“The Regulation on the Amendment of the Regulation on Safety of Pharmaceuticals” has been published in the Official Gazette dated 21 July 2022 and numbered 31899 and entered into force.
With the amendment of the Regulation, some of the revisions were made generally on the following subjects:
Amendments have been made in the definitions of the pharmacovigilance provincial officer and the medicinal products for human use.
Amendments have been made in the content of the suspected adverse reaction reports regarding biological, biotechnological products and reporter information.
In case of the updates to the Risk Management Plan require changes to additional pharmacovigilance or additional risk minimization activity or existing activities, the plan will need to be submitted to the Turkish Medicines and Medical Devices Agency immediately.
Regulations have been made for the preparation and submission of periodic benefit/risk assessment reports.
When the Turkish Medicines and Medical Devices Agency makes its own decisions about the safety of pharmaceuticals, it will be able to take into account the evaluations made by other pharmaceuticals authorities with comparable standards or regional or international organizations within the scope of trust and share information.
Revisions have been made regarding administrative sanctions.
You may access the Regulation from the link below:
https://lnkd.in/grwh8sDz