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Main  >  News  >  EEC has extended the use of national GMP certificates when registering drugs until the end of 2024

EEC has extended the use of national GMP certificates when registering drugs until the end of 2024

Margarita Grosheva

When registering drugs or bringing the registration dossier in line with the EAEU rules, by the end of 2024, it will be possible to use national GMP certificates. It will be possible to obtain national certificates only until the end of the current 2021. From 2022, all EAEU states will have to issue certificates of the union format.

By the end of 2024, manufacturers of medicines will be able to submit national documents confirming compliance with GMP requirements when registering medicines. This decision was made by the Council of the Eurasian Economic Commission, said the official representative of the commission Iya Malkina during a briefing, the correspondent of "FV" reports.

It will be possible to obtain national GMP certificates in the union until the end of 2021. From the beginning of 2022, all states of the union will switch to the issuance of GMP certificates only according to the rules of the EAEU, Malkina specified. She noted that manufacturers will have enough time to update GMP certificates in the union format. “In addition, the EEC Council decided to switch from January 1, 2023 to the union format of the GMP certificate when issuing certificates for medicines produced for export,” Malkina added.

Initially, this transition period was in effect until the end of last year. But in March, the associations of pharmaceutical manufacturers announced the impossibility of registering drugs due to the lack of GMP certificates issued according to the rules of the union.

The associations explained that due to the "extremely late" launch of the regulatory framework for the organization of inspection of enterprises for compliance with the EAEU good GMP practice, it was not possible to receive a union certificate in Russia immediately. In 2020, inspections according to the rules of the EAEU were not carried out in Russia, and the inspectorate is technically unable to simultaneously re-inspect more than 2 thousand production sites supplying drugs, the associations explained.

As reported by "FV", by April, according to the rules of the EAEU, less than 1% of all drugs on the Russian market were registered. According to the Ministry of Industry and Trade, as of April 9, 9 GMP certificates were issued in accordance with the requirements of the union.

 

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