Esin - Healthcare & Life Sciences Newsletter
The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published an announcement regarding European Union (EU) Regulation No. 2017/745, Regulation on Marketing Authorization of Foods for Special Medical Purposes and Regulation on Marketing Authorization of Traditional Herbal Medicinal Products. Moreover, the TİTCK has amended the Guideline on Early Access Programs for Pharmaceuticals, the Guideline on Marketing Authorization Renewal for Medicinal Products for Human Use and announced the Fourth Quarter Results on Market Surveillance and Inspection of Cosmetics and Biocidal Products.
EU Regulation No. 2017/745
On 16 January 2023, the TİTCK published an announcement on the proposed regulation amending the transitional clause of EU Regulation 2017/745 (“Regulation”) for reducing the risk of nonavailability of medical devices.
Article 120 of the Regulation, which regulates the transitional period, needs to be extended for various reasons, such as the fact that small and medium-sized enterprises are not sufficiently prepared to meet the new requirements, the high risk that many devices will not be certified before the end of the transitional period, and problems in the supply of medical devices within the EU.
In this regard, on 6 January 2023, the European Commission submitted and opened for public consultation a Proposal for a Regulation amending the relevant Article 120. Accordingly, for medical devices covered by a certificate issued by a notified body pursuant to Directive 90/385/EEC and Directive 93/42/ EEC as of 25 May 2017 and valid as of 26 May 2021, and for devices covered by a declaration of conformity issued under Directive 93/42/EEC before 26 May 2021 and for which the conformity assessment procedure under the Regulation requires the involvement of a notified body, 26 May 2024 is the latest date for placing on the market. This will be extended until the following dates for each category:
- 26 May 2026 for Class III custom-made implantable devices,
- 31 December 2027 for high-risk (Class III) devices,
- 31 December 2028 for low- and medium-risk devices (other Class IIb devices, Class IIa devices and Class I devices placed on the market in sterile condition or with a measuring function)
The Announcement is available here (in Turkish).
Guideline on Early Access Programs for Pharmaceuticals
On 19 January 2023, the TİTCK updated the Guideline on Early Access Programs for Pharmaceuticals. The Guideline sets out the principles and procedures for the procurement of medicinal products that do not have a marketing authorization in Türkiye, but that have (or do not have) a marketing authorization in other countries, for patients who have been unsuccessful with standard treatment methods and medicinal products that have marketing authorization in Türkiye, or patients who are no longer able to receive such treatments. In this regard, the Guideline includes various regulations such as the patients to be included in the program, the execution of the program, application stages, documents required for application, adverse event notification and termination of the program.
The Guideline is available here (in Turkish).
Fourth Quarter Results on Market Surveillance and Inspection of Cosmetics and Biocidal Products
On 23 January 2023, the TİTCK announced the results of its cosmetics sector market surveillance and inspection conducted in October, November and December 2022.
Of the 203 cosmetic products inspected by the TİTCK’s Cosmetics Supervision Department, 162 were noncompliant and 16 were unsafe. The responsible companies were subject to an overall administrative fine of TRY 545,340 (approximately USD 28,910).
Of the 10 type 1 and type 19 biocidal products inspected by the TİTCK’s Cosmetics Supervision Department, 5 were unlicensed and 1 was unsafe. The responsible companies were subject to an overall administrative fine of TRY 241,720 (approximately USD 12,814).
The 2022 fourth quarter results for cosmetic products 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 decrease in the number of inspected products and noncompliant products. In this regard, the total amount of administrative fines has decreased compared to the results for the third quarter of 2022.
The type 1 and type 19 biocidal products’ safety results reveal that there has been a decrease in the number of inspected, unlicensed and unsafe products. Accordingly, there is also a significant decrease in the total amount of administrative fines.
Regulation on Marketing Authorization of Foods for Special Medical Purposes
On 28 January 2023, the TİTCK published the Regulation on Marketing Authorization of Foods for Special Medical Purposes, effective as of 1 July 2023. The Regulation sets out various issues such as classification, marketing authorization and packaging of foods for special medical purposes. The main amendments introduced by the Regulation are as follows:
- For foods for special medicinal purposes to be placed on the market, the TİTCK must issue a marketing authorization. In addition, a sales authorization is also required for foods for special medicinal purposes to be placed on the market for the first time.
