俄罗斯药品注册-Drug registration - 俄罗斯药品注册, Drug registration, russia Drug registration,药品注册,Drug registration,

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