The Regulation on the Licensing of Medicinal Products for Human Use (“Regulation”) introduced by the Turkish Pharmaceuticals and Medical Devices Agency (“Agency“) which aims to regulate the procedures and principles relating to drug authorization processes and practices concerning licensed drugs, was published in the Official Gazette of December 11, 2021 and numbered 31686.

The regulation covers medicinal products prepared industrially or manufactured with a method containing an industrial process as well as natural and legal persons who apply for or have obtained marketing authorizations for these products.

With the introduction of the regulations, the regulations on the licensing of medicinal products for human use published in the Official Journal of January 19, 2005 and numbered 25705 and the regulations on the evaluation of bioavailability and bioequivalence of pharmaceutical medicinal products published in the Official Journal of May 27, 1994 and numbered 21942 have been repealed.

Some important issues regarding the changes introduced with the regulations can be summarized as follows;

  • When all the characteristics are taken into account, in the event that a product can be qualified as a medicinal product for human use and as a product falling within the scope of other related legislation, the provisions of the Regulation apply.
  • Regulations have been established regarding the application for marketing authorization, the method of application and the information and documents to be provided. In principle, applications for marketing authorization and all correspondence during the process must be made electronically.
  • With the settlement, practices regarding application evaluation processes have been developed and issues regarding application rejection have been clarified. In addition, detailed regulations have been developed on the licensing process and duration.
  • A special type has been established for the approval of allergenic products.
  • Abbreviated request types have been brought into line with European Union legislation, definitions and requirements have been clarified.
  • A conditional authorization procedure (emergency use approval) has been regulated in detail, in relation to medicinal products intended for the treatment, prevention or diagnosis of life-threatening diseases or diseases which create serious handicaps and /or drugs that will be used in an emergency against public health hazards recognized by the World Health Organization or the European Union or accepted by the Ministry of Health, provided that certain conditions of the regulations are met.
  • With regard to marketing authorization applications made for products marketed in co-marketing, the Agency assesses module 1 prepared in accordance with appendix 1 of the regulations for the application file compiled with a complete file. The application for marketing authorization can also be made with module 1 prepared in accordance with annex 1 of the regulation. For marketing authorization applications for co-marketed products made in this manner, further modules cannot be submitted during the authorization process or after authorization.
  • Concerning co-marketing products, in the event of withdrawal of marketing authorization for the product for which the application was made with a complete file, the MAs of the co-marketing products for which the application was approved only with the Module 1 prepared in accordance with Schedule 1 of the Regulations is also repealed. A transition process has been considered for co-marketed products for which the request has already been made and for which the authorization process is in progress.
  • An exception has been established regarding the approval of a transfer request which overrules the court’s decision in the event that the affected product is the only diagnostic or treatment option for a disease in Turkey.
  • Detailed rules regarding the suspension of marketing authorizations have been provided as part of the regulation. If at least one commercial batch of a licensed drug is not found on national or international markets for 30 consecutive months, the marketing authorization is suspended instead of withdrawn.
  • If the marketing authorization holder cannot release for any reason a product which is already on the market, the marketing authorization holder shall inform the Agency at least 30 days from advance. In addition, in case of suspension or withdrawal of the marketing authorization or recall or withdrawal from the market in other countries of medicinal products imported, exported or manufactured in Turkey under license, the holder of the authorization placing on the market informs the Agency.
  • In the event of loss of the marketing authorization or of the file, the holder of the marketing authorization or the applicant may contact the Agency. In this case, where appropriate, a new marketing authorization document is issued or the Agency provides a copy of the dossier to the applicant.
  • The authorization process for products with import permits and registration documents for which an application for marketing authorization has been made and interim products that qualify as medicinal products for human use must be finalized in one year from the entry into force of the regulation.

Subparagraphs (i) and (j) of paragraph 1 of Article 22 of the Regulation relating to the suspension of marketing authorizations enter into force one year after the publication, paragraph 1 of Article 29 relating to the he authorization to market blood products comes into force on January 1, 2025 and the other provisions of the regulation come into force on the date of its publication.

Please consult this link for the full text of the regulation published in the Official Journal of December 11, 2021 and numbered 31686 (only available in Turkish).

You can find the Agency’s announcement regarding the settlement via this link (only available in Turkish).

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