Eurasian Economic Commission (EEC) adopted a decision about the transition period to GMP. According to the information posted on the official website, the transition will run until 2024.
It means the manufacturers have almost run out of time and there are just six months left to obtain a national GMP certificate, e.g. Russian national GMP certificate. The deadline is 31st December 2021. Anyway, taking into account the fact that national certificates are valid for 3 years, it is possible to apply for registration with the national GMP Certificate of a single member of the EAEU country until the expiration date of the GMP certificate, not further than December 31, 2024.
However, EEC Council supposes that there must be plenty of time to obtain a new GMP certificate. Anyway, you will have to be done according to the Eurasian Economic Union (EAEU) regulations GMP based on the results of production inspections. Let us also put it in mind that those who are going to draw up the necessary documentation in 2022 will have to comply with the only new EAEU regulations.
The Council of the Eurasian Economic Commission has adopted one more decree, whereby released for export pharmaceuticals must be accompanied by a GMP certificate of the EAEU version from January 1, 2023. According to the above, you may provide a shrunk registration pack of documents if the medicine complies with EAEU rules is traded only in a single EAEU country.
* The full registration pack for pharmaceuticals consists of 5 Modules, which are called the "Common Technical Document":
1st Module contains administrative records;
2nd Module provides reviews and analyses based on the results of studies for 4th and 5th Modules.
3rd Module contains documents on the quality of the medicinal product;
4th and 5th Modules present research reports on the medicinal product
So, only 1 to 3 Modules you should provide in the shrunk registration pack.
Another change concerns those pharmaceutical companies that operate in the EAEU on an incomplete production cycle. The "in bulk" parameter will appear in the registration certificate which refers to drugs produced without consumer packaging. Thanks to this, manufacturers will be able to supply their products to the EAEU countries for subsequent packaging on site.
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