Russia will improve its procedure for state registration of medicinal products

| By | Drug Registration, GMP Standards
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A bill introduced to the State Duma is aimed at improving the legal and regulatory framework in the area of medicinal products circulation in terms of the confirmation of the state registration of drugs.

Currently, if the medicinal product is manufactured outside the Russian Federation, the confirmation of the state registration requires to provide a license for manufacturing the medicinal product and a copy of the certificate of compliance of the manufacturer of medicinal products with the requirements of the Good Manufacturing Practices issued by the authorized federal executive body.

At the time when it is necessary to submit the certificate in order to confirm the state registration of a medicinal product, such certificate may not be available to the manufacturer, as it could be in the process of re-registration, or not extended due to repair works at the plant, etc. This could make it impossible to submit the dossier to confirm the state registration of medicinal product and, as a result, lead to cancellation of the state registration of medicinal product (i.e., the removal of the medicine from the market) and the subsequent need for its re-registration (which significantly increases the time to make it available on the market).

The proposed amendments allow to provide, as an alternative to the manufacturing license and in order to confirm the state registration of medicinal products, the certificate of compliance of the manufacturer of medicinal products with the requirements of the Good Manufacturing Practices issued by the authorized federal executive body.

SOURCE: gmpnews.ru
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