Esin / Healthcare & Life Sciences - May 2023

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published the Regulation on the Use of Health Claims for Food and Food Supplements, the Guideline on the Use of Health Claims for Food and Food Supplements, the Regulation on Nuclear Medicine Services, the Regulation on Radiation Oncology and the Regulation on Cosmetic Products. The TİTCK also amended the Regulation on Health Claims of Products Offered for Sale with Health Claims, the Guideline on Procurement of Pharmaceuticals from Abroad, the Regulation on Radiology Services and the Regulation on Private Hospitals.

Regulation and Guideline on the Use of Health Claims for Food and Food Supplements

The TİTCK published the Regulation on the Use of Health Claims for Food and Food Supplements on 20 April 2023 and the Guideline on the Use of Health Claims for Food and Food Supplements on 26 April 2023. The main developments introduced by the Regulation are as follows:

• The Regulation removes the obligation to obtain authorization to use health claims. In this regard, enterprises registered or approved by the Ministry of Agriculture and Forestry can use the health claims in the relevant annexes for the products they manufacture or import without applying for authorization or notifying the TİTCK, provided that they meet the conditions set out in the Regulation. The claims allowed to be used are listed in the annex of the relevant Guideline. In any case, the health claims used in the labeling, promotion or advertisement of food and food supplements must be in a form that the average consumer can understand without causing ambiguity, inaccuracy, misleading, doubt or concern.
• The health claims in the annex of the relevant Guideline can be re-evaluated when deemed necessary for public health, and the health claim can be amended, suspended or canceled according to the results of the evaluation.
• Health claims must not be used for products with the same name as pharmaceuticals, medical devices and food for special medical purposes. The TİTCK can restrict the use of health claims on products with names similar to pharmaceuticals, medical devices and food for special medical purposes.
• Health claims can be used provided that the following information is included on the product label or, in the absence of a label, in the promotion and advertising of the product:
• A claim indicating the importance of a balanced and varied diet and a healthy lifestyle.
• The amount and the method of consumption of the food required to achieve the declared beneficial effect.
• A warning for people who should not consume the food, if necessary.
• A warning for foods that may adversely affect health if consumed in excess.
• The use of the following health claims is prohibited:
• Claims indicating that health may be adversely affected if not consumed.
• Claims referring to the amount or rate of weight loss or gain.
• Claims that include or imply expressions of appreciation, praise, recommendation or approval associated with the experience of the person whose testimony is used in relation to the products for which the health claim is used, or with national and international institutions and organizations.
• Claims relating to disease risk reduction and the development and health of children must include a statement that the disease referred to in the health claim has multiple risk factors and that changing one of these risk factors may or may not have a beneficial effect.
• Health claims cannot be used for beverages containing more than 1.2% alcohol by volume.
• Health claims cannot be used for food for special medical purposes. The Regulation is available here (in Turkish) and the Guideline is available here (in Turkish).

Regulation on Health Claims of Products Offered for Sale with Health Claims

On 20 April 2023, the TİTCK published the Regulation Amending the Regulation on the Health Claims of Products Offered for Sale with Health Claims. In this regard, to ensure compliance with the Regulation on the Use of Health Claims for Food and Food Supplements, the provisions on obtaining health claim authorization have been repealed.

The Regulation is available here (in Turkish).

Guideline on Procurement of Pharmaceuticals from Abroad

On 20 April 2023, the TİTCK updated the Guideline on Procurement of Pharmaceuticals from Abroad. In this regard, the Guideline was amended in accordance with the Regulation on Procurement of Pharmaceuticals from Abroad, which entered into force after being published in the Official Gazette dated 3 February 2023 and numbered 32093. The main amendments introduced by the Guideline are as follows:

