Healthcare & Life Sciences Newsletter - May 2024

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published the i) Guideline on the Labeling of Research Products and Auxiliary Pharmaceuticals, ii) 10th Turkish Pharmaceutical Market Monitoring Report and iii) Announcement on Product Tracking System Applications of Medical Devices That Will Not Be Certified By The Manufacturer In Accordance With The New Medical Device Regulation (MDR). The TİTCK also announced the First Quarter Results of the Market Surveillance and Inspection of Cosmetics and Biocidal Products.

Guidance on the Labeling of Research Products and Auxiliary Pharmaceuticals

On 22 March 2024, the TİTCK published the Guideline on the Labeling of Research Products and Auxiliary Pharmaceuticals. The main amendments introduced by the Guideline are as follows: ­

— The information on the outer and inner packaging of research products and auxiliary pharmaceuticals used in clinical trial must ensure the safety of volunteers and the accuracy, reliability and traceability of the data collected from the clinical trial and must be clearly legible and in Turkish. However, multilingual labels shall be allowed. ­

— The labeling of research products and auxiliary pharmaceuticals to be used in clinical trial must be performed in accordance with the requirements of good manufacturing practices.

— Research products and auxiliary pharmaceuticals must be packaged and labeled in accordance with the Guideline on Good Manufacturing Practices for Pharmaceutical Production Sites. In this regard, the sponsor will be responsible for ensuring that the packaging and labeling processes are carried out and documented in accordance with the principles of good manufacturing practices and the Guideline on Good Manufacturing Practices for Pharmaceuticals Production Sites.

— The information listed below must be provided on the outer and inner packaging of the products that have not been granted marketing authorization in Türkiye. However, the information that must be provided on the outer and inner packaging of research products and pharmaceuticals that have not been granted marketing authorization are further detailed in the annex of the Guideline.

— information identifying the contact person(s) involved in the clinical trial
— information identifying the clinical trial
— information identifying the pharmaceutical
— information on the use of the pharmaceutical

— Although it is essential that auxiliary pharmaceuticals be granted marketing authorization in Türkiye, pharmaceuticals that have been granted marketing authorization by other competent authorities may also be used as auxiliary pharmaceuticals if justified by reasonable grounds. In this case, the outer and inner packaging must be prepared in accordance with the Guideline. ­

— Research products and auxiliary pharmaceuticals that have been granted marketing authorization in Türkiye must be labeled in accordance with the Guideline or in accordance with the provisions set out in the Regulation on Packaging Information, Manuals and Tracking of Pharmaceuticals. ­

— Where required by the special conditions set out in the clinical trial protocol, additional information identifying the clinical trial and the contact person must be provided on the outer packaging and inner packaging of research products and auxiliary pharmaceuticals in Türkiye.

The Guideline is available here (in Turkish).

10th Turkish Pharmaceutical Market Monitoring Report

On 5 April 2024, the TİTCK published the 10th Turkish Pharmaceutical Market Monitoring Report to provide an overview of the Turkish pharmaceutical market. The Report analyzes the market status of pharmaceuticals for the years 2016 and 2022 by using the databases of Quintiles and IMS Health (IQVIA) and the Pharmaceutical Tracking System. In this regard, the Report’s findings on the market status are as follows:

— While the sales value of the Turkish pharmaceutical market had been TRY 21.10 billion in 2016, it increased to TRY 116.47 billion in 2022. In terms of box sales volumes, the sales volume increased from 2.19 billion boxes in 2016 to 2.64 billion boxes in 2022.

— In 2022, 78% of the total pharmaceuticals sold in Türkiye were financed by the Social Security Institution (SSI), 1.3% by private insurances and 20.7% by direct sales.

— In the period between 2016 and 2022, the ratio of manufactured pharmaceuticals increased compared to imported pharmaceuticals in terms of sales volume and sales value in 2022.

— While the sales value of the Turkish biotechnological pharmaceuticals market had been TRY 3.44 billion in 2016, it increased to TRY 20.48 billion in 2022. In 2022, the share of the biotechnological pharmaceuticals market in the total pharmaceuticals market was 17.58%.

— In 2022, pharmaceuticals with the active ingredient enoxaparin had the largest share in the manufactured biotechnological pharmaceuticals market in terms of both sales volume (boxes) and sales value, and their share in manufactured biotechnological pharmaceuticals was 92.03% in terms of sales volume (boxes) and 63.74% share in terms of sales value.

— As of 2022, the sales value of biosimilars in the Turkish pharmaceutical market has reached TRY 2.54 billion.

— The share of manufactured pharmaceuticals among biosimilars is 90% in terms of sales volume (boxes) and 64.2% in terms of sales value in 2022.

The Regulation is available here (in Turkish).

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

On 15 April 2024, the TİTCK announced the first quarter results of its cosmetic sector market surveillance and inspection conducted in January, February and March 2024.

Of the 287 cosmetic products inspected by the TİTCK’s Cosmetics Supervision Department, 116 were noncompliant and 147 were risky. The responsible companies were subject to an overall administrative fine of TRY 170,000 (approximately USD 5,267).

Of the 32 type-1 and type-19 biocidal products inspected by the TİTCK’s Cosmetics Supervision Department, 11 were noncompliant and 5 were risky. The responsible companies were subject to an overall administrative fine of TRY 609,516 (approximately USD 18,886).

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

The 2024 first quarter 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 both the number of inspected cosmetic products and the number of noncompliant products decreased when compared to the results of the fourth quarter of 2023. In this regard, there was also a decrease 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 while the number of noncompliant products has decreased. However, the total amount of administrative fines has increased when compared to the results of the fourth quarter of 2023.

Announcement on Product Tracking System Applications of Medical Devices That Will Not Be Certified By The Manufacturer In Accordance With The New Medical Device Regulation (MDR)

On 24 April 2024, the TİTCK published the Announcement on Product Tracking System Applications of Medical Devices That Will Not Be Certified By The Manufacturer In Accordance With The New Medical Device Regulation (MDR).

Accordingly, the provisions of Regulation (EU) 2023/607 of the European Parliament and the Council amending the transitional provisions of Regulations (EU) 2017/745 and (EU) 2017/746 on certain medical devices and in vitro diagnostic medical devices and the relevant amendments were published in the Official Gazette on 2 April 2023 and entered into force in Türkiye in line with the EU member states.

Medical devices manufactured within the scope of the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD), which cannot benefit from the transitional provisions, can be placed on the market by the manufacturer or importer until 26 May 2024. Medical devices that were legally placed on the market before this date can be maintained on the market for the shelf life of the product, if any.

Products that cannot benefit from the relevant transitional provisions cannot be placed on the market as of 26 May 2024. If it is found that a medical device is placed on the market in violation of the provisions of the aforementioned legislation, legal action will be taken within the scope of the Product Safety and Technical Regulations Law No. 7223 and the relevant technical regulations.

As of 26 May 2024, progressive singular product movement notifications (manufacturing notification, import notification, delivery notification, delivery to consumer notification, etc.) should not be made to the singular product stocks in the Product Tracking System (ÜTS) of products that do not benefit from the relevant transitional provisions. For products legally placed on the market prior to this date, singular product movement notifications can be made during the shelf life of the product, if any.

In this regard, the relevant movement notifications regarding the singular products that have been or will be placed on the market until 26 May 2024 must be made by the companies that perform the product registration of the products in question. As of this date, the singular product stocks in the ÜTS of the products that have not been placed on the market must be removed with the “stock correction” option under the production cancellation notification, import cancellation notification or junk/waste notification.

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.