‘A Compilation of Laws on Food and Drug DRUG ACT, B.E. 2510 AND ITS AMENDMENTS BHUMIBOL ADULYADEy, REX. Given on the 15th day of October B.E. 2510 Being the 22nd year of the present Reign His Majesty King Bhumibol Adulyadej has been graciously pleased to proclaim that; ‘Whereas itis expedient to revise the law on the sale of drugs; Be it, therefore, enacted by the King, by and with the advice and consent Of the Constituent Assembly in the capacity of the National Assembly, as follows Section 1. This Act is called the “Drug Act, B.E. 2510” Section 2. This Act shall come into force after the expiration of sixty days from the date of its publication in the Government Gazette. Section 3. The following shall be repealed: (1) The Sale of Drug Act, B.E. 2493; (2) The Sale of Drug Act (No. 2), B.E. 2498; (3) The Sale of Drug Act (No. 3), BE. 2499; (4) The Sale of Drug Act (No. 4), B.E. 2500; (5) The Sale of Drug Act (No. 5), B.E. 2508. Section 4. In this Act: “Drug” means: (1) Substances recognized by pharmacopoeia notified by the Minister. (2) Substances intended for use in the diagnosis, treatment, relief, cure or prevention of human or animal disease or illness. (3) Substances which are pharma chemicals or semi-processed pharma chemicals. (4) Substances intended to affect the health, structure or function of the human or animal body. Substances under (1) (2) or (4) shall not include: (a) Those intended for use in agriculture or industry as notified by the Minister, (b) Those intended for use as food-for human, operating goods, medical apparatus, cosmetics or device for use in the practice of medicine and a component thereof,2 A Compilation of Laws on Food and Drug (©) Those intended for use in science laboratory for research, analysis or n of disease which is not directly done to the human body “Modern drug” means a drug intended for use in the practice of medicine or the cure of an animal disease, “Traditional drug” mea traditional medicine or the cure or an animal disease which appears in a pharmacopoeia of traditional drug notified by the Minister, or a drug notified by the Minister as a traditional drug, or a drug of which formula has been registered as that of a traditional drug; “Dangerous drug” means a moder of traditional drug notitied by the verificat s or drug intended for use in the practice of the Minister as a dangerous drug; “Specially-controlled drug” means a modern or traditional drug notitied by the Minister as a specially-controlled drug; “External drugs” means moder or traditional drugs intended for use externally, “Specific place drugs” means modern or traditional drugs intended for use in specific places for ears, eyes, nose, mouth, anus, vagina or gutter urine. “Household medicine” measns a modern or traditional drug notified by the Minister as a household medicine; “Ready-packed drug” means a modern drug manufactured in a pharma- ceutical form, which is packed in a closed or sealed container or package and which has all the labels in accordance with this Act; “Herbal drug” means a drug derived from a plant, anit which has not yet been compounded, dispensed or denatured: “Practice of modern medicine” means the practice of medicine by | or mineral dependence on the knowledge acquired through leaming on a scientific basis; “Practice of traditional medicine” means the practice of medicine by dependence on the knowledge acquired from a textbook or through learning which is not (on a scientific basis; “Cure of animal disease” means any action performed directly on an animal body for the purpose of examination or treatment and includes the prevention of ase, elimination of disease, plastic surgery, castration or artificial insemination; “Produce” means manufacture, dispense, prepare or denature and includes change of drug form or apportion as ready-packed drug; “Active ingredient” means material ehich is an important component in the drug and has the power to treat, relief, care or prevent disease or illness to human or animal. “Strength of active ingrediens” means (1) The concentration of the drugs which has a quantify of active ingredients stated as weight per weight, weight per volume or quantity of activeA Compilation of Laws on Food and Drug ingredients per dosage. (2) The effect of healing of the drug that has been tested in laboratory in suitable way or has passed adequate controlled usage. “Sell” includes dispense of, distribute, issue or barter, for commerci purpose, and posses for sale; “Label” includes any picture, design or statement displayed on the container or package of a drug: “Accompanying literature” include paper or any other material that the meaning is shown through a picture, figure, sign or any text concerning the drug that is kept or included with the containers or packings of the drug. “Drug formula” means formulas of components regardless of form and shall included drugs in a processed form ready for use for humans and animals. “Modern medical practitioner” means a practitioner of modern medicine ifery or nursing under the law on the in the branch of medicine, dentistry, pharmacy, mich control of the practice of medicine; “Traditional medical practitioner” means a practitioner of traditional ‘medicine in the branch of medicine or pharmacy under the law on the control of the practice of medicine; “First-class pharmacist” means a first-class practitioner in the branch of medern pharmacy; “Second-class pharmacist” means a second-class practitioner in the branch of modern pharmacy; “First-class veterinary practitioner” means a first-class veterioary practitioner in the under the law on the control of the cure of animal diseases, “Second-class veterinary practitioner” means a second-class veterinary practitioner under the law on the control of the cure of animal diseases; sin case the licensee is, “Licensee” means a person licensed under this Ac 8 juristic person, it shall included the person appointed to conduct its affairs; “Licensing authority” means: 1) The Secretary-General of the Food and Drug Administration or the person entrusted by him for licensing the production of a drug or the importation or order of a drug in to the Kingdom; (2) The Secretary-General of the Food and Drug Administration or the person entrusted by him for the sale of a drug in Changwat Phra Nakhon; (3) The Changwat Governor, for the sale of a drug within his territorial Jurisdiction, except Changwat Phra Nakhon. “Committee” means the Drug Committee under this Act; “Official” means a person appointed by the Minister to implement this Act;4 A Compilation of Laws on Food and Drug “Minister” means the Minister having charge and contol of the execution of this Act. Section 5. The Minister of Public Health shall have charge and control of the execution of this Act, and the power to appoint official, to issue Ministerial Regulations prescribing fees not exceeding the rates hereto attached, granting exemptions from fees and prescribing other acts for the purpose of carrying out this Act. ‘Such Ministerial Regulations shall come into force upon their publication in the Government Gazette. Chapter Drug Board Section 6, There shall be a Board called the “Drug Board” consisting of the Permanent Secretary of the Ministry of Public Health as Chairman, Director-General of Department of Medical Services, Director-General of Department of Communicable Disease Department of Communicable Disease Control, Director-General of Department of Medical Sciences, Director-General of Department of Health, Secretary-General of the Food and Drug Board, a representative from the Ministry of Defence, are presentative from the Ministry of Agriculture and Cooperatives, two representatives from the Ministry of University Affairs appointed from the Office of the Council of State, Director of the Medical Registration Division of the Office of the Permanent Secretary for Public Health, as member ex officio, and not less than five but not more than nine qualified members appointed by the Minister of which at least two must be practitioner of tracitional medicine. Deputy Secretaries-General of the Food and Drug Administrative shall be member and secretary of the Board, and the Director of Drug Control Division of the office of Food and Drug Board shall be member and assistant secretary. Section 7. A qualified member shall hold office for a term of two years. An outgoing member may be re-appoined. Section 8. Apart from vacation office under section 7, a qualified ‘member vacated his office upon: (1) death; (2) resignation, (3) being retired by the Minister: (4) being a bankrupt: (5) being an incompetent or quasi-incompetent person:A Compilation of Laws on Food and Drug. (6) being imprisoned by a final judgment of the Court to a term of imprisonment, except for an offence committed through negligence or petty offence; (7) Suspension or revocation of his licence to practise medicine. When a qualified member vacates his office before the expiration of his term, the Minister shall appoint another person to replace him, and such person shall remain in office for the unexpired term of office of the member he replaces. Section 9. At a meeting of the Committee not less than one-third of the total number of its member must be present to constitute a quorum. If the Chairman is not present at the meeting, the members present shall elect one from among themselves to be presiding chairman. A final decision of the meeting shall be by majority of votes. Each member shall have on vote. In case of an equality of votes, the presiding chairman shall have a castin vote. Section 10. The committee shall have the duty to submit recommendations and opinions in the following matters: (1) the licensing of the production or sale of a drug, or importation or order of a drug into the Kingdom, and the registration of a drug formula; (2) the suspension, revocation of a licence or revocation of a drug formula registration; (3) the establishment of the rules, procedures and conditions concerning the production or sale of a drug importation or order of a drug into the Kingdom, importation of a drug as sample for examination, and the inspection of the place of production or sale of a drug, importation or order into the Kingdom and of storage of a drug; (4) the exercise of the power by the Minister under Section 76 or Section 77; (5) other matters as entrusted by the Minister. Section 11. The Committee shall have the power to appoint subcommittees to consider, study or analyze the matters within the authority of the Committee and Section 9 shall apply mutatis mutandis to meetings of the subcommittees. Chapter It Application for and Issue of a Licence Concerning Modern Drugs Section 12. No person shall produce or sell a modem drug, or import or order a moder drug into the Kingdom, unless he has obtained a licence from the licensing authority.6 ee, Compilation of Laws on Food and Drug The application for and grant of a licence shall be in accordance with the rules, procedures and conditions prescribed in the Ministerial Regulation, Section 13. The provisions of Section 12 shall not apply to: (1) The production of drugs by Ministries, public bodies and departments which have a duty to prevent or treat disease, and by the Thai Red Cross and pharmaceutical organization, (2) The production of drugs in accordance with the prescription of a Practitioners in the vacationers medicine or practitioners in the art of healing for a particular Patient or in accordance with the prescription of a veterinary for a particular animal, (3) The sale of herbal drugs which are not dangerous drugs, the sale of common household drugs, the sale of drugs by practitioners in the art of healing in the field of dentistry to their care of the sale of drugs by veterinaries to their treatment oF prevention of animal disease or the sale of drugs by ministries, public bodies and departments which have a duty to prevent or treat disease and by the Thai Red Cross and pharmaceutical organization, (4) The personal bringing into the Kingdom of drugs required for personal use for thirty drugs, (5) The importation by ministries, public bodies and departments which have a duty to prevent or treat disease, and by the Thai Red Cross and pharmaceutical organization. Section 14. The licensing authority may issue a licence to produce or sell modern drugs, or to import or order modern drugs into the Kingdom, when it appears that the applican (1) Is the owner of the business and has sufficient property or status to be able to establish and operate the business, (2) Is not less than twenty years of age, (3) Is resident in Thailand, (4) Has not been sentenced by the Courtds final judgment or a legitimate order to a jail term for an offense that requires guilty intentions as a component or in an offense against laws on narcotics, laws on substances having effects on the mind or nerve laws on the sale of drugs or this Act unless the offender has been released for not less than two years prior to the date of application for the licence, (S) Is not mentally defective or declared incompetent or quasi-incomplement, (6) Does not have any sickness as specified in the Government Gazette promulgated by the Minister, (7) Has premises to produce, sell, import or store drugs and equipment tor use in the production, sale or storage of drugs and the control or maintenance of the quality of drugs of the character and quantity prescribed in Ministerial Regulations,‘A Compilation of Laws on Food and Drug. (8) Uses a