‘‘The Draft Regulation on Homeopathic Medicinal Products”, (“Draft Regulation’’) has been drafted by Turkey Pharmaceuticals and Medical Devices Agency (TITCK) on 09.09.2021.
The Draft Regulation covers industrially prepared homeopathic medicinal products produced by a traditional or industrial method, and natural and legal persons who have applied for and/or been granted a license for them.
The purpose of the Draft Regulation is to determine the procedures and principles to be applied in licensing, packaging and distribution processes and practices regarding licensed homeopathic medicinal products to ensure that homeopathic medicinal products with protective, supportive, or curative effects on human health have the desired effectiveness, safety and required quality.
The terms regulated with the Draft Regulation are as follows:
• License application processes
• Persons who can apply for a license
• Conditions regarding packaging information and prospectus
• Information and documents required for submission
• Licensing and placing on the market
• Evaluation of the license application
• Responsibilities of the license holder
• Licensing results
• Suspension and cancellation of the license.
According to the provisions of the Draft Regulation, no homeopathic medicinal product that is not licensed by the Agency can be placed on the market.
The predicted criteria to be considered regarding the product while issuing the homeopathic medicinal product license by the Agency are as follows:
• Proven safety in the foreseen conditions of use,
• The quality has been demonstrated by appropriate technological and pharmaceutical properties.
The draft regulates those homeopathic medicinal products will be granted license for an indefinite period by reserving the Institution’s right for limitation of the license period ‘when necessary’. In the draft, the conditions for the limitation of the license period are ambiguous and, is left to the discretion of the Institution.
You may reach the full Turkish version of the Draft Regulation via the link below:
Homeopatik Tıbbi Ürünler Ruhsatlandırma Yönetmeliği Taslağı
Authors: Elif Kayral, Alara Biber