In order to facilitate the preparation of documentation to be submitted by marketing authorisation holders for the type IA variation procedure for medicinal products registered via the national procedure and minimise submissions of inaccurate documentation, as well as decrease the total time for review of type IA variations, a checklist has been prepared summarising various aspects to be considered before submission of the variation application to the State Agency of Medicines (SAM). The checklist is available on the homepage of SAM, in the section “Industry > Marketing authorization holders > Frequently asked questions (FAQ)”.
Please note that marketing authorisation holders must notify the competent authority regarding type IA or “do and tell” variations to marketing authorisation documentation within 12 months after their implementation (or immediately after implementation in case of IAIN variations), whereas SAM shall adopt a decision regarding the approval, rejection or partial approval of variations within 30 days. Type IA variation procedure does not include a validation phase during which issues related to completion of the variation application could be dealt with, neither does it foresee lengthy correspondence with marketing authorisation holders regarding correction of deficiencies in the documentation justifying the variations.
The checklist includes information regarding preparation and submission of an accurate variation application, as well as information regarding the justifying documentation for frequently proposed type IA variations. The checklist is intended to help with preparation of documentation and should not be submitted to the SAM together with the variation application and justifying documentation.