trade name which is not a repetition of or similar to the trade name used by a licensee whose licence is suspended or has been revoked for less than a full year, (9) Has persons to act in accordance with Section 38, Section 39, Section 40, Section 41, Section 42, Section 43 or Section 44 as the case may be. Person with duty to perform in accordance with (9) must remain at the place of production, place of sale or place of importation of drugs into the Kingdom and at the place only. In the event the applicant is a juristic person, the manager or agent of juristic person who conduct its affairs qualified under (2) and (3) and does not have prohibited characteristics as specified in (4) (5) or (6). Section 15. The categories of licences for modern drugs are as follows: (1) a licence to produce modern drugs; (2) a licence to sell modern drugs; (3) allicence for modern drug wholesase; (4) @ licence to sell only ready-packed modern drugs which are not dangerous or specially-controlled drugs; (5) allicence to sell only ready-packed modern drugs for veterinary use; (6) alicence to import or order drugs into the Kingdom; A licensee under (1) or (6) shall be also deemed to be licensed under (3) in respect of the drugs which he produces, imports or orders into the Kingdom, as the case may be. A licensee under (2) shall be also deemed to be licensed under (3) (4) and (5). A licensee under (3) shall be also deemed to be licensed under (4) and (5) for wholesase only. Section 16. A licence issued under Section 15 shall also cover the employees or agents of the licensee. An act of an employee or agent of the licensee covered under paragraph one shall be also deemed to be the act of the licensee unless the licensee can prove that it was impossible for him to have knowledge or control of such act. Section 17. Licence issued under Section 15 shall remain valid until the 31st December of the year of issue a licensee who wishes to renew his licence shall, before its expiration, file an application for renewal. When the application has been filed, the business may be continued until the Licensor gives and order refusing to renew the licence. Applications for renewal and renewal of licences shall be in accordance with the rules, procedures and conditions prescribed in Ministerial Regulations,8 A Compitation of Laws on Food and Drug A Licensee whose licence has expired not more than one month may file an application for excemption stating the reason for the extension of the licence but the application for excemption is not a reason for offenses committed prior to the application for extension of licence. An application for renewal of licence after one month from the date the licence has expired is not permitted. Section 18. Where the licensing authority does not issue nor grant the Tenewal of a licence, the applicant has a right to appeal in writing to the Minister within thirty day from the date of the receipt of the notice from the licensing authority informing that the licence will not be issued or renewal granted. ‘The decision of the Minister shall be final. ‘Where the licensing authority refuses to renew a licence to produce modern drugs ponding the decision of the appeal by the Minister under paragraph two, the Minister has, at the request of the appellant, the power to permit a temporary operation of the business. Chapter Ill Duties of a Licensee Concerning Modern Drugs Section 19. Licensees are prohibited from: (1) Produ: Prescribed in the licence with the exception of wholesale sales. (2) Producing or selling drugs which do not correspond to the category ing or selling modern drugs in premises other than those of license. (3) Selling modern drugsi which are dangerous or specially-controlled drugs to the licensee under section 15 (4). Section 20, Persons licensed to produce modern drugs must have at least two first class pharmacists with the duty to act as provided in Section 38 and provide at least one pharmacist on duty for the duration of business hours. Section 21. Persons licensed to sell modern drugs must have a first OF Second class pharmacist with the duty to act as provided in Section 39 or 40 on duty for the duration of business hours. Section 22. Persons licensed to sell modern package drugs other than dangerous or specially controlled drugs must have a first or second class pharmacist Or practitioners in the vocation medicine or first class practitioners in modern art of healing in the fields of dentistry, midwifery or nursing with the duty to act as provided in Section 41 on duty for the duration of business hours,‘A Compilation of Laws on Food and Drug. Section 23. Persons licensed to sell modern packaged drugs for veterinary use must have a first or second class pharmacist, first or second class veterinary with the duty to act as provided in Section 42 or 43 duty for the duration of business hours. Section 24, Persons licensed to import modern drugs must have a first with the duty to act as provided in Section 44 on duty at the premises to class pharma import drugs or store drugs for the duration of business hours. Section 25. Persons licensed to produce modern drugs shall: (1) arrange for a sign, in the public place in front of the premises for producing drugs accordance with the category of the license which can be easily seen from outside the building as follows: (a) @ sign show that itis a place for the production drugs; (b) a sign show first name, last name and qualification of the one who have the duty and the office time, Substances used in making the sign, appearance, colour, size of the sign, size of letters and the text on the sign shall be in accordance with Ministerial Regulations. (2) arrange for an analysis of the raw material and drugs produced before despatching them from the place of production, the evidence showing the particulars of each analysis to be kept for not less than five years. (3) provide labels corresponding to the formula registered affixed to containers and packing for drugs produced shall always be fully labelled to show: (a) the name of the drug; (b) numbers or codes of the certificate of formula registration; (©) the quantity of the drug contained; (@) the name and quantity or strength of the important active ingredients of the drug; (e) number or letters indicating the lot and analysis; (®) the name of the producer and the province where the place of production is located; (g) date of production; (h) the words “dangerous drug” “specially controlled drug drug” “specific place drug” as the case may be in clearly visible red letters where the drug is a dangerous or specially controlled or external or specific place drug; (@ the words “common household drug” if the drug is a common ‘external household drug; (the words “for veterinary use” in the event the drug is for veterinary use; (k) the expiry date if the drug has been notified by the Minister under Section 76 (7) or (8).10 A Compilation of Laws on Food and Drug (4) use labels and accompanying literature corresponding to the formula registered and the text on the label and accompanying literature must be easy to read, If the accompanying literature is in a foreign language, it shall also be in Thai (S) provide a warning as to the use of the drug in the label and accompanying literature in the eventit is a drug notified by the Minister under Section 76 (9), (6) prepare a list of raw materials used in the production of the drugs, a list of drugs produced, sold and keep samples of the drugs produced, in accordance with Ministerial Regulations. (7) do as otherwise provided in Ministerial Regulations. In the event that the drug produced cannot show the text in (3) (a) to (k) on the container, at least it must show the text in (3) (a) (d) and (k). In the event that the drug is produced for export outside the Kingdom, the text in the label and accompanying literature must have the name Thailand, any other text which the producer wishes to have exemption must receive permission from the licenser. In the event that the licensee to produce modern drugs wishes to change the label concerning the expiry date in (3) (k) must file an application according to the rules, procedures and conditions prescribed in Ministerial Regulations. Section 26. Persons licensed to sell modern drugs shal (1) arrange for a sign, in the public place in front of the premises for ly seen from selling drugs accordance with the category of the licence which can be ea outside the building as follows: (a) a sign show that itis a place for the selling drugs; (b) a sign show first name, last name and qualification of the person ‘who has the duty and the business hours; Substance is made for a sign, appearance, colour, size of a sign, size of letters and the text shown on the sign shall be in accordance to the Ministerial Regulations. (2) keep veterinary drugs in a place separate from other drugs. (3) Keep each of the following separately: (a) dangerous drugs; (b) specially controlled drugs; (©) other drugs; (4) keep a separate place for compounding drugs in accordance with Prescriptions of practitioners in the vocation medicine or practitioners in the modern art of healing or veterinaries and for the storage of drugs for such purposei A Compilation of Laws on Food and Drug. (5) provide that thecontainers and packing for drugs shall always be fully labeled as prescribed in Section 25 (3), (© prepare a list of drugs bought or sold as specified in Ministerial Regulations. (7) do as otherwise in Ministerial Regulations. The provisions of paragraph one shall apply mutatis mutandis to licensees who have been licensed under Section 15 (3) and (4).. Section 27. Persons licensed to import modern drugs shall: (1) arrange for a sign, in the public place in front of the premises for importing drugs in accordance with the category of the licence which can be easily seen from outside the building as follows: (a) a sign to show that it is a place for the importing drugs, (b) a sign show first name, last name and qualification of the one who have the duty and the office time, Substances used in making the sign appearance, colour, size of the sign, size of letter and the text shown in the sign shall be as prescribed in Ministerial Regulations. s of an (2) provide a certificate from the producer giving the particula analysis of the drug imported to be kept for not less than five years. If the certificate from the producer is in a foreign language, it shall also be in Thai, and the drug containers will always be fully labeled as prescribed at least in Section 25 (3), (a) (c) (d) (t) (h) and (k) with the exception of the text in (f) requires the name of city or country that the drug was produced instead of the name of the province. (3) before the drugs can be sold, the labels on the containers or packings must have all the characteristics and text as specified in Section 25 (3) with the exception of the text in (f) requires the name of city or country that the drug was produced instead of the name of the province. In the event that the drug brought or ordered into the Kingdom does not have the text required in Section 25 (3) (a) to (k) on the container, at least it must show the text in Section 25 (3) (a) (c) (e) and (k). (4) use labels and accompanying literature corresponding to the formula registered and text in labels and accompanying literature must easily seen. If the accompanying literature is in a foreign language, it shall also be in Thai. (5) prepare a list of drugs brought or ordered into the Kingdom, for sale or storage of sample drugs brought or ordered into the Kingdom. This shall be done in according with Ministerial Regulations. (6) do as otherwise provided in K12 A Compilation of Laws on Food and Drug RE Section 28. In the case where a licence is lost or materially destroyed, the licensee shall inform the licensing authority of it and file an application for a Hence substitute within fifteen days from the day he is aware of such loss os damage The application for and the issuance of a licence substitute shall be in cerance with the rules, procedure und conditions prescribed in the Mixiteriai Regulations. Section 29. Licensees shall display their licences of pharmacists, Practitioners in the vocation medicine, fist class practitioners in the modern act of healing in the fields of dentistry, midwifery or nursing or veterinaries in » conspicuous Place atthe place of production, sale or importation, asthe case may be. Section 30. No licensee shall move the Place to produce or sell drugs ie Import ot order drugs into the Kingdom, or the store drugs, except by permission of the licensing authority. Section 31. No licensee shall produce modern drugs at the place to Produce drugs while the pharmacist is not Present therein to perform the duties, ‘The application for and the grant of a permission shall be in accordance with the rules, procedures and conditions prescribed in the Ministerial Regulation Section 32, No licensee shall a dangerous or a specially-controlled drug while the pharmacist or the veterinary practitioner is not present to perform the duties, Section 33. When a licensee desires to change the person who performs the duties under Section 38, Section 39, Section 40, Section 41, Section 42, Section 43 OF Section 44, he shall notify the licensing authority of the same in writing, and the change may be made when a permission is granted by the licensing authority. In the case where a licensee has no person to perform the duties mentioned