The New Regulation on Licensing of Human Medicinal Products (the “Regulation”) prepared by the TITCK entered into force upon its publication in the Official Gazette numbered 31686 and dated December 11 2021. It has been seen that the purpose aimed with the Regulation is reflecting up-to-date processes present in the TITCK practice but did not exist in the previous regulation dated 2005 and providing compatibility of the legislation with the EU directive numbered 2001/83/EC.
In this context, the Regulation Article defines the terms and definitions of already existing concepts such as human medicinal products and active ingredients have been detailed. In contrast, new definitions regarding the concepts such as biosimilar products, hybrid application and production facility have been listed. Abridged license application types have been rearranged for compatibility with EU legislation, and the application requirements are defined more precisely.
An exception has been introduced for the products to prevent the problems on availability of drugs, which is the only diagnosis or treatment method available for disease in Turkey as acceptance of the transfer application regarding the license/permit or registration certificate without waiting for the court decision. In addition, with the addition to the provision regarding the suspension of the license, if at least one commercial batch of a licensed human medicinal product is not available in the domestic or foreign markets for an uninterrupted 30 months, the license is suspended instead of the license cancellation. If the product available on the market cannot be provided for any reason, the TITCK must be notified at least 30 days before this condition arises, per the amendment made to the responsibilities of the license owner.
The new EU-compliant legislation includes significant amendments regarding licensing process. Since some articles have not been implemented yet, we recommend that the announcements regarding the TITCK implementations should be followed frequently by the sector stakeholders.