The Ministry of Industry and Trade of the Russian Federation published a notification on the regulation.gov.ru portal on the preparation of a regulatory legal act on amendments to part 3 of article 47 of Federal Law of April 12, 2010 No. 61-FZ “On the Circulation of Medicines” regarding the import of drugs to the Russian Federation a specific batch of registered and (or) unregistered medicines intended for laboratory tests selected during the pharmaceutical inspection of the production of medicines for honey Qing application located outside the Russian Federation, samples.
In case of adoption, the document will enter into force in June 2020.
It is noted that the draft law is being developed with a view to realizing the Eurasian Union law provided for by the Agreement on Uniform Principles and Rules for the Circulation of Medicines within the framework of the Eurasian Economic Union (Concluded in Moscow on December 23, 2014). In accordance with the provisions of Article 10 of the Agreement and the Rules for conducting pharmaceutical inspections, approved by the Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 No. 83, if necessary, during the inspection, samples (samples) of materials or products are sent that are sent for testing to an authorized testing laboratory . The implementation of this norm will allow, if necessary, during the inspection to carry out sampling (samples) of materials or products, which will subsequently be sent for testing to an authorized testing laboratory of the Russian Federation.