Firms wishing to submit an application for marketing authorisation (MA) of a medicine under the decentralised procedure by choosing Belgium as the reference member state must take into account the new strategy put in place by the FAMHP in order to book a timeslot for this type of file.
FAMHP has published a paper on the implementation strategy for any marketing authorisation of a medicine under the decentralised procedure when Belgium has been chosen as the reference member state.
This document is the result of a broad and transparent communication with the representatives of the relevant stakeholders.
In the past the reservation of timeslots by FAMHP was to be made a year in advance, which was difficult for the industry, which was often obliged to cancel the reservation.
This is why FAMHP has decided to change its instructions in this matter
- to be sure to do the job of allocating resources properly;
- to have a more realistic procedure for applicants regarding the reservation of timeslots for this type of file;
- to ensure a transparent, realistic and credible view of the open timeslots.
Contact : presubmission-HUM@fagg.be