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Federal Law of the Russian Federation No. 61-FZ of April 12, 2010, on Circulation of Medicines (as amended up to Federal Law No. 425-FZ of December 28, 2017), Russian Federation
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Year of Version
2018
Dates
Entry into force:
September 1, 2010
Signature:
April 12, 2010
Type of Text
IP-related Laws
Subject Matter
Patents (Inventions),
Trade Names
Notes
This consolidated Federal law incorporates all the amendments up to “Federal Law No. 425-FZ of December 28, 2017, on Amendments to the Federal Law on Circulation of Medicines”, which entered into force on January 1, 2018; except for Article 1, paragraphs 2, 5 and 9, which will enter into force on January 1, 2020.
For the amendments introduced by the said Federal Law No. 425-FZ, see:
- Chapter 1, Article 4, paragraph 56);
- Chapter 6, Article 18, paragraph 2, subparagraph 1); Article 33, paragraph 1, subparagraph 1), c), d), paragraph 2, subparagraph 2); Article 34, paragraph 2, subparagraph 4);
- Chapter 12, Article 62, paragraph 2, subparagraph 1);
- Titles of Chapter 14 and Article 67, and paragraphs 4-12 of Article 67.
This consolidated Federal Law contains the following provisions, inter alia, relating to the definition of the trade name of a medicine, the patent validity of the original medicine, the registration of medicinal products including international non-proprietary names (INN), or chemical names and trade names, the cancellation of registration of different medicinal products under the same trade name, or of the same medicinal product under different trade names, and the indication of trade names on the packaging of medical products and in the State Register of Medicines:
- Chapter 1, Article 4, paragraph 17);
- Chapter 3, Article 7, paragraph 3;
- Chapter 6, Article 13, paragraph 6; Article 18, paragraph 2, paragraph 4, subparagraph 5); Article 32, paragraphs 5) and 6); Article 33, paragraph 1, subparagraph 1), a); subparagraph 2), a);
- Chapter 8, Article 46, paragraphs 1 and 2;
- Chapter 12, Article 62, paragraph 2, 2).
Available Texts
Main text(s)
Main text(s)
Russian
Федеральный закон Российской Федерации № 61-ФЗ от 12.04.2010 г. «Об обращении лекарственных средств» (с изменениями, внесенными в соответствии с Федеральным законом № 425-ФЗ от 28.12.2017 г.)
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WIPO Lex No.
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