Healthcare & Life Sciences Newsletter - April 2024

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published the Communiqué on Common Specifications for Nonmedical Product Groups Listed in Annex XVI of the Medical Device Regulation, and the Guideline on Cosmetic Product Safety Assessor, Training and Certification. The TİTCK also amended the Guideline on Good Distribution Practice Audits and the Cosmetic Products Regulation.

Guideline on Good Distribution Practice Audits

On 27 February 2024, the TİTCK updated the Guideline on Good Distribution Practice Audits. The main amendments introduced by the Guideline are as follows:

Pharmaceutical businesses that have a permit will be inspected by the TİTCK inspectors to evaluate the compliance of their operations with the Good Distribution Practices (“GDP”).

Pharmaceutical businesses will be granted a certain period of time, depending on the nature of the deficiencies, to remedy deficiencies identified during routine inspections. Evidence for the deficiencies remedied within the granted period of time must be submitted to the TİTCK.

The deficiencies identified during the routine controls carried out twice a year by the officers of Provincial/District Health Directorates will be recorded by obtaining the signature of the responsible manager, and the reports will be shared with the pharmaceutical businesses. These deficiencies must be remedied within 15 days and the documents confirming that the deficiencies have been remedied must be shared with the TİTCK.

The Guideline is available here (in Turkish).

Regulation Amending the Cosmetic Products Regulation

On 5 March 2024, the TİTCK published the Regulation Amending the Cosmetic Products Regulation. In this regard, the manufacturer, which is deemed as the responsible person for locally manufactured cosmetic products, can appoint a natural or legal person resident in Türkiye as the responsible person by a written agreement.

The Regulation is available here (in Turkish).

Communiqué on Common Specifications for Nonmedical Product Groups Listed in Annex XVI of the Medical Device Regulation

On 14 March 2024, the TİTCK published the Communiqué on Common Specifications for Nonmedical Product Groups Listed in Annex XVI of the Medical Device Regulation. The main developments introduced by the Communiqué are as follows:

The common specifications to be applied to all nonmedical product groups and specific product groups such as contact lenses and equipment for brain stimulation have been identified.

A product for which the manufacturer intends to conduct or is conducting a clinical trial to collect clinical data for clinical evaluation, and for which a notified body must be involved in the conformity assessment can be placed on the market and put into service until 31 December 2029, provided that: i) it is already lawfully placed on the market before 22 June 2023 and continues to comply with the requirements of national legislation applicable to the product before 22 June 2023; and ii) there is no significant change in its design and intended use. However, a product that meets the conditions can only be placed on the market or put into service from 22 June 2024 until 22 December 2024 if the sponsor receives a notification from the TİTCK or the competent authority of the relevant European Union member state confirming that the clinical trial application for the product has been completed, and that the clinical trial is within the scope of the Medical Device Regulation. In addition, a product that meets the conditions can only be placed on the market and put into service from 23 December 2024 to 31 December 2027 if the sponsor initiates the clinical trial. A product that meets the conditions can only be placed on the market or put into service from 1 January 2028 until 31 December 2029 if a written agreement is executed between the notified body and the manufacturer for the fulfillment of the conformity assessment.

A product for which the manufacturer does not intend to conduct a clinical trial but for which a notified body is required to be involved in the conformity assessment can be placed on the market or put into service until 31 December 2028, provided that: i) it is already lawfully placed on the market before 22 June 2023 and continues to comply with the requirements of national legislation applicable to the product before 22 June 2023; and ii) there is no significant change in its design or intended use. However, a product that meets the conditions can only be placed on the market or put into service from 1 January 2027 until 31 December 2028 if a written agreement is executed between the notified body and the manufacturer for the fulfillment of the conformity assessment.

The Communiqué is available here (in Turkish).

Guideline on Cosmetic Product Safety Assessor, Training and Certification

On 21 March 2024, the TİTCK published the Guideline on Cosmetic Product Safety Assessor, Training and Certification. The main developments introduced by the Guideline are as follows:

A cosmetic product shall be considered safe for human health if it is used under normal or reasonably predictable conditions of use, by considering the presentation of the product, labeling, instructions for use and disposal, and any other data or information provided by the responsible person in accordance with Law No. 6502 on Consumer Protection.

The responsible person must ensure that the cosmetic product undergoes a safety assessment and a report is issued before placing it on the market.

A person who has a diploma or other official document proving the completion of a theoretical and practical graduate education in pharmacy, toxicology, medicine or a similar discipline, or another education program recognized by the TİTCK as equivalent to the abovementioned can conduct the safety assessment.

The successful candidates who pass the exam conducted by the organization accredited by the Turkish Accreditation Agency (“TÜRKAK”) to certify product safety assessors under the TS EN ISO/IEC 17024 standard will be entitled to obtain a Cosmetic Product Safety Assessor Certificate.

If it is determined that the Cosmetic Product Safety Assessor has issued a report in violation of the legislation, their certificates shall be suspended by the certification body for a maximum period of 3 months. If the violation continues, the certificate will be withdrawn by the certification body.

The certificates of persons who have received product-safety assessor training and certification before the effective date of the Guideline shall be valid for 3 years as of 21 March 2024. At the end of this period, these persons must receive training and obtain a Cosmetic Product Safety Assessor Certificate in accordance with this Guideline.

The Guideline 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.