Healthcare & Life Sciences Newsletter - February 2024
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.
Successful