The Turkish Pharmaceuticals and Medical Devices Authority ("TİTCK") recently published Regulation on Serial Release of Vaccines and Immune Serums and Draft Guideline on Pharmacovigilance System. TİTCK has amended Guideline on the Issuance of Pharmaceutical Product Certificates, Free Sale Certificates and Pharmaceutical Product Registration Status Declaration Documents, Decree on the Pricing of Medicinal Products for Human Use, Regulation on Cosmetics and Regulation on Food Control Laboratories and announced the Third Quarter Results on Market Surveillance and Inspection of Cosmetics and Biocidal Products.
Regulation on Serial Release of Vaccines and Immune Serums
The Regulation on Serial Release of Vaccines and Immune Serums was published by TİTCK on 30 September 2022 and entered into force through its publication. In this regard, the need for managing the national serial release and market authorization processes, which are carried out within the framework of the Serial Release Guidelines, has been fulfilled.
The Regulation sets out the procedures and principles to be considered in the acceptance of the samples received with the serial release application to be made to the TİTCK and the conduct of quality control tests based on the analysis methods included in the World Health Organization ("WHO") guidelines, pharmacopoeias and the European Union Official Control Authorities for Serial Release ("EU OCABR") guidelines and the issuance of serial release certificates following the file review.
The main amendments introduced by the Regulation are as follows:
- The responsibilities of stakeholders involved in the serial release process are regulated. The producer, or the natural or legal person authorized on behalf of the producer is responsible for submitting a serial release application for each serial bulk, final bulk or finished product.
- In emergency situations that threaten public health, an extraordinary procedure may be used to accelerate the access to the product. In this case, for products originating from abroad, an evaluation can be made by reviewing the serial release certificate issued by the NRA/NCL of the country where the product is released, raw data of the laboratories, production process records, serial summary protocol and similar documents. On the other hand, in the rapid evaluation process for vaccines and immune serums produced and/or filled in Türkiye, after reviewing the raw data of laboratories, production process records, serial summary protocol, an evaluation is carried out within the framework of (i) panel testing with the domestic producer and (ii) reviewing the number of tests to be performed as a result of risk assessment.
The regulation is available here (in Turkish).
Guideline on the Issuance of Pharmaceutical Product Certificates, Free Sale Certificates and Pharmaceutical Product Registration Status Declaration Documents
The Agency published an updated Guideline on the Issuance of Pharmaceutical Product Certificate, Free Sale Certificate and Pharmaceutical Product Registration Status Declaration Documents on 21 October 2022.
As per the updates, it will be possible to file an application to obtain the Pharmaceutical Product Certificate and Pharmaceutical Product Registration Status Declaration for products that are manufactured in Türkiye but do not have a marketing authorization or marketing authorization application. In this context, the aspects to be taken into account when filling in the application forms have been determined.
The Guideline is available here (in Turkish).
Decree on the Pricing of Medicinal Products for Human Use
The Decree on the Amending the Decree on the Pricing of Medicinal Products for Human Use entered into force through its publication on 9 November 2022. Accordingly, a new rule to be applied in the determination of prices has been added to Article 2 of the Decree.
According to the new rule, discount practices that cause temporary price changes in the country/countries where the product is offered for sale, special practices regarding product classification and special taxation practices will not be taken into account in the calculation of the real source price. In addition, products that do not have retail sales in the country/ countries where they are offered for sale and are only available through hospitals will not be taken into account in the real source price calculation of products that have retail sales in Türkiye. Applicant companies must submit the documents certifying these issues to the TİTCK with the application.
The Decree is available here (in Turkish).
Draft Guideline on Pharmacovigilance System
- TİTCK published the Draft Guideline on Pharmacovigilance System on 16 November 2022. The Draft Guideline was prepared to explain the structure of the pharmacovigilance system established within TİTCK
- In this regard, the Draft Guideline provides guidance on many issues such as the pharmacovigilance system of TİTCK, data and records management, the duties of TİTCK related to pharmacovigilance and the distribution of duties by units, and the duties of TÜFAM.
The draft guideline is available here (in Turkish)
Third Quarter Results on Market Surveillance and Inspection of Cosmetics and Biocidal Products
TİTCK announced on 18 November 2022 the results of its cosmetics sector market surveillance and inspection conducted in July, August and September 2022.
Of the 371 cosmetic products inspected by the TİTCK's Cosmetics Supervision Department, 295 were noncompliant and 7 were unsafe. The responsible companies were subject to administrative fine of TRY 813,584 (approximately USD 43,673) in total.
Of the 29 type 1 and type 19 biocidal products inspected by the TİTCK's Cosmetics Supervision Department, 1 was noncompliant, 2 were unsafe and 12 were unlicensed. The responsible companies were subject to administrative fine of TRY 403,330 (approximately USD 21,650) in tota.
The cosmetic products' third quarter results of 2022 are available here (in Turkish).
The type 1 and type 19 biocidal products' third quarter results of 2022 are available here (in Turkish).
What Do the Results Say?
The cosmetic products' safety results reveal that there has been a significant increase in the number of inspected products and noncompliant products. On the other hand, the total amount of administrative fines has increased compared to the results of the second quarter of 2022.
The type 1 and type 19 biocidal products' safety results reveal that there has been a increase in the number of inspected, unlicensed and unsafe products but a decrease in the number of noncompliant products. Accordingly, there is also a significant increase in the total amount of administrative fines.
Conclusion
The TİTCK continues to provide guidance for companies working in the healthcare industry. Companies should carefully review the TİTCK's announcements and take 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.