• To procure pharmaceuticals that have not yet obtained marketing authorization in Türkiye or that have marketing authorization but are not available on the market for various reasons, for the diagnosis and treatment of diseases from abroad with a prescription for personal use, the patient’s doctor must make an initial pharmaceutical application to the TİTCK.
• The patient’s doctor must apply to the TİTCK via the Electronic Prescription System to request to use pharmaceuticals abroad.
• Applications for bulk procurement of pharmaceuticals in a medical emergency must be made by hospitals. The application must include information on the medical emergency in which the use of the pharmaceutical is foreseen, the name of the active substance to be procured and the foreseen procurement quantity.
• Pharmaceuticals to be procured from abroad must be manufactured within the scope of good manufacturing practices (“GMP”), and their quality, efficacy and safety must be demonstrated by clinical trials conducted in compliance with good clinical practices (“GCP”).
• Foreign pharmaceutical suppliers refer to public institutions and organizations approved by the Ministry, the Social Security Institution and the Turkish Pharmacists’ Association. Applications for pharmaceuticals containing active substances permitted to be supplied by the TİTCK can only be made by foreign pharmaceutical suppliers.
• Foreign pharmaceutical suppliers are obliged to establish and maintain a pharmacovigilance system. In this context, they may delegate their pharmacovigilance activities to a contracted pharmacovigilance service organization.
• The representative is responsible for fulfilling the obligations of the foreign pharmaceutical supply source on its behalf. The authorized representative must be a real or legal person resident in Türkiye. The appointment of a representative requires the issuance of a certificate of authorization and written acceptance by the foreign pharmaceutical supply source. In addition, for pharmaceuticals that have not been granted marketing authorization by the competent pharmaceutical authorities that are founding or permanent members of the International Council for Harmonization (“ICH”), the UK Medicines and Healthcare Products Regulatory Agency (“MHRA”) or the Australian Therapeutic Goods Administration (“TGA”), the representative must be exclusively authorized.

The Guideline is available here (in Turkish).

Regulation on Nuclear Medicine Services, Regulation on Radiation Oncology and Regulation on Radiology Services

On 25 April 2023, the TİTCK published the Regulation on Nuclear Medicine Services, the Regulation on Radiation Oncology and the Regulation Amending the Regulation on Radiology Services. The main amendments introduced by the Regulations are as follows:

• The newly opened nuclear medicine centers and radiation oncology centers can only be established within hospitals.
• Prior to the opening of nuclear medicine centers, radiation oncology centers and radiology centers (“Centers”), the responsible manager must make a preliminary authorization application to the Ministry of Health. An operating authorization certificate must be obtained within 2 years following the receipt of the preliminary authorization certificate. Subsequently, the Centers can be opened based on the operating authorization certificate issued by the Ministry of Health.
• To carry out radiation practices at the Centers, the necessary authorization must be obtained from the Nuclear Regulatory Authority (“NDK”). However, the authorization application cannot be made to NDK without obtaining a preliminary authorization certificate.
• Responsible managers are the primary contact person of the Ministry of Health in all kinds of transactions related to the activities, inspections and evaluations of the Centers.
• In the case of expiration, suspension, restriction, termination or cancellation of the license granted by the NDK, the Provincial Directorate of Health will be informed within 5 working days at the latest. The center’s activities shall be suspended for 3 months. If the center fails to carry out the necessary procedures in accordance with the NDK legislation within this period and fails to obtain a license from the NDK, the relevant unit/device will be removed from the activity permit. The center will continue its activities with its existing units/devices. However, if the license cannot be obtained for all units/devices, the operating license will be revoked by the Ministry of Health.

The Regulation on Nuclear Medicine Services is available here (in Turkish), the Regulation on Radiation Oncology is available here (in Turkish) and the Regulation Amending the Regulation on Radiology Services is available here (in Turkish).

