NEW REGULATIONS OF GOOD MANUFACTURING PRACTICE (GMP) IN THE TERRITORY OF THE EURASIAN ECONOMIC UNION

The Government of the Russian Federation published draft law No. 02/04/10-19/00096423 “On amendments in Federal law “On licensing of certain types of activity” and Federal law “On circulation of medical products” on the official website of the draft legal acts. The bill is expected to introduce multiple amendments into articles of the Federal law No. 61-FZ as of April 12, 2010 “On circulation of medical products”. Development of the present bill is caused by increased integration and creation of a single market of medical products on the territory of Eurasian economic union (hereinafter – “EEU”). For instance, in terms of EEU an agreement on unified principles and rules of circulation of medical products was adopted on December 23, 2014, the rules of good manufacturing practice of EEU were approved on November 3, 2016 by Resolution of Council of Economic Commission for Europe. Draft law creates legal framework for certification of Russian medical products manufacturing on compliance with the requirements of good manufacturing practice of EEU. In order to implement mentioned goal the draft law provides for extra powers of the Russian regulating authorities:

On organization of pharmaceutical inspections of medical products’ manufacturing for human use on compliance to requirements of good manufacturing practice of EEU,
On issuance, suspension, renewal, reissuance of compliance certificates of medical products’ manufacturers for medical use to requirements of good manufacturing practice of EEU (hereinafter – “EEU Certificate”),

On keeping data base of EEU Certificates.

Under subclause 13 article 2 of the bill detailed order of pharmaceutical inspection of the medical products’ manufacturing on compliance with the requirements of good manufacturing practice of EEU will be established by the Russian Government (document is currently not adopted). Expenses on conducting inspection shall be reimbursed by the producer. There are plans as well to establish provisions in Federal law No. 61-FZ as of April 12, 2010 “On circulation of medical products”, which will allow to suspend validity of license on manufacturing medical products in case of suspension of validity of EEU Certificate.

The bill prescribes mandatory order of obtaining EEU Certificate inter alia for the following acts:

Registration of medical drugs for human use (subclause 7 article 1 of the bill);
Inclusion of pharmaceutical substance produced for sale into public register of medical products (subclause 10 article 2 of the bill);
Obtaining decision on processing clinical trial of medical drug for human use (subclause 12 article 2 of the bill).

In the process of introducing medical products into business manufacturer’s authorized person will have to guarantee that the pharmaceutical products were produced in compliance with requirements of good manufacturing practice of EEU (subclause 12 article 2 of the bill).

Therefore, pharmaceutical companies (producers and importers) which plan to introduce Russian/foreign medical products into business will have to take into account new regulations of conducting pharmaceutical inspection in compliance with the regulations of EEU good manufacturing practice. At present time public discussion of the draft law is taking place as well as anti-corruption examination. The draft law is expected to come into force starting from July 1, 2020. From January 01, 2021 only EEU Certificates will be acknowledged on the territory of EEU but previously issued certificates (under Order of Ministry of Industry and Trade of the Russian Federation No. 916 as of June 14, 2013) will be valid until their expiration (3 years).

Authors:

Sergey Kislov, Partner

Ksenia Stepanischeva, Senior Associate

Sergey Truschin, Associate