List of documents for medical products authorization in Russia

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Главная Comments List of documents for medical products authorization in Russia
List of documents for medical products authorization in Russia
Thursday, 02 September 2010 20:20

Here you can find a complete list of documents necessary for the authorization of a drug product in Russia according to the requirements of Federal Law No. 61-ФЗ "On drugs".

 

Documents necessary for approval of a clinical trial:

1. a non-clinical study report, including description, results, and statistical analysis of the results obtained;

2. draft protocol of a clinical trial;

3. investigator’s brochure;

4. reports of clinical trials, bioequivalence and/or therapeutic bioequivalence studies of the product conducted in the applicant's country and other countries (including epidemiological studies of immunobiological products for immunological prevention and therapy of infectious diseases, including those of children) with description of performed studies of the product, results thereof, and statistical analysis of obtained results (at the applicant’s discretion).

5. document proving the payment of state fee for expert evaluation for approval of a clinical trial and ethic review upon the application for drug authorization.

Documents necessary for expert evaluation and risk/benefit assessment of a drug:

1. draft designs of primary and secondary (consumer) packaging of the drug product;

2. a document translated into the Russian language and certifying that the manufacturer of the drug product for authorization complies with GMP, issued by the competent authority of the manufacturer’s country and certified in accordance with the prescribed procedure;

3. draft regulatory documentation for the drug product or a reference to the relevant monograph;

4. drug product manufacturing process flow chart, its description and/or drug substance manufacturing process flow chart, its description;

5. a document translated into Russian and certifying that the drug substance manufacturer complies with GMP,issued by the competent authority of the drug substance manufacturer’s country, certified in accordance with the prescribed procedure and including the following:

a) drug substance name (international nonproprietary name or chemical name, and trade name);
b)
drug substance manufacturer’s name and address;
c)
drug substance shelf-life;

6. a document with information about quality parameters of the drug substance used for the manufacture of drug products;

7. regulatory documentation for the drug substance or a reference to the relevant monograph;

8. information about drug substance and transportation conditions, and other relevant information;

9. clinical study report or international multi-center clinical study reports, some of which have been conducted in the Russian Federation;

10. draft prescribing information including the following:

a) drug product name (international nonproprietary name or chemical name, and trade name);
b) pharmaceutical form, including names and quantities (strength) of drug substances and excipients;
c) pharmacotherapeutic group of the drug product;

d) therapeutic indications;

e) contraindications;
f) posology, method of administration and, if necessary, time of administration, duration of treatment (including in children below and over one year of age);
g) special precautions for use;

h) symptoms and treatment of overdose;
i) if necessary, peculiarities of action of the drugs following the first administration or discontinuation;
j) if necessary, actions to be taken by physicians (nurses), veterinary specialists, patients, or animal’s ownersin case one or several doses are missed;
k) adverse reactions that may occur following administration of the drug product;
l) interactions with other medicinal products and/or food;
m) use of the product in pregnant or breastfeeding women, children and adults with chronic diseases;
n) effects of the product on the ability to drive and use machines;
o) shelf-life and a warning that the product should not be used after the expiry date;
p) storage conditions;
q) a warning that the product should be kept away from children;
r) if necessary, special warnings and precautions for disposal of unused product;
s) name and address of the drug product manufacturer, and address of the manufacturing site
;
t)
dispensing conditions; (Added by Federal Law No. 313-ФЗ dated 29.11.2010).

11. a copy of the document (translated into the Russian language and certified in accordance with the prescribed procedure) certifying the authorization of the product if the product is authorized outside the Russian Federation.

12. drug product samples of submission and/or commercial batches, approved by the drug manufacturer’s head.

13. a drug substance sample in quantities necessary for quality evaluation.

14. test strains of microorganisms, cell cultures, samples of substances used for drug product quality control by comparing them with the test drug product, in amount sufficient for quality control methods.

15. document proving payment of state fee for expert evaluation of the drug quality and assessment of expected risk/benefit ratio of the drug for human use during the state registration.

Source:

Federal Law №61-ФЗ "On drugs”, Chapter 6 State registration of drug products, Article 18. Submission and review of applications for state registration of drug products, and provision of necessary documents

Order of Russian MoH No. 750н dated 26.08.2010 Regulations on Expert Evaluation of Drug Products for Human Use and Forms of Expert Opinions on the Results of the Evaluation

Federal Law No. 306-ФЗ dated 27.11.2010 On amendments to Parts 1 and 2 of the Internal Revenue Code of the Russian Federation and Russian Federal Law "On tax authorities of the Russian Federation"

Federal Law N 41-ФЗ dated 05.04.2010

Last Updated on Monday, 31 January 2011 13:30
 

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