In accordance with Article 15, paragraph 2 of Administrative Instruction (Health) No. 01/2024 on Variations of Medicinal Products, it is stipulated that the Guideline and the application are updated by AKPPM, while access to these documents is provided through the official website of AKPPM.
Referring to the interpretation provided by the Legal Office of the Ministry of Health, AKPPM is authorized to update the Guideline and the respective application without the need to amend or supplement Administrative Instruction (Health) No. 01/2024 itself, provided that such updates are published on the official website of AKPPM.
The latest updates at EU level (http://data.europa.eu/eli/C/2025/5045/oj) include changes to the structure of variation codes, renaming of chapters (e.g. from “B” to “Q” for quality changes), as well as the addition of new classification codes. These changes directly affect the way variations are submitted and assessed by applicants.
For more details, please find the attached document.
We also inform you that AKPPM currently does not have a contract for the development and maintenance of the application on the digital platform. For this reason, in order to avoid delays in submissions, the application process will continue to be carried out in the current system until its full update.
Furthermore, in order to facilitate the alignment of the new variation categories with the existing ones, please find the attached reference table.
For variations approved under the new categories in the European Union, it is required that, during submission, the appropriate variation type be clearly specified in the “Price Scope” section.