The Eurasian Economic Union (EAEU) is an economic union of states located primarily in northern Eurasia. A treaty aiming for the establishment of the EAEU was signed on 29 May 2014 by the leaders of Belarus, Kazakhstan and Russia, and came into force on 1 January 2015. Treaties aiming for Armenia’s and Kyrgyzstan’s accession to the Eurasian Economic Union were signed on 9 October and 23 December 2014, respectively. Armenia’s accession treaty came into force on 2 January 2015. Kyrgyzstan’s accession treaty came into effect on 6 August 2015. It participated in the EAEU from the day of its establishment as an acceding state.

Conducting a joint training GMP-inspection

On June 4 and 5, 2018 employees of FSI “SID & GP”conducted a joint training GMP inspection with representatives of the regulatory entities of the Republic of Kazakhstan and the Kyrgyz Republic.

EEC changed rules for registration of vaccines and use of GMP certificates

The Council of the Eurasian Economic Commission (EEC) has amended the rules for registration and expert examination of medicinal products for human use in the Eurasian Economic Union.

Russia will support pharmaceutical manufacturers with high level of localization

Russian Prime Minister Dmitry Medvedev signed the Decree No. 572 of May 12, 2018, aimed at supporting the manufacturers of medicinal products that perform all stages of production.

EEC continues to improve EAEU common market of medicines

The Board approved the passport and procedure for maintaining the reference book of international nonproprietary names. The decision provides for its inclusion in the EAEU unified regulatory and reference information system.

Belarus will reduce the period of bioequivalence studies

Now that the specialists and necessary equipment are located at the same site, the time to obtain the final report will be significantly reduced.

EAEU rules of Good Distribution Practice became effective on April 27

EAEU rules of Good Distribution Practice (GDP) were adopted by the Decision of the Council of the Eurasian Economic Commission (EEC) No. 80 of November 3, 2016, while their entry into force was postponed for 18 months.

Supplies of pharmaceuticals from Egypt to Russia jumped by 48%

In 2017, Egyptian exports to Russia grew by 35%. This was announced by Tarek Kabil, the Minister of Industry and Trade of Egypt, on April 7 in Cairo.

Project of EAEU unified goods traceability system was presented to the public

The unified goods traceability system in the EAEU will provide consumers with access to reliable information about products, allow businesses to reduce their transaction costs, let member states to monitor the payment of taxes.

EEC announces the start of drug registration under unified EAEU rules

The first applications have been submitted for registration of medicinal products under the unified rules of the Eurasian Economic Union (EAEU).

EAEU information system will be launched in less than a month

The common market information system, that allows pharmaceutical companies to submit their drug registration dossiers under two procedures in accordance with EAEU rules, is expected to start operating in Q1 2018.

First registrations of drugs under EAEU rules will take place in Kazakhstan

The pharmaceutical companies select the Republic of Kazakhstan as the reference country for registration of their products under the common market rules.

EAEU common market of medicines is based on European standards

In May 2017, the markets of medicinal products and medical devices in the five member states of the Eurasian Economic Union (EAEU) received the legal right to start operating as a common economic space

Russian Ministry of Industry and Trade takes steps to reduce drug prices

The Ministry of Industry and Trade of Russia prepared a draft law that would allow the medical manufacturers to minimize their payments of value added tax for imports and sales of medical products

EAEU may allow to register empty primary packages as medical devices

The Russian Ministry insists on mandatory registration of primary drug packages as medical devices, but only if they are imported empty into Eurasian Economic Union

128 draft pharmacopoeial monographs were approved in EAEU this year

drug development
More than 150 drafts of general pharmacopoeial monographs were reviewed by the Pharmacopoeia Committee of the Eurasian Economic Union in 2017

SID&GP and Department of Drug Provision of Kyrgyzstan will cooperate

cooperation handshake
An official meeting between the State Institute of Drugs and Good Practices and the Department of Drug Provision of the Kyrgyz Republic was held on December 13