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New Guidelines and Draft Regulation in Healthcare Law

Legal Alerts
Healthcare
Healthcare & Life Sciences

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The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK“) recently published the Guideline on Licensing of Allergen Products , the Guideline on the Application for Inspection of Good Clinical Practice and the Draft Regulation on the Use of Health Claims.

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

What does the Guideline on Licensing of Allergen Products introduce?
What does the Guideline on the Application for Inspection of Good Clinical Practice introduce?
The Draft Regulation on the Use of Health Claims has been published

What does the Guideline on Licensing of Allergen Products introduce?

New Development

In the Guideline on Licensing of Allergen Products (“Guideline“) published on 9 March 2022, the TİTCK set forth the procedures and principles regarding the simplified licensing conditions of industrial allergen products that are used for diagnosis and treatment. The Guideline is available here (in Turkish).

What’s New?

As per the Guideline which defines terms such as allergens, allergic diseases and allergen products and sets forth their basic characteristics, a separate license application must be submitted for each allergen product. During the license application, brief product information, instructions for use and packaging information about the allergen product should be prepared in accordance with the Regulation on Licensing of Medicinal Products, the Regulation on Package Information, Manuals and Tracking of Medicinal Products for Human Use and other relevant guidelines. Quality data is prepared in accordance with the “Allergen products” monographs of the European and Turkish Pharmacopoeias and the European Medicines Agency’s Committee for Medicinal Products for Human Use’s “Allergen Products Guideline: Production and Quality Issues.”

The license holder should notify the TİTCK regarding the variations in the licensed allergen product in accordance with the relevant regulations and guidelines. In addition, the license/temporary permit holder must apply to the TİTCK and obtain a permit to offer allergen products with a license or temporary permit for sale in the market.

Allergen products produced and offered for sale in the market of the European Union can be offered for sale on the Turkish market upon fulfilling the requirements set forth in the Guideline until 31 December 2024. The temporary permit of products whose licensing process is not completed or whose license application is rejected by this date will be canceled and their market placement will be ceased. Resubmitted temporary permit applications for products whose applications were rejected will not be evaluated by the TİTCK.

What does the Guideline on the Application for Inspection of Good Clinical Practice introduce?

New Development

In the Guideline on the Application for Inspection of Good Clinical Practice (“Guideline“) published on 8 March 2022, the TİTCK set forth the processes regarding applications to be submitted to the Vice Presidency of Inspection Services for the inspection of good clinical practice. The Guideline is available here (in Turkish).

What’s New?

Phase 1 clinical trials and bioavailability/Bioequivalence (BA/BE) studies are conducted in health institutions, organizations and research and development centers affiliated with the Ministry of Health or universities approved by the TİTCK. Inspections will be routinely conducted at these centers, at BA/BE centers operating abroad and at supporting and/or contracted research institutions, upon request.

The aforementioned inspection applications can be submitted to the TİTCK electronically through the electronic application system (EBS) in line with the directions specified under the Guideline. EBS registrations can be submitted on the website of the Electronic Application and Process Management System (EBS-ESY) (titck.gov.tr).

The Draft Regulation on the Use of Health Claims has been published

New Development

On 8 March 2022, the TİTCK published the Draft Regulation on the Use of Health Claims (“Draft Regulation“). The Draft Regulation sets forth the procedures and principles regarding the permit process and use of health claims. The Draft Regulation repeals the Regulation on Health Claims of Products Offered for Sale With Health Claims. Opinions on the Draft Regulation can be submitted via bdud.saglikbeyani@titck.gov.tr ​​until 1 April 2022. The Draft Regulation is available here (in Turkish).

What’s New?

As per the Draft Regulation, health claims cannot be used for products other than food and supplements, and products that have the same name or a similar name as the products licensed or permitted by the TİTCK by specifying the indication or purpose of use. Health claims for food and supplements are required: (i) not to be vague, inaccurate or misleading; (ii) not to cast doubt on the adequacy or safety of other products; (iii) not to promote or encourage the excessive consumption of a particular food; and (iv) not to cause fear in the consumers by referring to changes in body functions with written, visual or symbolic representations.

The fact that the disease referred to has multiple risk factors and that changing one of these risk factors may or may not have a beneficial effect should be stated on the labels, presentations and advertisements that include statements about the growth and health of children and reducing the risk of a disease. Health claims other than those on the reduction of a disease risk and the growth and health of children should be based on generally accepted scientific evidence, newly developed scientific evidence or protected proprietary data.

The Draft Regulation regulates the features of the food and supplementary foods on which health claims can be used. The health claims set forth in the annexes of the Health Claim User Guide can be used without submitting any applications or notifications to the TİTCK, provided that the food and supplementary foods are produced by companies that are registered to or approved by the Ministry of Agriculture and Forestry.

Those who want to use a health claim that is not included in the annexes of the Health Claim User Guide can submit their applications to the TİTCK electronically with the information and documents set forth under the Draft Regulation and in accordance with the New Health Claim Application Guide.

The use of a health claim in a product will not reduce the legal and criminal liability of the product owner. Product owners are responsible to the TİTCK for: (i) the compliance of the food or supplementary food with the legislation; (ii) responding to the requests of the TİTCK within the specified time; and (iii) complying with the regulations stipulated under the Turkish Food Codex regarding the products with health claims.

Conclusion

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