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Pursuant to Article 38 of Federal Law “On Circulation of Medicines”, the Government of the Russian Federation hereby decrees:
1. The attached ‘Rules for Accreditation of Medical Institutions for the Right to Conduct Clinical Trial of Medicinal Product for Medical use shall be approved.
2. It is hereby established that medical institutions engaged in clinical trials of medicinal products on the day when this Decree is enforced are granted the right to continue with such trials without accreditation for the right to conduct clinical trials of Medicinal Product for Medical use until September 1, 2011.
Vladimir Putin,
Prime Minister of the Russian Federation
Rules for Accreditation of Medical Institutions for the Right to Conduct Clinical Trial of Medicinal Product for Medical use
(approved by RF Government Decree No. 683 of September 3, 2010)
1. These Rules establish the procedure for accreditation of medical institutions for the right to conduct clinical trials Medicinal Product for Medical use (‘accreditation’) with the following purposes:
a) to establish safety and/or tolerance of medicinal products for healthy volunteers;
b) to select optimum dosage of medicinal products and treatment course for patients with specific diseases, optimum doses and vaccination patterns of immunobiological medicinal products for healthy volunteers;
c) to establish safety and efficiency of medicinal product for patients with specific diseases, and preventive efficiency of immunobiological medicinal products for healthy volunteers;
d) to research possibilities to expand indications for medical use and identify previously unknown side effects from registered medicinal products.
2. Accreditation can be granted for all or for one of the objectives listed in item 1 herein above.
3. Accreditation is granted by the Ministry of Healthcare and Social Development of the Russian Federation (‘the Accreditation Authority) in order to recognize the medical institution as sufficiently competent to conduct clinical trials of Medicinal Product for Medical use within a specific profile of medical activities engaged by the medical institution.
4. Accreditation requirements to be met by the medical institution for the purposes of accreditation include:
a) license for medical activities, and in case of clinical trials of medicinal products that contain narcotic medicinal products and psychotropic substances, - also license for activities related to circulation of narcotic medicinal products and psychotropic substances;
b) availability of an intensive care and resuscitation ward/department in case of clinical trials with medicinal products to establish that they are safe or can be tolerated by healthy volunteers;
c) availability of copies of regulatory legal acts that regulate the issues of organization and conduct of clinical research of medicinal products for medical application;
d) compliance with the approved officially rules of clinical practice;
e) protection of confidential information.
5. To be granted accreditation, the medical institution (‘Petitioner’) shall present (by recorded delivery mail with listed content) the following documents directly to the Accreditation Authority:
а) petition requesting issue of an Accreditation Certificate for the right to conduct clinical trials of medicinal products for medical application (‘the Accreditation Certificate’) in the format approved by the Accreditation Authority;
b) copies of constitutive documents;
c) statement from the United Federal Register of Corporate Entities;
d) copy of the license for medical activities;
e) copy of the license for activities related to circulation of narcotic medicinal products and psychotropic substances (in case of clinical trials of medicinal products that contain narcotic medicinal products and psychotropic substances);
f) copies of documents to confirm that the Petitioner has an intensive care and resuscitation ward/department (in case of clinical trials with medicinal products to establish that they are safe or can be tolerated by healthy volunteers);
g) copy of a document approved by the CEO of the medical institution to establish the procedure for handling confidential information.
6. The petition requesting issue of an Accreditation Certificate shall be signed by the Petitioner’s CEO or their authorized representative, and bear the official seal of the medical institution.
7. The Accreditation Authority may not request any other documents from the Petitioner other than specified herein.
8. The Accreditation Authority shall accept documents furnished by the Petitioner by the list and register them in accordance with par. 5 hereof on the day of submission.
9. Within 30 business days from receipt of documents submitted in accordance with par. 5 hereof, the Accreditation Authority shall examine them for completeness and reliability of information contained therein, and for the Petitioner’s compliance with the accreditation requirements, and by executive order of the (deputy) chief officer of the Accreditation Authority grant or refuse accreditation.
10. The Accreditation Authority may organize and conduct field inspection of the Petitioner in order to assess whether the Petitioner actually meets the accreditation requirements.
11. If the decision is to grant accreditation, the Accreditation Authority within 3 business days from the date of such decision shall send (hand over) to the Petitioner a copy of the executive order granting accreditation, and the Accreditation Certificate in the format of the Appendix hereto.
12. If the decision is to refuse accreditation, the Accreditation Authority within 3 business days from the date of such decision shall send (hand over) to the Petitioner a copy of the executive order refusing accreditation, with reference to the grounds for refusal.
13. Grounds to refuse accreditation include:
a) the Petitioner’s failure to meet the accreditation requirements;
b) failure to present all documents listed in par. 5 hereof;
c) false information found in documents presented under par. 5 hereof.
14. The effective period of the Accreditation Certificate shall be 5 years, or shorter if requested by the Petitioner.
15. The medical institution shall keep the Accreditation Authority informed about all changes in its organizational structure and conditions that may impact its ability to meet the accreditation requirements, within 15 business days from effect of such changes.
16. If the Accreditation Certificate is lost/damaged during its effective period, the medical institution has the right to receive a duplicate issued based on a request filed in writing with the Accreditation Authority, with description of the circumstances that cause the loss/damage of the certificate.
Duplicates of Accreditation Certificates shall be issued for a period not longer than the effect of the original lost/damaged certificate.
17. The effective period of the Accreditation Certificate may be extended by the Accreditation Authority based on a request from the medical institution, filed with the Accreditation Authority within 30 business days before the expiry of the Accreditation Certificate.
