Since 2020, SCEEMP is authorised to perform evaluation of interchangeability of approved medicinal products.
The following legal acts form the legislative basis for assessing interchangeability of approved medicinal products:
- Federal Law No. 61-FZ ‘On the Circulation of Medicinal Products’ dated 12 April 2010;
- Federal Law No. 475-FZ ‘On Amendments to the Federal Law ‘On the Circulation of Medicinal Products’ and the Federal Law ‘On Amendments to the Federal Law ‘On the Circulation of Medicinal Products’ dated 27 December 2019;
- Decree No. 1360 of the Government of the Russian Federation ‘On the Procedure for Determining Interchangeability of Medicinal Products for Human Use’ dated 5 September 2020 (in combination with the ‘Rules for Determining Interchangeability of Medicinal Products for Human Use’);
- Decree No. 1357 of the Government of the Russian Federation ‘On Approval of the Rules for Using Information on Interchangeable Medicinal Products for Human Use and Providing Explanations on Interchangeability of Medicinal Products for Human Use, as well as on Amending Requirements for the Contents of Purchasing Documents for Medicinal Products for Human Use that Are Procured by Government and Municipal Agencies’ dated 9 April 2020.
The provisions of these legal acts do not apply to medicinal products whose interchangeability was confirmed during marketing authorisation before 1 March 2020, as well as homeopathic and herbal medicinal products.
SCEEMP has compiled a list of interchangeable medicinal products for reference products and generic products supported by registration dossiers which include the results of bioequivalence studies or therapeutic equivalence studies with respect to the reference drug (hereinafter referred to as the List).
The List is compiled by SCEEMP by combining medicinal products into separate groups, each including interchangeable medicines. The List contains the following groups of interchangeable medicines:
- identical interchangeable medicines;
- interchangeable medicines not presented in dose units;
- reference interchangeable medicines;
- combination interchangeable medicines;
- generic interchangeable medicines;
- medicines whose interchangeability was confirmed during marketing authorisation before 1 March 2020;
- medicines authorised based on the results of bioequivalence studies or therapeutic equivalence studies with respect to the non-reference drug, provided that such drugs had been authorised based on the results of bioequivalence studies or therapeutic equivalence studies with respect to the reference drug.
Starting from 1 July 2020, the List is posted on the official website on the Internet, in accordance with the current legislation.
https://grls.rosminzdrav.ru/Default.aspx
This information is updated monthly, taking into account new authorised medicinal products for human use and variations made to the registration dossiers for already authorised medicinal products for human use.
Work is ongoing on updating the product information for generic medicines in accordance with the product information for the reference products, and on identifying generic medicines for which there are no results of comparative bioequivalence clinical studies or therapeutic equivalence studies with respect to the reference drug, available in the registration dossiers.