- Foods for special medical purposes are classified into three groups: i) containing standard nutrients; ii) containing nutrients developed specifically for a disease or health problem, which may constitute the sole source of nutrition for the user when used in accordance with the manufacturer’s instructions; and iii) nutritionally incomplete products that are not suitable for use as a sole source of nutrition, either standard formulated products or products whose nutrient content is tailored to a disease or health problem.
- Only vitamins, minerals, amino acids, other nitrogen containing compounds and other nutrients can be used to meet the nutrient requirements in the production of food for special medical purposes.
- Foods for special medical purposes developed to meet the nutritional requirements of infants and young children must not contain pesticide residues exceeding 0.01 mg/kg per active ingredient.
- Foods for special medical purposes must be packaged and the phrase “Food for Special Medical Purposes” (tr.”Özel Tıbbi Amaçlı Gıda”) must be added to the packaging. In addition, the information specified in the Regulation must be included on the packaging. Besides, the packaging of foods for special medical purposes developed to meet the nutritional needs of infants must not contain any elements, including pictures of babies, any photographs, figures and pictures that encourage the use of the product.
- For products that are within the scope of the relevant regulation but have been approved by the TİTCK before the publication of the regulation and for which import or manufacturing permits have been issued and placed on the market in this way, marketing authorization must be applied for from the TİTCK by 31 December 2025 at the latest. Until then, products can be placed on the market based on existing authorizations. However, if a marketing authorization is not issued within 1 year from the date of application, the existing authorizations will be deemed invalid.
The Regulation is available here (in Turkish).
Regulation on Marketing Authorization of Traditional Herbal Medicinal Products
On 3 February 2023, the Regulation on Marketing Authorization of Traditional Herbal Medicinal Products entered into force through its publication. It regulates various issues such as the marketing authorization of traditional herbal medicinal products and obtaining a sales permit. The main amendments introduced by the Regulation are as follows:
- Natural or legal persons residing in Türkiye must apply to the TİTCK for a marketing authorization to place a traditional herbal medicinal product on the market. In addition, a sales authorization must be obtained for the traditional herbal medicinal product to be put on the market for the first time.
- Traditional herbal medicinal products for which a marketing authorization application will be made must: i) be designed for use without a prescription for diagnosis or treatment without medical supervision of a doctor and have appropriate indications specific to traditional herbal medicinal products in terms of composition and intended use; ii) be prepared only for specific uses in accordance with a specific efficacy and posology; iii) be a medicinal product for human use for oral, externally imposed or inhaled use; and iv) the traditional use must be proven by bibliographic data.
- Natural persons wishing to obtain a marketing authorization must have graduated from a higher education institution in pharmacy, medicine or chemistry and be authorized to practice their profession in Türkiye; legal entities must employ a person with these qualifications as an “authorized person”.
- In issuing a marketing authorization, the TİTCK considers that quality is demonstrated by appropriate technological and pharmaceutical qualities and that efficacy and safety under conventional conditions of use have been proven.
- The marketing authorizations issued for traditional herbal medicinal products by the TİTCK will continue to be valid provided that the holder fulfills its responsibilities under the Regulation.
The Regulation is available here (in Turkish).
Guideline on Marketing Authorization Renewal for Medicinal Products for Human Use
On 7 February 2023, the TİTCK updated the Guideline on Marketing Authorization Renewal for Medicinal Products for Human Use. In this regard, amendments have been introduced for products that have an annotation stating that the validity of the marketing authorization has been “extended for 5 years”. The main amendments introduced by the Guideline are as follows:
- For products with an annotation on the marketing authorization stating that the validity of the marketing authorization has been “extended for 5 years”, i) a letter of approval regarding the currency of the short product information/ instructions for use, ii) a letter of approval regarding the comprehensive quality summary issued by the Technological Evaluation Unit for Marketing Authorized Products or the Biological and Biotechnological Products Unit, and iii) a letter of approval for the periodic benefit risk assessment report issued by the Pharmacovigilance Risk Management Unit of the TİTCK are not required for marketing authorization renewal applications to be submitted for the revision of “scientific review results have been found appropriate and the marketing authorization remains valid”.
The Guideline is available here (in Turkish).
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.