The objective of pre-submission meetings at the FAMHP is to give guidance on the preparation of an application for MA, registration or variation. A request for pre-submission meeting can be asked for procedures related to medicines for human and veterinary use, including homeopathic and herbal medicines.
A pre-submission meeting is highly recommended for:
- the applications for MA through the centralised procedure where Belgium acts as rapporteur or co-rapporteur, even if such a meeting is already organised by the European Medicines Agency (EMA).
- the applications for MA, variations and line-extentions, repeat use or worksharing where Belgium acts as a reference member state through the mutual recognition procedure or decentralised procedure.
The pre-submission meeting is mainly intended to address product-specific legal, regulatory and administrative issues.