismmuyox as Sastwiis, Asatvsis on Cuintoa Tatars Lioonca Nurmber : M/s. oo 7 of ifaro hoteby licensed to import 008 juve nsonanin he drug(s) eposiied below for the purpozo of test, examination, distribution as aamplee, analysis or clinical trial- ‘Thie licence ia subject to the conditions prescribed in regulation 26 of the Drugs Regulations made under the Cosmeties, Devices and Droge Act, No. 27 of 1980 as amended by Act, No. 38 of 1084. ‘The Licence shall ho valid for tho importation of one batch of drugs only and he valid for one sear from the dato of issue. ‘Namo(s) of Drug(e) with quontities which may be imported : lalate ec . 3. . Dato of issue : - “Authority. Sommpute ¥ Form Regulation 29 Avprsoarzox ror Ltoznos 70 Teor Davas ron Pensowan Use OF ssssens horeby apply for a licence to import the drug(s) specified below solely for my personal attach a presoription from a registered medical practitioner in regard to the need for the sald drug(e). ‘Namo of drag(s) and quantity :. Date tacssessnes Temdes: (©) oxtga—@ orem gunman GOssO:8 dendded 48 Boae 0180 wye—1985.12.02 AAT Pant I: Sno, (1)-GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA.1086.12.02 Form F Regulation 29 Sonmpuue V Lacexon to Inport Drvas ror PERSONAL USE Licence Number of is hereby licensed to import the following drug (6) in the quantities sperifed. Drag(e) Quantity This licence ts subject to the conditions prescribed in regulation 29 of the Drugs Regulations made under Cosmetics, Devices and Drugs Act No.27 of 1980 as amended by Act, No.38 of 1984 and shall bo in feree for a period ‘of one year from the date of issue unless it s earlier suspended or cancelled. Date of Tssve : Authority, Regulation 31 ‘Regulation 36 Sonzpurx VI AvrticaTion Fou Guan3/RuNEwar op A Licexce 10 Maxuractorz Brvos sx wax oy Dasto Manuracronn/ Smo Basio MANcracrorr/Fornvt.ation /REPACKING 1pWe f premises situated at — ‘horeby apply for a grant/renewal of a licence to manufaetare hy way of ........ 0m Name of Drug Dosage form(s) Details of the firm required for registration are given in the enclosed form, Signed : Namo and Address Form B Regulation 38 Sonspure VI Licexor 70 Manvracrorr Davos. . is/are hereby licensed to manufacture the drugs specified below at the premises ‘This licence ia eubject to tho conditions preseribed in regulation 34 of the Drugs Regulations mado under the Cosmeties, Devices and Drugs Act No. 27 of 1980 as amended by Act No. 98 of 1984 and ehall bo in force for one ‘year from tho date of issue, unloss it is earlier suspended or cancelled. ‘Namo of drug(¢) and dosage form(s) to which this licence is applied. pee 2 3. Date of issue Authority. WBA Lemma: (1) os¢s—G crams guvantgn BOD? Kenddied #8 Boas 00 &yd—1085.12.02 Pane igo. ()-GAZETT EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA.1086.12.02 Form A Rogalation 42, Scaxputn VIL AvsuivaTion son Lioesor 70 Sets, Daves (sx Rena) 1We of horeby apply for alicence to dealin drugs (by rotail)on promises situated at Signed Name and Address: Designation of applicant : Detaile regpived : Ts Liconcee a rogistered pharmacit Or. Is tho transaction carried out on hohslf of licences by a regiatered pharmacist Name and Address of a registered pharmacist Registration No Storage faclitios availablo in the premises Naxae and qualifentin of person(s) supervising datibuiton and preweration of drug. a licenoe been issued haforo and vevoked by the Drage Authority: Form B ~~ Regulation 44 Sonzoute VIL Lrosxos ro Sut Davos (nx Brzart Licenoe Number Mises nnn Ofnn snrisfare bexeby licensed to deal in diugs (by retail) on premisessittated at This Licence is subject to tho conditions proscribed in regulation 46 of the Drugs Regulations made under the Cosmetics, Devices and Drugs Act, No.27 of 1980 a amended by Act, No.38 of 1984 and shall he in foree for a poriod of one yeat from the data of iseuo unless it is earlier suspended or cancelled. Date of is8te tcc Authority, Form A ‘Regulation 56 Sonxpute VII Avrsication sox Licexon 70 Seut, Duvos (ax WKOLESAL2) TfWo of ‘heroby apply for a ficance to deal in drugs by (wholesale) on premises situated at Dato tens SigNOM Losenen ‘Namo and Addrdss Designation of applicant : Details Required « In licences a rogiatered