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

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

The Amendment Regulation includes certain changes made to the Regulation on the Licensing of Homeopathic Medicinal Products (“Regulation”), which was enacted through the Official Gazette dated July 8, 2023, and numbered 32242.

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 definition of prescription drugs prepared in pharmacies according to this formula has been detailed, and new conditions have been introduced within this scope.

▪️ The Product Safety and Technical Regulations Law, dated 05.03.2020 and numbered 7223, has been added to the legal basis of the Regulation.

▪️ Amendments have been made to the definitions within the Regulation, including a revision to the definition of “manufacturing site.”

▪️ 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.

▪️ The special timeline previously prescribed for homeopathic medicinal products within the licensing process has been removed.

▪️ The specific provisions related to homeopathic medicinal products have been excluded from the scope of application evaluations.

▪️ The rules regarding the substantive rejection of applications have been amended, and the analysis requirement for homeopathic medicinal products has been removed. Additionally, adjustments have been made to the evaluation process of applications related to homeopathic medicinal products.

▪️ It has been stipulated that if an application is substantively rejected and the applicant cannot be notified, the rejection may be announced on the Authority’s official website.

▪️ A separate regulation has been introduced for applications concerning homeopathic products claiming superiority over another licensed homeopathic medicinal product.

▪️ The responsibilities previously prescribed for license holders concerning the validity period of licenses have been removed from the scope of the Regulation.

▪️ The timelines for reintroducing products whose licenses have been suspended have been revised.

▪️ The extension periods for suspensions in cases where a license has been suspended for specific reasons under Article 23 of the Regulation have been amended.

▪️ The article regulating license transfers has been amended to include provisions for jointly marketed homeopathic medicinal products, and the timelines for the transferee to use old barcoded products after a license transfer have been revised.

▪️ The article concerning post-licensing variations has been updated to align with the Amendment Regulation.

▪️ An additional article has been introduced under exceptional circumstances, allowing the limited supply of a licensed homeopathic medicinal product to the market for a specific duration and quantity under certain conditions.

▪️ It has been stipulated that the provisional article included in the Regulation will not be applied until 01.01.2026.

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)