Recent Developments
The Turkish Medicines and Medical Devices Agency (“TİTCK“) published the Application Guideline on Medical Gas Manufacturing/Filling Facilities (“Guideline“) on April 10, 2019. The Guideline aims to provide guidance for medical gas manufacturing and filling facilities applying for activity permits with the TİTCK.
What’s New?
Pursuant to the Communiqué on Facilities Manufacturing, Filling, Storage and Selling Medical Gases, real and legal persons wishing to carry out medical gas manufacturing and/or filling activities must apply to the TİTCK and obtain an activity permit after undergoing an inspection by the TİTCK in accordance with good manufacturing practices. Accordingly, the Guideline sets out the formalities, content and procedures of the applications made by the medical gas manufacturing and filling facilities wishing to obtain or that have already obtained an activity permit. Companies can follow the instructions and step-by-step explanations provided in the Guideline to make their applications to the TİTCK.
Medical gas facilities that only store and/or sell medical gas, and medical gas facilities involved in these activities that also produce and/or fill medical gas are outside the scope of the Guideline. Companies running such facilities must apply to the Health Directorates regarding their storage and sales-related activities.
The Guideline and other relevant documents are available on the TİTCK’s website (in Turkish).
Conclusion
The TİTCK continues to provide guidance for companies in the healthcare industry. Companies should follow the TİTCK’s announcements and make their required applications to the TİTCK by following the instructions in the Guideline.
