Esin / Healthcare & Life Sciences Newsletter - September 2023

The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK”) recently published the Guideline on Scientific Advice for Pharmaceuticals. The TİTCK also amended (i) the Regulation on Pharmacists and Pharmacies, (ii) the Regulation on Bespoke Prosthetic and Orthotic Centers and Hearing Aid Centers, (iii) the Regulation on Opticianry Establishments, (iv) the Guideline on Scientific Meetings and Educational Activities to be Held within the Scope of the Regulation on Sale, Advertising and Promotion of Medical Devices, and (v) the Regulation on the Use of Health Claims for Food and Food Supplements. It also announced the Second Quarter Results on Market Surveillance and Inspection of Cosmetics and Biocidal Products as well as the Second Quarter Results for 2015 on Market Surveillance and Inspection of Cosmetic and Medical Devices.

Second Quarter Results on Market Surveillance and Inspection of Cosmetics and Biocidal Products

On 9 August 2023, the TİTCK announced the results of its cosmetics sector market surveillance and inspection conducted in April, May and June 2023.

Of the 254 cosmetic products inspected by the TİTCK’s Cosmetics Supervision Department, 247 were unsafe. The responsible companies were subject to an overall administrative fine of TRY 249,957 (approximately USD 9,199).

Of the 18 type 1 and type 19 biocidal products inspected by the TİTCK’s Cosmetics Supervision Department, 1 was unlicensed and 6 were unsafe. The responsible companies were subject to an overall administrative fine of TRY 408,600 (approximately USD 15,037).

The 2023 second quarter results for cosmetic products are available here (in Turkish).

The type 1 and type 19 biocidal products’ second quarter results for 2023 are available here (in Turkish).

What Do the Results Say?

The cosmetic products’ safety results reveal that there has been an increase in the number of inspected products and noncompliant products. However, the total amount of administrative fines has decreased compared to the results for the first quarter of 2023.

The type 1 and type 19 biocidal products’ safety results reveal that the number of inspected and unsafe products has increased, while the number of unlicensed products has decreased. Accordingly, there is also a significant decrease in the total amount of administrative fines.

Exceptions that may be made by the TİTCK for Serious Public Health Problems

On 18 August 2023, the TİTCK published (a) the Regulation Amending the Regulation on Pharmacists and Pharmacies, (b) the Regulation Amending the Regulation on Bespoke Prosthetic and Orthotic Centers and Hearing Aid Centers, and (c) the Regulation Amending the Regulation on Opticianry Establishments.

In this regard, the TİTCK can temporarily exempt pharmacies, bespoke prosthesis centers, orthotic centers, hearing aid centers, opticianry establishments — and their advertising or promotional activities in cases of pandemics, biological threats recognized by the World Health Organization or the European Union or accepted by the Ministry of Health, natural disasters such as earthquakes, floods, fires, or serious public health problems that stop or interrupt the normal life and activities of the whole or certain segments of the society.

The Regulation Amending the Regulation on Pharmacists and Pharmacies is available here (in Turkish); the Regulation Amending the Regulation on Bespoke Prosthetic and Orthotic Centers and Hearing Aid Centers is available here (in Turkish); the Regulation Amending the Regulation on Opticianry Establishments is available here (in Turkish).

Guideline on Scientific Meetings and Educational Activities to be Held within the Scope of the Regulation on Sale, Advertising and Promotion of Medical Devices

On 22 August 2023, the TİTCK updated the Guideline on Scientific Meetings and Educational Activities to be Held within the Scope of the Regulation on Sale, Advertising and Promotion of Medical Devices. The main amendments introduced by the Guideline are as follows:

• Images of the registration screens for the registration processes to be made to the TİTCK have been added to the guideline.
• In phased meetings, the audience for each phase of the meeting must consist of the same people. All phases of the meeting attended by these audiences shall be considered as a participation support.
• All phased meetings cannot exceed one year from the date of the first notification of registration in the Electronic Submission System (“ESS”). For phases exceeding one year, a new meeting registration must be submitted.
• The initial registration of all phases of the phased meeting must be submitted through the ESS by the end of the last day on which the first phase of the meeting is organized.
• If the audience registered by the sales center decides not to participate in the meeting, they must cancel their participation registration until the end of the last day of the meeting. Otherwise, the audience’s right to participate in the meeting shall be deducted even if they cannot attend the meeting.

The Guideline is available here (in Turkish).

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

On 23 August 2023, the TİTCK published the Regulation Amending the Regulation on the Use of Health Claims for Food and Food Supplements. The main amendments introduced by the Regulations are as follows:

• Health claims that are not included in the annexes of the guideline published by the TİTCK must not be used in the products.
• Products manufactured before 20 April 2023 but not placed on the market or contracted to be manufactured and for which a health claim is used in accordance with the repealed Regulation on Turkish Food Codex Nutrition and Health Claims, but which do not meet the conditions specified in the Regulation on the Use of Health Claims for Food and Food Supplements and the Guideline on the Use of Health Claims for Food and Food Supplements, can be placed on the market with a health claim on the label in accordance with the repealed Regulation on Turkish Food Codex Nutrition and Health Claims within one year from 20 April 2023, and the relevant health claim can be used until 31 December 2024.

The Regulation is available here (in Turkish).

Second Quarter Results for 2015 on Market Surveillance and Inspection of Cosmetic and Medical Devices

On 9 September 2023, the TİTCK announced the results of market surveillance and inspection of cosmetics and medical devices conducted in April, May and June 2015.

Of the 877 products inspected by the TİTCK, 211 were noncompliant and 30 were unsafe. The responsible companies were subject to an overall administrative fine of TRY 846,935 (approximately USD 31,169).

The 2015 second quarter results for cosmetic products and medical devices are available here (in Turkish).

Guideline on Scientific Advice for Pharmaceuticals

On 15 September 2023, the TİTCK published the Guideline on Scientific Advice for Pharmaceuticals. The Guideline sets out the procedures and principles regarding the TİTCK’s scientific advice on pharmaceuticals for which a marketing authorization application is planned, are in the process of marketing authorization, or which already have marketing authorization. The main developments introduced by the Guideline are as follows:

• “Scientific advice” is the TİTCK’s advice to the applicant on appropriate tests and studies to support the efficacy, safety and quality of a pharmaceutical. However, scientific advice is not considered as a reduction of the applicant’s responsibility during the development of the product or as a preliminary assessment of the data to be submitted during the marketing authorization application. Scientific advice is developed for applicants to submit different development projects to the TİTCK and to receive advice accordingly.
• Advice are given in light of current scientific knowledge and based on the documentation provided by the applicant. However, scientific advice will not be legally binding on the TİTCK or the applicant in relation to future applications, as circumstances may change and alternative approaches to those recommended may become appropriate.
• Scientific advice may be requested at any stage of a product’s development, including post-authorization. The TİTCK has the right to accept or reject requests.
• Applications for scientific advice must be submitted to the TİTCK with an official letter. Applications must include a cover letter, application form, additional documents and participant list.
• The TİTCK shall evaluate the applications within 30 days and notify the applicant in an official letter whether the request is accepted or not. The TİTCK shall respond to complete applications within 90 days.
• If deemed necessary by the TİTCK during the evaluation, a face-to- face or online scientific advice meeting can be held within 90 days after the applicant is notified. A summary report must be prepared at the end of the scientific advice meeting.
• Scientific advice given by the TİTCK for a pharmaceutical is considered confidential. Scientific advice must not be shared with the public or other applicants before and during the evaluation of a marketing authorization application, as well as after the marketing authorization has been granted.

The Guideline is available here (in Turkish).

Conclusion

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