Recent Developments in the Healthcare Sector

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The Turkish Pharmaceuticals and Medical Devices Authority (TİTCK) recently published: (i) the Guideline on the License Application for Homeopathic Medicinal Products and Guideline on the Packaging, Homeopathic Medicinal Product Information, Legibility and Tracking of Homeopathic Medicinal Products; (ii) the Guideline on the Implementation of the Regulation on Quality Compliance and Quality Control Tests of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices; and (iii) the Basic Requirements Guideline for COVID- 19 Vaccines’ Risk Management Plans.

Please click on the relevant link below for our specific notes regarding the recent development.

What does the Guideline on the License Application for Homeopathic Medicinal Products and the Guideline on the Packaging, Homeopathic Medicinal Product Information, Legibility and Tracking of Homeopathic Medicinal Products bring?
What does the Guideline on the Implementation of the Regulation on Quality Compliance and Quality Control Tests of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices cover?
What does the Basic Requirements Guideline for COVID- 19 Vaccines’ Risk Management Plans cover?

New development

The Homeopathic Medicinal Products Licensing Regulation (“ Regulation “) was published by the TİTCK on 24 December 2021. On 15 March 2022, the TİTCK published: (1) the Guideline on the License Application for Homeopathic Medicinal Products regarding the documents required in the license application to be submitted within the scope of the Regulation; and (2) the Guideline on the Packaging, Homeopathic Medicinal Product Information, Legibility and Tracking of Homeopathic Medicinal Products, which regulates the procedures and principles regarding the tracking of packaging and medical product information.

The TİTCK will start accepting license applications for homeopathic medicinal products via www.ebs.titck.gov.tr as of 1 April 2022.

The guidelines are available here (in Turkish).

What’s new?

The Guideline on the License Application for Homeopathic Medicinal Products

The guideline aims to provide guidance on the format of the chemical, pharmaceutical, biological and safety documentation in the license application for the homeopathic stock, starting materials of biological origin, and corresponding medicinal products.
The common technical document format consists of four main categories, as follows: (i) administrative information; (ii) general summaries; (iii) requirements on quality; and (iv) requirements on safety. The information content required to be included in each category and are presented end exemplified in the guideline.

The Guideline on the Packaging, Homeopathic Medicinal Product Information, Legibility and Tracking of Homeopathic Medicinal Products

The guideline sets forth the details regarding packaging, product information and legibility of homeopathic medicinal products that are industrially prepared and produced in a traditional or industrial method.
The phrase “Homeopathic Medicinal Product” is required to be clearly and legibly indicated on the packaging of homeopathic medicinal products.
The packaging should include information such as the name of the homeopathic medicinal product subject to the license, stock, pharmaceutical form, and content in terms of weight, volume or number of doses, auxiliary/carrier substances, usage instructions, storage conditions and shelf life, and information on registration and production.
In order to prevent misuse, different colors should be used in packaging to distinguish from similar products while avoiding the use of too many colors to prevent confusion.
The name and potency of the homeopathic medicinal product must be indicated on the outer packaging in braille. While specifying other information in braille is optional, indicating the expiration date is particularly recommended.
The guideline also includes recommendations on the print/font size and type, the layout and design of the information, and colors and expression to ensure legibility and comprehensibility of the information.
License holders are required to register the QR codes of homeopathic medicinal products in the Pharmaceutical Track System (İTS). The İTS will reject inappropriate QR codes that do not fulfill singularity, standards and content set forth by the İTS.
In addition to license holders, pharmaceutical warehouses, companies authorized for export, pharmacies, medical supply centers, and public and private reimbursement institutions that cover the cost of medicines are required to deactivate the product and submit necessary notifications in cases such as purchase, sale, return, cancellation, transfer, expiration, theft or deterioration of the product.
Movement records of: (i) homeopathic medicinal products will be made via QR code; and (ii) those of stakeholders will be made via Global Location Number.
License holders who dispatch more than one homeopathic medicinal product are required to use transport packages to ensure the reliability. Packaging identifier or an identifier including the QR code information of the products must be displayed on the transport package.

What does the Guideline on the Implementation of the Regulation on Quality Compliance and Quality Control Tests of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices cover?

New development

On 24 March 2022, the TİTCK published the Guideline on the Implementation of the Regulation on Quality Compliance and Quality Control Tests of Diagnostic Radiology, Nuclear Medicine and Radiotherapy Group Medical Devices (“ Regulation “). The guideline sets forth procedures and principles regarding the implementation of the Regulation.

The guideline is available here (in Turkish).

What’s new?

According to the Regulation, those who wish to obtain a working certificate on quality control of diagnostic radiology, nuclear medicine and radiotherapy group medical devices are required to apply for a medical physicist working certificate. The applications should be submitted to the TİTCK along with the information and documents set forth in the transitionary provisions under the guideline within 24 months from the publication (23 December 2021) of the Regulation, i.e., by 23 December 2023. Those who wish to obtain a medical physicist working certificate in order to perform quality control tests can also apply to the TİTCK by submitting the information and documents provided in the guideline.

What does the Basic Requirements Guideline for COVID- 19 Vaccines’ Risk Management Plans cover?

New development

The Basic Requirements Guideline for COVID- 19 Vaccines’ Risk Management Plans, published on 24 March 2022 as an addition to the Good Pharmacovigilance Practices (IFU) Guideline Module VI – Risk Management Systems dated 24 June 2015, entered into force on 23 March 2022. The guideline aims to provide post-marketing tracking of COVID-19 vaccines and prepare risk management plans.

The guideline is available here (in Turkish).

What’s new?

The risk management plan should include general information, safety specification, and pharmacovigilance plan, including post-registration safety studies, risk minimization measures including evaluation of the effectiveness of risk minimization activities, and a summary of risk management activities.

An example list of issues that should be taken into consideration in creating a summary safety report (SSR) application is also available under the guideline.

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.