Recently, a number of legislative amendments regarding medicinal products for human use have been published. The Regulation on Market Control of Medicinal Products for Human Use and Foods for Special Medical Purposes (“Regulation”) was published in the Official Gazette dated November 21, 2024. On the other hand, the Turkish Medicines and Medical Devices Agency (“TMMDA”) published two new guidelines on the licensing and co-marketing of human medicinal products.
This article will outline the main elements of these regulations.
1. Regulation on Market Control of Medicinal Products for Human Use and Foods for Special Medical Purposes
The Regulation sets out the procedures and principles to be applied in the planning, execution and evaluation of market control activities to be carried out in order to ensure the effectiveness, safety and quality standards of medicinal products for human use and foods for special medical purposes in the market, as well as the duties, authorities and responsibilities.
With the Regulation, the Regulation on Market Control of Medicinal products for human use published in 2023 was repealed and foods for special medical purposes were added to the scope of the new Regulation. In addition, as per the Regulation, a Market Control Planning Board (“Board”) will be established in order to make scientific and administrative evaluations in line with risk parameters on the establishment of the market control program for the products covered by the Regulation.
In this context, according to the Regulation, the Board will examine whether there are notifications or data on the efficacy, safety and quality of the products. In the event that the warnings issued for products found to be faulty as a result of market controls are ignored and the production of faulty products continues, action will be taken in accordance with the provisions of the Regulation on the Licensing of Medicinal Products for Human Use, the Regulation on the Licensing of Traditional Herbal Medicinal Products, Homeopathic Medicinal Products Licensing Regulation and the Regulation on the Licensing of Foods for Special Medical Purposes.
The Regulation has subjected foods for special medical purposes to a more detailed risk analysis and control process.
By adding the definition of “Blocking” to the Regulation, products that pose a public health risk can be temporarily stopped via the Drug Tracking System (ITS). Risk parameters have been detailed; criteria such as past withdrawals of products and GMP compliance level have been added. Withdrawal procedures were organized in more detail with class level and follow-up processes. Analysis methods have been expanded to include international harmonized standards and validated analysis methods. The definition of “Pharmaceutical Form” has been added to the Regulation, so that the form and presentation of products are included in the Regulation. Finally, laboratory processes have been detailed and the scope of elements such as specification, storage and transportation conditions have been expanded.
2. Guidance on the Circumstances Requiring Re-authorization for Licensed Medicinal Products for Human Use
On 11.11.2024, the TMMDA announced on its website that the Guideline on the Circumstances Requiring Re-authorization for Licensed Medicinal Products for Human Use has been updated. The Guideline was last amended on 01.07.2024.
With the updates in the annex of the Guideline, the processes regarding the relocation of the production site to Turkey or abroad, transition to a certified license, license transfer and loss of license have been detailed, and it has become mandatory to update documents such as summary of product characteristics (SmPC) and instructions for use (IFU). Pharmacovigilance authority approval and science service regulations have been made more detailed, while new requirements have been added for packaging and barcode changes.
These amendments aim to make licensing procedures more systematic and documentation more complete and transparent.
3. Guideline on Co-Marketing of Medicines
On 20.11.2024, the TMMDA announced on its website that the Guideline on the Circumstances Requiring Re-authorization for Licensed Medicinal Products for Human Use has been updated. Some amendments were also made to the Guideline on 07.06.2024.
With the amendments to the Guideline, updates have been made to organize the processes regarding co-marketed medicinal products for human use and the details regarding the application processes have been expanded. In particular, with the amendments made in Article 6, it has been made mandatory to include a table containing up-to-date information on the main product in the co-marketing applications, and it is now possible to apply within the scope of Type IADB in variation processes. In Annex-2 declaration and commitment section of the Guideline, more comprehensive commitments regarding quality processes have been introduced by adding details such as place of production, shelf life and packaging information about the main product. The Guideline also also aims to strengthen coordination between marketing authorization holders and manufacturers, to harmonize variation management and to detail documentation processes.
These amendments aim to make the authorization processes for co-marketed products more transparent and monitorable.