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New Guidelines on Authorisation and Packaging of Homeopathic Medicinal Products

On 24 December 2021, the Regulation on Licensing of Homeopathic Medicinal Products (Regulation) was published in the Official Gazette. Pursuant to the Regulation, on 15 March 2022 the Medicines and Medical Devices Agency published the Guidelines on Licensing of Homeopathic Medicinal Products (Turkish language) and the Guidelines on Packaging and Product Information, Readability and Tracking of Homeopathic Medicinal Products (Turkish language).

The Guidelines regulate the information and documents that must be submitted in the homeopathic medicinal product registration application and the information that should be provided in the registration application form and principles regarding packaging, tracking and summary of product characteristics.

Licence applications for homeopathic medicinal products will be accepted through the Medicines and Medical Devices Agency's electronic system as of 1 April 2022.

Source: Turkish Medicines and Medical Devices Agency: Guidelines on Homeopathic Medicinal Products (15 March 2022) (Turkish language).

First published by Practical Law Life Sciences Monthly Newsletter in Apr 05, 2022.


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