On 24 March 2022, the Turkish Medicines and Medical Devices Agency (Agency) published on its official website the Guideline on Essential Requirements for Risk Management Plans of COVID-19 Vaccines (Turkish language). The guideline is prepared as an attachment to Module IV of the Guideline on Good Pharmacovigilance Practices.
The guideline aims to provide detailed explanations on the procedures and requirements that marketing authorisation holders should complete for preparation of a risk management plan for COVID-19 vaccines, especially on routine and additional pharmacovigilance activities identified and potential risks. The guideline entered into force on 23 March 2022.
First published by Practical Law Life Sciences Monthly Newsletter in May 09, 2022.