Healthcare & Life Sciences Newsletter - November 2024

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published i) Regulation on the Withdrawal of Pharmaceuticals and Dietary Foods for Special Medical Purposes, ii) Announcement on Companies and the Users Making Document and Product Registration for Medical Devices, and iii) Announcement on Healthcare Service Providers.

The TİTCK also announced the Third Quarter Results of the Market Surveillance and Inspection of Cosmetics and Biocidal Products.

Furthermore, the Ministry of Treasury and Finance amended the Communiqué on Decree No. 32 on the Protection of the Value of the Turkish Currency (Communiqué No: 2008-32/34), which also impacts stakeholders in the healthcare industry. Meanwhile, the Presidency of the Republic of Türkiye amended the Decree on the Pricing of Pharmaceuticals.

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

On 7 October 2024, the TİTCK announced the third quarter results of its cosmetic sector market surveillance and inspection conducted in July, August and September 2024.

Of the 162 cosmetic products inspected by the TİTCK’s Cosmetics Supervision Department, 89 were noncompliant and 21 were risky. The responsible companies were subject to an overall administrative fine of TRY 381,254 (approx. USD 11,147).

Of the 27 type-1 and type-19 biocidal products inspected by the TİTCK’s Cosmetics Supervision Department, 5 were noncompliant and 9 were risky. The responsible companies were subject to an overall administrative fine of TRY 1,156,056 (approximately USD 33,802).

The third quarter 2024 results for cosmetic products are available here (in Turkish).

The third 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 increase in the number of inspected cosmetic products and noncompliant products when compared to the results of the second quarter of 2024. The increase in these figures is parallel to the increase in the total amount of fines imposed.

The type-1 and type-19 biocidal products’ safety results reveal that the number of inspected products has increased, whereas there has been no change in the number of noncompliant products compared to the results of the second quarter of 2024. However, there has been an increase in the total amount of administrative fines.

Announcement on the Companies and the Users Making Document and Product Registration for Medical Devices

On 7 October 2024, the TİTCK published the Announcement on the Companies and the Users Making Document and Product Registration for Medical Devices. The Product Tracking System (ÜTS) has been updated to enable a person to be defined as a company user of a maximum of 10 companies for the specified company types to eliminate potential difficulties that may arise in terms of data security and responsibility arising from situations where a person who makes document and product registration for medical devices on behalf of companies registered as “Manufacturer/Importer/Dealer/Exporter” and “Custom-made orthotic prosthesis center” is not the companies’ own employee. In this regard, a person currently registered as a user in more than 10 companies must update their registration until 1 January 2025.

The Announcement is available here (in Turkish).

Communiqué on Decree No. 32 on the Protection of the Value of Turkish Currency (Communiqué No: 2008-32/34)

On 8 October 2024, the Ministry of Treasury and Finance published the Communiqué (No: 2024-32/70) Amending the Communiqué on Decree No: 32 on the Protection of the Value of the Turkish Currency (Communiqué No: 2008-32/34). In this regard, service agreements concluded by notified bodies resident in Türkiye with manufacturers under the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation and labor agreements concluded with Turkish residents, are exempted from the prohibition on payment in foreign currency. Such agreements can now be concluded in foreign currency or indexed to foreign currency.

The Communiqué is available here (in Turkish).

Regulation on the Withdrawal of Pharmaceuticals and Dietary Foods for Special Medical Purposes

On 23 October 2024, the TİTCK published the Regulation on the Withdrawal of Pharmaceuticals and Dietary Foods for Special Medical Purposes and repealed the Withdrawal Regulation. The Regulation sets forth i) the withdrawal procedures for pharmaceuticals with marketing authorization or permission by the TİTCK, ii) active substances used in the production of such pharmaceuticals, and iii) dietary foods for special medical purposes, as well as the production, placing on the market and availability of the relevant products. The main amendments introduced by the Regulation are as follows: ­

Within the scope of the assessment and withdrawal, if necessary, of the defective product from the market, the marketing authorization/permit holder must:

– notify the marketing authorization holder in the exporting country and inform the TİTCK if the withdrawn batch(es) have been exported,

– inform the TİTCK of the content and reason for such withdrawal by the competent authority of other batches of a product manufactured abroad if the product holds marketing authorization or permit in Türkiye and is manufactured in the same facility as a product that is not placed on the Turkish market, determine the number of products withdrawn and carry out procedures for destruction or return the relevant products to their place of origin.

