The Turkish Medicines and Medical Devices Agency (‘’TMMDA’’) has published various guidelines on its website in the last two weeks and also announced that some of the guidelines have been revised.
The relevant guidelines and the issues regulated by these guidelines and the changes made are as follows:
Guideline on Procurement of Pharmaceuticals from Abroad
On 29.09.2023, it was announced that the Guideline on Supply of Medicines from Abroad was revised. In this context, the changes made in line with the revises are as follows:
- The duties and authorities of the Pharmaceutical Procurement Planning Commission have been transferred to the Pharmaceutical Procurement Planning Board.
- In the first drug applications to be made to the TMMDA, it is now required to submit ‘’a reasoned decision of a council consisting of at least 3 specialist doctors regarding the primary disease of the patient’’.
- It is regulated that the authorization documents issued by the manufacturers/marketing authorization holders of medicinal products for human use or by the companies licensed regionally or globally by the marketing authorization holders should be wet signed/electronically signed. In addition, it is stated that the relevant authorization documents should include the contact e-mail address of the authorized person of the company issuing the authorization. In this framework, it is regulated that authorization documents with wet signature/electronic signature should be submitted to the TMMDA until 31.12.2023.
- While the former Guideline provision stipulating that the reference medicine to be used within the scope of the research in clinical trials conducted in our country, especially at the phase 3 level, can be procured by foreign pharmaceutical suppliers covered ‘’biotechnological/biosimilar’’ product development studies, with the new amendment,, the researches covered by this provision have been revised as researches related to the development of ‘’medicinal products for human use’’.
- ‘’Informed Patient Consent Form for Drugs to be Procured from Abroad’’ and ‘’Authorization Certificate’’ and ‘’Declaration’’ documents to be submitted by marketing authorization holders have been added to the annexes of the Guideline.
Guideline on Excipients in the Packaging Information and Instructions for Use of Medicinal Products for Human Use
On 06.10.2023, it was announced that three different guidelines on the packaging information and instructions for use of medicinal products for human use were updated.. These Guidelines are as follows:
- Guideline on Packaging Information and Instructions for Use of Medicinal Products for Human Use
- Guideline on the Readability of Packaging Information and Instructions for Use of Medicinal Products for Human Use
Guideline on Excipients in the Packaging Information and Instructions for Use of Medicinal Products for Human Use
With the aforesaid revises, the information required to be included on the packaging of medicinal products for human use that have been authorized or for which an application for authorization has been made and how the information should be stated have been clarified.
Guideline on the Cases Requiring Re-authorization for Licensed Medicinal Products for Human Use
Published on 10.10.2023, this Guideline sets out the principles and details regarding the procedures for the transfer of marketing authorization, issuance of lost marketing authorization and transition to certified marketing authorization for licensed medicinal products for human use. In addition, the annex of the Guideline includes a table of information on transition to certified marketing authorization and information on lost marketing authorization.
TCOKKA – Guideline Determining Common Specification for Non-Medical Product Groups Listed in Annex XVI of the Medical Device Regulation
In another announcement published on 10.10.2023, it was declared that some amendments were made to the Guideline Determining Common Specifications for Non-Medical Product Groups listed in Annex XVI of the Medical Device Regulation. With the transition provisions of the mentioned Guideline; compliance with the European Union (‘’EU’’) legislation has been ensured in parallel to the Commission Implementing Regulation No. 2023/1194.
Guidelines on the Working Procedures and Principles of the Priority Evaluation Board for Medicinal Products for Human Use
On 12.10.2023, it was announced that this Guideline was updated and the procedures and principles regarding the work of the Priority Evaluation Board for Medicinal Products for Human Use established within the TMMDA were determined with this update. The prioritization application request form is included in the annex of the Guideline.
Guidelines on the Scheduling Processes of Marketing Authorization Applications for Medicinal Products for Human Use
Finally, with the announcement dated 12.10.2023, it was declared that amendments were made to this Guideline. In this context, it has been explained how the scheduling processes will be carried out for the applications whose preliminary evaluation is deemed appropriate by the TMMDA for marketing authorization applications for medicinal products for human use.