Article 18. Submission and Review of Applications for State Registration of Medicinal Products and Submission of Necessary Documents

1. For the purpose of state registration of a medicinal product, the developer of the medicinal product or any other legal entity authorized by such developer (hereinafter –the “applicant”) submits to the relevant authorized federal executive body carrying out state registration of medicinal products an application for state registration of the medicinal product, as well as necessary documents in the manner prescribed by the relevant authorized federal executive body, of which the registration dossier for the medicinal product is formed (hereinafter – the “registration dossier”).

2. An application for state registration of a medicinal product shall contain:

1) name and address of the applicant and (or) developer of the medicinal product and address of the place of manufacturing of the medicinal product;
2) name of the medicinal product (international nonproprietary name or chemical and trade names);
3) list of substances composing the medicinal product specifying the quantity of each;
4) dosage form, dosage rate, methods of administration and use and validity period of the medicinal product;
5) description of pharmacological and pharmacodynamic or immunobiological properties of the medicinal product;
6) maximum ex-works price for the medicinal product included in the list of vital and essential medicinal products as posted by the manufacturer, in case of state registration of such product;
7) statement on the lack of the need to conduct a clinical trial and bioequivalence study of the medicinal product permitted for medical use within the territory of the Russian Federation for over twenty years, specifying normative legal acts which prove such period of use.

3. The registration dossier shall comprise the following documents:

1) draft designs of primary packages and secondary (retail) packages for the medicinal product;
2) document certifying the compliance of the manufacturer of the medicinal product to be registered with the requirements of the good manufacturing practices, issued by a competent authority of the country of origin of the medicinal product to be registered and certified in the prescribed manner, as translated into the Russian language;
3) draft normative documentation or normative document for the medicinal product or reference to a relevant pharmacopeia monograph;
4) process flow diagram for manufacturing of the medicinal product and its description, and (or) process flow diagram for manufacturing of the pharmaceutical substance and its description;
5) document certifying the compliance of the manufacturer of the pharmaceutical substance with the requirements of the good manufacturing practices, issued by a competent authority of the country of origin of the pharmaceutical substance and certified in the prescribed manner, as translated into the Russian language, containing the following information:

a) name of the pharmaceutical substance (international nonproprietary name or chemical and trade names);
b) name and address of the manufacturer of the pharmaceutical substance;
c) pharmaceutical substance shelf-life;

6) document containing data on qualitative indicators of the pharmaceutical substance used in manufacturing of the medicinal products;
7) normative documentation or normative document for the pharmaceutical substance, or reference to a relevant pharmacopoeia monograph;
8) information on conditions of storage and transportation of the medicinal product, and other information;
9) report on the results of preclinical testing of the medicine for medical use containing description, results and statistical analysis of the results of the preclinical testing;
10) report on the results of preclinical testing of the medicine and clinical trial of the medicinal product for veterinary use;
11) draft protocol of a clinical trial of the medicinal product for medical use;
12) investigator’s brochure;
13) patient information sheet;
14) information on remunerations and compensations paid to the patients (healthy volunteers and ill patients) (hereinafter – the “patients”) involved in clinical trials of the medicinal product for medical use, bioequivalence and (or) therapeutic equivalence studies;
15) report on the results of international multicentre clinical trials of the medicinal product for medical use, partially conducted in the Russian Federation;
16) draft instructions for use of the medicinal product containing the following information:

a) name of the medicine (international nonproprietary name or chemical and trade names);
b) dosage form indicating the names and quantitative level (activity) of the pharmaceutical substances and excipients;
c) pharmacotherapeutic group of the medicinal product;
d) indications for use;
e) counterindications for use;
f) dosage regimen, mode of administration, time of administration of the medicinal product, if necessary, and duration of treatment (including those for children under and over one year old);
g) safety precautions on use;
h) overdose symptoms; relief measures in case of overdose;
i) references, if necessary, to specific effects of the medicinal product at first use or withdrawal thereof;
j) description, if necessary, of actions to be undertaken by a physician (physician’s assistant), veterinary specialist, patient or animal’s owner in case of omission of one or several doses of the medicinal product;
k) possible side effects of the medicinal product;
l) interaction with other medicinal products and (or) food substances or animal food substances;
m) possibilities and specifics of medical use of the medicinal product in pregnant women, women in period of lactation, children or adults with chronic deceases;
n) information on possible effect of the medicinal product on the ability to drive and operate machinery;
o) validity period and indication not to use the medicinal product after its expiry;
р) storage conditions;
q) indication to keep the medicinal product away from children;
r) special safety precautions to be used when destructing unused medicinal products, if necessary;
s) terms of possible use of animal products after the animal has been administered the medicinal product for veterinary use;
t) name and address of the manufacturer of the medicinal product and address of the place of manufacturing of the medicinal product;
u) dispensing conditions;
(clause “u” introduced by Federal Law of November 29, No. 313-FZ)

17) copy of the document certifying registration of the medicinal product if it is registered outside the Russian Federation translated into the Russian language and certified in the prescribed manner;
18) documents submitted in accordance with articles 19 – 23 hereof.

4. At the applicant’s request, reports on the results of clinical trials, bioequivalence and (or) therapeutic bioequivalence studies of the medicinal product conducted in the applicant’s country and other countries (including epidemiological or episootological trials of immunobiological medicinal products designed for immunobiological prophylaxis and treatment of infectious diseases, including with children), containing descriptions of the trials of the medicinal product conducted, their results and statistical analysis of the results obtained may be submitted.

5. The following documents shall be enclosed with an application for state registration of a medicinal product:

1) document certifying payment of the state duty for performance of expert examination of the documents submitted to obtain permits to conduct clinical trials of the medicinal product for medical use and ethical expert examination when applying for state registration of the medicinal product;
2) document certifying payment of the state duty for performance of expert examination of the quality of the medicine and expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product permitted for use within the territory of the Russian Federation for over twenty years when applying for state registration of the medicinal product;
3) document certifying payment of the state duty for performance of expert examination of the quality of the medicine and expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product for medical use when applying for state registration of the medicinal product, for which international multicentre clinical trials have been conducted, partially within the territory of the Russian Federation;
4) document certifying payment of the state duty for performance of expert examination of the quality of the medicine and expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product for veterinary use when applying for state registration thereof.

6. The results of the nonclinical trials of medicinal products and clinical trials of medicinal products submitted by the applicant for state registration of the medicinal products shall not be obtained, disclosed, used for commercial purposes and for purposes of state registration without applicant's permission within six years from the date of the state registration of the medicinal product.

Violation of the prohibition specified by this Clause shall entail the responsibility in accordance with the legislation of the Russian Federation.

The circulation of medicines in the Russian Federation registered with violation of this Clause shall be prohibited.
(clause 6 introduced by Federal Law of October 11, 2010, No. 271-FZ)