in paragraph one, he shall notify the licensing authority of the same in writing within Seven days from the date he has no such person. Section 33 bis. In the event that the person with duty to perform at the place production, sale or importation of drugs into the Kingdom is not able to perform the duty temporaly, not more than 60 days the licensee must Provide a person with the same qualifications as the person with duty, to perform the duty instead the licensee Must submit a prior written notification to the licensor and it shall be deemed that the Person performing the duty instead is the person with duty under Section 38, Section 39, Section 40, Section 41, Section 42, Section 43 or Section 44 as the case may be. The written notification under paragraph one shall be as prescribed in the Commissionus regulations, Section 34. A person, having the duties under Section 38, Section 39, Section 40, Section 41, Section 42, Section 43 or Section 44, who no longer desires ‘© Perform the duties, must notify the licensing authority of the same in writing within Seven days from the date of the termination of his duties,i 13 ‘A Compilation of Laws on Food and Drug. Section 38. Any licensee who ceases to operate the licensed business under this Act shall notify the licensing authority of the same in writing within fifteen days from the date of cessating thereof, and the licence shall be deemed to expire from the date of the cessation of the business as notified. Section 36. A licensee who notifies of the cessation of the business any sell his remaining drugs to another licensee or to a person deemed appropriate by the licensing authority within ninety days from the date of the cessation of the business except where the licensing authority allows an extension for the said period. Section 37. If a licensee dies and a person who is qual licensee under this Act gives notice of his desire to the licensing authority within thirty days from the date of the death of the licensee, to continue the operation of the licensed business of the deceased, such person may continue to operate the business until the licence expires, In such case, the person giving notice of his desire shall be deemed a licensee under this Act from the date of the death of the licensee. Chapter IV Duties of a Pharmacist, a First-Class Modern Medicial Practitioner In the Branch of Medicine, Dentistry, Midwifery of Nursing, Or a Veterinary Practitioner ied to be a Section 38. First class pharmacists under Section 20 on duty at the place of production for the whole duration of business hours and have following duties: (1) exercise control to insure that the production of drugs conforms to the formulae registered under Section 79, (2) exercise control to insure that drug labels and accompanying as Section 25 (3) (4) and (5). (3) exercise control to insure that packing and labeling of drug containers or packings is correct as this Act, (4) exercise control over the sale of drugs to insure compliance with Section 39, (5) exercise control the list of drugs and keeping sample drugs under Section 25 (6), (6) do as otherwise provided in Ministerial Regulations. Section 39. First class pharmacists under Section 21 on duty at the Place of sale of modern drugs during the duration of business hours and shall have the following duties:4A Compilation of Laws on Food and Drug (1) exercise control over the separation of drugs under Section 26 (2) and (3), (2) exercise control over labelling in accordance with Section 26 (5), (3) exercise control over the sale of drugs to insure compliance with this Act, (4) compound drugs at the place provide by the licensee in accordance with Section 26 (4), (5) label containers or packings for drugs compounded to the prescriptions of practitioners in the vocation medicine, practitioners in the modern art of healing or veterinaries in accordance with the rules, procedures and conditions prescribed in Ministerial Regulations. (6) exercise control over the delivery of dangerous or specially controlled drugs or drugs prescribed by practitioners in the vocation medicine, practitioners in the modern art of healing or veterinaries, (7) exercise control the list of drugs under Section 26 (6), (8) do as otherwise provided in Ministerial Regulation. Section 40. A second-class pharmacist under Section 21 shall act in accordance with Section 39 in the same way as a first-class pharmacist except that he may not dispense, sell and deliver a specially-controlled drug. Section 41. First or second class pharmacists practitioners in the vocation medicine, first class practitioners in the modern art of healing in the field of dentistry, midwifery or nursing under Section 22 on duty at the place of sale of modern drugs, only packaged drugs that is not dangerous drugs or specially controlled drugs during the duration of business hours and shall have the following duties; (A) exercise control over labelling in accordance with Section 26 (5), (2) exercise control to insure that packaged drugs are not broken and sold in any from but that produced by the producer, (3) exercise control in preparing the list of drugs under Section 26 (6), (4) do as otherwise provided in Ministerial Regulations. Section 42, First class pharmacists or first class veterinary as under Section 23 on duty at the place of sale of modern drugs, only packaged drugs for animals during the duration of business hours and shall have the following duties: (1) exercise control over the separation of drugs under Section 26 (3), (2) exercise control over labelling in accordance with Section 26 (5), (3) exercise control in insure that package drugs for veterinary use are not broken and sold in any form but that produced by the producer, (4) exercise control over the delivery of packaged dangerous or specially controlled drugs for veterinary use, (5) exercise control the lost of drugs as Section 26 (6), (©) do as otherwise provided in Ministerial Regulations.‘A Compilation of Laws on Food and Drug. 15 Section 43. A second-class pharmacist or a second-class veterinary practitioner under Section 23 shall act in accordance with Section 42 in the same way as a first-class pharmacist or a first-class veterinary practitioner except that he may not deliver a ready-packed drug for veterinary use which is a specially-controlled drug. Section 44. First class pharmacists under Section 24 on duty at the place of importation of drugs into the country or place of storage during the duration of business hours and shall have the following duties: (1) exercise control over the importation of drugs to insure confor to the formular registered under Section 79, (2) exercise control over labelling in accordance with Section 27 (2) and (3), (3) exercise control with procedures connected with the licence of the producer showing the details of the analysis of drugs under Section 27(2) and accompanying documents under Section 27 (4), (4) exercise control over the sale of drugs to insure compliance with Section 39, (5) exercise control the list of drugs and keeping sample drugs as Section 27(5), (6) exercise control over the importation of drugs, (7) exercise control over the storage of the imported drugs at the storage place, (8) do as otherwise provided in Ministerial Regulations. Section 45. Pharmacists, practitioners in the vocation medicine, first class practitioners in the modern art of healing in the fields of dentistry, midwifery or nursing, veterinaries shall be prohibited from doing any act in a place for the production, sale or importation of drugs without being named as the persons having the duty to act in Chapter V Application for and Issue of a Licence Concerning Traditional Drugs such place. Section 46. No person shall produce or sell a traditional drug, or import of order a tra onal drug into the Kingdom, unless he has obtained a licence from the licensing authorit16 A Compilation of Laws on Food and Drug The application for and the grant of a licence shall be in accordance with the rules, procedures and conditions prescribed in the Ministerial Regulation. Section 47. The provisions of Section 46 shall not apply to: (1) the production of a drug by a Ministry, sub-Ministry, Department in its function of the prevention or treatment of a disease, the Thai Red Cross Society and the Government Pharmaceutial Organization, (2) the preparation of a traditional drug by a traditional medical practi- tioner in accordance with the pharmacopoeia notified by the Minster under Section 76 (1) only for his own patients or for resal; (3) the sale of a herbal drug which is not a dangerous drug or the sale of a household medicine; (4) the importation of a drug with the person into the Kingdom not exceeding the amount required for his personal use for thirty days, and the importation or order of a drug into the Kingdom by a Ministry, sub-Ministry, Department in its function of the prevention or treatment of a disease, the Thai Red Cross Society and the Government Pharmaceutical Organization. Section 48. The licensor may issue a licence to produce, sell or import traditional drugs when it appears that the applicant: (1) is the owner of the business and has sufficient property or status to be able to establish and operate the business, (2) is not less than twenty full, years of age, (3) is resident in Thailand, (4) has not been sentenced by the courts or a legitimate order to a jail term for an offense that requires guilty intentions as a compenent or in an offense against laws on narcotics, laws on substanced having effect on the mind or nerve, laws on the sale or drugs or this Act unless the offender has been released for not less than two years prior to the date of application for the licence, (5) is not mentally defective, or declared incompetent or quasi-incompetent, (6) is not afflicted as notified by the Minister in Government Gazette, (7) has the clean and hygienic premises to produce, sell, import or store drugs, (8) use a trade which is not a repetition of or similar to the trade name used by a licensee whose licence is suspended or has been revoked for less than a full year, (9) has persons to act in accordance with Section 68, 69 or 70. Person who has the duty to comply with (9) must be permanently person either at a place of producing the medicine, or place of import or export the medicine only.‘A Compilation of Laws on Food and Drug. 7 In the event the applicant is a juristic person, the managers or agents of juristic person conducting the business must have characteristics as prescribed in (2) and (5) and do not have prohibited characteristics as prescribed in (4) (5) or (6). Section 49. The categories of licences for traditional drugs are as follows: (1) a licence to produce traditional drugs; (2) a licence to sell traditional drugs; (3) a licence to import or order tra A licensee under (1) or (3) shall be also deemed to be licensed under (2) jonal drugs into the Kingdom. in respect of the drugs which he produces, or imports or orders into the Kingdom, as the case may be. Section 50. A licence issued under Section 49 shall also cover the employees or agents of the licensee. An act of an employee or agent of the licensee covered under paragraph one shall be also deemed to be the act of the licensee unless the licensee can prove that it was impossible for him to have knowledge or control of such act. Section 51. Licences issued under Section 49 shall remain valid until the 31st December of the year of issue. A licensee who wishes to renew his licence shall, before its expiration, file an application for renewal. When the application has been filed, the business may be continued until the licensor gives an order refusing to renew the licence. Applications for renewal and permission shall be in accordance with the rules, procedures and conditions prescribed in Ministerial Regulations. A licensee whose licence has expired not more than one month may file an application for exemption stating the reason for the extension of the licence but the application for exemption is not a reason for offenses committed prior to the application for extension of licence which is deemed to be conducting business with an expired licence. An application for renewal of licence after one month from the date the licence has expired is not permitted. Section 52. Where the licensing authority does not issue, or grant the renewal of, a licence, the applicant has a right to appeal in writing to the Minister within thirty days from the date of receipt of the notice from the licensing authority that the licence will not be issued or renewed. ‘The decision of the Minister shall be final. Where the licensing authority refuses to renew a licence to produce traditional drugs pending the decision of the appeal by the Minister under paragraph two, the Minister has, at the reguest of the appellant, the power to permit a temporary operation of the business.18 A Compilation of Laws on Food and Drug Chapter VI Duties of a Licensee Concerning Traditional Drugs Section 53. No licensee shall produce or sell traditional drugs outside the place prescribed in the licence, except in case of a direct wholesale to a licensee to sell traditional drugs. Section $4. Persons licensed to produce traditional drugs must have traditional medical practitioner with the duty to act as provided in Section 68 on duty during the duration of business hours. The person applying for licence under clause one which produces more than fifty formulas shall have