On 9 March 2022, the Turkish Medicines and Medical Devices Agency (Agency) published on its official website the Guidelines on Licensing of Allergen Products (Turkish language). The Guidelines were prepared in accordance with the Regulation on Licensing of Human Medicinal Products (Regulation) which was recently published (see Legal update, New Regulation on licensing of medicinal products for human use (Turkey)). The Regulation divided the abridged marketing authorisation application into six different categories including an allergen product application, in parallel with EU legislation.
The Guidelines introduce technical terminology regarding allergen products and provide information on required documents, testing standards and other procedures to be completed within the scope of allergen product applications. The Guidelines entered into force on 9 March 2022.
Source: Turkish Medicines and Medical Devices Agency: announcement dated 9 March 2022.
First published by Practical Law Life Sciences Monthly Newsletter in Apr 05, 2022.