Compliance Quarterly

Türkiye

Pricing of medicinal products for human use updated

Pricing of Medicinal Products for Human Use has been updated. The exchange rate update, which was previously made once a year, was made for the second time this year with this latest update. Accordingly, 1 Euro was fixed to TL 14,0387 pursuant to the Presidential Decree No: 7399.

Regulation on the use of health claims in food and food supplements amended

The Turkish Pharmaceuticals and Medical Devices Authority (TİTCK) published an amendment to its regulation about health-related labels in food and food supplements on August 23, 2023. Accordingly, only disclaimer and labels provided in the annexes of the guidelines published by TITCK can be used on food and food supplements. A transition period for a period of one year is provided for such products and supplements produced in accordance with the now-repealed Turkish Nutrition Codex before the entry in force of this new amendment and which do not comply with the current guidelines, for the use of such previously approved labels under the Codex until the end of 2024.

Regulation on the provision of health services at home published

The Turkish Ministry of Health published the regulation on the provision of health services at home. The regulation expands the scope of the services and introduces new standards, especially with respect to definite term services (following hospital release) and indefinite term (long-term services). The relevant recipient group is re-defined, with the persons over the age of 80 acquiring the right to obtain such services directly, without the requirement to provide evidence of any requisite health condition. The Regulation also brings forth new requirements and conditions for the service providers with respect to the scope and method of services to be provided at the houses of such recipients. The Regulation also included remote or tele-health services in its scope allowing the patients receiving such services without being physically in the same location with healthcare practitioners.

A new software (called ESYS) will be used for such types of services and the Ministry is currently working on the updates and improvements of such IT systems.

Guidelines on GMP Audits Outside of Turkey renewed

The Turkish Pharmaceuticals and Medical Devices Authority (TITCK) renewed its guidelines on October 5, 2023 with respect to the GMP audits of the manufacturing facilities for products manufactured abroad and imported into Turkey. The guidelines allow a risk-based audit for products which had been subject of a previous audit and had obtained a certificate from TITCK for a period of three years. If the relevant facilities had already been audited by TITCK, the relevant importer may request an audit to be carried on file, without actual physical on-site inspection, before the expiry of the validity of the GMP. With respect to products about which TITCK had already made a decision to conduct an on-site inspection, the importer shall not be permitted to request an audit on file.