Esin / Healthcare & Life Sciences Newsletter - October 2023

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published the Guideline on the Conditions Requiring the Renewal of Marketing Authorization for Pharmaceuticals and the Guideline on the Scheduling Processes of Applications for Marketing Authorization of Pharmaceuticals.

The TİTCK also amended (i) the Guideline on Scientific Advice for Pharmaceuticals, (ii) the Guideline on Applications for GMP Audits of Foreign Production Facilities and (iii) the Guideline on Common Specifications for Nonmedical Product Groups Listed in Annex XVI of the Medical Device Regulation.

Guideline on Scientific Advice for Pharmaceuticals

On 29 September 2023, the TİTCK updated the Guideline on Scientific Advice for Pharmaceuticals. In this regard, the TİTCK will not give scientific advice on the selection of a reference product.

The Guideline is available here (in Turkish).

Guideline on Applications for GMP Audits of Foreign Production Facilities

On 5 October 2023, the TİTCK updated the Guideline on Applications for GMP Audits of Foreign Production Facilities. The main amendments introduced by this Guideline are as follows:

• Facilities whose rights of risk-based audit have expired must be audited on-site when the GMP validity period expires. However, if there is a current and valid audit conducted by the TİTCK at the relevant facility, an application can be made within the scope of the audit on file.
• Applications for audit on file cannot be made for products for which an on-site audit decision has been made as a result of the evaluation within the scope of the risk-based audit.
• For GMP audits to be carried out on-site in foreign production facilities, an explanation for not meeting the conditions of the audit on file and the reason for the application must also be submitted.

The Guideline is available here (in Turkish).

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

On 6 October 2023, the TİTCK updated the Guideline on Common Specifications for Nonmedical Product Groups Listed in Annex XVI of the Medical Device Regulation. In accordance with Regulation (EU) No. 2023/1194, this amends the dates specified in the transitional provision regulating the process for the products to be placed on the market and put into service provided that they meet certain conditions.

The Guideline is available here (in Turkish).

Guideline on the Conditions Requiring the Renewal of Marketing Authorization for Pharmaceuticals

On 9 October 2023, the TİTCK published the Guideline on the Conditions Requiring the Renewal of Marketing Authorization for Pharmaceuticals. The main amendments introduced by this Guideline are as follows:

• Applications for the transfer of marketing authorization and all required information and documents must be submitted to the Pharmaceuticals with Marketing Authorization Unit by the real or legal person who will take over the marketing authorization by paying the application fee through the document type “Application for Transfer of Marketing Authorization.”
• Applications to transfer marketing authorization must include any of the following: a court decision stating that the marketing authorization has been transferred; a decision from the execution office stating that the marketing authorization has been sold through compulsory execution; or a trade registry certificate of the parties to the transfer agreement with a contract drawn up in the presence of a notary public. The agreement must include the name of the relevant product, the date and number of the marketing authorization, the names and addresses of the parties and a record of the complete delivery of the existing product file to the transferee.
• Transferring marketing authorization is only performed for pharmaceuticals with marketing authorization and will not be performed for allergenic products with temporary authorization.
• For pharmaceuticals without certified marketing authorization, an application for a transition to a certified marketing authorization must be submitted to the Pharmaceuticals with Marketing Authorization Unit by 11 December 2026.
• The application for a transition must include the following: the receipt showing that the marketing authorization fee has been paid and containing the product name; the original copy of marketing authorization previously issued for the product; and the table of information completely and correctly filled in. If there is a change that requires an annotation to the old type of marketing authorization but the relevant record is not included in the marketing authorization, all approval letters regarding such changes must be submitted.
• For pharmaceuticals whose marketing authorization has been lost, an application for lost marketing authorization must be made to the Pharmaceuticals with Marketing Authorization Unit.
• The application for a lost marketing authorization must include the following: a receipt showing that the marketing authorization fee has been paid and containing the product name; a copy of the previous marketing authorization for the product; if available, a newspaper advertisement stating that the marketing authorization has been lost; and a complete and correctly filled in table of information on the lost marketing authorization. If there is a change that requires an annotation to be made but the relevant record is not included in the marketing authorization, all approval letters regarding such changes must be submitted.

The Guideline is available here (in Turkish).

Guideline on the Scheduling Processes of Applications for Marketing Authorization of Pharmaceuticals

On 12 October 2023, the TİTCK published the Guideline on the Scheduling Processes of Applications for Marketing Authorization of Pharmaceuticals. This Guideline will enter into force on 1 January 2024. The main amendments introduced by the Guideline are as follows:

• The list of active substances awaiting scheduling for those whose preliminary evaluation is deemed appropriate by the TİTCK and the list of active substances of pharmaceuticals for which the marketing authorization process has started will be published on the official website of the TİTCK in the first week of each month.
• Applications for the evaluation of innovative products must be made to the Priority Evaluation Unit. After the evaluation, an application for marketing authorization must be made.
• The application submitted to the TİTCK for the marketing authorization of a pharmaceutical will be subject to a preliminary evaluation by the Preliminary Examination Unit. Evaluations will be carried out in the order of the application date, and pharmaceuticals that pass preliminary evaluation will be included in the scheduling list.
• Applications that pass the preliminary evaluation are listed in the scheduling list as follows: (i) the first biosimilars, (ii) the first pharmaceutical equivalents, (iii) pharmaceuticals containing the active ingredients of the medicinal products included in the Foreign Drug Price List, (iv) innovative products, (v) blood products, (vi) other biological medicinal products, including immunological pharmaceuticals (except allergen products and blood products), (vii) allergen products, (viii) pharmaceuticals included in the essential medicine list, (ix) pharmaceuticals designated as other essential medicine, and (x) pharmaceuticals excluded from the specified product groups. Applications within the same category will be ranked according to the date of application.
• The first three applications from the first biosimilar, allergenic products, pharmaceuticals included in the essential medicinal product list and pharmaceuticals designated as other essential medicinal products will be considered. The first five applications from the first pharmaceutical equivalent group and the group of pharmaceuticals other than the mentioned product groups will be considered.
• The marketing authorization process for pharmaceuticals included in the scheduling list will be initiated in February, May, August and November only.
• Within the scope of the Guideline on the Procedures and Principles of the Priority Evaluation Board, applications given priority by the TİTCK will be initiated without being included in the scheduling list.

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 necessary actions to ensure compliance.