Starting in 2022, pharmaceutical manufacturers will only be issued GMP certificates if their manufacturing practices are in accordance with the uniform regulations of the Eurasian Economic Union (EAEU). But what exactly is the EAEU and what does the implementation of these new regulations mean?

The idea of closer economic cooperation emerged in the 1990s, shortly after the collapse of the Soviet Union. However, cooperation within the framework of the Commonwealth of Independent States (CIS) did not go particularly well. Russia, Belarus and Kazakhstan therefore decided to found a new organization. The first stone for the formation of the EAEU was laid in 2010, when these three countries established a customs union, whereby a single market of Russia, Belarus and Kazakhstan began to form. With effect from January 1, 2015, the Eurasian Economic Union Agreement came into force, replacing the previous customs union. At the same time, Armenia and Kyrgyzstan also joined the new union, meaning that five post-Soviet states are now members of the EAEU.

Path to standardization – Its impact on the pharmaceutical industry and GMP

Immediately after the EAEU was founded, work began on drafting the standardized regulations, including the GMP regulations that are now relevant to the pharmaceutical industry. The new GMP guidelines were adopted in 2016 and have been in effect since 2017; there are now plans to bring the national guidelines of the member states in line with the Union regulations. To this end, the EAEU Commission set the member states a transitional period deadline, initially until December 31, 2020, such that new GMP inspections should be carried out in accordance with EAEU law starting in 2021. The GMP certificates previously issued under national law were to remain valid and the medicinal products already approved could remain in circulation until the end of 2024. Due to the COVID-19 pandemic, the transition period for the changeover to the new GMP regulations was extended until the end of 2021. The deadline was then extended by another year in a decision by the Council of the Eurasian Economic Commission. Effective January 1, 2023, GMP certificates will only be issued in accordance with the standardized regulations of the EAEU.

The EAEU GMP guidelines are essentially based on GMP guidelines in the EU. The previously applicable national GMP guidelines in Russia, Belarus and Kazakhstan were translated versions of the European GMP guidelines with only minor adjustments. In Armenia, the European GMP guidelines were recognized as national Armenian regulations. The GMP guidelines of these countries are therefore very similar. This means that nothing stands in the way of the changeover to the standardized GMP guidelines of the Eurasian Economic Union.

Language connects: The Russian language

There is another important aspect to mention: all EAEU member states were formerly constituent republics of the Soviet Union. The Russian language is widely spoken in all five countries and is also the working language of the Economic Union in accordance with Article 110 of the EAEU Treaty. For this reason, GMP inspections under EAEU law are carried out in Russian. Of course, foreign pharmaceutical manufacturers wishing to market its products in the EAEU area must also successfully pass a GMP inspection in order to obtain a valid GMP certificate. At GMP-inspection.com, we have specialized in interpreting and translating in the pharmaceutical and GMP sector for many years. Our experienced translators and interpreters have already supported more than 30 GMP inspections by authorities from Russia, Belarus and other countries of the Eurasian Economic Union and would be happy to assist your company in the event of an upcoming inspection by the authorities.

Image: Eurasian Commission, commons.wikimedia.org