pharmacies} OF Is the Transaction carried out on behalf of licence by a registered pharmacist ‘Name and qualifioation of pocson (a) suporvising distribution and proservation of dru Fras licenoe been issued before and revoked by the Druga Authority, Tombs: () oga—§ cans gérmaigin o8Ds8 Unddad gS Beau «od op4—1089.12.02 Purr I 829, ()-GAZETTE EXIRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA-10%6 Form B Regulation 53 Sonuoune VIII Taensen 20 Sez, Davos (uy Watoursane) Licenoe Number : Mys. «-isfare hereby licesssed to desl in drugs (wholwealo) on proinises situated at ‘This liconco is subject to the conditions prosoribed in regulation 60 of the Drugs Regulations mado under the Coameties, Devicos und Drugs Act, No.27 of 1980 as amended by Act, No.38 of 1984 nnd shall be in foroe for a poriog of one year from the dote of issue unless enrlier suapended or cancelled. Date of irene Authority Form © Sonmpoue VIL Rogulation 61 , ApexicaTion You Revpwat or Licenor To Dean nv Daves (Wrounsaues/Reram) iWe of .. hereby apply for renowal of licence to deal in drugs by (wlio ‘on premises situated nt Bapiry date of lat registration : Signed: Name and Address 7 Designation of applicant Form A Sounpon IX Regulation 68 Aeruiaamos ror Livrxor ro Teaxsronr Devos or Diswninovi0w. Wo .. 1 Of hereby apply for a Ticonee to teausport registered drugs. Status of applicant: Licensed dealer Oo ‘conse importer Liconsed manacturer (ok off appropriate box.) Sigpet Name: . Licence No: Addr068 on Data: Desigaation of applicant : Form B ~ Scuzpuus IX Laomxen #0 Traxsron Davos FOR Drsversortox Licence Number : Mi. . ia/aro horeby ligonsed to transport So This lioonce is ovbjeot to tho conditions prescribed in regulation 70 of the Drugs Regulations made under the Cosmetics, Devices and Drugs Act, No. 27 of 1980 as amended by Act, No. 38 of 1984 and shall be iu force for 1 potiod of one yecr from the date of isme unless earlier suspended or cancelled, Date of issue t... 80.A Tomes: (1) aves com yori e@ube? denoted gS Dome osd wye-—1985.12.02 ‘Pant L8xo. (1)-GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA-1085.12.02 Sonspuus X ‘Regulation 74 ‘The package insort shall contain tho following information : (@) Pharmacology Pharmacological actions. ‘Mechanism of action (if known), Relevant pharmocokinotio data. (©) Clinical Information Indications. Contraindications. Crecautions. Warnings. Adverso effects. Drug interactions. Dosage regimen. Average doss and dose range for adults and children. Dosing interval. Average duration of treatment, Dosages in special situstions e.g, ronal, hepatio and cardiac insuilloioney Ocerdasag Brief clinical description of symptoms. Trostiaent of overdosage. (0) Pharmaceutical Information Dosage forms and strengths of different dosage forms Storage conditions and shelf life (expiration date). Package sizes. Desoription of product og tablet size, colour, markings ete, ‘Name and addross of manufecturer (if not given earlier). Regulations 6 Regulations 15 Regulations 25 Regulations 33, Regulations 45 Regulations 59 SoanpeLe XT Regulations 69 BES 1. Certificate uf Registration. —Tho feo for the Oortificate of Registration shall be as follows — (1) Rupoes five hundved for registration of a drug ; . @) Rupees two hundred and ‘fifty for the renewal of registration of a drug ; Provided that tho application for the renewal of registration is mado six months before the expiry of the validity of the Certificate of Registration, (3) A fee of rupees fifty shall bo paid for a ditplioate copy of the Cortificate of Registration if the ‘original is damaged or lost and auch copy of the certificate shall bear the words “ duplicate copy”. 2, Licence to Deal in Drugs (Retail) —fee for a licendo to deal in drugs (retail) is Rs. 500/- (Five Hundred) 3. Licence to Deal in Druge {Wholesale).—Feo for a licence to deal in drugs (Wholesale) is Rs. 1000/-. (One Thousond 4. Licence to Import Drugs. Feo for a liconce to import registored drugs is Rs. 1000 ]-. (Qne Thousand) 5, Licence Feeto Manufacture Drags.—Tho fee for a licenco to manufacture drugs is Rs:1000/-.(One Thousand) ‘PRINTED AT HE DEPARTMENT OP GOVERNMENT PRINTING, GRE LANKA

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