Turkey introduces Regulation on Licensing of Medicinal Products for Human Use


The Turkish Regulation on Licensing of Medicinal Products for Human Use, which sets the necessary conditions for the quality, effectiveness and safe release of medicinal products for human use on the market, was published in the Official Gazette of 11 December 2021 by the Turkish Medical and Medical Devices Authority. This Regulation repeals the Regulation on Licensing of Medicinal Products for Human Use published in the Official Gazette of 19.1.2005 and numbered 25705 and the Regulation on the Evaluation of Bioavailability and Bioequivalence of Pharmaceutical Preparations published in the Official Gazette of 27.5.1994 and numbered 21942.

The Regulation aims to ensure compliance with the updates to EU Directive 2001/83/EC on the Community Code Relating to Medicinal Product For Human Use.

Emergency authorisation and exceptional licence

The main change introduced by the Regulation is the authorisation for emergency use. The Regulation applies to medicinal products for human use intended for the treatment, prevention or medical diagnosis of life-threatening or seriously debilitating diseases, as well as to medicinal products for human use intended for use in emergencies to combat public health threats that are recognised by the WHO or the EU or accepted by the Turkish Ministry of Health, even if comprehensive clinical data on efficacy and safety are not yet available.

The Regulation introduces conditional licensing (i.e. authorisation for use in emergencies) to ensure safe and rapid access to treatment:

  • The benefit/risk ratio of the human medicinal product is positive;
  • The applicant is able to provide comprehensive clinical data;
  • There is no medical diagnostic, preventive or treatment method that adequately addresses this need, or even if there is a method that addresses this need, the proposed method offers a great advantage for the treatment of patients.

In addition, the Regulation established an exceptional licence procedure for cases where the therapeutic indications of the medicinal product for human use are so rare that the applicant cannot be expected to provide comprehensive evidence and detailed information or where the collection of such information would be contrary to generally accepted ethical principles of medicine. This shall only apply if the applicant demonstrates that it is not possible for objective reasons to provide comprehensive data on the efficacy and safety of the medicinal product.

A special type of application has been defined for the licensing of allergenic products and it is envisaged that the details of the application will be regulated in a separate guidance document.

The licensingof advanced therapy medicinal products has been removed from the scope of the Regulation and will be regulated by another regulation.

Changes to the application procedures

The procedure for the rejection of applications has been clarified. The application shall be rejected if the information and documents requested by the Authority are not submitted, with the exception of the preliminary assessment, or if the required explanation for the non-submission of such information and documents is not provided to the Authority within 30 days at the latest.

The procedures for assessing licence applications have been clarified in detail. In this context, for each licence application submitted to the Agency, the applicant will receive a maximum of three written responses and two oral responses for each of the following cases. The licence application is rejected if:

  • Under normal conditions of use, the potential risk is greater than the positive effect of the treatment;
  • Its therapeutic effect is insufficient or not sufficiently proven;
  • If applicable, the bioavailability is insufficient; or
  • In applications for biosimilar medicinal products, similarity to the biological reference product cannot be demonstrated.

Previously, magisterial radiopharmaceutical product approvals were open-ended, provided they were limited in the health facility. In order to encourage the licensing of larger radiopharmaceutical products, the authority has restricted the granting of open-ended authorisations.

Previously, there were no mechanisms to obtain opinions from the authority on the permit application. With the new regulation, the authority is entitled to provide scientific advice to the applicant during the authorisation procedure, upon request and for a fee, in order to avoid interruptions in the assessment of an application.

Additional technical changes

Previously, a blood product licensed and authorised for sale, as well as each batch of medicinal products for human use containing blood products to be imported, had to be analysed before being placed on the market. However, in order to ensure the safe use of blood products and to eliminate the risk of viral contamination, it is now obligatory to carry out an analysis in plasma pools for each batch to be placed on the market and for the final product. The date of entry into force of the provision on the obligation of serial analysis of plasma pools is 1 January 2025.

If at least one commercial batch of an licensed medicinal product for human use is not available on the national or international market for a continuous period of 30 months, the marketing authorisation shall not be cancelled but suspended.

Procedures have been established for the marketing licence of blood products imported in bulk and processed into finished products in Turkey and for the checks to be carried out on each batch of bulk products before import licenceare finalised.

It is obligatory to complete the licensing process by submitting the required documents to the Authority within one year of the entry into force of this Regulation. This applies to products with import authorisations and registration certificates for which a licence application has been submitted, as well as to intermediate products of medicinal products for human use.

For medicinal products for human use that do not have a certified marketing licence, the necessary arrangements have been made to submit an application to the Authority for a transition to a certified marketing licence, in accordance with the transition timetable announced by the Authority within 60 months of the entry into force of the Regulation.

For more information on the healthcare sector in Turkey and the Regulation on Licensing of Medicinal Products for Human Use, please contact your CMS partner or your local CMS experts: Dr Döne Yalçın> and Taner Elmas.