18. Having examined a request to extend the effective period of the Accreditation Certificate and materials from reviews of the medical institution’s compliance with the rules of clinical practices, the Accreditation Authority shall take decision whether extension of the effective period of the Accreditation Certificate is granted or refused, within 15 business days from receipt of such request.
Accreditation Certificates for medical institutions shall be extended by 5 years.
Failure by the medical institution to meet the accreditation requirements can be used as grounds to refuse extension of the effective period of the Accreditation Certificate.
19. Should the medical institution change its name or location, the Accreditation Certificate must be reissued.
20. Requests to reissue the Accreditation Certificate shall be filed with the Accreditation Authority within 15 business days from the date of corresponding changes in the United Federal Register of Corporate Entities.
The request to reissue the Accreditation Certificate shall have enclosed copies of documents confirming that changes were actually made to the United Federal Register of Corporate Entities.
21. The Accreditation Certificate shall be reissued within 10 business days from the Accreditation Authority’s receipt of the request to reissue the Accreditation Certificate with relevant enclosures.
22. A medical institution granted accreditation and intending to conduct clinical research of medicinal products for medical use in a domain not covered by its original accreditation shall apply for a new Accreditation Certificate.
23. While Accreditation Certificate are reissued and new Accreditation Certificates received by the medical institution in the cases specified in paragraphs 19 and 22 hereof, the course of clinical research of medicinal products for medical use shall not be interrupted.
24. During the effective period of the Accreditation Certificate, the Accreditation Authority shall review compliance of the medical institution with the accreditation requirements through the procedure of Federal Act ‘Protection of Rights of Corporate Entities and Individual Entrepreneurs in the Course of Government Control (Supervision) and Municipal Control’.
25. Should review of the medical institution reveal any non-compliance with the accreditation requirements, the issuing Accreditation Authority shall suspend the effect of the Accreditation Certificate until such non-compliance is eliminated.
The Accreditation Authority shall resume the effect of the Accreditation Certificate after the medical institution eliminates accreditation non-compliance.
26. The Accreditation Authority may rule to suspend/resume the effect of the Accreditation Certificate within 10 business days from the date of registration of documents confirming the medical institution’s non-compliance with accreditation requirements or elimination thereof.
The Accreditation Authority shall hand over/send a copy of such rule to the concerned medical institution within 3 business days.
27. The effect of the Accreditation Certificate is canceled in the following cases:
a) expiry of the effect of the Accreditation Certificate;
b) early conclusion of clinical research of medicinal product for medical use as regards declared purposes, by request of the medical institution;
c) liquidation or re-organization of the medical institution.
28. The Accreditation Authority shall take decision to cancel the effect of the Accreditation Certificate within 10 business days from receipt of documents that confirm events listed in par. 27 hereof.
29. When the Accreditation Certificate is cancelled, a decision to terminate its effect shall be also the decision to cancel the Accreditation Certificate.
The Accreditation Authority shall hand over/send a copy of such decision within 3 business days to the medical institution, whose Accreditation Certificate ceased its effect.
30. The Accreditation Authority shall recall the Accreditation Certificate in the following cases:
a) the medical institution fails to comply with the Accreditation Authority’s rule to eliminate non-compliance within 10 days from such rule;
b) the medical institution fails to meet any accreditation requirements that have been used as grounds to suspend the effect of the Accreditation Certificate at least twice during its effective period.
31. In case of cancellation or termination of the Accreditation Certificate, the concerned medical institution shall terminate its clinical trials of medicinal products.
32. The Accreditation Authority shall keep a registry of medical institutions accredited for the right to conduct clinical trials of medicinal product for medical use (‘the Registry’) in its officially approved format, and publish it on its official website.
33. The Accreditation Authority shall add information to the Registry within 5 business days from the date of issue, extension, reissue, suspension, resumption, cancellation or terminate of the Accreditation Certificate.
34. All information contained in the Registry shall be public domain and open, and shall be made available as statement from the Registry to individuals and corporate entities within 10 business days from the date of requests for such information.
35. For issue of Accreditation Certificates, federal fees shall be paid, as and how regulated by the Russian federal tax legislation.
36. In accordance with the Russian federal law, the medical institution has the right to challenge the Accreditation Authority’s decisions to refuse accreditation, or decisions related to extension, reissue, suspension, resumption, cancellation or terminate of the Accreditation Certificate.
Appendix to Rules of Accreditationи of Medical Institutions for the Right to Conduct Clinical Trials of Medicinal product for medical use
(form)
Accreditation Certificate for the right to conduct clinical trials of medicinal product for medical use
‘____’ ________20___, No. ________
(date)
1. This Certificate is issued to _________________________________________________________________
(full and abbreviated name, corporate and ownership form of the medical institution)
2. Main Federal Registration Number of medical institution’s statutory registration:
__________________________________________________________________
(OGRN and details of the document on the medical institution’s existing recordin United Federal Register of Corporate Entities)
3. Location _________________________________________________________
and place of operation ________________________________________________
(mailing addresses of official location and place of operation, telephone/fax numbers, email addresses of the medical institution)
4. Taxpayer’s ID __________________________________________________________________
(INN and details of the tax registration document)
5. Clinical trials of medicinal product for medical use, including international multi-center, domestic multi-center, post-registration, for government registration, and for other purposes, in accordance with rules clinical practice, with objectives:
__________________________________________________________________
(specify purpose of clinical research ofmedicinal product for medical use covered by this Certificate)
6. This Certificate is issued with effect until ‘___’_________20___, by decision of the Ministry of Healthcare and Social Development of the Russian Federation, Executive Order No. ___ of ‘___’ ___________20___.
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The effect of this Certificate is extended until ‘_____’_____________20___, by decision of the Ministry of Healthcare and Social Development of the Russian Federation, Executive Order No. ___ of ‘___’ ___________20___.
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