Tag: EAEU

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.

SID&GP representatives participated in GEP-Russia 2018

gep-russia-2018
On October 16, representatives of FSI "State Institute of Drugs and Good Practices" (SID&GP) took part in the GEP-Russia International Conference in Moscow (Russia).

EAEU opens pharma market for foreign manufacturers

eec
Prospective entry into the market of the EAEU of foreign medicinal products registered according to the national procedures of the EAEU States were discussed by the Member of the Board.

SID&GP participated in PIC/S Committee meeting

sid&gp
Tatyana Nikolko, Deputy Head of the Administration for Pharmaceutical Products Inspection and Evaluation took the floor with a presentation on the Russian GMP Inspectorate.

EEC approved a number of documents for the common market of medicines

eaeu
The College of the Eurasian Economic Commission (EEC) approved the Guidance on Analytical Method Validation and adopted the Guidance on General Issues of Clinical Trials.

Conducting a joint training GMP-inspection

Тренинг
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

EAEU
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

manufacturing
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

eec
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

lab
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

drugs
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%

pills
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

eec
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

pills
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

EAEU
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

drugs
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

EAEU
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