a traditional medical practitioner as the person performing the duty under Section 68 on duty during the duration of the business hours. Section 5. Persons licensed to sell traditional drugs must have a traditional medical practitioner with the duty to act as provided in Section 69 on duty during the whole duration of business hours. Section 56. Persons licensed to import traditional drugs must have a traditional medical practitioner with the duty to act as provided in Section 70 on duty at the place of import of traditional drugs or the storage of drugs during the duration of business hours. Section 57. Persons licensed to product traditional drugs shall: (1) arrange for a sign, in the public place in front of the premises for producing drugs accordance with the category of license which can be easily seen from outside the building as follows: (a) a sign show that it is a place for the production drugs, (b) a sing show first name, last name and qualification of the one who have a duty and the office time Substances in made for a sign, appearance, colour, size of a sign, size of literal and the text show on the sign shall be in accordance with Ministerial Regulations. (2) provide labels corresponding to the formular registered be affixed to the containers and packings for drugs produced shall always be fully labelled to show: (a) the name of the drug; (>) numbers or codes of the certificate of formula registration; (©) the quantity of the drug contained; (@) numbers or letters indication the lot;‘A Compilation of Laws on Food and Drug. 19 (©) the name of the producer and the province where the place of production is located; (0) date of production; (g) the words “traditional drug” must have provided easily seen; (h) the words “external drug” or “Specific place drug” as the case may be in clearly visible red letters where the drug is an external or specific place drug; (i) the word “common household drug” if the drug is a common household drug; (the word “for veterinary use” in the event the drug is for veterinary use; (3) use labels and accompanying literature corresponding to the formula registered and the text on the labels and accompanying literature must be easy to read. If the accompanying literature is in a foreign language, it shall also be in Thai; (4) prepare a list of drugs produced or sold as prescribed in Ministerial Regulations. (5) do as otherwise provided in Ministerial Regulations. In the event that the drug is produced cannot show the text in (2) (a) to (j) on the container, at least it must show the text in (2) (a), (c) or (4). In the event that the drug is produced for export outside the Kingdom, the text in the label and accompanying literature must have the name Thailand any other text which the producer wishes to have exemption must receive permission from the licensor and the text in (2) (g), (h) and (i) shall not be applied. Section 58. Persons licensed to sell traditional drugs shall: (1) arrange for a sign in the public place in front of the premises for selling drugs accordance with the category of license which can be easily seen from outside the building as follows: (a) a sign show that itis a place for the selling drugs; (b) a sign show first name, last name and qualification of the one who have the duty and the office hours, Substances is made for a sign, appearance, colour size of a sign size of literal and the text shown an the sign shall be in accordance to the Ministeria Regulations. (2) provide that the containers and packings for drugs shall always be fully labelled as prescribed in Section 57 (2). (3) do as otherwise provided in Ministerial Regulations. Section 59. Persons licensed to import traditional drugs shall: (1) arrange for a sign in the public place in front of the promises for importing drugs accordance with the category of license which can be easily seen from outside the building as follows:2A Compilation of Laws on Food and Drug (a) a sign show that itis a place for the importing drugs: (b) a sign show first name, last name and qualification of the one who have the duty and the office hours, Substances is made for a sign, appearance, colour, size of sign, size of literal and the text shown on the sign shall be in accordance to the Ministerial Regulations. (2) the drug containers will always be fully labelled of the drug imported as prescribed at least in Section 57 (2) (a) (c) (£) and (g) with the exception of the text in (e) requires the name of city or country that the drug was produced of the name of the province. (3) before the drugs can be sold, the labels on the containers or packages n $7 (2) with the exception must have all the characteristics and text as specified in Se of the text in (f) requires the name of city or country that the drug was produced instead of the name of the province. In the even that the drug brought or ordered into the Kingdom does not have the text required in Section 57 (2) (a) to (j) on the container, at least it must show the text in Section 57 (2) to () on the container, at least it must show the text in Section 57 (2) (a) (c) and (d). (4) use labels and accompanying literature corresponding to the formula registered and text labels and accompanying literature must easily seen. If the accom- panying literature is in a foreign language, it shall also be in Thai. (5) prepare a list of drugs brought or ordered into the Kingdom, for sale or storage of sample drugs brought or ordered into the Kingdom. This shall be done in accordance with Ministerial Regulations, (6) do as otherwise provided in Ministerial Regulations”. Section 60. In case of loss or destruction in the essential part of a licence, the licensee shall notify the licensing authority of the same and file and application for a licence substitute within fifteen days from the date of knowledge of such loss or destruction. The application for and the issue of a licence substitute shall be in accordance with the rules, procedures and conditions prescribed in the Ministerial Regulation. Section 61. A medical precitioner in a con: import or order drugs into the Kingdom, as the case may be. Section 62. No licensee shall move the place to produce or sell drugs nsee shall play his licence and that of the traditional jous place at the place to product or sell drugs, or to to import or order drugs into the Kingdom or to store drugs except by permission of the licensing authority.‘A Compilation of Laws on Food and Drug. 2 ‘The application for and the grant of a permission shall be in accordance with the rules, procedures and conditions prescribed in the Ministerial Regulation. Section 63. When a licensee desires to change the person who performs the duties under Section 68, Section 69 or Section 70, he shall notify the licensing authority of the same in writing, and the change may be made when a permission is granted by the licensing authority. In the case where a licensee has no person to perform the duties mentioned in paragraph one, he shall notify the licensing authority of the same in writing within seven days from the date he has no such person. Seetion 63 bis. In the event that the person with duty to perform at the place of production sale or importation of drugs into the Kingdom is not able to perform the duty temporarily not more than 60 days, the licensee must provide a person with the same qualification as the person with duty, to perform the duty instead, the licensee must n to the licensor and if shall be deemed that the person n 69 or submit a prior written notifies performing the duty instead is the person with duty under Section 68, Sei Section 70 as the case may be. The written notification under paragraph one, shall be as prescribed in the Commission regulations. Section 64. A person, having the duties under Section 68, Section 69, or Section 70 who no longer desires to perform the duties, shall notify the licensing authority of the same in writing within seven days from the date of the termination of his duties. Section 65. Any licensee who ceases to operate the licensed business under this act shall notify the licensing authority of the same in writing within fifteen days from the date of cessation thereof, and the licence shall be deemed to expire from the date of the cessation of the business as notified. Section 66. A licensee who noti ies of the cessation of the busines ‘may continue to sell remaining drugs to another licensee or the a person deemed appropriate by the licensing authority within ninety days from the date of the cessation of the business concept where the licensing authority allows an extension for the said period. Section 67. If a licensee dies and a person who qualified to be a licensee under this act gives notice of his desire to the licensing authority within thirty days from the date of the death of the licensee to continue operating the licensed business of the deceased, such person may continue to operate the business until the desire shall be deemed nce expires. In such case the person giving notice of a licensee under this act from the date of the death of the licensee.mA Compilation of Laws on Food and Drug Chapter VII Duties of a Traditional Medical Practitioner Section 68. Traditional medical practitioner under Section S4 on duty at the place of production during the duration of business hours and shall have the following duties, (1) exercise control insure that the production of drugs conforms to the formulae registered under Section 79, (2) exercise control to insure that drugs labels and accompanying as Section 57 (2) and (3), (3) exercise control to insure that packing and labelling of drug containers or packings is correct as this act, (4) exercise control over the dale of drugs to insure compliance with Section 69, (8) exercise control over the list of drugs under Section 57 (4), (6) do as otherwise provided in Ministerial Regulations. Section 69. Traditional medical practitioner under Section 55 on duty of the place of drugs during the duration of business hours and shall have the following duties. (1) exercise control over labelling in accordance with Section 58 (2), (2) exercise control over the sale of drugs to insure compliance with this act, (3) do as otherwise over in Ministerial Regulations. Section 70. Traditional medical practitioner under Section 56 on duty at the place of importation or place of storage during the duration of business hours and shall have the following duties. (1) exercise control over the importation of drugs to insure conformity to the formulae registered under Section 79, (2) exercise control over labelling in accordance with Section 59 (2), (3) exercise control to insure that accompanying as Section 59 (4), (4) exercise control over the sale of drugs to insure compliance with Section 69, (5) exercise control the list of drugs under Section 59 (5), (6) exercise control the importation of drugs, (7) exercise control over the storage of drugs imported at the place of storage, (8) do as otherwise provided in Ministerial Regulations.‘A Compilation of Laws on Food and Drug Section 71, Traditional medical practitioner shall be prohibited from doing any act in a place for the production sale or importation of drug without being named as the persons having the duty to act in such place. Chapter Vill Fake Drugs, Sub-Standard Drugs, Deteriorated Drugs Section 72. It shall be prohibited to produce, sell or import the following drugs: (1) fake drugs, (2) sub-standard drugs, + 3) Deteriorated drugs, (4) Drugs which has not been registered, (5) Drugs whose formula registration has been cancelled for the licensee to produce drugs and licensee to import drugs into the Kingdom or drugs which the drug formula registry has been withdrawn for more than 6 months for the licensee to sell drugs. (6) Drugs whose formula registration has been ordered cancelled by the Minister. The text in (4) shall not be applied the Ministries and Departments with duty to prevent or cure disease the Thai Red Cross or the Pharmaceutical Department. Section 73. The following drugs or substances are fake drugs: (1) a drug or substance which is wholly or partly an imitation of a genuine drug; (2) a drug which shows the name of another drug, or an expiry date which is false; (3) @ drug which shows a name or mark of a producer, or the location of the produce the drug, which is false; (4) Drugs which falsely show that they are in accordance with a formula which has been registered; (5) Drugs produced with active substances which quantity or strength lower than the minimum or higher than the maximum standards prescribed in the registered formula under Section 79 by more than twenty percent. Section 74. The following are sub-standard drugs: (1) Drugs produced with active substances which quantity or strength are lower than the minumum or higher than the maximum standards prescribed in the registered formula to a degree less than the stated in Section 75 (5), (2) Drugs produced so that their purity or other characteristics which are important to their quality differ from the standards prescribed in the registered formulam4 A Compitation of Laws on Food and Drug under Section 79 or drug formulas which the Minister has ordered the drug formuls registry under Section 86 bis. Section 75. ‘The following drugs are deteriorated drugs: (1) a drug the expiry date of which as shown on the label has been reached (2) a drug which has so denatured as to have the characteristics of a fake drug under Section 73 (5) or a drug differing from the standard under Section 74, Chapter 1X Notices Concerning Drugs Section 76. ‘The Minister is empowered to give notice in the Government Gaxette listing: (1) Pharmacopoeias; (2) Substances which are drugs; (3) Dangerous drugs; (4) Specially controlled drugs; (5) Common household drugs; (6) Traditional drugs; (7) Drugs whose expiry date must be given on the label; (8) Duration of usage of some drugs; (9) Drugs for the use of which a warning must be given in the accompanying literature and the text of such warnings. In the event that the Minister has fixed the duration of usage of any drug under (8) if any licensee can prove or that with evidence that the duration of usage might be longer than that fixed by the Minister, the Minister with the approval of the Committee may lengthen the duration of usage for that drug for the licensee who was able to prove or text as a particular case by giving notification in the Government Gazette. Section 77. The Minister shall have the power to publish in the Government Gazette specifying a disease or the symptoms thereof, which a drug is prohibited from being advertised as capable of curing, mitigation. Treating or preventing. Section 77 bis. For the purpose of safeguarding the welfare of the people, the Minister with the recommendation of the Commission has the power to fix the number of placr of sale of drug in a particular area by giving notification in the Government Gazette. Section 78. A Notification of the Minister under this Chapter shall be ‘made upon the recommendation of the Committee.