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Legal Alerts

21/12/2020

Recent Developments in the Healthcare Sector

Legal Alerts
Healthcare
Healthcare & Life Sciences

 

The Turkish Medicine and Medical Devices Authority (“TİTCK”) updated Guidelines for Clinical Trial Applications on December 4, 2020. TİTCK also published a new Circular on Registration of Technical Technical Service Providers and Relevant Technical Personnel, and a new announcement on Medical Devices Sold in Pharmacies on December 11, 2020. Please click on the relevant link below for our specific note regarding recent developments:

TİTCK Updates Guidelines for Clinical Trial Applications
TİTCK Publishes New Circular on Registration of Technical Service Providers and Relevant Technical Personnel
TİTCK’s Announcement on Medical Devices Sold in Pharmacies

TİTCK Updates Guidelines for Clinical Trial Applications​

New Developments

The Turkish Medicine and Medical Devices Authority (“TİTCK”) updated the Guidelines for Clinical Trial Applications to the Clinical Trials Department and the Guidelines for Clinical Trial Applications to the Ethics Committee (“Guidelines”). The updated Guidelines entered into force on December 4, 2020.

What’s New?

On December 1, 2019, the TİTCK updated the guidelines for clinical trial applications in order to ensure that the clinical trial applications to the Clinical Trials Department and Clinical Trials Ethics Committee are duly made in accordance with the Clinical Trails Module. In line with the feedback received, the TİTCK re-evaluated and updated the Guidelines.

The main changes to the Guidelines for Clinical Trial Applications to the Clinical Trials Department are:

  • The Ethics Committee’s decisions can be presented physically or utilizing electronic signatures.
  • If the competent authority of the relevant country publicly publishes the reference numbers used for information relating to a Good Manufacturing Practices Certificate, these reference numbers can be presented to the TİTCK.
  • If the clinical research cannot be initiated despite the permission of the TİTCK, applicants will follow the steps set out in the Guidelines.

The main changes to the Guidelines for Clinical Trial Applications to the Ethics Committee are:

  • If the competent authority of the relevant country publicly publishes the reference numbers used for information relating to a Good Manufacturing Practices Certificate, these reference numbers can be presented to the TİTCK.
  • If the clinical research cannot be initiated despite the permission of the TİCK, applicants will follow the steps set out in the Guidelines.
  • SUSAR (suspected unexpected serious adverse reaction) ranking lists that are within the scope of security notifications can be reported within 60 days after the data lock point.

The information notes on the Clinical Research Module were also updated. The updated guidelines and information notes are available online here (in Turkish).

Conclusion

The TİTCK continues to provide guidance for companies involved in clinical trials. Accordingly, companies should carefully review the TİTCK’s guidelines, follow the TİTCK’s announcements and execute their clinical trial applications by following the TİTCK’s instructions.

TİTCK Publishes New Circular on Registration of Technical Service Providers and Relevant Technical Personnel

New Developments

The Turkish Medicines and Medical Devices Agency (“TİTCK“) published a new Circular on the Registration of Technical Service Providers and Relevant Technical Personnel (“Circular“) on December 9, 2020.  The Circular establishes the main principles and procedures for the registration of technical service providers and relevant technical personnel with the Product Tracking System (tr. ÜTS“).

What’s New?

Last year, the TİTCK published the Circular No. 2019/1, requiring technical service providers and the relevant technical personnel of medical devices subject to the after-sales maintenance and repair process to register with the ÜTS. Registration with the ÜTS started as of December 9, 2020.

Pursuant to the new Circular, health service providers will require technical service providers and relevant technical personnel of medical devices to be registered with the ÜTS for service purchases within the scope of the Circular. In addition, technical service providers must have a Service Place Qualification Certificate relevant to their service and valid in the specified standards of the Turkish Standards Institute. Health service providers will also require the Service Place Qualification Certificate for service purchases within the scope of the Circular.

The Circular is available here (in Turkish).

Conclusion

The TİTCK continues to provide guidance for medical device companies. Companies should carefully review the TİTCK’s Circular, follow the TİTCK’s announcements and complete their required registrations through the ÜTS regarding technical service providers and technical personnel.

TİTCK’s Announcement on Medical Devices Sold in Pharmacies

Recent Development

On December 11, 2020, the Turkish Medicine and Medical Devices Agency (“TİTCK“) announced the list of medical devices that can be sold in pharmacies in accordance with the Regulation on the Sale, Advertising and Promotion of Medical Devices (“Regulation“).

What’s New?

The Regulation establishes the main principles and procedures regarding the sales, advertising, and promotional activities of medical devices offered to the market. Pursuant to changes made in the Regulation, medical devices other than those exempted can be sold in pharmacies without any authorization or permission.

Medical devices that can be sold in pharmacies are listed below, with the exception of devices (i) that are sold, adapted, or applied in hearing aid centers, orthosis centers, optician institutions, or dental prosthesis laboratories; and (ii) that are used exclusively by healthcare professionals or applied in medical device sales centers:

  • Medical devices in pharmaceutical form
  • Medical devices used for the application of pharmaceuticals
  • Medical devices listed in Annex-3 of the Regulation
  • Devices intended for individual use

The TİTCK’s relevant announcement is available online here (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 Regulation.