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Recent Developments in the Healthcare Sector

Legal Alerts
Healthcare
General

 

On January 6, 2021, the Turkish Medicine and Medical Devices Authority (“TİTCK”) presented the draft Regulation on Cosmetic Products for public opinion. The TİTCK announced that it updated the Guideline on the Registration of Technical Service Providers and Relevant Technical Personnel. The TİTCK also issued new announcements regarding the Pharmaceuticals Tracking System, List of Overseas GMP Inspected Facility, and Activities and Early Access Programs for Pharmaceuticals.

Please click on the relevant link below for our specific note regarding recent developments:

TİTCK Publishes Draft Regulation on Cosmetic Products
TİTCK Updates the Guideline on Registration of Technical Service Providers and Relevant Technical Personnel
TİTCK Issues Announcement on the Pharmaceuticals Tracking System
TİTCK Updates Announcement on the List of Overseas GMP Inspected Facility and Activities

TİTCK Issues Announcement on Early Access Programs for Pharmaceuticals

TİTCK Publishes Draft Regulation on Cosmetic Products

The Turkish Medicines and Medical Devices Agency (“TİTCK“) presented the draft Regulation on Cosmetic Products (“Draft Regulation“) on January 6, 2021 for public opinion. Within the scope of harmonization with EU legislation, the Regulation is based on the EU Cosmetic Products Regulation No. 1223/2009 (“EU Regulation“).

What’s New?

The Current Regulation on Cosmetic Products (“Regulation“) was prepared based on the Cosmetics Directive 76/768/EEC (“Cosmetics Directive“). There was a need for a legislative amendment as the EU Regulation replaced the Cosmetics Directive on July 11, 2013. In this regard, the TİTCK prepared the Draft Regulation, which is in line with the EU Regulation.

The Draft Regulation introduces the following amendments:

  • Requires the designation of a legal or natural person who is a resident of Turkey as the responsible person in order to place cosmetic products on the market. The Draft Regulation stipulates additional obligations for the responsible person and distributor by increasing their liability in order to eliminate the risks associated with cosmetic products and to protect human health. In the event the cosmetic products does not meet the relevant requirements of compliance under the Draft Regulation, the responsible person and distributor must notify the TİTCK and take corrective measures.
  • Introduces certain prohibitions on the testing of ingredients or compositions used in the manufacture of cosmetic products on animals and placing these products on the market. These prohibitions apply to animal testing of cosmetic products containing ingredients or combinations of ingredients finished products as well as the finished cosmetic products.
  • The date of minimum durability can be preceded by the symbol shown in Annex II of the Draft Regulation, as well as the expression “best used before the end of__”.

The Draft Regulation, the EU Regulation, and a comparative chart of the two regulations are available here (in Turkish).

TİTCK Updates the Guideline on Registration of Technical Service Providers and Relevant Technical Personnel

The TİTCK announced that it updated the Guideline on the Registration of Technical Service Providers and Relevant Technical Personnel (“Guideline”) in line with the Circular No. 2020/6. The Guideline sets out the principles and procedures regarding the registration of technical service providers and relevant technical personnel on the Product Tracking System (tr. “ÜTS”).

The Guideline introduces the following amendments:

  • Enables technical service providers to update information on the ÜTS, such as adding and removing personnel records.
  • Enables health service providers to make queries of technical service providers and relevant technical personnel via the ÜTS.

The Guideline is available here (in Turkish).

TİTCK Issues Announcements on the Pharmaceuticals Tracking System 

TİTCK announced that technical adjustments were made to the Pharmaceutical Tracking System (tr. İTS“).

The distribution of pharmaceuticals used for the treatment of Covid-19 and provided by the State Supply Office (tr. DMO“) is carried out through the Provincial Health Directorate. The technical adjustments to the İTS allow pharmaceutical companies to make the necessary notifications through the Provincial Health Directorate’s Global Location Number (“GLN“). Hospitals where the pharmaceuticals are physically delivered can receive the pharmaceuticals by using the product receipt notification.  Accordingly, hospitals will be able to make the mandatory consumption notifications via İTS. Throughout the process, the Provincial Health Directorate will not carry out any actions on İTS.  The announcement is available here (in Turkish).

TİTCK Updates List of Overseas GMP Inspected Facility and Activities

The GMP inspection applications for products produced abroad and imported to Turkey is carried out within the scope of the Guideline on Applications for GMP Inspections of Foreign Production Facilities. The TİTCK announced that it updated the List of Overseas GMP Inspected Facility and Activities (“List“), which includes the details of the facilities and inspections the TİTCK audited between 2017 and 2020, to be used as the basis for GMP inspection applications.

The updated List is available here (in Turkish).

TİTCK Issues Announcement on Early Access Programs for Pharmaceuticals

The Guideline on the Early Access Programs for Pharmaceuticals (“Guideline“) set outs the principles and procedures for early access programs for pharmaceuticals. The TİTCK announced that it published an updated List of Early Access Programs for Pharmaceuticals for 2020-2021. The list includes the details of early access programs for pharmaceuticals and up-to-date quota information.

The list is available here (in Turkish).

Conclusion

The TİTCK continues to guide medical device companies regarding their obligations under healthcare regulations. Accordingly, companies should follow the TİTCK’s announcements and carry out sale activities per the procedures and principles set out in the regulations.