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:

  1. 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 Manufacturing Practice;
  1. if the respective application is filed starting from 1 January 2016 – the documents specified in Articles 18 p.4 pp.3 and 4 of the Circulation Law.

The amendments also define the list of documents that must be attached to the application for confirmation of the state registration of medicines for veterinary use. It is clarified that the applicant authorised to file with the competent federal executive authority the application to amend the documents contained in the registration dossier to the registered medicine for medical use, as well as to the registered medicine for veterinary use, is the holder or owner of the registration certificate to the medicine or another legal entity authorised by the latter. The procedure for termination of the clinical trials of a medicine in the event of detection by the federal executive authority performing control and supervision in the area of healthcare (hereinafter – the controlling authority) of violations of the Good Clinical Practice in the course of the relevant clinical trials which affect the completeness and(or) accuracy of the trials is modified: the controlling authority at first suspends the clinical trials and sends to the medical organisation conducting the trials a notice to eliminate the violations revealed.

In the event the medical organisation fails to eliminate the revealed violations within the period specified in the notice, the controlling authority takes a decision on the termination of the clinical trials and submits to the competent federal executive authority the opinion on the violations of the Good Clinical Practice so that the latter took a decision on withdrawal of the permit to conduct the clinical trials from the date of the decision on suspension thereof.

Furthermore, the transition provisions of the Federal Law No. 429-FZ dated 22 December 2014 (hereinafter - the Law 429) were supplemented.

It is provided that up to 1 January 2016 for the purposes of the Circulation Law (as amended by the Law 429) a reference medicine shall be deemed the respective original medicine.

It is clarified that:

  • the state registration of medicines the applications for which have been filed with the registering authority before the date of entry into force of the Law 429 shall be made in accordance with the requirements of the legislation on the circulation of medicines effective until such a date;
  • applications for the renewal of the state registration of a medicine, for examination of the medicine quality and for the study of ratio of expected benefits to the possible risk of the use of the medicine for medical use submitted to the registering authority before the date of entry into force of the Law 429 shall be considered as well in accordance with the requirements of the legislation on circulation of medicines effective until that date.

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