Regulation on Licensing of Medicines Amended

On 27 May 2023, the Regulation Amending the Regulation on Licensing of Human Medicinal Products (Turkish language) (Regulation) was published in the Official Gazette numbered 32203.

With the amended provisions, a new reason for the suspension of the licence has been introduced in connection with licence transfer applications. To avoid suspension, licence holders must submit documentation showing that the production site complies with the Good Manufacturing Practice Guidelines and the Production Site Authorisation Certificate for the active substance production site operating in Turkey.

A new responsibility is introduced for the licence holder, requiring them to notify the Medicines and Medical Devices Agency of the rejection of a licence application in another country or the withdrawal of that application by the applicant.

The obligation to submit a notified body opinion or CE certificate for medicinal products containing an integrated medical device has been extended until 31 December 2028.

The Regulation is in force as of the date of publication.

First published by Practical Law Life Sciences Monthly Newsletter in 04.07.2023.

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