Drug approval system of

Uzbekistan

Ibragimova Mukhabbat Yahyaevna

Head of department
Center of pharmaceuticals and medical devices policy
General Administration for Quality Control of Pharmaceuticals
and Medical Equipment of Ministry of Health of Uzbekistan
August 2017 – Seoul/Osong
General information about Uzbekistan
• Location: Central Asia. It borders with the Republic of Kazakhstan, Turkmenistan,
Kyrgyzstan, Tajikistan and Afghanistan. Located between the rivers Amu Darya and Syr
Darya
• State territory: 448 900 км2
• Administrative-territorial division: 12 regions, autonomous republic of
Karakalpakstan and the capital Tashkent. Tourist cities - Samarkand, Bukhara and Khiva.
• Population: More than 32,000,000 people. More than 100 nations and nationalities. 80%
of Uzbeks, other Tajiks, Turkmens, Kazakhs, Russians, Koreans ... 51% of population live
in cities and 49% in rural areas. More than 60% of population is young people. The most
densely populated country in Central Asia (65.8 people per 1км2).
• History: More than 3000 years of statehood, it is located at the crossroads of the Silk Road.
This year will be 26 years of independence.
2
 Legislation: Laws
• "On pharmaceuticals and pharmaceutical activities" dated 04/01/2016.
• "On denunciation of Agreement on Providing Population with Medicines, Vaccines
and Other Immunobiological Preparations, Medical Devices and Medical Equipment
Produced in Territory of the Member States of Commonwealth of Independent States
dated December 18, 2007.
• "On protection of citizens health" dated August 29, 1996
• "On narcotic drugs and psychotropic substances" dated 19.08.1999
• "On Sanitary and Epidemiological Well-being of the Population" dated August 26,
2015
• "On compulsory treatment of patients with chronic alcoholism, drug addiction or
substance abuse" dated 09.12.1992
3
 Legislation: Presidential Decrees and
Orders

• "On measures to support domestic manufacturers of pharmaceuticals and

medical products" dated 14.07.2006.
• "On measures to further improve provision of population with medicines and
medical products" dated October 31, 2016.
• "On Program of Measures for Further Development of Republic's
Pharmaceutical Industry for 2016-2020" dated 16.09.2016.
• "On measures to create favorable conditions for accelerated development of
pharmaceutical industry of Republic" dated April 20, 2017
• "On measures to further improve sale of medicines and medical products,
licensing of pharmaceutical activities" dated February 14, 2017

4
Legislation: Decrees and orders of Cabinet of Ministers of Uzbekistan

• "On approval of regulations on procedure for registration of pharmaceuticals and

medical products and issuance of registration certificate" dated December 22, 2014.

• "On measures to further improve tender sales" dated 14.09.2015.

• "On measures to further improve licensing of pharmaceutical activities" dated

12.05.2017.

• "On regulation of import of ready-made medicines" dated 25.02.2011

5
 Privileges for local manufacturer

• Presidential Decrees №2911 dated 20.04.2017 "ON MEASURES TO CREATE

FAVORABLE CONDITIONS FOR ACCELERATED DEVELOPMENT OF
PHARMACEUTICAL INDUSTRY OF UZBEKISTAN" dated April 20, 2017
Until 2021, manufacturers of pharmaceutical products are exempt from income tax and payment of
customs duties, excise and VAT as per approved list
• Decrees of Cabinet of Ministers №49 dated 25.02.2011"ON REGULATION OF IMPORT OF
READY-MADE MEDICINES"
20% of VAT is levied for importing 67 medicines produced by local producers
• Inter-ministerial Decree No.1952 dated 08.05.2009 "ON APPROVAL OF LIST OF
IMPORTED RAW MATERIALS FOR PRODUCTION OF PHARMACEUTICALS AND
MEDICAL DEVISES, WHICH ARE EXAMPT FROM PAYMENT OF VALUE ADDED
TAX"
20% VAT on pharmaceutical raw materials is not collected according AS PER approved list
6
Pharmaceuticals Registration statistics
At the moment, 8557 medical products have been registered in Uzbekistan
in 172 pharmacotherapeutic groups. Products of 72 groups do not have any
local production

