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Recent Developments in the Healthcare Sector – December 2021

Legal Alerts
Healthcare
General

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The Turkish Pharmaceuticals and Medical Devices Authority (TİTCK) has published announcements on biocidal products, the Overseas Drug List, products whose class has changed in accordance with the Medical Device Regulation, international and domestic Good Manufacturing Practices (GMP) certification and inspection processes.

Please click on the relevant link below for our specific notes regarding recent developments:

What Additional Measures Will Be Taken during the Pandemic concerning Overseas GMP Inspection and Certification Processes?
What Additional Measures Will Be Taken concerning Domestic GMP Inspection and Certification Processes?

How to Apply for a Biocidal Product License?
Which Drugs Will be Included in the Overseas Drug List?
What Actions Must be Taken concerning Products whose Class has hanged within the Medical Device Regulation?

What Additional Measures Will Be Taken during the Pandemic concerning Overseas GMP Inspection and Certification Processes? 

On 3 December 2021, the TİTCK published an announcement concerning GMP inspections and GMP certificates of overseas production facilities. The announcement details the extensions that will be applied to the validity periods of GMP certificates and inspections applications during the pandemic. The announcement is available here (in Turkish).

What’s New?

Taking into account the ongoing pandemic conditions, a number of new measures will be implemented for overseas production facilities, without prejudice to the inspection right of the TİTCK, including the following:

  • The validity period of GMP certificates of overseas production facilities that meet certain conditions has been extended until 31 December 2022, without any need for further application.
  • For facilities previously inspected by the TİTCK: The application will be made within the scope of Article B of the Guidelines for Applications for GMP Audits of Overseas Production Facilities (“Guide“).
  • For facilities not previously inspected by the TİTCK: If products with high priority and priority decisions taken by the Priority Evaluation Board have been inspected by an authority that is a member of PIC/S, but these products do not meet the conditions of Article B of the Guide; an exceptional assessment will be made by requesting various additional documents on the application file.
  • If the importer companies have difficulties in obtaining documents from the production site, documents sent from abroad can be sent to the TİTCK by email, provided that a declaration is made that the documents will be submitted as soon as they are obtained.

What Additional Measures Will Be Taken concerning Domestic GMP Inspection and Certification Processes?

On 3 December 2021, the TİTCK announced that the certificate periods of domestic production facilities, whose GMP certificate period has expired, have been extended for approximately one year if they meet certain criteria. The announcement is available here (in Turkish).

What’s New?

Within the scope of the post-pandemic normalization process pursuant to the Normalization Measures Circular for month of June of the Ministry of Internal Affairs dated 1 June 2021 No. E-89780865-153-8878, the general domestic GMP inspections started in the second half of 2021. The GMP certificate periods of the domestic pharmaceutical manufacturers, whose inspection has not yet been carried out and provided that three years have passed since the last general inspection, have been extended until 31 December 2022.

How to Apply for a Biocidal Product License?

On 30 November 2021, the TİTCK published an announcement regarding the transactions that will be made through the Ürün Takip Sistemi (Product Tracking System – tr. (ÜTS)) regarding biocidal products. The relevant announcement contains instructions concerning the license application for product type-1 and product type-19 biocidal products. The announcement is available here (in Turkish).

What’s New?

License applications for product type-1 and product type-19 biocidal products can be made via ÜTS as of 9 December 2021. The application will not require physical documentation; the process will be carried out through documents carrying an electronic signature. However, the TİTCK reserves the right to request physical documents, if necessary.

Once the application has been filed, the documents may be updated a maximum of three times. If the missing documents are not submitted in those three times, the application will be terminated without further evaluation. In this case, a new license application must be filed via ÜTS.

Additionally, product type-1 and product type-19 biocidal products, which are licensed by the General Directorate of Public Health and whose validity period expires on 31 December 2021, are permitted to be on the market until 31 December 2022. As long as certain test reports concerning the application meet the conditions specified in the Instruction on the Analysis of Product Type-1 and Product Type-19 Biocidal Products of the TİTCK, no document renewal will be made by the TİTCK regarding the licenses of these products. However, the tests must be renewed if they do not meet the relevant criteria.

Which Drugs Will be Included in the Overseas Drug List?

On 24 November 2021, the TİTCK published an announcement concerning the Overseas Drug List prepared pursuant to Law No. 984 on Shops Selling Toxic and Active Chemicals Used in Pharmaceutical Trades and Artistic and Agricultural Works (“Law on Shops Selling Toxic and Active Chemical Substances”). The announcement is available here (in Turkish).

What’s New?

As per Article 11 of the Law on Shops Selling Toxic and Active Chemical Substances, medicinal products for human use that are not licensed in Turkey or are licensed but not available on the market for various reasons, can be procured from abroad by public institutions and organizations approved by the Ministry of Health, as well as by the Social Security Institution and the Turkish Pharmacists Association, under certain specific conditions. Products procured following Article 11 will be added to the Overseas Drugs List and it is mandatory for the permit/license holder to apply for a license within three years from the date of entry into the list and to obtain a license within two years from the date of application, at the latest.

The TİTCK published the list of products on the Overseas Drug List that have not been licensed, however, they have completed their three year-limit after being added to the relevant list, and/or have six months left to complete their three years. The Overseas Drug Evaluation Commission will evaluate the list. Following this, products that are deemed appropriate to remain on the list despite not having a license/permit may continue to be procured, subject to the approval of the presidency.

What Actions Must be Taken concerning Products whose Class has hanged within the Medical Device Regulation?

On 16 November 2021, the TİTCK published an announcement concerning products that are not “registered” in the ÜTS, among the medical devices whose risk class has changed within the scope of the new Medical Device Regulation. The announcement is available here (in Turkish).

What’s New?
On 6 July 2021, the TİTCK announced that medical devices, whose risk group has changed and thus require the approval of an approved institution, may be kept on the market until 26 May 2024 under certain conditions. The new announcement underlines that in order to make an application from the ÜTS for the registration of products whose class will change, an application must be made via the TİTCK website — Türkiye İlaç Ve Tıbbi Cihaz Kurumu (titck.gov.tr) — with a petition containing information specified in Annex-1 of the announcement.

Conclusion
The TİTCK continues to provide guidance for companies working in the healthcare industry. Companies should carefully review the TITCK’s announcements and take necessary actions to ensure compliance.