‘A Compilation of Laws on Food and Drug. 25 Chapter X Registration of a Drug Formula Section 79. Any person licensed to produce or import drugs who wished produce or import druge whose fhodern drugs or traditional drugs is required first to the competent officer for registration of the formula. Upon receipt of a certificate of formula registration, the Drug may be produced or imported. Section 79 bis. Section 79 shall not be applied to: (1) drugs that is pharmaceutical chemicals or semi-processed pharma- ceutical chemicals that is not packaged drugs, (2) Herbal drugs, (3) Sample drugs that have received permission to produce, import into the Kingdom for application to register drugs formula in a regulations and conditions prescribed in Ministerial regulations. Section 80. The application for registration of a drug formula under Section 79 shall give the following particulars: (1) the name of the drug; (2) the name and quantity of the ingredients of the drug; (3) the drug contents; (4) the analytical method of the standard of a modern drug in the cordance with the rules case where the analytical method employed is not in the pharmacopoeia notified by the Minister; (5) the label; (© the accompanying leaflets; (7) other particulars as prescribed in the Ministerial Regulation, Section 81. An amendment of particulars in the registration of a drug formula may be made upon the permission of the official. Section 82. An application for a drug formula registration or an amendment of the particulars thereof, and the issue of a certificate of a drug formula registration or an amendment of the particulars thereof shall be in accordance wit and conditions as prescribed in the Ministerial Regul Section 83, The competent officer shall be prohibited fromed registering a drug formula when the committee is of opinion that: (1) the drug is included in Section 72 (1) ot (6); the rules, procedures n.26 A Compilation of Laws on Food and Drug ———_ ee (2) the application for registration of the drug formula is not in conformity with Section 80 and Section 82; (3) the properties ascribed to the drug whose formula is to be registered are incredible or the drug may be unsafe for use; (4) the name used for the drug is boastful, impolite or may be misleadin, (S) drugs using the name not compatible to the good culture of Thailand @ way that might destroy the value of the Thai language; The order refusing to register the drug formula by competent officials shall be final, Section 84, ‘The provisions of Section 83 shall apply mutatis mutandis ‘o the amendment of particulars inthe registration of drug formula. Section 85. The licensee to produce drugs ot licensee to import drugs into the Kingdom must submit an annual report concerning the production or importation cof drugs that the formula has been registered each formula in the form prescribed in Ministerial Regulations within the 31th March of the following year. Any drug that the formula has been registered but not produced or not imported into the Kingdom for two consecutive years, the drug formula shall be withdrawn, Section 86. If, after registration of formula, it appears that the drug does not have the properites as registered or may be unsafe for use or is a drug included in Section 72 (1) or the drug has changed into a material intended for use as food or 4 cosmetics will permission and has received permit 10 sell the food under controlled or has received a certificate of registration of cosmetics as prescribed in the law concerning Cosmetics, the Minister, with advice of the committee, is empowered to order the cancellation of such drug formula registration. Concellation shall be by notification in the Government Gazette. Order of the Minister shall be final Section 86 bis. For the purpose of safeguarding the welfare of the drugs Ses, the Minister with the advice of the Committee is empowered to order a change in the Registration of drug formula as deemed appropriate or necessary. Section 87. In case of loss or destruction in the essential part of a Certificate of drug formula registration, the licensee shall notify the official of the same and file an application for a certificate substitute within fifteen days from the date of knowledge of such loss or destruction. The application for and the registration shall be in accordance with the rules, procedures and conditions as sue of a certificate of a drug formula Prescribed in the Ministerial Regulation.‘A Compilation of Laws on Food and Drug 27 Chapter XI Advertisement Section 88. An advertisement for the sale of drug shall (1) not be boastful of its therapeutic properties or of its ingredients as being miraculously or completely capable of curing, mitigating, treating or preventing a disease or illness, nor shall any other wording of similar meaning be used (2) not falsely or exaggeratedly show its therapeutic properties; (3) not cause to be understood that it has a substance as its chief or component ingredient, which in fact it has not or does have but less than the quantity as caused to be understood; (4) not cause to be understood that it an abortifacient or a stong emmenagogue; (5) not cause to be understood that it is an aphrodisiac or a birth control drug; (6) not show the therapeutic properties of a dangerous or a specially- controlled drug; (7) contain no certification or laudation of its therapeutic properties by any other person; (8) not show its therapeutic properties as being capable of curing, mitigating, treating or preventing disease or symptom thereof as notified by the Minister under Section 77. ‘The provision of (5) and (6) do not apply to the statement on the label or accompanying leaflet of a drug, and those of (1), (4), (5), (6), (7) and (8) do not apply to an advertisement directed to a medical practitioner or a veterinary practitioner. Section 88 bis. ‘The advertisement to sell drugs through radio amplifier, television slides or motion picture or through printed matter must: (2) receive permission for the text, sound or picture used in the advertisement from the licensor; (2) follow the conditions set by the licensor. Section 89. No sale of drugs shall be advertised impolitely, or by means of singing and dancing, or by showing the distress or suffering of a patient. Section 90. No sale of drugs shall be advertised by means of a gift or lottery drawing.2A Compilation of Laws on Food and Drug Section 90 bis. The Secretary of the food and Drugs Administration is, empowered to issue written orders to cease any advertisement deemed to be contrary to this act. Chapter Xil Officials Section 91. In the performance of their duties, competent officers are empowered to: (1) enter upon the premises for the production, sale, importation or storage of drugs during working hours to inspect compliance with this act; (2) take reasonable quantities of drugs as samples for testing or analysis; (3) in the event there is reason to suspect the committee of an offence under this act may can enter any premises in the interests of prosecution, size or attach drugs and tools and equipment concerned with such offence including drug containers ot packings and documents concerning such drug; (4) announce the results of test and analysis of the quality of the drugs texted under (2) to the poblic with the consent of the Committee in the interest of protecting the safety of the drug users; (5) In the event that the competent officials learn that any drug is not safe or might be harmful to drug users the competent officials are empowered to call for the storage or order the licensee to produce drugs or the licensee to import drugs into the Kingdom recall their drugs within a period fixed by the competent offici: empowered to destroy the drugs in accordance with the rules, procedures as prescribed in Ministerial Regulations. In the performance of their duties under paragraph one, competent officers shall be giver, reasonable facilities by licensee and all persons concerned with the production sale or importation of drugs on the said premises. Section 92. In the execution of his duty, the official must show his identity card at the request of the persons concerned. The identity card of an official shall be in the form prescribed in the Ministerial Regulation. Section 93. The drug as well as the drug container or package and document seized under Section 91, the owner of which is not apparatus, or for which the public prosecutor has give a final non-prosecution order, or which the court has not adjudged confiscated, and which is not claimed by its owner or possessor within Is and isA Compilation of Laws on Food and Drug 29 ninety days from the date of its seizure or the date of knowledge of the final order of non-prosecution or the date of the courtis final judgment, as the case may be, shall become the property of the Ministry of Public Health. If the article seized is perishable or if the delay would risk damage or incur storage costs in excess of the market price of the drug, the official may arrange to sell such drug as well as the drug container job package and document at public auction before the prescribed time. The net proceeds therefrom shall be held in its stead. Section 94. In the execution of this act, the official shall be an official under the penal Code. Chay Suspension and Revocation of a Licence Section 98. When it appears to the licensing authority that any licensee has not complied with this act or the Ministerial Regulation issued under this Act, the licensing authority, with the advice of the Board, has the power to order the suspension of the licence for a period of not more than one hundred and twenty days each time; or where a licensee is prosecuted for an offence under this act, the same may order the suspension of the licence pending the final judgment of the court. A licensee whose licence has been suspended must cease the production or sale of drugs, or the importation or order of drugs into the Kingdom, as the case may be; during such suspension, he may not apply for any other licence under this Section 96. When it appears to the licensing authority that a licensee lacks the qualifications under Section 14 or Section 48, the licensing authority with the advice of the Committee has the power to order the revocation of the licence. ict. A licensee whose licence has been revoked must cease the production or sale of drugs, or the importation or order of drugs into the Kingdom, as the case may be, and may not apply for any licence under this act until a period of two years from the date of the revocation has elapsed. It shall be at the discretion of the licensing authority Whether or not to issue another licence. Section 97. The order of suspension or revocation of a licence shall be Notified in writing to the licensee, and where the person whose licence has been Suspended or revoked is not found or refuses to accept the said order, it shall be posted in @ conspicuous place at the place to produce or sell drugs, or import or order drugs into the Kingdom, and the licensee shall be deemed to have knowledge thereof from the date of its Posting.30 A Compilation of Laws on Food and Drug ‘The orders of suspension and revocation of a licence may also be published in a newspaper or by other additional means. Section 98. The licensing authority with the advice of the Committee, has the power to order the withdrawal of the suspension of a licence before the expiration of the time limit when satisfied that the licensee whose licence has been suspended has complied with this act or the Ministerial Regulation issued under this act. Section 99. The licensee whose licence has been suspended or revoked has a right to appeal to the Minister within thirty days from the date of knowledge of the order. The Minister has the power to dismiss the appeal or to amend the order of the licensing authority in a way favorable to the appellant. The decisions of the Minister