A Withdrawal Evaluation Commission (“Commission”) will be established to: i) evaluate the notifications and complaints submitted to the TİTCK; ii) assess the non-compliances detected during the audit, inspection and market control activities carried out by the TİTCK; iii) decide on the level of withdrawal and the lot numbers scheduled to be withdrawn; and iv) make a scientific assessment of the measures and actions to be taken other than withdrawal according to the nature of the noncompliance detected.

The supply chain levels to be covered by the withdrawal have been updated as follows:

– A level: All contactable users and recipients

– Level B: all locations that supply the product to the end user

– Level C: pharmaceutical businesses

Except for the first class of withdrawal, where serious and lifethreatening health problems arise or can be expected to arise, administrative sanctions may be imposed without withdrawal if the Commission determines that the defect or non-compliance detected does not have a negative impact on consumer health and safety and the relevant non-compliance is considered as occasional.

The TİTCK may grant a one-time extension of four weeks for the submission of the final report by the marketing authorization/permit holder regarding the scope of the withdrawal, upon request.

In addition to the relevant sanctions stipulated in the Law on Pharmaceuticals and Medicinal Preparations No. 1262, Turkish Penal Code No. 5237 and the Misdemeanors Law No. 5326, an administrative fine ranging from TRY 48,113 (approx. USD 1,400) to TRY 481,113 (approx. USD 14,002) in accordance with the Product Safety and Technical Regulations Law No. 7223 may be imposed on any marketing authorization/permit holder, manufacturer, pharmaceutical business and pharmacy that continues to sell the defective batch after the withdrawal announcement and does not implement the recall decision.

The Regulation is available here (in Turkish).

Decree on Pricing of Pharmaceuticals

On 24 October 2024, the Presidency of the Republic of Türkiye published the Decree Amending the Decree on the Pricing of Pharmaceuticals (“Decree”). The main amendments introduced by the Decree are as follows:

When determining the real source prices of pharmaceuticals, the amount of active substances will be compared regardless of the solvent.

The following warehouse profit rates will apply when determining the retail price of products other than pharmaceuticals:

– 8% for amounts up to TRY 328 (including TRY 328)

– 6% for amounts between TRY 328-657 (including TRY 657)

– 3% for amounts above TRY 657

The value of EUR 1 in TRY to be used in the pricing of pharmaceuticals was increased by 23.5% to TRY 21.6721. When applying this increase, the offsetting will not be applied to the products.

The thresholds have been set at TRY 74.72 for price-protected products and TRY 39.05 for other products in proportion to the change in the value of EUR.

The value of EUR 1 in TRY to be used in pricing the above-mentioned pharmaceuticals will also apply in 2025, and no new EUR assessment will be made for 2025.

When applying the increase, except for non-refundable products, the remaining increases of up to TRY 4 for products in the Detailed Drug Price List with a Sale Price to Warehouse above TRY 55.90 (including TRY 55.90) will be exempt from offsetting during the EUR value update. A periodic EUR value update will be made, excluding the remaining increases. In this context, the selling prices of the products to the warehouse will be added to the selling prices of the products without changing their TRY value.

During the real source price change period of 2024, the value of EUR 1 (one) in TRY to be used in the pricing of the abovementioned pharmaceuticals will also be applied in the real source price change list without re-application from the products evaluated based on the application until 24 October 2024.

The Decree is available here (in Turkish), and our legal alert on the pricing of pharmaceuticals is available here for details.

Announcement on Healthcare Service Providers

On 25 October 2024, the TİTCK published the Announcement on the Healthcare Service Providers. In this regard, the relevant provision of the Regulation on Quality Compliance and Quality Control Tests of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices, requiring medical devices used in diagnostic radiology, nuclear medicine and radiotherapy applications that produce or emit ionizing radiation to have quality compliance and quality control procedures performed by persons and institutions authorized by the TİTCK, has been abolished as of 23 December 2024 until a further announcement to be made by the TİTCK.

The Announcement 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.