Quantity Share
Medicines of foreign countries 4 409 52%
Medicines of CIS 1 782 21%
Local medicines 2 366 28%
Total 8 557 100%

7
TOP 20 pharmacotherapeutic groups for registration
№ Pharmacotherapeutic group Foreign countries CIS Local Total
1 Antibiotic 664 222 400 1286
2 Non-steroidal anti-inflammatory drug 232 70 96 398
3 Antihypertensiveagent 223 70 80 373
4 Vitaminsandminerals 126 75 131 332
5 Expectorant 88 46 101 235
6 Antiviralagent 124 61 32 217
7 Agent for correction of metabolic processes 100 61 53 214
8 Antifungalagent 101 48 64 213
9 Antiallergicagent 102 38 53 193
10 Antitumoragent 153 30 1 184
11 Analgesic-antipyretic 90 43 45 178
12 Anti-inflammatoryagent 53 18 107 178
13 Antiseptic 15 25 131 171
14 Antiulcer 122 15 29 166
15 Glucocorticosteroid 84 45 18 147
16 Nootrop 45 54 31 130
17 Remedy for symptoms of ARI 90 6 33 129
18 Agentstimulatinghematopoiesis 97 4 28 129
19 Salinesolution 10 22 90 122
20 Agentfor treatment of ENT diseases 67 41 14 122
Total for the top twenty 2586 994 1537 5117
8
Pharmacotherapeutic groups with 10 or more registered foreign drugs
and no any local production.
Number of local
Pharmacotherapeutic group Number of foreign medicines
№ medicines
1 Insulin products 36
Agents predominantly used in ophthalmology
2 34
Hormone pituitary, hypothalamus and their analogue
3 27
4 Oralcontraceptive 25
5 Immunodepressant 20
Agent against motion sickness syndrome
6 18
7 AcneRemedy 16
8 Remedy mainly used in dentistry 16
9 Tranquilizer 16
10 Angioprotector 12
11 Antihypoxant, antioxidantagent 12
Regulator of calcium-phosphorus metabolism
12 11
13 Cardiacglycoside 11
Narcoticanalgesic
14 10
Opioidanalgesic
15
9
List of molecules and forms which are not produced in Uzbekistan (1)

Pharmacotherapeutic group INN Forms

Solution
Insulin products Insulin glulisine, Insulin human, Insulin pigs, Insulin Suspension
detemir, Insulin lispro, Insulin aspart

Aminobenzoic acid, Hydrocortisone,

Phenilephrine, Emoxipine, Tetryzoline, Drops
Agent predominantly used in
Dexpanthenol, Carbomer, Dexamethasone, Fusidic Ointment
ophthalmology
acid, Hypromellose, Tobramycin, Potassium iodide, Lyophilizate
Phenylephrinihydrochloridum, Solution
Methylethylpiridinol, Ranibizumab Gel

Hormone pituitary, Octreotide, Chorionicgonadotropin, Solution

hypothalamus and their analogue Somatropin, Urofollitropin, Follitropin, suspension
Menotropin, Demoxytocin, Terlipressin Lyophilizate

Oral contraceptive Desogestrel, Levonorgestrel, Ethinylestradiol, Tablets

Ulipristal, Lynestrenol Dragee

10
List of molecules and forms which are not produced in Uzbekistan (2)

Pharmacotherapeutic group INN Forms

Etanercept, Tofacitinib, Ciclosporin

Immunodepressant Leflunomide, Mycophenolatemofetil Lyophilizate Tablets
Tacrolimus, Infliximab, Everolimus Capsules
Basiliximab Solution
Agents against motion sickness syndrome Betahistine, Dimenhydrinate Tablets