shall be final. ‘The appeal under paragraph one does not stay the enforcement of the order of suspension or revocation of the licence. Section 100. A person whose licence has been revoked may sell his remaining drugs to another licensee or to a person deemed appropriate by the licensing authority within a period of sixty days from the date of knowledge of the order of the revocation of the licence or the decision of the Minister, except where the licensing authority allows an extension for the said period. Chapter XIV Penalties Section 101. Any person who violates Section 12 shall be liable to imprisonment for a term not exceeding five years and to a fine not exceeding the thousand baht. Section 102. Any licensee who violates Section 19 or Section 30 shall be liable to a fine from two thousand to five thousand baht. Section 103. Any licensee who does not comply with Section 20, Section 21, Section 22, Section 23 and Section 24 shall be liable to imprisonment not exceeding three months or a fine not exceeding five thousand baht or both and shall be liable to a fine of five hundred baht per day until the licensee has performed correctly to the law. Section 104. Any licensee who produces, salls or imports drugs after his licence has expired without having applied for renewal of the licence shall be liable to a fine one hundred baht per day for each day the licence has expired. Section 105. Any licensee who fails to comply with Section 25, Section 26 or Section 27 shall be liable to a fine from two thousand to ten thousand baht.31 ‘A Compilation of Laws on Food and Drug. Section 106. Any licensee who fails to comply with Section 28, Section 29, Section 33, Section 35, Section 60, Section 61, Section 63, Section 81 or Section 87 shall be liable to a fine not exceeding one thousand baht. Section 107. Any person who violates Section 31 or Section 32 shall be liable to a fine from one thousand to five thousand baht. Section 107 bis. Any licensee not giving notification to providing a replacement to perform duty as prescribed in Section 33 bis shall be liable to fine of not more than five hundred baht. Section 108. Any person who is charged with the duties and fails to comply with Section 34 or Section 64 shall be liable to a fine not exceeding five hundred baht. Section 109. Any person who is charged with the duties and fails to comply with Section 38, Section 39, Section 40, Section 41, Section 42, Section 43 or Section 44 shall be liable to a fine from one thousand to five thousand baht. Section 110. Any person who violates Section 45 shall be liable to a fine from one thousand to five thousand baht. Section 111. Any person who violates Section 46 shall be liable to imprisonment for a term not exceeding three years and to a fine not exceeding tive thousand baht. Section 112. Any licensee who violates Section 53 or Section 62 shall be liable to fine from one thousand to three thousand baht. Section 113. Any licensee who does not comply with Section 54, Section 55 or Section 56 shall be liable to imprisonment not exceeding one month or a fine not exceeding two thousand baht or both and shall be liable to a fine of one hundred baht per day until the licensee has performed correctly to the law. Section 114. Any licensee who fails to comply with Section 57, Section 58 or Section 59 shall be liable to a fine from one thousand to five thousand baht. Section 114 bis. Any licensee not giving notification to providing a € of not replacement to person duty as prescribed in Section 63 bis shall be liable to a more than five hundred baht. Section 115. Any traditional medical practitioner who fails to comply with Section 68, Section 69 or Section 70 shall be liable to a fine from five hundred to two thousand baht. Section 116. Any traditional medical practitioner who violates Section 71 shall be liable to a fine from five hundred to two thousand baht. Section 117. Any person producing a fake drug in violation of Section 72 (1) shall be liable to imprisonment for a term from three years to life and to a fine from ten thousand to fifty thousand baht.32 ___A Compilation of Laws on Food and Drug Section 118. Any person who, in violation of Section 72 (2) or (5), produces a drug differing from the standard or a drug the formula registration of which the Minister has ordered revoked, shall be liable to imprisonment for a term from two to five years and to a fine from four thousand to twenty thousand baht. Section 119. Any person who, in violation of Section 72 (1), sells a fake drug or imports or orders a fake drug into the Kingdom, shall be liable to imprisonment for a term from one to twenty years and to a fine from two thousand to ten thousand baht. If the person acting under paragraph one acted without knowledge that the drug was fake, he shall be liable to a fine from one thousand to five thousand baht. Section 120. Any person who, in violation of Section 72 (2) or (5), sells or imports or orders into the Kingdom, a drug differing from the standard or a drug the formula registration of which the Minister has ordered revoked, shall be liable to imprisonment for a term from six months to three years and to a fine from one thousand to five thousand baht. If the person acting under paragraph one acted without knowledge that the drug differed from the standard or that its formula registration had been ordered revoked by the Minister, he shall be liable to a fine not exceeding five thousand baht. Section 121. Any person who, in violation of Section 72 (3), sells or imports or orders into the Kingdom a deteriorated drug, shall be liable to imprisonment for a term not exceeding one year or to a fine not exceeding three thousand baht, or to both, If the person acting under paragraph on acted without knowledge that the drug, had deteriorated. He shall be liable to a fine not exceeding three thousand baht. Section 122. Any person who, inviolation of Section 72 (4), produces, sells, or imports or orders into the Kingdom a drug without a formula registration, shall be liable to imprisonment for a term not exceeding three years or to a fine not exceeding five thousand baht, or to both Section 123. Any licensee who fails to comply with Section 79 shall be liable to imprisonment for a term not exceeding three years or to a fine not exceeding five thousand baht, or to both. Section 123 bis. Any licensee not performing as prescribed in Section 83 paragraph one shall be liable to a fine from one thousand baht to five thousand baht and shall be liable to a fine of one hundred baht per day until the licensee has performed correctly. Section 123 ter. Any licensee submitting a false annual report concerning the production or importation of drugs into the Kingdom as prescribed in Section 85 paragraph one shall be liable to imprisonment not exceeding three months or a fine not exceeding five thousand baht or both.A Compilation of Laws on Food and Drug. 33 Section 124. Whoever advertises the sale of drugs violation of Section 88, Section 88 bis, Section 89 and Section 90 shall be liable to imprisonment not exceeding six months or a fine not exceeding ten thousand baht or both. Section 124 bis. Whoever violates the order suspending the advertisement for sale of drugs by the Secretary of the Food and Drug Administration as prescribed in Section 90 bis shall be liable to imprisonment not exceeding three months or a fine not exceeding five thousand baht or both and shall be liable to fine of five hundred baht per day until the order has been followed. Section 125. Whoever, failing to give facility, obstructs a competent officer in the performance of his duties or not obeying the order of competent officials under Section 91 shall be liable to imprisonment not exceeding one month or a fine not exceeding one thousand baht or both. Section 125 bis. Any licensee who produces drugs, sell drugs or import drugs into the Kingdom while the licence to produce sell or import drugs into the Kingdom as the case may be, is suspended as prescribed in Section 95 shall be liable to imprisonment not exceeding five years and a fine of not exceeding ten thousand baht. Seetion 126. When a penalty is imposed under Section 101, Section 111, Section 117, Section 118, Section 119, Section 120, Section 121 or Section 122, the drug, the instrument and the accessory appliance used in the production of the drug, as well as the drug container or package relating to the offence of the case shall be con! by the Ministry of Public Health in order to be destroyed or dealt with as it deems appropriate. ated Section 126 bis. All the offense in this act which the penaltyis a fine only, the Secretary of the Food and Drugs Administration or a person the Secretary of the Food and Drug Administration authorized is empowered to set the fine.34 A Compilation of Laws on Food and Drug DRUG ACT (NO. 5), B.E. 2530 ree BHUMIBOL ADULYADEY, REX. Given on the 30th day of December B.£. 2530 Being the 42nd year of the present Reign His Majesty King Bhumibol Adulyadej has commanded it be proclaimed that; Whereas it is deemed appropriate to revise the law on the drugs, His Majesty the King is graciously pleased to have enacted an Act by advice and consent of Parliament as follows: Section 1. This Act is called “Drug Act (No. 5) B-E. 2530". Section 2. This Act shall come into force as and on the day after the date of publication in the Government Gazette. Section 3. The Act on control of standard of biological substance, B.E. 2483, is hereby repealed. Section 4. The definitions “External Application Drug” Application Drug”, “Ready Packed Drug”, “Produce” and “Sale” in Section 4 of the Drug Act, BE. 2510, as amended by the Drug Act (No. 3) B.E. 2522, shall be repealed and replaced by the followings: “Extemal Application Drug” means modern drug or old folk drug which is for external application. This shall not include Specific Area Application Drug. “Specific Area Application Drug” means modern drug or old folk drug which is used for specific area, such as ear, eye, nose, mouth, annus, vagina orifice or urinary orifice. “Ready Packed Drug” means modern drug or old folk drug produced in various pharmaceutical form, packed in container or sealed package with label correctly | in accordance with this Act. “Produce” means make, mix blend or transform, and means to include changing the form of drug, dividing the drug with the intention of making ready packed drug. This is whether there is a label or not. “Sale” means retail, wholesale distribute, dispense, disburse, exchange for ‘commercial benefit, and shall mean to include to have in possession for sale. Section 5. Add to the definition the words “wholesale” and “port of entry” between the word “sale” and “label” under Section 4 of the Drug Act B.E. 2510 as amended by specific Area is Act, as follows: Government Gazette Vol. 104 part 278 Special issued page I date 31 December 1987.‘A Compilation of Laws on Food and Drug. 35 “Wholesale” means sale direct to the licensee to sell drug licensee for wholesale of drug, Ministry, Bureau, Department, Thai Red Cross Society. Pharmaceutical Organization, Licensee to operate place of treatment, practitioner of pharmaceutical profession, practitioner of nursing professing, practitioner of pediatrics, practitioner of nursing and pediatrics, practitioner of modern art of healing or practitioner of animal disease healer. “Port of Entry” means the port or any place in the Kingdom which the Minister has announced in Government Gazette to be the port for inspection or drug ordered or imported into the Kingdom.” Section 6. Add the following as paragraph two of Section 13 of the Drug Act, B.E. 2510, as amended by the Drug Act (No. 3) B.E. 2522: “Person exempted under (1) and (5) shall have to comply with the criteria, procedures and conditions prescribed under Ministerial Regulation.” Section 7. The provision of (9) in Section 14 of the Drug Act, B.E. 2510 as amended by the Drug Act (No. 3) B.E. 2522, shall be repealed and replaced by the following: “(9) There are those who will comply with Section 38, Section 39, Section 40, Section 40 bis, Section 41, Section 42, Section 43 or Section 44, as the case may be. Section 8. The provision of Section 15 of the Drug Act B.E. 2510, shall be repealed and replaced by the following: “Section 15. Category of license for modern drug are as follows: (2) License to produce modern drug. (2) License to sell modern drug. (3) License to wholesale modern drug. (4) License to sell modern drug, only for ready packed medicine which is not dangerous drug or specially controlled drug. (5) License to sell modern drug, only for ready packed drug for animals. (6) License to bring in or import modern drug in to the kingdom. It shall be considered that holder of license under (1) or (6) is also holder of license under (3) for the drug which he brings in or imports in to the kingdom also, | asthe case may be. It shall be considered that holder of license under (2) is also holder of license under (3), (4) and (5). It shall be considered that holder of license under (3) is also holder of license under (4) and (5), but only for wholesale.” Section 9. Theprovision of Section 19 of the Drug Act, B.E. 2510 as amended by the Drug Act (No. 3) B.E. 2522 shall be repealed and replaced by the followin,36 A Compilation of Laws on Food and Drug “Section 19. It is prohibited that the holder of license: (1) Shall produce or sell modern drug outside the area specified in the license, except for wholesale. (2) Shall