Amendments To The Federal Law ‘On Medicines Circulation'

The Federal Law No. 241-FZ dated 13 July 2015 (hereinafter - the Law 241) introduced amendments to the Federal Law No. 61-FZ dated 12 April 2010 'On The Medicines Circulation' (hereinafter - the 'Circulation Law'), as well as to the Federal Law, dated 22 December 2014 No. 429-FZ (which had significantly amended the Circulation Law with the effect from 1 July 2015).

An overview of the principal amendments effective from 13 July 2015 is provided below.

Draft decisions of the executive bodies of constituent entities of the Russian Federation on the establishment and(or) change of the threshold for wholesale mark-ups and the thresholds for retail mark-ups to the actual selling prices set by manufacturers for the medicines included in the list of vital and essential medicines (hereinafter - thresholds of mark-ups to the VEM prices) are subject to approval by the federal executive body in charge of the state regulation of prices (tariffs) for goods (services), such approval to be granted according to the procedure established by the Government of the Russian Federation.

At the same time, the scope of authority of the federal executive bodies is supplemented with the authority to approve draft decisions of the executive bodies of constituent entities of the Russian Federation on the establishment and(or) change of threshold of mark-ups to the VEM prices.

The amendments clarified that for the purposes of the fast-track procedure for examination of medicines for the state registration of first three medicines to be registered in the Russian Federation as generic medicines and medicines intended only for minor citizens, the priority of such medicines is determined in accordance with the number and date of incoming applications for the state registration of such medicines within a single international non-proprietary name of a medicine or generic name of a medicine.

It is provided that in order to confirm the state registration of a medicine for medical use (upon expiry of the initial term of its registration) the following documents should be enclosed to the relevant application:

if the application to confirm the state registration of a medicine for medical use is filed before 31 December 2015 - the documents issued by the competent authority of the medicine's manufacturer country, certified according to the established procedure and translated in Russian language which confirm the compliance of the manufacturer with the requirements of the Good...