AcneRemedy Azelaiс acid, Zinc hyaluronate, Isotretinoin Cream, Suspension

Azelaic acid, Isotretinoin, Tretinoin Gel, Capsules
Metronidazole
Remedy mainly used in dentistry Benzidamine
Gel, Solution, Spray

Tranquilizer Afobazolum, Diazepam, Phenazepam, Hydroxyzine,

Alprazolam, Tofisopam, Hydroxyzine, Mebicar, Tablets, Solution,
Oxazepam, Etifoxine Capsules

11
List of molecules and forms which are not produced in Uzbekistan (3)

Pharmacotherapeutic group INN Forms

Gel, Tablets,
Angioprotector Quercetin,Alprostadil,Ginkgo biloba, Granules, Capsules,
Aesculushippocastanum L. Solution
Solution
Antihypoxant, antioxidantagent
Epinephrine, Phenylephrine, Norepinephrine

Regulator of calcium-phosphorus Calcium carbonate, Lanthanum carbonate, Tablets, Suspension,

metabolism Cholecalciferol, Calcitrol, Calcitonin Capsules, Solution,
Granules, Spray
Tablets, Solution
Cardiacglycoside
Digoxin, Corglycone, Quabain, G-Strophanthine
Solution, Tablets,
Narcoticanalgesic
Tramadol, Fentanyl, Flupirtine Capsules
Solution
Opioidanalgesic Tablets
Tramadol, Morphine, Trimeperidine, Fentanyl
12
Drugs Provision on Essential Medicines

• There are 437 medicines in essential medicines list.

55% of them are produced in the country and 45% are
imported

13
LAW №399 dated 04.01.2016 “ON MEDICINES AND PHARMACEUTICAL
ACTIVITIES” (1)

Article 3. Basic concepts

• Following basic concepts are used in this Law:
• Pharmaceuticals - remedy obtained on the basis of medicinal substances and auxiliary
substances; medicinal substances; drugs permitted for use in medical practice for
prevention, diagnosis and treatment of diseases, as well as for changing status and
functions of human body;
• Medicinal substances - substances of natural or synthetic origin, possessing
pharmacological, immunological or metabolic activity or used for diagnostic purposes,
permitted for use in medical practice;
• Medicines - dosed, packaged medicines ready for use;
• Medicinal plant raw materials - plants or its parts containing biologically active
substances used for manufactureing medicinal products;
14
 LAW №399 dated 04.01.2016 “ON MEDICINES AND PHARMACEUTICAL
ACTIVITIES” (2)

Article 12. State registration of pharmaceuticals, medical devices and medical equipment
• Pharmaceuticals, medical devices and medical equipment are permitted for use in medical practice after
their state registration.
• Following is subject to state registration:
Pharmaceuticals;
New combinations of pharmaceuticals registered in Uzbekistan;
Pharmaceuticals previously registered in Uzbekistan, but produced in other forms, dosages or by other
manufacturer;
Medical devices;
Medical equipment.
• State registration of pharmaceuticals, medical devices and medical equipment is carried out by Ministry of
Health of Uzbekistan.
• Registered pharmaceuticals, medical devices and medical equipment are included in State Register of
Pharmaceuticals, Medical Devices and Medical Equipment Permitted for Use in Medical Practice.
15
 LAW №399 dated 04.01.2016 “ON MEDICINES AND PHARMACEUTICAL
ACTIVITIES” (3)

• State registration of pharmaceuticals with different medicinal substances under the same trade
name is not allowed.
• Valid registration certificate is issued for a period of five years on the basis of state registration of
pharmaceuticals, medical devices and medical equipment.
• Validity of registration certificate may be extended at request of registration certificate holder
attaching necessary documents. Application for prolonging registration certificate validity must
be submitted within three months before expiration of its validity.
• After expiry of registration certificate validity, pharmaceuticals, medical devices and medical
equipment are permitted for sale and use in medical practice, provided they are produced during
period of validity of expired registration certificate.
• Registration certificate holder is required to inform Ministry of Health of Uzbekistan about new
data regarding safety, quality and effectiveness of pharmaceuticals, medical device and medical
equipment.

