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Legal Alerts

12/04/2021

Recent Developments in the Healthcare Sector

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The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK“) published a number of announcements covering various topics, including biocidal products, electronic scientific meetings and readability tests during the first quarter of 2021.

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

Biocidal Products Now Under TİTCK’s Supervision
TİTCK Published Application Guidelines for Electronic Scientific Meetings and Electronic Product Promotion Meetings
TİTCK Postponed Submission Date of Readability Test for Authorization of Pharmaceuticals

Biocidal Products Now Under TİTCK’s Supervision

New Developments

Further to the amendments to the Presidential Decree published in the Official Gazette No. 30887 on September 13, 2019, “biocidal products that directly come in contact with the human body (Product Type-1 and Product Type-19)” are now under the governance and supervision of the TİTCK. The licensing of biocidal products will be handled by the Cosmetic Products Department under the TİTCK. Accordingly, the TİTCK added “biocidal” under the “Activity Areas” on its official website. The TİTCK’s announcement is available here (in Turkish).

What’s New?

The TİTCK announced that the following information and documentation on biocidal products will be provided under the “Biocidal” activity area:

  • Relevant legislation
  • Licensing/Authorization processes
  • Trainings
  • Risk assessment documents
  • Information on analysis of products subject to licensing, and active substances
  • Turkish versions of guidelines published by the European Chemical Agency (ECHA)

TİTCK Published Application Guidelines for Electronic Scientific Meetings and Electronic Product Promotion Meetings

New Developments

The TİTCK published the Application Guidelines for Electronic Scientific Meetings and Electronic Product Promotion Meetings (“Guidelines“) based on the Regulation on Promotion of Pharmaceuticals (“Regulation“). The Guidelines provide detailed explanations on electronic applications made to the TİTCK by relevant companies (e.g. marketing authorization holders) for scientific meetings and electronic product promotion meetings.

What’s New?

According to the Guidelines, relevant companies must apply to the TİTCK for electronic scientific meetings they wish to sponsor. Companies must notify the TİTCK of the national meeting at least five business days before the meeting, and provide information on the content of the meeting, a list of potential participants, cost items and organized events. For international meetings, the TİTCK must be notified at least 30 business days before the meeting.
The Guidelines also provide that electronic product promotion meetings can only be organized as one-day events, which cannot be longer than four hours; these meetings cannot be organized using the health organizations’ meeting sources/infrastructures; or published or archived on the health organizations’ websites.  The Guidelines are available here (in Turkish).

TİTCK Postponed Submission Date of Readability Test for Authorization of Pharmaceuticals

New Developments

The TİTCK announced that the final submission date for readability tests for the authorization of pharmaceuticals is postponed to August 31, 2021. The TİTCK noted that authorization and sales permit approval procedures will be carried out on the condition that the applicant company undertake that the readability tests will be submitted by the deadline. The TİTCK’s announcement is available here (in Turkish).

What’s New?   

On April 3, 2020, the TİTCK announced that as part of COVID-19 measures, readability tests, which are necessary for the authorization of pharmaceuticals, may be submitted later, before the sales permit application. Accordingly, the TİTCK announced that the deadline for the submission of readability tests are postponed from December 31, 2020 to August 31, 2021.

Conclusion

The TİTCK continues to provide guidance for companies working in the medical industry. Companies should carefully review the TİTCK’s announcements and take the necessary actions to ensure compliance.