The Turkish Medicines and Medical Devices Agency (“TİTCK“) published the Batch Release Guideline (“Guideline“) on October 31, 2018. The Guideline provides instructions for companies that will apply to the TİTCK to obtain batch certificates and permissions.
Pursuant to the Regulation on Manufacturing Sites for Medicinal Products for Human Use (“Regulation“), companies carrying out batch release activities only on their facilities must apply to the TİTCK to obtain batch certificates with the information and documents specified in Annex 2 of the Regulation. In addition, importers wishing to engage in batch release only must obtain permission from the TİTCK within one year from the date of publication of this Regulation.
In this respect, the TİTCK aims to provide convenient instructions for companies regarding their batch release applications. Companies can review and follow the instructions and information in the Guideline to make batch release applications for their facilities with ease.
Guideline is available on the TİTCK’s website.
The TİTCK continues to provide guidance for pharmaceuticals companies. Pharmaceuticals companies should regularly follow the TİTCK’s announcements, carefully review the requirements set forth in the Regulation and make their batch release applications in accordance with the Guideline.