Obtaining new Registration certificates in the EAEU format

Unified Register of Medicines of the Eurasian Economic Union (info page ) in July — September 2022 was completed with four Registration certificates for medicines of the PIQ-PHARMA LLC:

• LP-№(001054)-(RG-RU) from 07/20/2022 for Dibikor® tablets 250 mg;
• LP-№(001110)-(RG-RU) from 08/04/2022 for Dibikor® tablets 500 mg;
• LP-№(001245)-(RG-RU) from 09/21/2022 on Pantogam® tablets 250 mg;
• LP-№(001236)-(RG-RU) from 09/20/2022 for Pantogam® tablets 500 mg.

The corresponding sets of documents for bringing the dossier of medicines into compliance with the requirements of the EAEU were submitted in March — May 2022.

Types of drugs in accordance with the EAEU classification are as follows: Dibikor® tablets 250 mg and 500 mg are well–studied, Pantogam® tablets 250 mg and 500 mg are original.

All of the above Registration Certificates are issued termless and allow the drugs to be traded on the market of the Russian Federation.

At the moment, the Ministry of Health of Russia has a set of documents for bringing the dossier into compliance with the requirements of the EAEU for the reproduced drug Gabapentin capsules 300 mg. Obtaining a Registration certificate in the EAEU format for Gabapentin is planned in the first quarter of 2023.