The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently amended: i) the Decree on the Pricing of Pharmaceuticals, ii) the Guideline on the Classification of Diversification Applications and Variation Applications, iii) the Guideline on Procurement of Pharmaceuticals from Abroad, and iv) the Guideline on Testing, Control and Calibration Activities to be Conducted under the Regulation on Testing, Control and Calibration of Medical Devices.
The TİTCK also abolished the Measures to be taken in Clinical Trials Due to the Covid-19 Pandemic.
Guideline on the Classification of Diversification Applications and Variation Applications
On 7 February 2024, the TİTCK updated the Guideline on the Classification of Diversification Applications and Variation Applications. Accordingly, CE certificates or certificated institution opinions regarding the integrated medical device will not be sought in cases where the pharmaceutical subject to the diversification application includes an integrated medical device, and the applicant submits a declaration stating that there is no change/addition/subtraction in the integrated medical device of the currently authorized pharmaceutical or any change that might affect the performance of the device.
The Guideline is available here (in Turkish)
Guideline on Procurement of Pharmaceuticals from Abroad
On 13 February 2024, the TİTCK updated the Guideline on Procurement of Pharmaceuticals from Abroad. The main amendments introduced by the Guideline are as follows:
- The TİTCK can request the initiation of the Program on
Early Access to Pharmaceuticals for Humanitarian Purposes from
marketing authorization holder companies upon the evaluation of the
initial pharmaceutical applications to be made in cases where
currently authorized pharmaceuticals and all of the treatment
alternatives are used, or in cases requiring their use in the
diagnosis and/or treatment of diseases for patients with
conditions that prevent their use.
- The Informed Consent Form for Pharmaceuticals to be Procured from Abroad must bear a doctor's stamp.
The Guideline is available here (in Turkish).
Guideline on Testing, Control and Calibration Activities to be Conducted under the Regulation on Testing, Control and Calibration of Medical Devices
On 20 February 2024, the TİTCK updated the Guideline on Testing, Control and Calibration Activities to be Conducted under the Regulation on Testing, Control and Calibration of Medical Devices. The main amendments introduced by the Guideline are as follows:
- The process steps to be followed by the conformity assessment
bodies authorized to provide testing, control and calibration
services regarding the application for personnel removal,
addition-removal-update of reference equipment, and enlarging the
scope and downscoping through Product Tracking System
(“ÜTS”) have been added.
- In terms of the required tests to be applied to the devices
within the scope of the Regulation on Testing, Control and
Calibration of Medical Devices, the necessary equipment for the
tests, the relevant standards/ guidelines/instructions that can be
taken as reference, and the range of test results through which the
device can be evaluated are determined based on the product
groups
- If the required tests are to be conducted in accordance with
a different standard/guideline/instruction or by using
different equipment, the organization must apply to the TİTCK
by petition and obtain permission.
- Test, control and calibration reports must be uploaded to the ÜTS within 60 days (at the latest) of the service provision date.
The Guideline is available here (in Turkish).
Decree on the Pricing of Pharmaceuticals
On 23 February 2024, the Presidency published the Decree Amending the Decree on the Pricing of Pharmaceuticals. The value of EUR 1 in TRY determined by the amendment published on 16 December 2023 and entered into force on 25 December 2023 will continue to apply for 2024, and no new value of EUR 1 in TRY will be established. In this regard, the value of EUR 1 in TRY to be used in the pricing of pharmaceuticals will continue to be calculated as TRY 17.5483.
The Decree is available here (in Turkish).
Conclusion
The TİTCK continues to provide guidance for companies working in the healthcare industry. Companies must carefully review the TİTCK'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.
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