of October 28, 2015 No. 1154
About procedure for determination of interchangeability of medicines for medical application
According to article 27.1 of the Federal law "About Drug Circulation" Government of the Russian Federation decides:
1. Approve the enclosed Rules of determination of interchangeability of medicines for medical application.
2. Determination of interchangeability of the medicines for medical application registered till July 1, 2015 or after this date with observance of provisions of parts 7 and 8 of article 3 of the Federal Law of December 22, 2014 No. 429-FZ "About introduction of amendments to the Federal law "About Drug Circulation" is performed till December 31, 2017 according to requirements of article 3 of the specified Federal Law and Rules approved by this resolution.
3. The Ministry of Health of the Russian Federation posts on the official site on the Internet of the data on the registered medicines for medical application concerning which the Ministry issues to federal state budgetary institution on conducting examination of medicines task for determination of interchangeability of these medicines.
4. To make to the Ministry of Health of the Russian Federation and Federal Antimonopoly Service explanations on use of the Rules approved by this resolution.
Russian Prime Minister
Approved by the Order of the Government of the Russian Federation of October 28, 2015 No. 1154
1. These rules establish procedure for determination of interchangeability of medicines for medical application (further - medicines).
2. These rules do not extend to reference medicines, medicinal vegetable drugs, homeopathic medicines and medicines which are resolved for medical application in the Russian Federation more than 20 years and concerning which carrying out research of their bioequivalence is impossible.
3. Interchangeability of medicine is determined in the course of its state registration based on comparison with reference medicine by the parameters specified regarding 1 article 27.1 of the Federal law "About Drug Circulation" when carrying out in accordance with the established procedure by the commission of experts of the federal state budgetary institution on conducting examination of medicines which is under authority of the Ministry of Health of the Russian Federation, examination of medicine regarding examination of quality of medicine and (or) examination of the attitude of the expected advantage towards possible risk of use of medicine.
4. Determination of interchangeability of bioanalog (biosimilar) medicine (bioanalogue) is performed taking into account the data on absence obtained by results of conduct of clinical trials at it clinically significant distinctions of safety, efficiency and immunogenicity in comparison with reference medicine.
5. Absence in the instruction on medical application of medicine of the indications to use specified in the instruction on medical application of reference medicine and protected by the valid patent is not obstacle for determination of interchangeability of medicine.
6. Conclusion about interchangeability (not interchangeability) of medicine is drawn up in the form of appendix to the conclusion of the commission of experts specified in Item 3 of these rules in the form approved by the Ministry of Health of the Russian Federation.
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