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Main  >  News  >  Unified Pharmacopoeia enters into force in the EAEU from March 1

Unified Pharmacopoeia enters into force in the EAEU from March 1

In the Eurasian Economic Union (EAEU), from March 1, a set of provisions and requirements has been introduced that establish the permissible level of quality of medicines (pharmacopoeia), TASS reports. This will allow the EAEU pharmaceutical manufacturers and regulators to apply uniform approaches to assessing the quality of medicines.

The introduction of such requirements will help create uniform quality standards for medicines for their access to the pharmaceutical market. The measure also ensures the harmonization of the standards of the EAEU states in the field of training pharmaceutical personnel.

Manufacturers of medicinal products that were previously registered in the common EAEU market must, within a five-year period - by January 1, 2026 - bring their regulatory documents on the quality of medicinal products in line with the Union Pharmacopoeia.

The EAEU Pharmacopoeia is a tool for regulating the quality of medicines within the common market. It determines the level of quality established by the specifications of drug manufacturers, which must not be lower than pharmacopoeial requirements. Requirements

the EAEU pharmacopoeias apply to medicines for both medical and veterinary use.

Pharmacopoeial monographs were prepared by the profile committee of the EAEU, taking into account the national codes of documents on the quality of medicines of the Union states, as well as regional documents of the European Union.

 

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