produce or sell modern drug incorrect with the type of license. (3) Sell modern drug which is dangerous drug or specially controlled drug, to the holder of license under Section 15 (4).” Section 10. Add the following as paragraph two of Section 20 of the Drug Act, B.E. 2510, as amended by the Drug Act (No. 3) B.E. 2522: “In case it is necessary for the benefit of control of production of modern drug, the licensor shall stipulate that the holder of license to produce modem drug has first class pharmacist as the operator under Section 38 more than the number specified under paragraph one in accordance with the criteria specified under Ministerial Regulations.” Section 11. Add the following as Se ion 21 bis of the Drug Act, B.E, 2510: “Section 21 bis. Holder of license to wholesale modern drug shall have first class pharmacist as the operator under Section 40 bis at the place of wholesale of modern drug or storage of modern drug, during office hours.” Section 12. The provision of Section 25 of the Drug Act, BE. 2510, as amended by the Drug Act (No. 3) B.E. 2522, shall be repealed and replaced by the following: “Section 25. The holder of license to produce modern drug shall carry out the following: (1) Arrange to have the board be put up openly at the place of production of modem drug as specified in the license, which can be seen from outside the building, being: (a) Board to show that itis the place for production of drug. (b) Board showing the name, sumame and qualifications of person carrying out the duty and the hours of work. The material for making the board, characteristic, colour and size of the board, size of characters and content in the board (2) Provide the analysis of raw material and drug produced before taking it out of the place of production, for which there shall be details of evidence of every analysis and which must be kept for not less than five years. (3) Arrange to have the label according to the ingredient and affix it at the container and package of the drug produced, and the label shall show: (a) Name of drug. (b) Number or code of registration of drug ingredient. (©) Quantity of drug packed.‘A Compilation of Laws on Food and Drug 87 (d) Name and quantity or potent of substance giving effect, which is the important ingredient of drug, which shall be the same as registered. (©) Number or character showing the time of production or analysis. (8) Name of producer of drug and province where the production is. (g) Date of production. (h) The word: “Dangerous drug”, “Specially controlled Dru; Use”, or “Specific Use” as the case may be, in red, clearly seen as dangerous drug, specially controlled drug, external use or specific use. (i) The word “Ordinary Household Medicine” in case it is ordinary external ine. (i) The word “Animal Drug” for the case it is drug for animal use. (k) The word “Expiry” and show the date of expiry of drug in case itis the drug which the Minister has announced under Section 76 (7) or (8). (4) Use the label and document as prepared according to the ingredient, and the article shall be clearly readable. If the article in the document is in English, there shall be translation. (5) There shall be warning in the use of drug at the label and document. For the drug announced by the Minister under Section 76 (9), in case the label contain the ingredient of drug, the warning on the use of drug may be shown at any part of the label or in gradient. (6) Prepare the list of raw material used for production of drug, list of drug produced and sold, and storage of drug as specified under Ministerial Regulation. (7) Other as specified under Ministerial Regulation. In case the container of drug is so small that the label showing the wording, as mentioned under (3) cannot be all stated, the holder of license to produce modern medicine shall be exempted not to show the wording as mentioned under (3) (¢), (d) (e) (f (h) (i) or (k) whether any or all when approval has been granted by the licensor. In case it is drug produced for export, the wording in the label shall also Stated the name of Thailand, while other wording if to be exempted permission shall have to be obtained from the licensor first. In case the holder of license to produce modern drug wish to amend the label concerning the date of expiry of the drug under (3) (k), and application shall be submitted according to the criteria, methods and conditions specified under the Ministe- rial Regulation.” Section 13. The provision of paragraph two of Section 26 of the Drug Act, B.E. 2510, as amended by the Drug Act (No. 3) B.E. 2522, shall be repealed and replaced by the following: “The provision of paragraph one shall apply to the holder of license to sell drug under Section 15 (4) and (5) mutatis mutandis.” household mec38 A Compilation of Laws on Food and Drug Section 14. Add the following as Section 26 bis of the Drug Act, BE. 2510. “Section 26 bis. The holder of license to sell modern drug shall comply with Section 26 paragraph one mutatis mutandis, except that there is no need to provide section of mixing of drug under (4).” Section 15. The provision of Section 27 of the Drug Act, B.E. 2510, as amended by the Drug Act (No. 3) B.E. 2522, shall be repealed and replaced by the followin; “Section 27. The holder of license to bring in or import modern drug into the kingdom, shall comply with the following: (1) Provide a board to be put up openly at the place where drug is brought in or imported into the kingdom which is stated in the license and can be easily seen from outside, being: (a) The board to show that it is the place where drug is brought in or imported into the kingdom. (6) Name and surname and qualification of operator and time of operation. (2) At the time of bringing in there shall be certificate of the manufacturer showing details of the analysis of drug brought in or imported into the kingdom, which shall be kept for five years. The certificated of the manufacturer abroad if in foreign language shall have Thai translation and there shall be label as specified under Section 25 (3) at the container and package of the drug, except for the content in (f) the name and country where the site for manufacturing of the drug shall be stated in place of the province. (3) Before offering the drug for sale, there shall be label at the container and package, having the characteristic and content in full as specified under Section 25 (3), except for the content in (f) the name and country where the site for manufacturing of the drug shall be stated in place of the province, also state the name of the importer of drug into the kingdom and the province where the drug imported is kept. (4) Use the label and ingredient document as prepared for the drug, and the content in the label and ingredient document shall be clearly readable. The ingredient document if in foreign language there shall be translation in Thai also. (5) There shall be warning on the use of drug in the label and ingredient deocument for the drug under Notification of the Minister under Section 76 (9). The ‘warning on the use of drug if in foreign language there shall be Thai translation also. In case the label contain the ingredient document, the warning on the use of drug may be shown in any part of the label or in the ingredient document. (6) Prepare the list of drug brought in to imported into the kingdom and those sold and also collect the sample of drug brought in or imported into the kingdom.‘A Compilation of Laws on Food and Drug. 39 This shall be according to Ministerial Regulation. (7) Others as specified in Ministerial Regulation. ‘The case drug is brought in under (2) or drug sold under (3) is packed in very small container that the label and content under Section 25 (3) cannot be all shown, the holder of license to bring in or import modern drug shall be exempted from showing, the content under Section 25 (3) (c) (4) (e) (6) (g) (i) or Gj) any or all when approval has been obtained from the licensor. Section 16. Add the following as Section 27 bis of the Drug Act, B.E. 2510. “Section 27 bis. Modern drug brought in or imported into the kingdom shall have to pass the inspection of the competent official at the customers station of import. The Inspection of the competent official shall be in accordance with the criteria and procedures as specified under Ministerial Regulation.” Section 17. The provision of paragraph one of Section 33 of the Drug ‘Act, B.E. 2510, shall be repealed and replaced by the following: “Section 33. When the holder of license shall wish to change the operator under Section 38, Section 39, Section 40, Section 40 bis, Section 41, Section 42, Section 43 or Section 44, the licensor shall be notified in writing, and the said operator may be changed when approval has been obtained from the licensor.” Section 18. The provision of Section 33 bis of the Drug Act, B.E. 2510, as amended by the Drug Act (No. 3), B.E. 2522, shall be repealed and replaced by the followin, “Section 33 bis. In case the person who has the duty of performing duty in the place where drug is manufactured, place where drug is sold or place where drug is brought in or imported into the kingdom, is unable to perform his duty temporary for a period of not more than sixty days, the holder of license shall arrange for other qualified person to perform duty on his behalf, for which the holder of license shall notify the licensor in writing first, and it shall be considered that the person so replaced shail have the same duty as the operator under Section 38, Section 39, Section 40, Section 40 bis Section 41, Section 42, Section 43 or Section 44, as the case may be. Notification in writing under paragraph one shall be in accordance with the regulation as the Committee has specified.” Section 19. The provision of Section 34 of the Drug Act, B.E. 2510, shall be repealed and replaced by the following: “Section 34. ‘The person with the duty as stated under Section 38, Section 39, Section 40, Section 40 bis, Section 41, Section 42, Section 43 or Section 44, who does not with to perform his function any further shall notify the licensor in writing not more than seven days after he is relieved from his duty.”40 A Compilation of Laws on Food and Drug Section 20. Add the following as Section 40 bis to the Drug Act, B.E. 2510: “Section 40 bis. The first class pharmacist under Section 21 bis, shall be at the place for wholesale of the modern drug or for storage of drug, throughout the time of ‘operation and shall have the following duties: (1) Control the Separate storage of drug under Section 26 (2) and (3). (2) Control the operation relating to label under Section 26 (5). (3) Control the preparation of drug record under Section 26 (6). (4) Control the wholesale of modern drug, (5) Others as specified under Ministerial Regulations.” Section 21. The provision of Section 44 of the Drug Act, B.E. 2510, as amended by the Drug Act (No. 3) B.E. 2522, shall be repealed and replaced by the following: “Section 44. The first class pharmacist under Section 24 shall be at the place for bringing in or importing into the kingdom or for storage of drug, throughout the time of operation and shall have the following duties: (1) Control drug brought in or imported into the kingdom so that they are cortect with the ingredient registered under Section 79. (2) Control the operation relating to Section 27 (2), (3) and (5). (3) Control the operation relating to certificate of the manufacturer to show the details of analysis of drug under Section 27 (2) and ingredient document under Section 27 (4). (4) Control the sale of drug to be in accordance with Section 39. (5) Control the preparation of drug record and collection of drug sample according to Section 27 (6). (6) Control the bringing in or importing into the kingdom of drug. (7) Control the storage of drug brought in or imported into the kingdom at the place of storage. (8) Others as specified under Ministerial Regulations. Section 22. Add the following as (2 bis) of Section 47 of the Drug Act, B.E, 2510: “(2 Bis) The sale of old fashioned drug by the holder of license to sell modern drug, wholesaler of modem drug, and seller of modern drug only for ready packed drug which is not dangerous or specially controlled drug.” Section 23. The provision of Section 53 of the Drug Act, B.E. 2510, shall be repealed and replaced by the following: “Section 53. It is prohibited that the licensee to producer or sell old folk drug, outside of the area specified in the license, except for wholesale.”4 Compilation of Laws on Food and Drug. 41 Section 24. Add the following as Section 54 bis of the Drug Act, > B.E. 2510: “Section 54 bis. The licensee to manufacture old folk drug who manufacture the drug by mean of palletizing, coating or similar means, and who also uses chemical ‘or semi-finished chemical for palletizing, coating or similar means, including to use ative in the old folk drug, shall have to comply with the criteria and method as specified under Ministerial Regulation.” Section 25. The provision of paragraph two of Section 57 of the Drug ‘Act, BE. 2510, as amended by the Drug Act (No. 3) B.E. 2522, shall be repealed and replaced by the following: “In case the container of drug is so small the label containing all the content under (2) may not be shown, the licensee to produce old folk medicine shall be exempted to show the content under (2) (c) (4) (e) (g) (h) (i) or Gj) whether one or all, when approval has been obtained from the