16
LAW №399 dated 04.01.2016 “ON MEDICINES AND PHARMACEUTICAL ACTIVITIES” (4)

Article 13. Pharmacovigilance

• Pharmacovigilance is an activity aimed at identifying, evaluating and
preventing adverse unintentional and unfavorable reactions for body
observed in humans when using pharmaceuticals in accordance with
instructions for its use.
• Treatment and prophylactic institutions, pharmacies and organizations
that produce, sell and use pharmaceuticals must inform Ministry of
Health of Uzbekistan in writing about all cases of detection of adverse
reactions in use of pharmaceuticals

17
 DECREE OF CABINET OF MINISTERS OF UZBEKISTAN №. 352 dated 22.12.2014 “ON
APPROVAL OF REGULATION REGARDING REGISTRATION OF PHARMACEUTICALS AND
MEDICAL DEVICES (MD) AND ISSUANCE OF REGISTRATION CERTIFICATE (RC)”

Structure
• I. General Provisions
• II. Permits and conditions
• III. Documents and samples
• IV. Regulations
• V. Changes and additions to RC
• VI. Re-registration and renewal of RC
• VII. Suspension and termination of RC
• VIII. Register of issued RC

18
II. Permits and conditions

• Observance of legislative acts and normative documents;

• Providing comprehensive information on the reasons for making changes, their impact
on efficiency, safety and quality indicators;
• Mandatory regular notification to the General Administartionabout new data regarding
pharmaceuticals’ pharmacological efficacy and safety;
• Timely elimination of shortcomings indicated by experts
• Presenting samples of pharmaceuticals and medical devices and other materials in
prescribed time frame

19
III. Documents and samples

• а) Applicationasper approvedform
• b)Copy of state registration certificate of business entity;
• c) Registration documents in duplicate;
• d)Samples of medecines (for three-time testing in three industrial series), standard
refference of substances, control materials of specific reagents and quality
certificates for them.

• Confidential information in documents should not be disclosed by the General

Administartion

20
 IV. Regulations

• Registration fee for one pharmaceuticals is 6000 USD including VAT. For each
additional dose of the same pharmaceuticals if submittet simultaneous with the
same pharmaceuticals will cost 600 USD. This money will not be refunded.
• Approval and issuanceperiod of RC is a maximum of 180 working days from
date of application receipt. This period does not include time spent by applicant
to eliminate shortcomings (45 working days), to provide clinical trial programs
and samples (45 working days), as well as duration of clinical trials.
• RC issuance fee –75 USD
• The General Administartion may conduct (independently or with involvement of
third parties or independent experts) examination of registration documents,
inspection checks, laboratory tests, pharmacological and toxicological studies,
preclinical studies, bioequivalence testing.

21
 Departments of the General Administartion involved in registration (1)

а) Registration department:
• Conducts primary examination of documents and materials;
• Makes correspondence with applicant;
• Concludes contract and issues invoice;
• Transfers documents for examination to State CenterLaboratory, PharmacologicalCommittee,
Pharmacopoeial Committee, Committee on New Medical Equipment and to Drug Control Committee;

b) State CenterLaboratory:
• Carries out examination of registration documents;
• Assesses regulatory documents, conducts tests to determine whether samples of medecine or medical
device meet requirements of regulatory documents;
• Transmits test reports, documents of medecine or medical device to Pharmacopoeia Committee,
Pharmacological Committee and Committee for New Medical Equipment;

