Pre-submission meetings

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.

How to apply for medicines for human use

How to apply for medicines for veterinary use

How to apply for homeopathic and herbal medicines

Last updated on 12/07/2017