|
В.I
|
Administrative documents
|
|
В.I.1
|
Inventory of documents and date with the number of pages and copies being stated
|
|
В.I.2
|
Application for the state registration of a drug or for amendments to be made into the registration documents
|
|
В.I.3
|
Documents supporting the competence of an application for state registration (warrant for submission of documents and data for state registration (amendments), a letter about no misuse of intellectual property subjects)
|
|
В.I.4
|
Receipt for the state registration payment of the drug
|
|
В.I.5
|
Original payment order on state charge for the state registration of the drug
|
|
В.I.6
|
Application to the Russian Committee of Health Care Control for the registration of the drug (amendments)
|
|
В.I.7
|
The name of the drug, including international nonproprietary name, scientific name in Latin, basic synonyms
|
|
В.I.8
|
The original name of the drug, if it is registered as a trademark in accordance with the legislation of the Russian Federation on trademarks, service trademarks and the name of the manufacturer, its city and country (trademark certificate)
|
|
В.I.9
|
List of the components of the drug, their amount
|
|
В.I.10
|
Instruction for use of the drug, drawn up in compliance with the requirements laid down in Article 16 of the Federal Law No. 86-ФЗ “On Drugs” dated June 22, 1998
|
|
В.I.11
|
Drug quality certificate (attested copy attached by its translation signed by the authorized person of the applicant)
|
|
В.I.12
|
Drug price offer
|
|
В.I.13
|
Documents supporting the registration of the drug, if it registered outside the Russian Federation
|
|
В.II
|
Description of pharmaceutical properties
|
|
В.II.14
|
Components of the drug
|
|
В.II.15
|
Active substance(s) (manufacturer’s certificate)
|
|
В.II.16
|
Excipients (manufacturer’s certificate)
|
|
В.II.17
|
Ready-made dosage form (the contents of active ingredients; limits of tolerance; physicochemical and biological properties); rationale for choosing a method of production and (primary and secondary) package; microbiological properties
|
|
В.III
|
Data on drug manufacture
|
|
В.III.18
|
Legal address of the manufacturer of the drug (confirmation of the manufacturer’s country)
|
|
В.III.19
|
Site(s) of manufacture (confirmation of the compliance with good manufacturing practice)
|
|
В.III.20
|
Material balance sheet
|
|
В.III.21
|
Brief sheet scheme of a process and its controlling methods
|
|
В.III.22
|
Control of manufacture stages and intermediates
|
|
В.III.23
|
Validation and/or qualification of the process
|
|
В.IV
|
Data on drug quality control
|
|
В.IV.24
|
Original pharmacopoeial article of the enterprise (that of the normative document)
|
|
В.IV.25
|
Methods for controlling the quality of the drug; specifications; analytical procedures; validation of analytical procedures; series analysis; characteristics of impurities; rationale for specifications
|
|
В.IV.26
|
Standards or reference materials (a reference to the manufacturer in case of standards; a copy of the manufacturer’s certificate with the attested translation being attached in case of reference substances)
|
|
В.IV.27
|
Samples of the drug for testing its quality (confirmation of the readiness of making examination for quality)
|
|
В.IV.28
|
Primary and secondary package of the drug (confirmation of permission for its use in the manufacturer’s country)
|
|
В.IV.29
|
Models of labels for the primary and secondary packages of all claimed dosages
|
|
В.IV.30
|
Results of testing for stability in the claimed types of primary package
|
|
В.V
|
Information on the results of preclinical pharmacological and toxicological studies of the drug
|
|
В.V.31
|
Introductory brief overview of performed preclinical trials
|
|
В.V.32
|
Reports on performed trials
|
|
В.V.33
|
Pharmacology: results of the trials confirming the pharmacological activity of the drug
|
|
В.V.34
|
Pharmacokinetics: absorption; distribution; metabolism; excretion; drug interactions
|
|
В.V.35
|
Toxicology: systemic toxicity, specific toxicity
|
|
В.V.36
|
List of references
|
|
В.VI
|
Information on the results of clinical trials of the drug
|
|
В.VI.37
|
Pooled analysis of the study results of the effectiveness and safety of the drug. Summarized results of individual studies; comparative analysis of the results of individual studies; populations to be studied; comparison of the results obtained in different efficacy studies; comparison of the results in individual groups of patients; analysis of the results of recommended dosage studies.
|
|
В.VI.38
|
Pooled analysis of the results of safety. Safety evaluation methods; pattern and frequency of adverse reactions; clinically significant changes in laboratory parameters; drug interactions; development of the withdrawal syndrome.
|
|
В.VI.39
|
List of references
|