For further information,
please contact:

Senior Associate

Associate

Legal Alerts
https://www.esin.av.tr/wp-content/themes/esin/images/esin.jpg

Recent Developments in the Healthcare Sector – January 2022

Legal Alerts
Healthcare
Healthcare & Life Sciences

              Click the button to listen to our legal alert now!

 

The Turkish Pharmaceuticals and Medical Devices Authority (TİTCK) has published announcements regarding (i) testing, control and calibration of medical devices, (ii) medicines that are counterfeit or illegal and that go outside the legal supply chain, (iii) amendments to regulations regarding biocidal products, and (iv) the recall process.

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

What Does the Guide on Test, Control and Calibration of Medical Devices Regulates?
What Does the Guide on Unlawful Medicines Bring?
What Changes are Made to the Regulation on Biocidal Products?
What Does the Recall Guide Include?

What Does the Guide on Test, Control and Calibration of Medical Devices Regulates?

Recent Development

The TİTCK published on 6 January 2022, the Guide on the Implementation of the Regulation on Test, Control and Calibration of Medical Devices (“Medical Device Guide“). The Medical Device Guide entered into force on the date of publication and is available here (in Turkish).

What’s New?

Pursuant to the Medical Device Guide, all processes for the test, control and calibration of medical devices must be carried out through the Product Tracking System (tr. “ÜTS“). Accordingly, organizations wishing to obtain an authorization certificate for providing test, control and calibration services must file an electronic application on the Ürün Takip Sistemi (saglik.gov.tr) website of the ÜTS. The Medical Device Guide explains all the steps to follow as well as the necessary documents for the application. If the application is approved, the applicant organization will be given an authorization certificate of Conformity Assessment Organization (tr. “UDK“). In addition, working certificates will be issued for the responsible manager and expert, who must be employed by a UDK.

UDKs are liable to draft a report summarizing all testing, control and calibration activities carried out, in accordance with the relevant legislation. It is mandatory to include the distinctive sign — which is provided in article 8 of the Medical Device Guide and includes the authorization certificate information of the relevant organization — on the upper left side of the report. Further information concerning the drawing of the distinctive sign is available here (in Turkish).

Additionally, UDKs are liable to have their test devices calibrated at least once in a year in accordance with the relevant national or international standards. UDKs who receive an accreditation certificate after fulfilling this obligation will not be requested to fulfill the metrological traceability requirement; UDKs who did not receive such accreditation certificate will also have to fulfill the metrological traceability requirement.

Authorization and work certification provided prior to the entry into force of the Medical Device Guide will remain valid. Organizations whose UDK application processes are still ongoing at the entry into force of the Medical Device Guide will have to comply with the Medical Device Guide.

What Does the Guide on Unlawful Medicines Bring?

Recent Development

The TİTCK published on 5 January 2022, the Guide on Counterfeit, Illegal or Out-of-the-Legal-Supply-Chain Medicines (“Guide“). The Guide seeks to define the responsibilities of stakeholders in the fight against counterfeit, illegal or out-of-the-legal-supply-chain medicines in terms of public health, and to guide the actions to be taken in this context. The Guide is available here (in Turkish).

What’s New?

The Guide regulates actions and measures to be taken by the TİTCK and other stakeholders in cases of certain unlawful acts:

  • Out-of-the-legal-supply-chain medicines. If the medicines that hold a marketing authorization and carries a data matrix are sold outside pharmacies, the TİTCK will determine the source of the medicines going out of the legal supply chain via the Medicines Tracking System (tr. “İTS”). Relevant sanctions will be applied to the parties responsible for illegal actions.
  • Counterfeit or illegal medicines. If a marketing authorization holder is notified of a counterfeit or illegal medicine, the marketing authorization holder must immediately contact the TİTCK by using the form provided in Annex-2 of the Guide. The marketing authorization holder must fully cooperate with the TİTCK during the investigation of notified allegations. If such medicines are located in a pharmaceutical warehouse or a medicine manufacturing facility, they must be labelled “Not for sale!” and kept separate from the medicines that will be sold. The TİTCK must also be notified immediately. If an attempt is made to sell the medicines by reaching out to a pharmacy or a hospital through an illegal sales channel, the attempt must be reported to the TİTCK immediately by filling out the form in Annex-1 of the Guide. The TİTCK will ensure that the products are recalled from the supply chain and destroyed in accordance with the applicable legislation. The TİTCK will also initiate judicial and administrative proceedings against responsible parties.
  • Non-conforming medicines. Non-conforming medicines and their promotional materials must be recalled from the market by the city health directorates authorized by the TİTCK and must be destroyed pursuant to the relevant legislation.
  • Promotion and sale of medicines online. The Medicine Supervision Department of the TİTCK regularly checks the internet for any promotion and sale of medicines online. If such promotion or sale is detected, the Ministry of Health will decide to block the access to such content and notify the Information Technologies and Communication Authority to block public access to such content.

What Changes are Made to the Regulation on Biocidal Products?

New Development

The Ministry of Health published on 30 December 2021, the Amending Regulation to the Regulation on Biocidal Products (“Regulation“) in the Official Gazette No. 31705. The Regulation bring new rules concerning biocidal product applications and biocidal product labels. The Regulation entered into force on the date of publishing and is available here (in Turkish).

What’s New?

The sources published by the European Chemicals Agency will be taken as primary sources in the assessment of the biocidal product applications made in accordance with the Regulation. Other international sources will be used if these are not sufficient. In addition, toxicology and ecotoxicology tests submitted during active substance and biocidal products applications must be conducted in accordance with the Regulation on Principles of Good Laboratory Practice, Harmonization of Test Units, Supervision of Good Laboratory Practices and Studies (“Good Laboratory Practices Regulation“). Other tests that will be submitted during the application must be performed by organizations that have proven compliance in accordance with the Good Laboratory Practices Regulation.

All information on the label sample approved by the Ministry of Health must be included on the biocidal product label. The label in question must also contain a data matrix that will ensure the traceability of the biocidal product. Other information and slogans may be freely placed on the product, provided that they are located outside the necessary label information.

What Does the Recall Guide Include?

New Development

The TİTCK published the Recall Guide on 17 December 2021. The Recall Guide regulates the rules and responsibilities for the effective recall of products that are considered to be faulty or inconvenient. It is available here (in Turkish).

What’s New?

If the TİTCK determines by any means (e.g., via market supervision and inspection activities carried out by the Medicine Supervision Department of the TİTCK ) that the product in the market is faulty or inconvenient, it may decide to recall the product. Moreover, the TİTCK may decide to recall a product on the basis of notifications regarding product faults from international communication channels.

In addition, if a marketing authorization holder or a manufacturer company detects a fault in the product, they are obliged to apply to the TİTCK for voluntary recall using the form in Annex-1 of the Recall Guide. If necessary, the sale of the product may be blocked through İTS until the investigation is concluded. The TİTCK will publish the blocking decision on its public website. If the product is found faulty by the end of the investigation, it will be recalled from the market.

The TİTCK determines the class and level of the withdrawal process, along with the recall decision. Accordingly, the significance of the defect in the product and the stakeholders of the product in the supply chain (for example, end user or pharmaceutical warehouse) are determined for each recall process. The responsible party is obliged to notify the designated stakeholders in accordance with the rules set out in the Recall Guide.

Conclusion

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