Turkish Medicines and Medical Devices Agency (“TMMDA”) has published five new guidelines and one draft regulation on its website in recent days. Summaries regarding the relevant legislation and their content are provided below respectively.
Guideline on the Application for Inspection of Good Clinical Practice
Guideline on the Application for Inspection of Good Clinical Practice, which has been introduced to define issues regarding the applications that will be submitted to TMMDA Inspection Services Vice Presidency within the scope of inspection of good clinical practice and relevant processes, has been published on TMMDA’s web site on 8 March 2022.
In general, it has been stated in the Guideline on the Application for Inspection of Good Clinical Practice that Phase 1 clinical trials and bioavailability/Bioequivalence (BA/BE) studies will be conducted in health institutions, organizations and research and development centers affiliated with the Ministry of Health or universities approved by the TMMDA. Besides, it has also been regulated that inspections of these centers will be conducted within the scope of routine inspection and inspections of the BA/BE centers operating abroad and supportive inspections and/or inspections of Contracted Research Organizations will be conducted upon request.
Draft Regulation Regarding the Use of Health Claims
Draft Regulation Regarding the Use of Health Claims (“Draft Regulation”), which has been introduced to regulate new health claim permission processes and procedures and principles regarding the use of health claims in products, has been published on TMMDA’s website on 8 March 2022. After taking effect, the Draft Regulation will repeal Regulation on Health Claims of Products Offered for Sale with Health Claims.
Parties wishing to submit opinions regarding the Draft Regulation may fill in the form provided below and submit it to bdud.saglikbeyani@titck.gov.tr e-mail address until 1 April 2022:
Guideline on Licensing of Allergen Products
Guideline on Licensing of Allergen Products, which regulates the procedures and principles regarding the simplified licensing conditions of allergen products used for the purposes of diagnosis and treatment has been published on TMMDA’s website on 9 March 2022.
Issues such as allergen diseases and products, types of licensing applications, documents needed for application, and process and transactions after the licensing have been regulated by the Guideline on Licensing of Allergen Products.
Moreover, it has also been regulated that allergen products which are produced in any of the European Union member states and currently found in the market in European Member states can be released to the market until 31 December 2024 on the condition that some requirements will be satisfied.
Guidelines on Homeopathic Medicinal Products
As is known, Regulation on Licensing of Homeopathic Medicinal Products has been published in the Official Gazette dated 24.12.2021 and numbered 31699. Guideline on License Applications of Homeopathic Medicinal Products and Guideline on Packaging, Product Information, Readability and Follow-up of Homeopathic Medicinal Products, which have been prepared accordingly, have been published on the TMMDA’s website on 15 March 2022.
Licensing applications for homeopathic medicinal products will be started to be accepted as of 1 April 2022 through www.ebs.titck.gov.tr within the scope of the mentioned legislation.
- Guideline on License Applications of Homeopathic Medicinal Products
By the Guideline on License Applications of Homeopathic Medicinal Products, information and documents required to be submitted for the homeopathic medicinal product license application and information regarding the license application form have been regulated. Documents required to be included in the license application file as per the Regulation on Licensing of Homeopathic Medicinal Products will be submitted to TMMDA in accordance with the requirements provided in the Guideline on License Applications of Homeopathic Medicinal Products.
- Guideline on Packaging, Product Information, Readability and Follow-up of Homeopathic Medicinal Products
With this Guideline, procedures and principles of transactions that will be made for the license applications in terms of the package, homeopathic medicinal product information, readability and follow-up have been determined.
TMMDA Guideline on Communication Cooperation and Information Sharing
Lastly, TMMDA Guideline on Communication Cooperation and Information Sharing has been published on TMMDA’s website on 15 March 2022. Relevant Guideline has been prepared to guide information publicly shared regarding the regulatory and supervisory activities carried out by TMMDA, cooperated external stakeholders, any kind of application, contact and other communication activities that fall into the activity field of TMMDA.
Conclusion
It is seen that TMMDA has published many guidelines and introduced legislation in order to make framework legislation more understandable, to make practice issues clear and to guide companies operating in the sector.
We believe that companies operating the sector must closely follow the relevant guidelines and legislation, be aware of the rights and obligations brought by these and ensure compliance of their business processes with these.