Click the button to listen to our legal
alert now!
The Turkish Pharmaceuticals and Medical Devices Authority ("TITCK") 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 TITCK's Supervision
TITCK Published Application
Guidelines for Electronic Scientific Meetings and Electronic
Product Promotion Meetings
TITCK Postponed Submission Date of
Readability Test for Authorization of
Pharmaceuticals
Biocidal Products Now Under TITCK'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 TITCK. The licensing of biocidal products will be handled by the Cosmetic Products Department under the TITCK. Accordingly, the TITCK added "biocidal" under the "Activity Areas" on its official website. The TITCK's announcement is available here (in Turkish).
What's New?
The TITCK 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)
TITCK Published Application Guidelines for Electronic Scientific Meetings and Electronic Product Promotion Meetings
New Developments
The TITCK 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 TITCK 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 TITCK for electronic scientific meetings they wish to sponsor.
Companies must notify the TITCK 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 TITCK
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).
TITCK Postponed Submission Date of Readability Test for Authorization of Pharmaceuticals
New Developments
The TITCK announced that the final submission date for readability tests for the authorization of pharmaceuticals is postponed to August 31, 2021. The TITCK 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 TITCK's announcement is available here (in Turkish).
What's New?
On April 3, 2020, the TITCK 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 TITCK announced that the deadline for the submission of readability tests are postponed from December 31, 2020 to August 31, 2021.
Conclusion
The TITCK continues to provide guidance for companies working in the medical industry. Companies should carefully review the TITCK's announcements and take the necessary actions to ensure compliance.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
