For the attention of heads of companies producing medicines

Pepeliaev Group advises that on 3 March 2014 the Russian Ministry of Justice registered Order No. 1607 of the Russian Ministry of Industry and Trade dated 4 October 2013 "On approving the Administrative Regulation for the Russian Ministry of Industry and Trade to perform the state function of licensing control over the manufacturing of medicines for medical use" (the "Regulation").

This Regulation establishes a procedure for the Russian Ministry of Industry and Trade to carry out licensing control over the manufacturing of medicines for medical use.

The Regulation will come into force 10 days after it is officially published. As of the date of this alert, the Regulation has not been published.

Summary of the main provisions of the Regulation:

The following aspects are subject to state control under the Regulation:

  • information regarding the licensed activity, contained in the the documents of the legal entity engaged in manufacturing medicines for medical use (the "manufacturer");
  • the state of the premises, buildings, constructions, technical facilities, equipment and other facilities used in the course of manufacturing;
  • whether the manufacturer's employees comply with the licensing requirements;
  • measures taken by manufacturers to comply with other licensing requirements established by the law regarding the licensing of the manufacturing of medicines for medical use, as well as to comply with orders to eliminate any violations of the licensing requirements that have been identified.

The Regulation establishes the rights and obligations of those who exercise the control and those who are controlled during the state control procedure, which is implemented in the form of inspections that may be scheduled or non-scheduled, desk or field.

In particular, the annual plan of scheduled inspections is posted on the official website of the Ministry of Industry and Trade and manufacturers will be able to familiarise themselves with it in advance. The following factors may serve as grounds for non-scheduled inspections: if the deadline expired that was established to perform an order to eliminate a violation identified earlier, if the period for suspending a licence has terminated, if a request for a non-scheduled inspection has been received or complaints from individuals or companies have been submitted, etc. As in situations swhen other authorities perform inspections, the field inspection is aimed at establishing whether the licensing requirements are complied with not only on paper, but are actually observed. 

According to the general rule, an inspection may not exceed 20 business days. With regard to small businesses, the total duration of scheduled field inspections must not exceed 50 hours a year or 15 hours a year with regard to micro-businesses.

Based on results of licensing control, the Ministry of Industry and Trade prepares an inspection report and, if any violation has been identified, issues an order to eliminate such violations, specifying the deadline for eliminating them. The Regulation also establishes a regime for adopting administrative measures envisaged by Russian legislation in situations where violations are identified (in particular, the procedure for suspending a licence has been established).

In addition, the Regulation sets out the procedure and forms of control over the performance of the state function and the procedure to complain against the actions (omissions) and decisions of state officials. The timelines for officials of the Ministry of Industry and Trade to consider a complaint shall not exceed 30 days from the date on which such complaint was registered. In certain situations, the timelines for considering a complaint may be extended, but not by more than 30 days.

To think about, to do

In connection with the above new developments, we suggest that companies:

  1. Familiarise themselves with the procedure for the Ministry of Industry and Trade to perform licensing control and use its provisions when liaising with representatives of the ministry during inspections;
  2. Monitor on a regular basis information regarding scheduled inspections of compliance with the licensing requirements, posted on the official website of the Ministry of Industry and Trade; http://www.минпромторг.рф