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Legal Alerts
09/06/2022

Recent Developments in the Healthcare Sector – 24 September 2021

Legal Alerts
Healthcare
Healthcare & Life Sciences

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The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK“) has published announcements on the amendments to the regulation on cosmetic products, licensing homeopathic medical products and free promotional samples and press release.

Please click on the relevant link below for our specific notes regarding recent developments:

Amendment to the Regulation on Cosmetic Products
The Draft Regulation on Licensing Homeopathic Medicinal Products is Published
New Rules Concerning the Distribution of Free Promotional Samples and Press Release

Amendment to the Regulation on Cosmetic Products

Recent Development

The Regulation concerning the Amendment to the Regulation on Cosmetic Products (“Regulation“) was published in the Official Gazette No. 31592 (Additional Issue) on 8 September 2021. The relevant amendment regulates various changes to the lists of substances that are used in cosmetic products. The relevant amendment is available here (in Turkish).

What’s New?

The following lists within the annexes of the Regulation are extended:

  • List of Prohibited Substances in Cosmetic Products
  • List of Substances that must not be Contained in Cosmetic Products Except for Certain Restrictions
  • List of Colorant Substances Allowed for Use in Cosmetic Products
  • List of Preservative Substances Allowed for Use in Cosmetic Products
  • List of UV Filters Allowed for Use in Cosmetic Products

The Draft Regulation on Licensing Homeopathic Medicinal Products is Published

Recent Development

The TİTCK published the Draft Regulation on Licensing Homeopathic Medicinal Products (“Draft Regulation“) on 9 September 2021. The Draft Regulation addresses the licensing process to ensure that homeopathic medicinal products have the required efficacy, safety and quality. The Draft Regulation will be open to public consultation until 20 September 2021. The Draft Regulation is available here (in Turkish).

What’s New?

The Draft Regulation foresees the obligatory licensing of homeopathic medicinal products.

The Draft Regulation forecasts that TİTCK will only evaluate the registration applications for homeopathic medicinal products that meet the following criteria:

  • The product must only be used orally or externally.
  • The packaging or other parts of the product must not indicate specific therapeutic indication.
  • The product must be diluted to ensure the safety of the medicinal product.

The Draft Regulation details steps to be taken during the application process along with the necessary information and documents. In addition, subjects such as the mandatory elements in the outer and inner packaging of homeopathic medicinal products and the content of the prospectus are regulated in detail.

The license is valid indefinitely. However, the TİTCK may exceptionally decide to limit the duration of the license to a certain time. The license owner must also request a sales permit from the TİTCK prior to placing the homeopathic medicinal products on the market for the first time. However, it is not necessary to obtain a sale permit for transactions that cause changes in the packaging information, specifications or prospectus of the product. The license owner is also responsible for producing the product under accepted conditions, updating the prospectus if necessary for correct and safe use, responding to the issues requested by the TİTCK in a timely manner and ensuring the availability of the product in the market.

In case of the non-fulfilment of the licensing obligations, the Draft Regulation sets forth the suspension and cancellation of the license as a sanction. The list of sanctioned homeopathic medicinal products will be published on the TİTCK’s website.

The promotion of homeopathic medicinal products is subject to the Regulation on Promotional Activities of Medicinal Products for Human Use.

New Rules Concerning the Distribution of Free Promotional Samples and Press Release

Recent Development

The TİTCK updated the Guideline on the Application for Distribution of the Free Promotional Sample and Press Release (“Guideline“) on 3 September 2021. The update brings new definitions along with certain amendments to the conditions of application for free promotional samples. The Guideline is available here (in Turkish).

What’s New?

A number of new definitions such as free promotional samples, demo device, Drug Tracking System (İTS in Turkish) have been added to the Guideline. Additionally, a number of changes to the application conditions of free promotional samples have been introduced. Accordingly, the license/permit owner of the product that will be promoted is obliged the make a free promotional sample production notification through İTS. After that, the notified free promotional sample may be provided to the healthcare professional. However, a distribution notification must be made within 60 days at the latest from the date the free promotional sample is provided. Moreover, the list of documents to be submitted during the free promotional sample application is extended.

Conclusion

The TİTCK continues to provide guidance for companies working in the healthcare industry. Companies should carefully review the TİTCK’s announcements and take the necessary actions to ensure compliance.