FAS will obligate all pharmaceutical manufacturers to submit the necessary documents in order to determine substitutability of medicinal drugs

23-12-2016 | 11:13

The Federal Antimonopoly Law (FAS Russia)has drafted amendments to the Law on drug circulation (No.61-FZ)

The amendments are designed to entitle the Ministry of Health Care of the Russian Federation to enquire information from the holders of registration certificates necessary to determine substitutability of medicinal drugs registered under the rules in effect before 1 July 2015.

The draft Law establishes the procedure and time frame for data enquiries to determine pharmaceuticals substitutability. The amendments entitle the authorized body to suspend drug usage if a registration certificate holder fails to submit data after the first enquiry and abolish state drug upon repeated failure to submit the enquired documents.

The draft Law also formalizes the functions of the Ministry of Health Care to keep the Register of medicine drug substitutes, which will enable implementation of the decision of the Council of the Eurasian Economic Commission on the rights of EAEU member-states and determine drug substitutability in accord with the national law.

The draft Law is forwarded to the Ministry of Health Care in due course and is published by the Ministry for public notification which will take place on 7 January 2017.

“The draft Law allows the expert institution to complete by the end of 2017 the work on determining all medicines registered in Russia and suppresses unfair conduct of market participants that take advantages of the gaps in the law. The draft Law will help start determining drug substitutability under the frame of the common market of the Eurasian Economic Union”, pointed out Deputy Head of FAS Department for Control over Special Sphere and Trade, Yulia Ermakova.