The announcement made by the MMDA said that the "Regulation on Variations in Licensed Human Medicinal Products" was prepared in line with current requirements and published in the Official Gazette on December 18, 2021, and that the guidelines regulating the relevant processes in the variations to be made after registration in line with the related EU directive pursuant to developing health and pharmaceuticals technologies was also updated.
The following issues are regulated in the updated Guidelines.
• The presentation of the variations specified as Type IA in the guidelines can be made as “notifications”. Thus, the variation is first implemented, and then, depending on the variation type (normal or direct notification), the Institution can be notified.
• Thanks to the "pre-evaluation" process specified in the legislation for applications, the loss of time in the evaluation of the application will be prevented by checking that the application information and documents are complete before the main evaluation takes place.
• In particular, the quality-related variations and the processes for submitting these variations are detailed, and the conditions and documents required to be submitted by the license holders in the notification/application procedures are specified. The current guidelines elaborate not only on the administrative and quality changes, but also the application and notification processes for the variations relating to medical devices, PMF/VAMF, safety, efficacy and pharmacovigilance, introduced with the new human medicinal product.
• Applications for "diversification" are defined in the new Regulation and the scope of applications for variation is clearly stated under Annex-1 to the Regulation.
Said Guidelines and Form are available via the links below.
For your kind attention.
https://titck.gov.tr/storage/Archive/2021/announcement/VARYASYONKILAVUZU_dee3cf5d-07fb-43be-a37b-95949ed208f1.pdf