22
Departments of the General Administartion involved in registration (2)
c) Pharmacopeia Committee:
• Conducts examination of registration documents, protocols of laboratory tests;
• Requires applicant to replace or include alternative methods, additional indicators and
methods of analysis in regulatory documents, taking into account modern achievements of
science and technology, as well as physical and chemical properties of active and auxiliary
substances;
• Conducts re-examination of registration documents with involvement of independent
experts;
• Sends samples and documents of medecine to State Center laboratory for additional tests
in cases when it is impossible to reproduce methods of analysis, lack of its specificity,
sensitivity and accuracy, as well as in case of amendments to regulatory documents that
require testing of methods of analysis;
• Approves normative documents of pharmaceuticals and medical devices;
• Makes recommendations to Expert Council to register or refuse medicine;
23
Departments of the General Administartion involved in registration (3)

d) Pharmacological Committee:
• Conducts examination of administrative, pharmacological, toxicological and
clinical parts of registration documents;
• Conducts re-examination of registration documents with involvement of
independent experts;
• Determines types of tests, approves relevant clinical bases for clinical trials,
makes recommendations for clinical trial programdevelopment and approves
them;
• Makes recommendations to Expert Council to register medecine with or
without clinical trials or to refuseit;
• Approves instructions (leaflets) of medecines or changes to instaruction;
• Carries out pharmacological supervision;

24
Departments of the General Administartion involved in registration (4)

e) Committee on New Medical Equipment:

• Conducts examination of registration documents, protocols of laboratory analysis,
clinical (medical) test materials;
• Conducts re-examination of registration documents with involvement of
independent experts;
• Based on specifics of medical devices, provides ts testing;
• Gives recommendations on development of clinical (medical) testing programs and
coordinates clinical (medical) testing programs;
• Determines types of tests, approves relevant clinical bases for clinical (medical)
testing;
• Controls clinical trials of medical devices;
• Approves instructions (manual) and labeling of medical devices or changes or
additions to them;
• Prepares regulatory documents of medical devicesfor approval;
• Makes recommendations to Expert Council to register medical devices with or
without clinical (medical) tests or to refuse registration for them;
25
Departments of the General Administartion involved in registration (5)

f) The Drug Control Committee:

• Conducts examination of drug registration documents containing narcotic drugs, psychotropic
substances and precursors;
• When examining medicinal products containing narcotic drugs, psychotropic substances and
precursors, checks presence of these substances in state-controlled list of narcotic drugs,
psychotropic substances and precursors, checksif permission is obtained for their medical use,
whether it is prescription product and Makes proposals to Pharmacological and Pharmacopeia
Committees;
g) Pharmaceutical Inspection:
• Conducts inspection of production conditions and quality control;
• Issues certificate on availability of production and quality control conditions for appropriate type of
pharmaceuticals and medical devices;
• Inspection is carried out by decision of Expert Council, adopted on the basis of expert opinion of
Pharmacopoeia and Pharmacological Committees after examination of registration documents.
26
Expert Council

Expert Council on the basis of conclusions of Pharmacopoeia Committee,

Pharmacological Committee, Committee on New Medical Equipment,
and other departments of GeneralAdministration, within seven working
days, decides whether to give or refuse RC. Within a day General
Administration proves Expert Council decision.

27
The reason for refusal to issue RC may be the following: (1)
• Incomplete submission of documents, samples and other required materials;
Unconformity of applicant with permission requirements and conditions;
Inaccurate or distorted information in the documents;
Obtaining prooved negative conclusion on the basis of studies, inspections (surveys) or
other scientific and technical assessments, implementation of which is mandatory.
• Refusal to issue RC for other reasons, including for reasons of inexpediency, is not
allowed.
• A notice of denial of registration is issued in writing, indicating reasons for refusal,
specifying legislation and time limit (not less than 10 days) during which applicant,
after eliminated reasonsof denial, may submit documents for reconsideration. In this
case, the General Administration repeatedly reviews, within 10 days, relevant
documents certifying the elimination of reasons for refusal. Reconsidiration is free of
charge.
28
The reason for refusal to issue RC may be the following: (2)

