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The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK“) has published announcements on the authorized laboratories, support of healthcare professionals attending scientific meetings, European Database on Medical Devices (EUDAMED), drugs supplied from abroad, and Social Security Institution Communiqué on Health Practices (tr. SUT).
Please click on the relevant link below for our specific notes regarding recent developments:
How to Submit Applications for Authorized Laboratories?
Which Documents Are Required for the Meetings to be Supported by the License/Permit Holders?
How to Register EUDAMED as an Actor within the Scope of the Medical Device Regulation?
What Changes Does the Updated Overseas Drug Supply Guide Bring?
What Changes Made to the SGK Health Practices Certificate?
How to Submit Applications for Authorized Laboratories?
TİTCK published the Guideline on Procedures and Rules concerning Working Principles of Authorized Laboratories (“Guideline“). The Guideline contains instructions regarding the authorization of the TİTCK laboratories that will analyze certain products as part of their duties, such as pharmaceuticals, cosmetics and biocidal products that come into contact with the human body. The Guideline is available here (in Turkish).
What’s New?
Laboratories will conduct quality control analysis concerning pharmaceuticals, cosmetics and biocidal products that are in direct contact with the human body. Manufacturers of medical enteral nutrition products, medical biological products, biotechnological products and medical devices must first apply to the TİTCK by submitting the relevant documents explaining the work in detail. The application will be finalized within 90 days. Institutions whose applications are approved by the TİTCK will be authorized by the issuance of an Authorization Certificate for Analysis.
The Analysis Authorization Certificate is valid for one year. A renewal application should be made to the TİTCK 90 days before the validity expires. If this period is missed, the renewal application will be considered a new application.
Authorized laboratories will be audited by the TİTCK at least once a year. The audit may result in approval or a decision to suspend and/or revoke the authorization. Laboratories whose analysis authorization has been revoked as a result of the audit will not be able to apply for a new authorization within one year.
Which Documents Are Required for the Meetings to be Supported by the License/Permit Holders?
On 4 October 2021, the TİTCK announced changes to the list of required documents within the scope of the COVID-19 normalization process. The changes concern applications made for healthcare professionals who will participate in scientific meetings held pursuant to the Regulation on Promotional Activities of Medicinal Products for Human Use (“Regulation“) to support the registration/permit holders. The relevant announcement is available here (in Turkish).
What’s New?
Provided that they comply with certain conditions, license/permit holders may support healthcare professionals who will participate in the national and international scientific meetings pursuant to the Regulation. Due to the COVID-19 pandemic, healthcare professionals for whom support applications have been made to the TİTCK are requested to obtain a permit issued by the health institution official with which they are affiliated, stating that they can participate in face-to-face scientific meetings. However, within the scope of the normalization process, the aforementioned letter will not be requested by the TİTCK in the applications of healthcare professionals for scientific meetings that will be held as of 4 October 2021.
The TİTCK’s approval in this regard is only an approval of the relevant license/permit holder to support the healthcare professional in question, and does not equate to healthcare professional’s approval to attend the meeting.
How to Register EUDAMED as an Actor within the Scope of the Medical Device Regulation?
On 18 October 2021, the TİTCK published the EUDAMED User’s Guide (“Guide“) within the scope of the Medical Device Regulation (“Regulation“) published in the Official Gazette No. 31499 dated 2 June 2021. The Guide consists of a Turkish translation of the text published by the European Commission. In addition, the Guide contains instructions addressed to economic operators within the scope of the Regulation on how to register to the actor registration module in EUDAMED. The Guide is available here (in Turkish).
What’s New?
The Regulation obliges economic operators to register certain data, such as medical devices placed on the market or certificates issued by notified bodies, to EUDAMED. The Guide also contains detailed explanations on the use of EUDAMED in order to fulfill this obligation properly. In this context, the Guide includes explanations on many subjects such as economic registration to EUDAMED, account termination, reviewing registered actors, user access management, user access and management of authorization documents.
What Changes Does the Updated Overseas Drug Supply Guide Bring?
With its announcement dated 23 October 2021, the TİTCK has updated the Guideline for Drug Supply and Use from Abroad (“Guide“) and made some changes in Annex-5. Within the scope of the update, additional standards applicable to medicinal products for human use supplied from abroad have been determined. The Guide and the Annex-5 are available here (in Turkish).
What’s New?
The update includes changes regarding the relevant international institutions and regulations applicable to the supply of medicinal products for human use. Accordingly, instead of the American Food and Drug Administration, the European Medicines Agency, the Pharmaceutical Control Convention and the Pharmaceutical Control Cooperation Program, the activities of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) and its permanent and founding members, the United Kingdom competent authority (“MHRA”) and Australian competent authority (“NPL”) will be taken as basis. The supply of medicinal products for human use in the Overseas Medicines List included in Annex-1 of the Communiqué must comply with the regulations introduced in the updated Annex-5 (Rules to be followed by Suppliers during the Supply of Medicines from Abroad). Accordingly, the products supplied must be licensed and placed on the market by providing scientific efficacy, safety and quality data by the MHRA and NPL. In addition, the supplied products must have been produced in facilities that have been audited by the MHRA and NPL in compliance with Good Manufacturing Practices.
In addition, it is obligatory to submit the Certificate of Origin, Certificate of Analysis and Release Certificate during the delivery of products by foreign pharmaceutical suppliers. A product-based Good Manufacturing Practices inspection will be conducted if a request is made by the Overseas Drug Evaluation Commission to add a product to the Overseas Drug List, excluding the products manufactured in the countries specified in sub-paragraphs of paragraphs a and b of Article 5(3) of the Guide.
Products that do not comply with the provisions of the Guide on the date of publication, but whose tenders have been announced or made by foreign drug suppliers, will continue to be supplied during the current tender conditions and duration.
What Changes Made to the SGK Health Practices Certificate?
The Social Security Institution Communiqué on Health Practices was amended with the Official Gazette No. 31640 dated 26 October 2021. The Communiqué includes various regulations regarding drugs to be used for certain diseases and equivalent drugs. The Communiqué is available here (in Turkish).
What’s New?
Within the scope of the amendment, a number of provisions have been introduced for drugs and active substances to be used for various diseases such as chronic kidney failure or Prader Will syndrome in children. Additionally, a change was made in the discount application to be applied in drugs. In this context, SGK will be able to create an equivalent group and/or therapeutic reference group. Only drugs that are in the equivalent group will be substituted in pharmacies.
In addition, amendments were made to the following annexes of the Communiqué:
- Annex-4/A List of Medicines to be Paid
- Annex-4/D List of Medicines Exempted from the Patient Contribution Fee
- Annex-4/E List of Systemic Antimicrobial and Other Drugs Prescribing Rules
- Appendix-4/F List of Medications to be Given with a Health Report in Outpatient Treatment
- Annex-4/G List of Medications to be Paid Only in case of Inpatient Treatment
Conclusion
The TİTCK continues to provide guidance for companies in the healthcare industry should carefully review the TİTCK’s announcements and take the necessary actions to ensure compliance.
