Relations in the public health protection domain of the Russian Federation are subject to Federal Law No. 323-FZ dated November 21 (russian version), 2011 «On the Fundamentals of Public Health Protection in the Russian Federation» («323-FZ»). In particular, Article 38 of 323-FZ defines products qualifying as Medical Products («MPs»), procedure for their circulation in the Russian Federation, etc.
In accordance with Article 38(4) of 323-FZ, MPs shall be registered in the Russian Federation in line with the rules approved by Decree No.1416 issued by the Government of the Russian Federation on December 27, 2012 «On Approving the Rules for Registering Medical Products with Government Authorities» (the «Registration Rules»). Based on the requirements of paragraph 10 of the Registration Rules, list item a), the submissions to be provided for registering an MP with government authorities must include a copy of the document confirming the powers of the manufacturer’s authorized representative, that is, Power of Attorney.
Paragraph 4 of the Registration Rules defines an authorized representative of a manufacturer as:
«a legal entity registered in the Russian Federation authorized by the manufacturer of a medical product to represent such manufacturer in connection with the circulation of the medical product in the Russian Federation, including conformity assessment procedures and registration with government authorities, in whose name a marketing authorization for the medical product may be issued.»
Therefore, to have its MP approved for circulation in the Russian market, the manufacturer must appoint an authorized representative and issue a Power of Attorney in his or her name, as specified above, in accordance with the laws of the country where the manufacturer is located.