Belgium
A new web-based eAF (electronic Application Form) from the Product Lifecycle Management Portal (PLM Portal) has been established for variation applications for non-centrally authorised products.
The use of this new web-based eAF is recommended, yet, the current interactive PDF-version for the eAF can still be used with regard to submitting variation applications for medicinal products.
The recommendation of this new web-based eAF is part of a gradual transition towards making the PLM Portal web-based eAF the mandatory method for all human variation applications for products authorised via a DCP (decentralised procedure), MRP (mutual recognition procedure) or NAP (national authorisation procedure).
This form is not intended for centrally authorised products.
There is no exact timeline specified to determine when the PDF-eAFs will be denied, but based on the estimated timeline, this is foreseen at earliest in 2026 (depending on the feedback and optimisation process of the new form).
Please find more information and support links via the FAMHP website:
Variations for human medicines applications: new recommended form | FAMHP
FR: Demandes de modification pour les médicaments à usage humain : nouveau formulaire recommandé | AFMPS