Article 39.  International Multicentre Clinical Trial of Medicinal Product for Medical Use or Post-registration Clinical Trial of Medicinal Product for Medical use

1. An international multicentre clinical trial of a medicinal product for medical use in the Russian Federation or a post-registration clinical trial of a medicinal product for medical use shall be carried out under a permit to conduct a clinical trial of the medicinal product issued by the authorized federal executive body upon the results of the expert examination of the documents required for obtaining a permit to conduct an international multicentre clinical trial of the medicinal product or post-registration clinical trial of the medicinal product and ethical expert examination.

2. To obtain a permit to conduct an international multicentre clinical trial of a medicinal product for medical use or a post-registration clinical trial of a medicinal product for medical use, the applicant shall submit to the authorized federal executive body:

1) application for obtaining a permit to conduct an international multicenter clinical trial of a medicinal product for medical use or a post-registration clinical trial of a medicinal product for medical use;
2) documentary proof to confirm payment of the state duty for issuance of a permit to conduct an international multicentre clinical trial of a medicinal product for medical use, or the state duty for issuance of a permit to conduct a post-registration clinical trial of a medicinal product for medical use;
3) report on preclinical testing of the medicine and a report on earlier clinical trials of the medicinal product for medical use (if any);
4) clinical trial draft protocol for the medicinal product for medical use;
5) investigator's brochure;
6) information sheets of the patients enrolled in the clinical trials of the medicinal product for medical use;
7) data about the investigators’ work experience in the relevant specializations and their clinical trial experience;

7¹) the details of medical organizations which are scheduled to conduct clinical trial of medicinal product for medical use (full and brief names of medical institution, legal form of medical institution, the seat and business location of medical institution, telephone, telefax, email address);
(as amended by Federal Law of November 29, 2010, No. 313-FZ)
7²) estimated terms of the clinical trial of the medicinal product for medical use;
(sub-clauses 7² introduced by Federal Laws of October 11, 2010, No. 271-FZ)

8) the copy of contract of compulsory insurance, made in accordance to the standard rules for compulsory insurance, with specifying the maximal number of patients involved in clinical trial of medicinal products for medical use;
(as amended by Federal Law of November 29, 2010, No. 313-FZ)
9) composition of the medicinal product required for obtaining a permit to conduct an international multicentre clinical trial of the medicinal product for medical use;
10) the document created by manufacturer of the medicinal product, which contains data on parameters (qualitative indicators) of the medicinal product for medical use, produced for conducting of clinical trials.
(as amended by Federal Law of November 29, 2010, No. 313-FZ)

3. In the period not longer than five business days on filing the application referred to in Sub-clause 1, Clause 2 of this Article and the appropriate documents, the authorized federal executive body shall:

1) check the data contained in the applicant’s documents for completeness and accuracy;
2) make a decision on expert examination of the documents to issue a permit to conduct an international multicentre clinical trial of the medicinal product for medical use or a post-registration clinical trial of the medicinal product for medical use and ethical expert examination, or on rejection of such expert examinations;
3) notify the applicant of the decision in writing or, in the event of rejection, indicate the reasons of such rejection.

4. Failure to submit a full package of documents prescribed in Clause 2 of this Article, or lack of sufficient list of appropriate details or information to be presented in the documents shall be a reason for rejection of expert examination of the documents required for issuance of a permit to conduct an international multicentre clinical trial of a medicinal product for medical use or a post-registration clinical trial of a medicinal product for medical use and ethical expert examination.

5. Expert examination of the documents required for obtaining a permit to conduct an international multicentre clinical trial of a medicinal product for medical use or a post-registration clinical trial of a medicinal product for medical use and ethical expert examination, and issuance of a permit to conduct an international multicentre clinical trial of medicinal product for medical use or a post-registration clinical trial of medicinal product for medical use shall be performed in the procedure established in articles 20 - 22 of this Federal Law.

6. Decision on rejection of expert examination of the documents required for obtaining a permit to conduct an international multicentre clinical trial of a medicinal product for medical use or a post-registration clinical trial of a medicinal product for medical use and ethical expert examination and on rejection of issuance of a permit to conduct an international multicentre clinical trial of a medicinal product for medical use or a post-registration clinical trial of medicinal product for medical use may be appealed in the manner prescribed by the laws of the Russian Federation.