The Regulation Amending the Regulation on the Licensing of Human Medicinal Products Has Been Published

The Regulation Amending the Regulation on the Licensing of Human Medicinal Products (“Amendment Regulation”) was published in the Official Gazette dated December 3, 2024, and numbered 32741, and entered into force as of its publication date.

The Amendment Regulation includes certain changes made to the Regulation on the Licensing of Human Medicinal Products (“Regulation”), which was put into effect with the Official Gazette dated April 13, 2013, and numbered 28617.

The key highlights of the Amendment Regulation are as follows:

• The term “legal entities” used throughout the Regulation has been replaced with “commercial companies.”
• The term “preclinical” used throughout the Regulation has been replaced with “pre-clinical.”
• The provisions of the Regulation on Clinical Trials of Human Medicinal Products, published in the Official Gazette dated May 7, 2023, and numbered 322032, have been excluded from the scope of medicinal products intended for use in research and development activities.
• The Product Safety and Technical Regulations Law, dated March 5, 2020, and numbered 7223, has been added to the legal basis of the Regulation.
• The definition of “mandatory case application” has been included in the definitions covered by the Regulation.
• In addition to minor wording changes regarding the information and documents required for license applications, the submission of certain new documents has been made mandatory.
• The rules regarding the procedural rejection of applications have been amended, stipulating that applications rejected on procedural grounds will be canceled.
• A new regulation has been introduced addressing cases where an application is procedurally rejected, a new license application is submitted, and the requested changes are not reflected in the updated file. Additionally, a provision regarding jointly marketed products has been included.
• The article concerning licensing processes to be prioritized has been amended, and Article 37/A has been added to the Regulation to define priority processes.
• Changes have been made to the minimum considerations observed during the evaluation of applications.
• The rules regarding the substantive rejection of applications have been amended, and the requirement for analysis of the human medicinal product has been removed. Additionally, adjustments have been made to the evaluation process of applications related to human medicinal products.
• The prescribed timelines for products whose licenses have been suspended and are intended to be reintroduced to the market have been revised.
• The article on the responsibilities of the license holder has been amended, introducing an obligation to notify the Authority in cases where a license application for imported, exported, or domestically manufactured human medicinal products under license is rejected in other countries or the application is withdrawn by the applicant.
• Amendments have been made to the article regulating license transfers, introducing provisions regarding jointly marketed human medicinal products and revising the timelines for the transferee to use old barcoded products following a license transfer.
• Regulations have been introduced regarding the information and documents required for market authorization of blood products.
• Additional articles have been included in the Regulation under exceptional circumstances, allowing for the limited supply of a licensed human medicinal product to the market for a specific duration and quantity under certain conditions.
• It has been stipulated that allergen products manufactured in any European Union member state and already available in the EU market may be placed on the market until 01.01.2026.
• A provisional article has been added to the Regulation concerning products whose licensing process is ongoing as of 01.03. 2024.
• A provisional article has been introduced for products transitioning from the traditional herbal medicinal product category to the human medicinal product category, requiring a license application to be submitted within 1 year and the application process to be completed within 5 years.

The Amendment Regulation will enter into force as of its publication date, and its provisions will be executed by the President of the Turkish Medicines and Medical Devices Agency.

The full text of the Amendment Regulation can be reached through this link. (Only Available in Turkish)