• If elimination of reasons for refusal by applicant entails a change in the properties of

pharmaceuticals and medical devices сoncerningto quality, efficiency and safety,
application is deemed to be re-filed and reviewed by General Administration on general
basis.
• When reconsidering documents, it is not allowed to General Administrationto bring
reasons for refusal which were not previously stated in writing to applicant, except for
bringing the reasons for refusal associated with documents certifying elimination of the
previously mentioned reasons.
• The application for reconsidiration after expiry of time indicated in notice of refusal is
considered to be submitted again and is considered by General Administrationon general
basis

29
 VI. Re-registration and renewal of RC

• In case of transformation of applicant’s business entity, change of its name or location,

without changing place of operation (postal address), the applicant or its legal successor
is obliged to submit to General Administrationapplication for re-registration of
RCattaching documents confirming specified information not later than seven working
days after above mentioned changes have happened.
• Application for extending the validity of RC with all necessary documents must be
submitted to General Administrationthree months before the expiration of RC validity.
• The cost of validity extension of RC for 5 years is 50% of registration fee.
• In case of loss or damage RC, a duplicate is issued at the request of applicant in 5 days.
• Cost for issuing RCduplicate is 50% of registration fee.

30
 VII. Suspension and termination of RC

• Single rude violation of permissive requirements and conditions,

which gives grounds for RC termination are:
• Evasion of inspections of compliance with permissive
requirements and conditions;
• Causing harm to life and health of citizens or creating real threat
of causing such harm.

31
DOCUMENTS submitted for registration of medicinal products * (1)
Pharmaceuticals

Medicinal Homeopathi
Medicament substance МIBP
plant raw c medicine
materials

1 2 3 4 5 6 7

I. General Documentation

I Content
IA Administrative data
I A 1. Application according to approved form + + + + +
I A 2. Certificate of pharmaceutical product (CPP) issued in accordance with WHO recommendation + - + + +
(notarized)
in case of absence: registration certificate in manufacturer country
I A 3. GMP certificate (indicating date and results of last inspection) + + + + +
I A 4. Copy of license to carry out pharmaceutical activities + + + + +

I A 5. If several manufacturers participate in production process, documents of points IА2, IА3, IА4 are + + + + +
submitted to all participants of production
I A 6. License agreement (agreement) to manufacture (before the expiration of the patent for the original + - - + +
drug)
I A 7. Copy of patent (if any) + + + + +
I A 8. Document confirming quality of active substance (certificate of analysis from manufacturer, + + + + +
certificate of conformity, protocol of analysis, analytical passport, entry control, etc.)
I A 9. Document confirming quality of finished product of three industrial series (certificate of analysis, + + + + +
protocol analysis, etc.)
I A 10. Document on prion safety for substances of animal origin from manufacturer, certificate on absence + + - + +
of spongiform encephalopathy of cattle (BSE/TSE)
32
DOCUMENTS submitted for registration of medicinal products * (2)

Pharmaceuticals

Medicamen Medicinal Homeopath

substance МIBP
t plant raw ic medicine
materials
1 2 3 4 5 6 7

I. General Documentation

I A 11. Information on refusal to register, withdraw from market by competent authority or + + + + +

applicant, on termination of validity of registration certificate or suspension by competent
authority (specifying reason in case of precedents)
IB Brief description of the medicinal product (SmPC), labeling and instructions for use

I B 1. ** Brief description of the drug (SmPC) + - + + +

I B 2. Copy of instruction for use of medicinal product approved in country of manufacturer, draft + - + + +
instruction for use in state and Russian languages
I B 3. Models of packages and markings in color on paper and electronic media + + + + +
IC Detailed description of pharmacological surveillance and risk management system for + - - + +
medical use of medicinal product proposed by applicant
ID Document confirming availability of qualified person responsible for pharmacovigilance, for + - + + +
collection and recording of adverse reactions detected in Uzbekistan

IЕ Reports of independent experts on chemical, pharmaceutical and biological documentation, + - + + +

pharmaco-toxicological documentation, clinical documentation (information on main
properties of medecine)

