On 5 December 2022, Federal Law No. 502-FZ of 05.12.2022 “On Amendments to Article 56 of the Federal Law “On Circulation of Medicines” Regulating the Activities of production Pharmacies in Russia (the “Law”) was officially published.
The new rules are aimed at meeting the needs of vital indications of patients in individual doses of medicines, including ultra-small doses in pediatric practice, and medicines registered in the state register of medicines, but temporarily absent from the pharmaceutical market of the Russian Federation, by manufacturing them in pharmacy organizations, as indicated in the explanatory note to the Law1.
Currently, Russian legislation allows pharmacies, veterinary pharmacy organizations, and individual entrepreneurs, if they have the necessary license, to produce medicines using only pharmaceutical substances from the state register2. According to the new Law, medicines and pharmaceutical substances that are in the state register or the unified register of medicines of the EAEU can be used in the manufacture of medicines3.
At the same time, individual entrepreneurs are excluded from Article 56 of the Federal Law "On Circulation of Medicines" and cannot producing medicines according to the Law even if they have a license for pharmaceutical activity4.
Please note that these regulations come into force on 1 September 20235.
2 Paragraph 2 of Article 56 of the Federal Law “On Circulation of Medicines”
3 Paragraph 2 of Article 1 of the Law
4 Paragraph 1 of Article 1 of the Law
5 Article 2 of the Law