Regulation on Cosmetic Products

On 8 May 2023, the TİTCK published the Regulation on Cosmetic Products. The Regulation has been prepared within the framework of harmonization with the European Union legislation in line with the European Parliament and of Council Regulation (EC) No. 1223/2009 dated 30 November 2009 on cosmetic products. The Regulation will enter into force on 8 November 2023. In addition, the Regulation repealed the Cosmetic Regulation published in the Official Gazette dated 23 May 2005 and numbered 25823. The main developments introduced by the Regulation are as follows:

• Cosmetic products can only be placed on the market if a real or legal person resident in Türkiye is appointed as the responsible person. The responsible person must ensure that the obligations set out in the Regulation are complied with for each cosmetic product placed on the market.
• For cosmetic products manufactured in Türkiye, if the manufacturer is resident in Türkiye, the responsible person will be deemed as the manufacturer itself. If the manufacturer is resident abroad, the person resident in Türkiye authorized by a written agreement will be deemed as the responsible person. On the other hand, the responsible person for imported cosmetic products is the importer. However, the importer can appoint a person resident in Türkiye as the responsible person by authorizing them through a written agreement.
• In cases where the responsible person is authorized and appointed by a written agreement, the liability of the responsible person is the same as the manufacturer or the importer.
• The distributor becomes the responsible person and is legally liable on the same basis as the manufacturer if it places a cosmetic product on the market under its own name or trademark or makes a change to a cosmetic product already placed on the market that can affect its compliance with the applicable requirements.
• Responsible persons are responsible for taking the necessary corrective measures immediately to bring a cosmetic product into a conforming state, withdraw it from the market or recall it if they assess or have reason to believe that a cosmetic product placed on the market does not comply with the Regulation. If the cosmetic product poses a risk to human health, responsible persons must immediately inform the TİTCK, in particular about the noncompliance and any corrective action taken.
• If distributors assess or have reasons to believe that a cosmetic product does not comply with the requirements set out in the Regulation, they must not place the product on the market until it complies with the relevant requirements and must ensure that the necessary corrective measures are taken to bring the product into compliance, withdraw it from the market or recall it in respect of the products they have on the market. In addition, if the cosmetic product poses a risk to human health, distributors must immediately inform the TİTCK and the responsible person, in particular about the noncompliance and any corrective action taken.
• The TİTCK is establishing a national list of common criteria with reference to the common criteria published by the European Commission for claims that may be used on cosmetic products. If the manufacturer or its suppliers have not carried out animal testing on the finished cosmetic product, its prototype or any of its ingredients, or if they have not used any ingredients that have been tested on animals for the purpose of developing a new cosmetic product by others, the responsible person can state that no animal testing has been carried out on the product packaging or on any document, note, label, paper strip or card accompanying or mentioning the product.
• Products placed on the market in accordance with the repealed Cosmetic Regulation can be kept on the market until 8 November 2025.

The Regulation is available here (in Turkish).

Regulation on Private Hospitals

On 13 May 2023, the TİTCK published the Regulation Amending the Regulation on Private Hospitals. The main developments introduced by the Regulation are as follows:

• Hospitals with a high bed capacity in the preliminary authorization certificate for private hospitals can start operating with a capacity of no less than 100 beds to provide services in all areas included in the license issued in accordance with the preliminary authorization certificate. This must be shown in the activity permission certificate. Within 5 years after the commencement of operation, the bed capacity can be increased to reach the capacity specified on the license. At the end of the 5 years, the bed capacity not put into operation will be canceled and the license will be reissued according to the new situation.
• The original work certificate for medical and nonmedical staff must be kept in the personnel file and in the polyclinic room to be presented when necessary.
• In private hospitals, an adequately illuminated and ventilated and at least 16 square meters wide polyclinic examination room must be allocated for the clinical specialties registered in the operating authorization certificate.
• If there is no suitable private health institution to conclude a contract in the city where the doctor’s clinic provides services in the relevant branch due to the limitations and/ or requirements specified in the legislation, a contract can be concluded by obtaining the opinion of the relevant commission established by the Ministry of Health for planning purposes in a possible nearby city.

The Regulation is available here (in Turkish).

Conclusion

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

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