33
DOCUMENTS submitted for registration of medicinal products * (3)

Pharmaceuticals

Medicina Homeop
Medicam substanc
l plant athic МIBP
ent e
raw medicine
materials
1 2 3 4 5 6 7

II. Chemical, pharmaceutical and biological documentation

II Content + + + + +
II A Composition
II A 1. Composition of pharmaceuticals + - + + +
II A 2. Packing (short description) + + + + +
II A 3. Pharmaceutical development (justification of composition, choice of + - + + +
primary packaging, etc.)
II B Method of manufacturing (scheme of technological process, draft of
technological regulations)
II B 1. Production formula + + + + +
II B 2. Manufacturing process + + + + +
II B 3. Control in production process (operational control) + + + + +
II B 4. Process validation + + + + +
34
DOCUMENTS submitted for registration of medicinal products * (4)

Pharmaceuticals

Medicamen Medicinal Homeopathi

substance МIBP
t plant raw c medicine
materials

1 2 3 4 5 6 7

II. Chemical, pharmaceutical and biological documentation

II C Methods of control of raw materials * + + + + +

II C 1. Active substance *
II C 1.1. Normative documents (specifications and methods of quality control)* of active substances + + + + +

II C 1.2. Scientific data * + + + + +

II C 1.2.1. Nomenclature * + + + + +
II C 1.2.2. Description * + + + + +
II C 1.2.3. Production * + + + + +
II C 1.2.4. Quality control in production process (intermediate control) + + + + +
II C 1.2.5. Chemical development + + + + +
II C 1.2.6. Impurities * + + + + +
II C 1.2.7. Butch analysis* + + + + +
II C 1.2.8. Information on stability studies, reports and shelf life + + + + +
35
DOCUMENTS submitted for registration of medicinal products * (5)
Pharmaceuticals

Homeopat
Medicame Medicinal
substance hic МIBP
nt plant raw
medicine
materials
1 2 3 4 5 6 7

II. Chemical, pharmaceutical and biological documentation

II C 2. Excipients
II C 2.1. Normative documents (specifications and established methods of quality control) of + - - + +
auxiliary substances
II С 2.2. Scientific data + - - + +
II С 2.3. Butch analysis*
II C 3. Packing material (inner / outer packaging) + + + + +
II C 3.1. Specifications and established methods for quality control of packaging materials and + + + + +
quality certificates
II C 3.2. Scientific data + + + + +
II D Methods for quality control of intermediate products + + + + +
II E Methods for quality control of final product
II E 1. Specifications and methods of quality control with authentic translation into Russian + + + + +

II E 1.1. Regulatory document of pharmaceuticals + + + + +

II E 1.2. Standards information + + + + +
II E 1.3. Explanatory note to normative document + + + + +
II E 1.4. When extending registration period, copy of approved normative document + + + + +

36
DOCUMENTS submitted for registration of medicinal products * (6)

Pharmaceuticals

Homeopat
Medicame Medicinal
substance hic МIBP
nt plant raw
medicine
materials

1 2 3 4 5 6 7

II. Chemical, pharmaceutical and biological documentation

II E 2. Scientific data + + + + +
II E 2.1. Validation of analytical methods and comments, standards (working standards) + + + + +
II E 2.2. Butch analysis + + + + +
II F Stability
II F 1. Methods for stability studying + + + + +
II F 2. The results of stability test for at least 3 industrial or pilot (pilot) series (data and reports + + + + +
of stress tests and long-term tests in real time)
II G Information on dissolution profile (for solid dosage forms) + - - + +
II Н Data on bioavailability, bioequivalence (for generics), for parenteral forms of generics - + - - + +
safety and efficacy data
II K Control data on animals - - - - +
II L Data on likely environmental hazard for preparations containing genetically modified + + - - +
organisms
II M Periodicallyupdated Security Report + - + + +
II Q Additional information confirming quality + + + + +

