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.
First published by Practical Law in 04.04.2023.