The upcoming amendments in the Federal Law No 61
Recently draft amendments of the Federal Law №61 “On drug circulation” dated 12/04/2010 were published. According to the current Law interchangeable medicines are medicine with proved therapeutic equivalence or bioequivalence when compared with the reference medicines and have equivalent content of active substances, excipients and the same form of administration. The characteristics of interchangeable medicines are listed in the article 27.1. It was suggested to add the aspect that interchangeable medicines (with regard to a certain reference medicine) will be of interchangeable between each other. According to the current review of the Federal Law points listed in this article are not applicable to reference medicines, herb medicines, homeopathic medicines and medicines which have been used in the Russian Federation for more than 20 years and for which it is impossible to study bioequivalence. After the amendments the points listed in this article will not applicable only to reference medicines, herb medicines and homeopathic medicines.
Moreover, it was suggested to add this article with extra aspects. According to the amendments it will be necessary to develop general medicinal product labels for all interchangeable medicines as well as maintenance of registers of typical medicinal product labels and interchangeable medicines. The expert body will determine whether the drugs registered before the effective date of this Law and which were beyond the interchangeability or which were determines as non-interchangeable are now may be considered as interchangeable. To determine whether the drugs for which documents were submitted for market registration before the effective date of this Law will be done by conducting a trial and comparing these drugs with reference medicines.
In the note for these draft amendments it is stated that these changes were prepared in order to implement the article 3 of the decision of the Council of the Eurasian Economic Commission dated 03/11/2016 № 92 about separate issue of drug circulation in order to improve the regulation of drug circulation.
