The Turkish Medicines and Medical Devices Agency has published a new regulation on Licensing of Medicinal Products for Human Use in the Official Gazette (Turkish language) numbered 31686 of 11 December 2021. This Regulation introduces new provisions that amount to a comprehensive amendment of the abolished Regulation of the same name. The noteworthy new provisions of the Regulation are as follows:
- In the definitions section of the Regulation, some of the concepts are defined in detail while definitions of number of new concepts such as biosimilars, herbal medicinal products, pharmacopeia, licensor firm and Priority Evaluation Board have been added.
- The Agency may provide scientific advice to the marketing authorisation (MA) applicant prior to the application or during the MA process, subject to a fee.
- The information and documents requested during MA application process are regulated more comprehensively.
- The MA will no longer require a renewal application five years from the MA grant date unless there is an additional renewal request for pharmacovigilance reasons.
- New grounds for suspension and cancellation of MA are introduced.
- The liabilities of the MA holder are defined more precisely.
- A Priority Evaluation Board has been established to evaluate the conditions for granting conditional MAs and granting MA in exceptional cases.
- Rules and principles regarding conditional MA grant (Emergency Use Authorisation) have been set out in detail.
The Regulation entered into force on 11 December 2021. However, provisions regarding suspension of authorisation and blood products will enter into force on 11 December 2022 and 1 January 2025 respectively.
First published by Practical Law, in 05.01.2022