New Health Law Guidelines and Proposed Regulations

The Turkish Pharmaceuticals and Medical Devices Authority (“TITCK“) recently released the Allergen Product Licensing Guideline, Good Clinical Practice Inspection Application Guideline, and Draft Regulations on the Use of Health Claims.

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

What does the Licensing Guideline mean? introduced allergenic products?

What does the Good Clinical Practice Inspection Application Guideline introduce?

Draft regulations on the use of health claims have been published

What does the Licensing Guideline mean? introduced allergenic products?

New development

In the Guideline on Licensing of Allergenic Products (“Guideline“) published on March 9, 2022, the TİTCK has defined the procedures and principles concerning the simplified conditions for the authorization of industrial allergen products used for diagnosis and treatment. The guideline is available here (In Turkey).

What’s new?

In accordance with the guideline which defines terms such as allergens, allergic diseases and allergenic products and sets out their basic characteristics, a separate license application must be submitted for each allergenic product. When applying for a license, brief product information, instructions for use, and allergen product packaging information should be prepared in accordance with the Medicines Licensing Regulations, packaging, manuals and monitoring of medicines for human use and other relevant guidelines. The quality data is prepared in accordance with European and Turkish Pharmacopoeia “Allergen Products” monographs and European Medicines Agency “Allergen Products Guideline: Production and Quality Issues”.

Licensee shall notify TİTCK of variations of the licensed allergen product in accordance with applicable regulations and guidelines. In addition, the holder of the license/temporary permit must apply to TİTCK and obtain a permit to offer allergenic products with a license or temporary permit for sale in the market.

Allergenic products produced and offered for sale on the European Union market may be offered for sale on the Turkish market if they meet the conditions set out in the guideline until December 31, 2024. The temporary authorization of products for which the authorization process has not been completed or whose license application has been rejected by this date will be canceled and their placing on the market will be interrupted. Resubmitted temporary permit applications for products whose applications have been rejected will not be assessed by TİTCK.

What does the Good Clinical Practice Inspection Application Guideline introduce?

New development

In the Directive on the Application for Good Clinical Practice Inspection (“Guideline“) published on March 8, 2022, the TİTCK has defined the processes regarding applications to be submitted to the Vice Presidency of Inspection Services for Good Clinical Practice Inspection. The guideline is available here (In Turkey).

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 carried out regularly at these centres, at BA/BE centers operating abroad and at auxiliary and/or contracted research institutions, upon request.

The above-mentioned inspection requests can be submitted to TİTCK electronically through the Electronic Request System (EBS) in accordance with the instructions specified in the Directive. EBS entries can be submitted on the website of the Electronic Application and Process Management System (EBS-ESY) (titck.gov.tr).

Draft regulations on the use of health claims have been published

New development

On March 8, 2022, the TİTCK published the Draft Regulations on the Use of Health Claims (“Draft regulation“). The proposed regulations set out the procedures and principles regarding the authorization process and the use of health claims. The proposed regulations repeal the Health Claims Regulations for Products Offered for Sale with Health Claims. The Notices on the draft regulations can be submitted via [email protected] until April 1, 2022. The draft regulations are available here (In Turkey).

What’s new?

According to the draft regulations, health claims cannot be used for products other than foods and supplements, and products that have the same or similar name as the products authorized or authorized by the TİTCK by specifying the indication or purpose of use. Health claims for foods and supplements must: (i) not be vague, inaccurate or misleading; (ii) not to question the suitability or safety of other products; (iii) not to promote or encourage excessive consumption of any particular food; and (iv) not scare consumers by referring to changes in bodily functions by written, visual or symbolic representations.

The fact that the disease referred to has multiple risk factors and that modifying one of these risk factors may or may not have a beneficial effect must be indicated on labels, presentations and advertisements which include statements about the growth and health of children and reducing the risk of disease. Health claims other than those concerning the reduction of 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 characteristics of foodstuffs and food supplements on which health claims may be used. The health claims set out in the annexes of the Guide to the Use of Health Claims may be used without submitting applications or notifications to the TİTCK, provided that the foodstuffs and dietary supplements are produced by companies registered or approved by the TİTCK. Ministry of Agriculture and Agriculture. Forestry.

Persons who wish to use a health claim which is not listed in the annexes of the Guide to the Use of Health Claims may submit their applications to TİTCK electronically with the information and documents provided for in the draft regulations and in accordance with the new guide. application of health claims. .

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 TİTCK for: (i) compliance of the food or complementary food with legislation; (ii) respond to TİTCK’s requests in a timely manner; and (iii) comply with the regulations stipulated in the Turkish Food Codex regarding products bearing health claims.

Conclusion

The TİTCK continues to provide guidance to companies working in the healthcare sector. Businesses should carefully review TİTCK announcements and guidelines and take necessary steps to ensure compliance.

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RECENT DEVELOPMENTS

Amendments to Communiqué on Debt Securities No. VII-128.8 (”Debt Securities Release”) and the Communiqué on Asset-Backed and Mortgage-Backed Securities No. III-58.1 (”abs Communicated”) entered into force by its publication in the Official Journal n° 31154 of June 13, 2020.

The Amendments are consistent with the amendments made in the Covered Bonds Communiqué No. III-59.1 dated May 14, 2020 (Changes to the Covered Bonds Communiqué), which reflects the approach defined by the 11th development plan for 2019-2023 and the annual program of the presidency for 2020 for the issues carried out by mortgage credit institutions (“MFI”).

What’s new?

Emission ceilings

  • The issue ceiling provided for in the Debt Securities Communiqué will not apply to debt securities issued by MFIs.
  • The limits applicable for the calculation of the issue cap under the ABS Communiqué will not be applicable to asset-backed and mortgage-backed securities (“abs” and “MBSrespectively) issued by MFIs or funds established by MFIs.

CMB fee rate

  • The Capital Markets Council (“CMB”) the commission rates indicated in the Debt Securities Announcement will be zero until 31 December 2021 for issues of debt securities to be made by MFIs. Effective January 1, 2022, half of the CMB commission rates set out in the Debt News Release will apply to such issues.
  • In the case of issues of ABS and MBS to be made by MFIs, half of the CMB commission rates set out in the ABS announcement will apply. However, CMB fee rates will be applied at zero per thousand until December 31, 2021.

Conclusion

Considering the potential economic effects of the COVID-19 outbreak, the CMB is reducing MFI issuance costs and raising the cap to further incentivize their issuance. In this regard, while the CMB invites MFIs to play a more active role in vulnerable economic conditions, it also provides them with a functional support mechanism through the aforementioned exemptions.

The content is provided for educational and informational purposes only and is not intended and should not be construed as legal advice. This may qualify as “lawyer advertising” requiring notice in some jurisdictions. Prior results do not guarantee similar results. For more information, please visit: www.bakermckenzie.com/en/disclaimers.

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