Healthcare & Life Sciences Newsletter - January 2024

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently amended: i) the Regulation on Private Health Institutions for Outpatient Diagnosis and Treatment; ii) the Regulation on Private Hospitals; iii) the Guideline on Application for Facilities of Pharmaceuticals; and iv) the Guideline on the Procedures and Principles of Pharmacovigilance Activities Conducted by Contracted Pharmacovigilance Service Organizations and Marketing Authorization Holders. It also announced Fourth Quarter Results of the Market Surveillance and Inspection of Cosmetics and Biocidal Products.

Fourth Quarter Results of the Market Surveillance and Inspection of Cosmetics and Biocidal Products

On 15 January 2024, the TİTCK announced the results of its cosmetic sector market surveillance and inspection conducted in October, November and December 2023.

Of the 871 cosmetic products inspected by the TİTCK’s Cosmetics Supervision Department, 853 were noncompliant and 4 were risky. The responsible companies were subject to an overall administrative fine of TRY 220,000 (approximately USD 7,189).

Of the 39 type-1 and type-19 biocidal products inspected by the TİTCK’s Cosmetics Supervision Department, 20 were noncompliant and 2 were risky. The responsible companies were subject to an overall administrative fine of TRY 217,920 (approximately USD 7,121).

The 2023 fourth quarter results for cosmetic products are available here (in Turkish).

The 2023 fourth quarter results for type-1 and type-19 biocidal products are available here (in Turkish).

What Do the Results Say?

The cosmetic products’ safety results reveal that both the number of inspected cosmetic products and the number of noncompliant products increased when compared to the results of the third quarter of 2023. In this regard, there has also been an increase in the total amount of fines imposed.

The type-1 and type-19 biocidal products’ safety results reveal that the number of inspected and noncompliant products has increased. However, the total amount of administrative fines has decreased when compared to the results of the third quarter of 2023.

Regulation on Private Health Institutions for Outpatient Diagnosis and Treatment

On 16 January 2024, the TİTCK published the Regulation Amending the Regulation on Private Health Institutions for Outpatient Diagnosis and Treatment. The main amendments introduced by the Regulation are as follows:

• Polyclinics shall only be authorized as type-A or type-B polyclinics.
• Polyclinics with two or more positions shall not be provided with additional positions.
• Private health institutions can issue sick-leave or incapacity reports, medical reports for the use of pharmaceuticals, medical devices and equipment used in their treatment, and driver or prospective driver medical reports for the patients they treat.
• The Ministry of Health can permit private health institutions to issue reports by considering the needs of the region, the capacity of public health service providers, the personnel status of the private health service provider and the type of report. Excluding the cases permitted by the Ministry of Health, private health institutions cannot issue health status reports other than those mentioned above, even if they are duly organized.
• To permit private health institutions to issue health status reports, the private health institutions’ license must include specialties of internal diseases, otorhinolaryngologic diseases, general surgery, eye diseases, orthopedics and traumatology or physical therapy and rehabilitation, neurology, or psychiatry, and the board member doctor in this specialty must work on a full-time basis in the private health institution.
• If the required physical space and minimum medical equipment defined for the polyclinic room are available, specialists on dermatological and venereal diseases, plastic reconstructive and aesthetic surgery specialists and doctors with a medical aesthetic certificate approved by the Ministry of Health can provide aesthetic medical services within the scope of their competencies, based on their curriculums and certificates under medical practices permitted by the health institution in medical centers, polyclinics and clinics.

The Regulation is available here (in Turkish).

Regulation on Private Hospitals

On 16 January 2024, the TİTCK published the Regulation Amending the Regulation on Private Hospitals. In this regard, the number of specialist physician transfers between private hospitals and the sum of the number of specialist physicians transferred within and outside the province cannot exceed one-third of the total number of specialist physicians of the transferring hospital.

The Regulation is available here (in Turkish).

Guideline on Application for Facilities of Pharmaceuticals

On 22 January 2024, the TİTCK updated the Guideline on Application for Facilities of Pharmaceuticals. The main amendments introduced by the Guideline are as follows:

• If a facility, which only has an authorization for the manufacturing of traditional herbal medicinal products or only for the analysis based on the serial release of finished products, intends to manufacture pharmaceuticals by expanding the scope of its authorization, it must first apply to the TİTCK with the document type “Application for Opening a Manufacturing Site/Additional Activity Audit.”
• To classify the product to be manufactured, an application must first be made to the Pharmaceuticals Authorization Department of the TİTCK under the document type “Application for Classification of Pharmaceutical For Advanced Treatment” for each product during the initial and additional activity applications to be made for manufacturing facilities of pharmaceutical for advanced treatment.
• The certificate for facilities whose Good Manufacturing Practices compliance level meets minimum standards shall be issued following the submission of corrective preventive action documents regarding the deficiencies determined in the facility at the end of the audit.
• The authorization documents for the manufacturing site for manufacturing facilities, which were formerly issued physically with wet signatures, will now be issued through the system using the electronic database of the TİTCK, with electronic signatures and QR codes. Additionally, the documents will be available on the TİTCK’s web page.
• Following an assessment of changes to the existing operational areas or equipment of an authorized facility that are not classified as major, the applicant shall be instructed apply for an additional activity audit if deemed necessary.
• The application for deputy responsible manager shall not be applicable in cases where the responsible manager resigns. In these cases, a new responsible manager must be appointed immediately.

The Guideline is available here (in Turkish).

Guideline on the Procedures and Principles of Pharmacovigilance Activities Conducted by Contracted Pharmacovigilance Service Organizations and Marketing Authorization Holders

On 24 January 2024, the TİTCK updated the Guideline on the Procedures and Principles of Pharmacovigilance Activities Conducted by Contracted Pharmacovigilance Service Organizations and Marketing Authorization Holders.

In this regard, the provision regarding the requirement to document at least 1 year of work in the field of pharmacovigilance to work as a pharmacovigilance officer in Contracted Pharmacovigilance Service Organizations will enter into force on 1 July 2025.

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.