37
 Pharmaceuticals

Medicamen Medicinal Homeopath

substance МIBP
t plant raw ic medicine
materials

III. Pharmacological and toxicological documentation

III Content + + + + +
III A Toxicity with single administration and administration of repeated doses (acute, subacute, + - - + +
chronic toxicity)
III B Influence on reproductive function + - - - +
Data on teratogenicity, gonadotoxicity and embryotoxicity
III C * Data on mutagenicity + - - - +
III D * Data on carcinogenicity + - - - +
III Е Pharmacodynamics (specific action, general pharmacological properties (for medical + - - + +
immunobiological preparations - reactogenicity, specific activity)
III F Pharmacokinetics (absorption, distribution, metabolism, excretion) + - - - +
III G Data on bioequivalence (for generics), for MIBP - comparative characteristics + - - - +
III Н * Data on local irritant effects (for MIBP, including vaccines - immunogenicity) + - - - +
III K * Addiction to medecine and cumulative properties + - + - +
III L * Antigenicity + - - - +
III М Additional safety information + + + + +
IV. ** Clinical documentation

IV Content + + + + +
IV A Data on clinical pharmacology (pharmacodynamics, pharmacokinetics) (in vivo for + - - + +
medical immunobiological preparations - data on epidemiological, clinical,
immunological efficacy)
IV B Results of clinical trials, scientific publications, reports + - - + +
IV С Post-registration experience data (if any) + - - + +
IV D Additional information confirming effectiveness and safety, quality, clinical effectiveness + - - + +
and safety and other additional information after registration
38
Notes:

• *) The documents indicated in the list are required taking into account origin,
properties, features of method of obtaining / producing medicinal products; If
some parts of documentation are not included in registration dossier, reason
should be indicated in appropriate place under appropriate title.
• **) If available.
• ***) For medicinal products of animal origin, following additional information
should be provided in Section IIC1:
• Data on species, age, diet and geographic region of origin of animals from which
raw materials are obtained;
• Data on nature (category) of tissue from which the raw material for production of
medicinal product is derived, in terms of its danger with regard to content of
prions;
• Technological scheme of processing raw materials with indication of extractants,
temperature regime, etc..;
• Control methods of raw materials..

39
LIST of documents submitted for registration of medical device (1)
• 1. List of submitted documents.
• 2. Letter of attorney from manufacturer to person authorizing himto conduct
the registration process.
• 3. General information about medical device.
• 4. Registration certificate of medical product (if medical device was previously
registered).
• 5. Normative document that includes order and methods of testing medical
device, standard for similar products.
• 6. For product of batch production, draft of organization’sstandard/
pharmacopeial article, technological regulations, technological instruction.
• 7. Passport for medical equipment, analytical passport for medical device.
• 8. Technical description of medical equipment.

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LIST of documents submitted for registration of medical device (2)

• 9. Information on laboratory tests, technical tests, preclinical studies and

clinical (medical) tests.
• 10. Test methods, programs and protocols (for sterile medical products - tests
conducted in last year) on medical devices.
• 11. Information on compliance of medical device with international standards
(if available).
• 12. Methods of verification of medical equipment (for measuring devices).
• 13. Information on absence of infectious agents in "in vitro" - diagnostic tools
prepared from human blood.
• 14. Information on stability in storage and transport of "in vitro" - diagnostic
tools.
• 15. Illustrated promotional materials, brochures, catalogs, photo size not less
than 13 x 18 cm.
• 16. Sample of medical device (in sufficient quantity for carrying out tests in
accordance with normative document).
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LIST of documents submitted for registration of medical device (3)

• 17. Protocol of analyzes of presented series of medical products.

• 18. Colored graphic models of primary and secondary packaging.
• The above mentioned documents are submitted to General
Administration in two copies.
• Copies of documents must be readable and certified with seal and
signature of head of organization.

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Thank you!

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