licensor.” Section 26. The provision of Section 59 of the Drug Act, B.E. 2510, as amended by the Drug Act (No.3) B.E. 2522, shall be repealed and replaced by the following: “Section 59. The licensee to bring in or import old folk drug shall have to comply with the following: (1) Arrange to have a board put up openly in front of the place for bringing or importing drug into the kingdom, as stated in the license which is easily seen from outside, as follows: (a) Board showing that it is the place for bringing in or importing drug in to the kingdom. (b) Board showing the name and surname of the person who is operating and the time of operation. ‘The material for making the board, characteristic, paint, size of the board, size of wording and the wording on the board shall be as specified under Ministerial Regulation. (2) In importing there shall be label as specified under Section 57 (2) at the container and package of the drug, except for (e) which shall state the city and country which the manufacturer is in place of the province. (3) Before selling the drug, there shall be label at the container and package having the characteristic and wording in full as specific under Section 57 (2), except for (©), which shall state the city and country of the manufacture in place of the provinee, and the name of the importer and province where the drug has been imported shall also be Stated. (4) Use the label and ingredient document as registered, and the wording in the label and ingredient document shall be clearly readatle. The ingredient document,42 A Compilation of Laws on Food and Drug if in foreign language shall have Thai translation also. (5) Prepare the list of drug imported into the kingdom and sold, and drug imported into the kingdom shall be collected as specified under Ministerial Regulation (6) Other things as specified under Ministerial Regulation. ‘The case drug is imported under (2) or drug to be sold under (3) is packed in very small container so that the label with the wording under Section S7 (2) cannot be shown, the importer of old folk drug shall be exempted not to display the wording under Section 57 (2) (c) (A) (e) (g) (h) (i) or @) whether one or all when approval has been obtained from the licensor.” Section 27. And the following as Section 59 bis of the Drug Act, BE. 251 “Section 59 bis. The old folk drug brought in or imported into the kingdom, shall have to pass the test of the competent official at the customers station of import. The test of the competent official shall be according 10 the criteria and method specified under Ministerial Regulation.” Section 28. Add the following as Section 75 bis of the Drug Act, BE. 2510: “Section 75 bis. It is prohibited that anyone should sell ready packed drug of several ingredient as one set, with the purpose that the buyer use it to relieve, cure or prevent disease or any symptom of disease specially. The provision of paragraph one shall not be enforced with the first class tise the art of healing in dentistry, pharmacist, medical practitioner, or person who pra ‘who sells it to own patient, and the veterinarian who sells it for the animal he is treatin Section 29, Add the following as Section 77 ter of the Drug Act, B.B. 2510: “Section 77 ter. For the benefit of control of the drug brought in or imported into the kingdom, the Minister shall have power to announce in the Government Gazette specifying the customs station for bringing in the drug.” Section 30. Add the following as (4) of Section 79 bis of the Drug Act, B.E, 2510, as amended by the Drug Act (No. 3) B.E. 2522: (4) Drug which has been permitted to be brought in or imported into the ingdom under the criteria, method and conditions which the Minister as approved by the ‘Committee has announced in the Government Gazette. Section 31, The provision of Section 86 of the Drug Act, B.E. 2510, as amended by the Drug Act (No.3) B.E. 2522, shall be repealed and replaced by the following: “Section 86. Any drug which has been registered, if afterwards it appeared that said drug does not have the properties as registered or may not be safe to the users of being imitated drug under Section 72 (1) or that drug has changed in the objective for use as food or cosmetics, by receiving license to sell as food under special control or by—— compilation of Laws on Food and Drug. ving the certificate of registration as cosmetics under the law on such, the Minister advice of the Committee, shall have power to revoke the ingredient, and the revocation ail be made by announcing in the Government Gazette. ‘The order of the Minister shall be final.” Section 32. The provision of paragraph two of Section 88 of the Drug ‘Act, BLE. 2510, shall be repeated and replaced by the following: “The provision in (5) and (6) is not enforced to the content in the label or recient document and the content in (i) (4) (5) (6) (7) and (8) shall not be enforced to advertisement made direct by the person who carries out the art of healing, person “who practices the art of medicine, or the veterinarian.” . Section 33. The provision of Section 103 of the Drug Act, B.E. 2510 as ‘amended by the Drug Act (No. 3) BE. 2522, shall be repealed and replaced by the following: “Section 103. Any licensee who shall not comply with Section 20, Section “21, Section 21 bis, Section 22, Section 23, Section 24, shall be penalised with a term of imprisonment of not more than three month or a fine of not more than five thousand baht, or both, and a further fine of five hundred baht per day until it shall be correctly complied with.” Section 34. The provision of Section 105 of the Drug Act, B.E. 2510, shall be repealed an replaced by the following: “Section 105. Any licensee who shall not comply with Section 25, Section 26, Section 26 bis or Section 27, shall be penalised with a fine from two thousand baht to thousand baht.” Section 35. Add the following as Section 105 bis of the Drug Act, BE. 2510: “Section 105 bis. Whoever shall not comply with Section 27 bis or Section 59 bis, shall be penalised with a fine from two thousand baht to ten thousand baht.” q Section 36. The provision of Section 109 of the Drug Act, B.E. 2510, ‘hall be repealed and replaced and replaced by the following: “Section 109. Whoever shall not comply with Section 38, Section 39, Section 40, Section 40 bis, Section 41, Section 42, Section 43 or Section 44, shall be penalised with a fine of one thousand baht.” Section 37. Add the following as Section 113 bis of the Drug Act, BE. 2510: “Section 113 bis. Any licensee who shall not comply with Section 54 bis shall penalised with a fine of not more than five thousand baht.” Section 38. Add the following as paragraph two of the Drug Act, BE. 2510;A Compilation of Laws on Food and Drug “Manufacturing of imitated drug according to Section 73 (2), (3) or (4) which is in violation of Section 72 (1), if the manufacturer can prove that the drug is not harmful to the user, he shall be penalised with a term of imprisonment of not more than five years and a fine of not more than twenty thousand baht.” Section 39. The provision of Section 118 of the Drug Act, B.E, 2510, shall be repealed and replaced by the following: “Section 118, Whoever shall manufacture drug incorrect with the standard or drug which the Minister has revoke the registration, in violation of Section 72 (2) or (6), shall be penalised with a term of imprisonment of two to five years, and a fine from four thousand baht to twenty thousand baht.” Whoever manufactures drug whose registration has been revoked which is a violation against Section 72 (5), shall be penalised with a term of imprisonment of not more than two years or a fine of not more than twenty thousand baht, ot both.” Section 40. The provision of Section 120 of the Drug Act, B.E. 2510, shall be repealed and replaced by the following: “Section 120. Whoever sell or bings in or imports into the kingdom drug which is incorrect with the standard which the Minister has revoked the registration or the drug which the registration has been revoked, has violated Section 72 (2) or (6), shall be penalised with a term of imprisonment of not more than three years and a fine of not more than five thousand baht. Whoever sells or brings in or imports into the kingdom drug whose registration has been revoked in violation of Section 72 (5) shall be penalised with a term of imprisonment of not more than one year or a fine of not more than ten thousand baht, or both. If the offender under paragraph one and paragraph two, has violated the ‘Act without knowing that it is drug which is not correct with the standard that the Minister has revoked registration or the drug which has been revoked the registration, shall be fine not more than five thousand baht.” Section 41. Add the following as Section 122 bis of the Drug Act, B.E. 2510: “Section 122 bis. Whoever shall violate Section 75 bis shall be penalised with a term of imprisionment of not more than five years or a fine of not more than fifty thousand baht, or both.” Section 42. The provision of Section 124 of the Drug Act, B.E. 2510, as amended by the Drug Act (No.3) B.E. 2522, shall be repealed and replaced by the following: “Section 124. Whoever advertise the sale of drug in violation of Section 88, Section 88 bis, Section 89 or Section 90, shall be penalised with a fine of not more than one hundred thousand baht.”‘A Compilation of Laws on Food and Drug. 4s Section 43. Add the following as paragraph two of Section 126 of the Drug Act, B.E. 2510, as amended by the Drug Act (No. 3), BE. 2522: “In case there is seizure of drug, container or package or drug, and documents relating to the offence, the Secretary of the Food & Drug Agency or person assigned by the Secretary of the Food & Drug Agency, may fine by making comparison when the offence agrees to the things seized to belong to the Ministry of Public Health.” Section 44. Add the following as (2 bis) of A, Category of modern drug and rate of fee, annexed to the Drug Act, B.E. 2510, as amended by the Drug Act (No. 3) B.E. 252: “(2 bis) Licenxe to sell.” Section 45. The licensee to sell modern drug, only the ready made drug which is not dangerous drug or specially controlled drug, if cannot find a person under Section 22 of the Drug Act, B.E. 2510, to perform the duty in being at the place for the sale of drug throughout the opening time, the said licensee shall be entitled to receive the training or assign other person to receive the training from the Ministry of Public Health. ‘After having been trained the person who has completed said training shall be stationed at the place for the sale of modern drug, only for ready packed drug which is not dangerous drug or specially controlled drug, of his own or of the licensee who has assigned that person to receive the training, by having the duty as stated under Section 41 of the Drug Act, BE. 2510: ‘The training under paragraph one shall be completed within five years from the date this Act is enforced, after such time there shall not be further training. ‘The curriculum of the training, qualification of the trainee and the expenses. the trainee has to pay shall be in accordance with the regulation specified by the Ministers. In case the licensee to sell modern drug only for ready packed drug which is not dangerous drug or specially controlled drug, which the person who has completed the training is the operator under paragraph one has moved the place for sale of drug, ‘or in case the licensee to sell modern drug only for ready packed drug which is not dangerous drug or specially controlled drug can provide evidence that he is the successor Of the licensee for sale of modern drug only for ready packed drug which is not dangerous drug or specially controlled drug which the person who have been trained is carrying out the duty under paragraph one, it shall be considered that the place for sale of drug which has moved or which the licensee can produce said evidence is the place for sale of drug which the person who has completed the course can carry out performing the work under paragraph one. For the protection of the welfare of the public the Minister shall have the Power to publish a notification specifying that the person who has been trained under Section 48 of the Drug Act (No. 3) B.E. 2522, and under this Act to receive additional training from time to time as deemed appropriate.46 A Compilation of Laws on Food and Drug Section 46. The provision of Section 29 of the Drug Act, B.E. 2510 shall be enforced with the licensee to sell modem drug only for ready packed drug which is not dangerous drug or specially controlled drug, which there is person who has complete the training course under Section 48 of the Drug Act (No. 3) B.E. 2522, or under Section 45 of this Act, shall be the person who carries out Section 41 of the Drug Act, B.B. 2510, in showing evidence of the certificate of the training course at the place for sale of drug, mutatis mutandis. Section 47. ‘The provision of Section 45 of the Drug Act, B.E. 2510, shall be enforced to the person who has completed the training course under Section 48 of the Drug Act (No. 3) B.E. 2522, or under Section 45 of this Act, in the performance of duty at the place for the sale of modern drug, only for ready packed drug which is not dangerous drug or specially controlled drug, mutatis mutand Section 48. The Minister of Public Health shall be in charge and control of this Act. Counter-signed by GEN. PREM TINSULANONDA. PRIME MINISTER