On 17 February 2023, the Turkish Medicines and Medical Devices Agency (Agency) made an announcement (Turkish language) on its official website that it had published a Guideline on Human Medicinal Products that are Co-marketed (Guideline). The Guideline came into force on the day of its publication.
The Guideline aims to provide guidance on licensing of co-marketed human medicinal products, cancellation or suspension of the main product's marketing authorisation and determining the responsibilities of the marketing authorisation holders of co-marketed products in line with the Regulation on Licensing of Human Medicinal Products. The Guideline is in force as of date of publication.
First published by Practical Law in Apr 04, 2023.