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Main  >  News  >  Amendments to the Rules for Registration and Expertise of Medicines in the EAEU have been prepared

Amendments to the Rules for Registration and Expertise of Medicines in the EAEU have been prepared

The Council of the Eurasian Economic Commission (EEC) has prepared a draft Decision on amendments to the Rules for the registration and examination of medicines for medical use in the EAEU. The draft document has been published on docs.eaeunion.org and will be discussed until November 27, 2020.

The EEC draft decision is aimed at solving the following problems:

• the need to ensure in a short time the transition of a significant (more than 17,000) number of production sites to the requirements of Good Manufacturing Practice (GMP) of the Union in the period 2020-2024, prevention of queues for inspection of production sites and related interruptions in the supply of products to the pharmaceutical market ;

• suboptimal requirements for the volume of the registration dossier to bring the registration dossier in line with the law of the EAEU when a drug is circulated on the market of one Member State;

• the lack of the possibility of importing a bulk product into the territory of the EAEU for the purpose of its further use by domestic manufacturers in the technological process during the packaging and packaging of medicinal products.

The proposed amendments to the legislation should protect the interests of manufacturers of medicinal products (subjects of the pharmaceutical market that are involved in completing the registration dossier), authorized bodies (expert organizations) that perform the procedure for assessing the registration dossier of a medicinal product from the standpoint of proving its safety, compliance with a given quality standard, best efficiency and favorable risk-benefit profile, pharmaceutical inspectorate of the Member States.

The proposed regulation assumes:

• to extend the deadline for submission of documents confirming the compliance of production with the requirements of good manufacturing practice issued to the manufacturer of the medicinal product by the authorized body of the Member States for 4 years - until December 31, 2024;

• to introduce the possibility of submitting an abbreviated registration dossier when bringing a previously registered medicinal product into compliance with the Union law for circulation on the market of one Member State;

• to provide an opportunity to indicate the form of packaging of a bulk product in the registration certificate, which will allow for the import into the territory of the EAEU of a bulk product for the purpose of its further use by domestic manufacturers in the technological process when packing and packaging medicinal products.

According to the EEC experts, the revision of the transition period upward will ensure a smooth transition from national documents confirming the compliance of production with the requirements of good manufacturing practice to the unified documents of the Union and will help drug manufacturers to adapt to the new requirements as comfortable as possible.

Reducing the volume of registration dossiers for medicinal products traded on the market of one of the Member States will reduce the costs of manufacturers associated with the preparation of registration dossiers. And the indication of the packaging of bulk products in the registration certificate will allow the development of pharmaceutical industries involved in the stage of packaging and packaging of bulk dosage forms of drugs supplied to the territory of the EAEU from third countries.

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