The Turkish Pharmaceuticals and Medical Devices Authority ("TİTCK") recently updated the Guideline on the Conditions Requiring the Renewal of Marketing Authorization for Pharmaceuticals.
The TİTCK also announced the Second Quarter Results of the Market Surveillance and Inspection of Cosmetics and Biocidal Products.
Guideline on the Conditions Requiring the Renewal of Marketing Authorization for Pharmaceuticals
On 1 July 2024, the TİTCK updated the Guideline on the Conditions Requiring the Renewal of Marketing Authorization for Pharmaceuticals. The main amendments introduced by the Guideline are as follows:
- If the original marketing authorization is lost in the transfer of marketing authorization through a notary public, a "Lost Marketing Authorization Application" must be submitted before the transfer application is made, and the original marketing authorization must be provided by the current marketing authorization holder.
- A co-marketing agreement, including the written approvals of the real persons or companies that will engage in co-marketing, and the trade registry certificates of the parties, must also be submitted during the transfer of marketing authorization for pharmaceuticals subject to co-marketing manufactured or to be manufactured in Türkiye.
- Variation applications to change the place of manufacturing
from abroad to Türkiye or vice versa must be submitted to the
Technological Evaluation Unit of Pharmaceuticals with Marketing
Authorization in accordance with the Guideline on Variations in
Pharmaceuticals with Marketing Authorization. Upon successful
completion of the quality control, the Technological Evaluation
Unit of Pharmaceuticals with Marketing Authorization shall forward
the application file of the pharmaceuticals to the Pharmaceuticals
with Marketing Authorization Unit for administrative evaluation.
The applicant must provide the following information and documents
requested by the Pharmaceuticals with Marketing Authorization Unit
to finalize the variation applications regarding the change of the
place of manufacturing from abroad to Türkiye or vice versa,
and to issue a marketing authorization:
- Original copy of the marketing authorization previously granted for the pharmaceutical;
- Current summary of product information and/or instructions for use;
- Drafts of the inner and outer packaging prepared for all packaging sizes of the product;
- If the product is imported or manufactured under license, a document issued by the licensor company proving that the importing real person or the company is the sole authorized representative for the importation of the product into Türkiye, or its manufacture, marketing authorization and sale in Türkiye;
- If the product is subject to co-marketing, the document showing that the co-marketing authorization has been granted to a real person or a company other than the sole authorized representative in Türkiye, and the written approvals of the real person or the company for co-marketing;
- If the marketing authorization holder for a product to be manufactured in Türkiye is not the manufacturer company, a contract manufacturing agreement with a manufacturer fulfilling the conditions specified in the Regulation on Manufacturing Facilities for Pharmaceuticals, and the trade registry certificate of the manufacturer company;
- A receipt containing the product name, indicating that the marketing authorization fee determined annually by the Ministry of Treasury and Finance has been paid;
- If changing the barcode of the product is requested, the barcodes registered to the title and address of the marketing authorization holder company for all package sizes of the product;
- The table provided in Annex 4 of the Guideline regarding the change of the place of manufacturing from abroad to Türkiye or vice versa.
- If the applicant requesting a transfer has a product with a different trade name that has the same active substance as the product subject to transfer, the applicant must apply to the Pharmaceuticals with Marketing Authorization Unit through the document type "Marketing Authorization Transfer (Administrative) Type IB" for a trade name change for the product subject to transfer, and ensure that the trade name of this product and the transferred product are the same.
- If the applicant intends to transfer some of its products with the same trade name as the product subject to transfer, but with different strength/pharmaceutical forms, a trade name change application must be submitted to the Pharmaceuticals with Marketing Authorization Unit through the document type "Marketing Authorization Transfer (Administrative) Type IB" for the pharmaceuticals subject to transfer.
- If the applicant has a product with a marketing authorization and with the same strength, pharmaceutical form and indication as the product for which the transfer is requested, the transfer shall not be carried out.
- If the scientific validity period of the marketing authorization has expired, a confirmation that the marketing authorization is still valid must be obtained from the Pharmaceuticals with Marketing Authorization Unit. As of 1 January 2025, the transfer process will not be carried out for pharmaceuticals for which the marketing authorization renewal application made during the transfer process is not approved.
- For pharmaceuticals for which the validity period of the marketing authorization has expired, the transition to certified marketing authorization and lost marketing authorization procedures will not be carried out until the renewal of the marketing authorization is completed.
The Guideline is available here (in Turkish)
Second Quarter Results of the Market Surveillance and Inspection of Cosmetics and Biocidal Products
On 9 July 2024, the TİTCK announced the second quarter results of its cosmetic sector market surveillance and inspection conducted in April, May and June 2024.
Of the 81 cosmetic products inspected by the TİTCK's Cosmetics Supervision Department, 19 were noncompliant and 5 were risky. The responsible companies were subject to an overall administrative fine of TRY 160,000 (approximately USD 4,825).
Of the 16 type-1 and type-19 biocidal products inspected by the TİTCK's Cosmetics Supervision Department, 10 were noncompliant Return to Contents and 4 were risky. The responsible companies were subject to an overall administrative fine of TRY 910,890 (approximately USD 27,471).
The second quarter 2024 results for cosmetic products are available here (in Turkish).
The second quarter 2024 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 there has been a significant decrease in the number of inspected cosmetic products and noncompliant products when compared to the results of the first quarter of 2024. However, the decrease in the total amount of fines imposed is not parallel to the decrease in these figures.
The type-1 and type-19 biocidal products' safety results reveal that there has been a decrease in the number of inspected products and the number of noncompliant products when compared to the results of the first quarter of 2024. However, there has been an increase in the total amount of administrative fines.
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.
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.
