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The Turkish Medicine and Medical Devices Authority (“TİTCK“) published the new Regulation on Marketing Authorization of Pharmaceutical Products (“Regulation“). The Regulation sets forth new rules on critical issues such as application processes for marketing authorizations and approval for emergency use.
New Development
The TİTCK published the Regulation in Official Gazette No. 31686 on 11 December 2021. The Regulation is drafted in line with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on Medicinal Products for Human Use and Commission Regulation No 507/2006 of 29 March 2006 on the Conditional Marketing Authorization for Medicinal Products for Human Use, within the scope of the harmonization process with the European Union legislation. The Regulation introduces new rules on many different subjects, such as the application for marketing authorization of pharmaceutical products for human use, the evaluation of applications, the renewal and suspension of marketing authorizations, obligations, sales and approval for emergency use. The Regulation, which entered into force on the day of publication, is available here (in Turkish).
What’s New?
Application for Marketing Authorization
Pursuant to the Regulation, marketing authorization applications are made electronically and the list of documents to be submitted during the application has been expanded. Accordingly, additional information and documents, such as a description of control methods used by the manufacturer of the pharmaceutical product for human use and, when the research is carried out abroad, the applicant’s declaration containing a statement that the research meets the ethical requirements set out in the Regulation on Clinical Trials of Pharmaceuticals and Biological Products, along with the results of the clinical research, must be submitted. All official documents obtained from abroad, except for parts found appropriate by the TİTCK, must be submitted in Turkish, with an apostille annotation or consular approval. In addition, the elements that should be included in the short product information prepared for healthcare professionals are listed in the Regulation.
Assessment of an Application for a Marketing Authorization
According to the Regulation, marketing authorization processes are initiated in February, May, August and November. However, the TİTCK is entitled to assess applications that are approved by the Priority Assessment Board with priority.
If an excuse concerning failure to correct deficiencies in an application for a marketing authorization, the marketing authorization fee and the information and documents requested during the preliminary evaluation process are not submitted to the TİTCK in a timely manner, the application for marketing authorization will be procedurally rejected.
In certain situations that arise during the marketing authorization application assessment process, the applicant will be given a maximum of three written and two oral answers. If the necessary information and documents are not completed within the time given, the application will be rejected on the merits. The rejection decision is notified to the applicant. The rejection decision may be announced through the TİTCK’s website if the notification cannot be made. The applicant reserves the right to object to the rejection decision within 45 days as of the notification date or the announcement. However, this will not hinder the applicant’s further applications for a marketing authorization.
Renewal and Suspension of the Marketing Authorization
The marketing authorization is valid for five years, and an application must be submitted to the TİTCK for renewal at least nine months prior to the expiry of this period. Once renewed, the marketing authorization is valid indefinitely, unless the TİTCK decides on an additional five-year renewal assessment for various reasons.
The Regulation extends the situations in which the marketing authorization must be suspended. Accordingly, the marketing authorization must be suspended in the following cases:
- Unless in certain exceptional situations, at least one commercial batch has not been placed on the market within the first 30 months from the date of issuance of the marketing authorization of the pharmaceutical product
- Failure to place on the market — in Turkey or abroad — at least one commercial batch of a pharmaceutical product for human use that is manufactured in Turkey and previously released to the market within the scope of a data matrix application, for an uninterrupted 30-month period.
Liabilities of the Marketing Authorization Owner
The Regulation extends the liabilities of the marketing authorization owner. If the marketing authorization owner will not be able to place a product on the market, it must notify the TİTCK at least 30 days before this situation occurs. If the marketing authorization of a pharmaceutical product for human use that is imported, exported or manufactured in Turkey is revoked, suspended, recalled or withdrawn in the country for quality, efficacy or safety reasons, it is mandatory to inform the TİTCK of the issue.
Sales Permit for Pharmaceutical Products
It is mandatory to obtain a sales permit for products that will receive a marketing authorization by the TİTCK and put on the market for the first time. The application for a permit is made by submitting the relevant documents as per the Regulation to the TİTCK. It is not necessary to obtain a new sales permit for changes to a pharmaceutical product for human use, except for a change of the place of manufacturing, change of packaging size, marketing authorization transfer and suspension of the marketing authorization.
As an exception, as of 1 December 2025, an additional sales permit must be obtained for each batch of blood products which owns a sales permit, for which a marketing authorization has been applied for, or which has a marketing authorization. Similarly, it is mandatory to apply to the TİTCK for a sales permit for each series of immunologic products — except for allergenic products — which owns a sales permit, for which a marketing authorization has been applied for, or which has a marketing authorization.
Conditional Marketing Authorization (Emergency Use Authorization)
The Regulation sets forth a special application procedure for the marketing authorization of pharmaceutical products for human use for the treatment, prevention or diagnosis of life-threatening or severely disabling diseases and critical pharmaceutical products for human use to be used in emergencies against public health threats recognized by the World Health Organization, the European Union or the Ministry of Health. The validity of an emergency use authorization is one year. Renewal may be requested by applying to the TİTCK 90 days before the expiry of this period. The TİTCK is set to publish further regulations on this issue.
Conclusion
The Regulation sets forth essential changes to the marketing authorization processes of pharmaceutical products. Companies working in the health sector must carefully review the Regulation and the TİTCK’s announcements on the implementation of the Regulation, and comply with their legislative liabilities upon the TİTCK’s directions.
