Please send your questions to one single email address at the FAMHP.

If you don’t know which service is competent, send your question to the general email address of the FAMHP: welcome@fagg-afmps.be.
Your question will be forwarded to the competent department.

Type of question

comm@fagg-afmps.be
0032 2 528 40 12

Spokesperson (Ann Eeckhout)
0032 495 23 71 69

Type of question

Applications for Scientific-Technical and regulatory advice (WTA)

Applications for advice on the regulatory status of a borderline product

Questions about (pre)clinical research and development of new drugs, therapies and innovative technologies

Questions about a Marketing Authorisation for a medicine for human use

Applications for new authorisations (centralised procedure, national procedure and mutual or decentralised recognition procedure (MRP or DCP))

Applications for variations and renewals

prelicensing@fagg-afmps.be

postlicensing@fagg-afmps.be

Questions about distribution activities of Active Pharmaceutical Ingredients or medicines

Questions about inspections of manufacturers of medicines, raw materials of Active Pharmaceutical Ingredients and about Good Manufacturing Practices (GMP)

Questions about inspections of clinical trial stakeholders (sponsors, CRO, Ethics Committees, phase 1 centres, research sites, etc.) and Good Clinical Practices (GCP)

Questions on accreditation of qualified persons, market surveillance and quality issues

Questions about pharmacovigilance inspections and the tasks and responsibilities of the marketing authorisation holder for a medicine

Questions about veterinary medicines including questions on

• marketing authorisations;
• parallel imports;
• clinical trials;
• publicity and promotion;
• distribution.

• requests for Project Information Meetings where research is informally presented at an early stage
• requests for Portfolio Meetings
• questions about research and development of new medicines, treatments and innovative technologies

Questions on research and development of medicines
Questions about Clinical Trial Applications (CTA)

Questions about the CTR pilot project

ct.rd@fagg-afmps.be

CTRPilot@fagg-afmps.be

Questions about pharmacovigilance and adverse reactions

Reporting adverse reactions
(medicines for human use)

Reporting adverse reactions
(medicines for veterinary use)

vig@fagg-afmps.be

www.eenbijwerkingmelden.be (NL)
www.notifieruneffetindesirable.be (FR)

www.eenbijwerkingmelden-dieren.be (NL)
www.notifieruneffetindesirable-animaux.be (FR)

medicrime@fagg-afmps.be

Questions on

• qualification
• classification
• invitations for European/national meetings

All other questions and enquiries about subjects that do not qualify for other email addresses 

Questions about clinical trials

Questions about performance studies

Questions about serious adverse events

Applications for Scientific-Technical and Regulatory advice for innovative devices (medical devices, in vitro diagnostics (IVD), combination products of a medical device with a medicine or human body material ...)

Applications for advice from a Notified Body to the FAMHP

Applications for advice on the regulatory status of a borderline product

Questions about (pre)clinical research and development of new medicines, therapies and innovative technologies

NB.meddev@fagg-afmps.be

Questions about Compassionate Use

Questions about derogations

Questions about appeals

All vigilance related documents and questions:

• (serious) incident
• Manufacturer Incident Report (MIR)
• Periodic Summary Report (PSR)
• Field Safety Corrective Action (FSCA)
• Field Safety Notice (FSN)
• Trend report
• Post Market Surveillance (PMS) report
• Periodic Safety Update Report (PSUR) + evaluation
• Breast Implant Associated – Anaplastic Large Cell Lymphoma (BIA-ALCL)
• All security and safety issues with devices

vigilance.meddev@fagg-afmps.be

• inspection dossiers
• advertising and promotion of medical devices
• self-checking guide (Good Distribution Practices)
• the section “My control/Self-checking form” on the FAMHP portal
• violations of the medical devices and IVD legislations by registered actors

medicrime@fagg-afmps.be

Questions about marketing and distribution notifications

Questions about registration of actors

Questions about online applications (except the web portal of the FAMHP)

Questions about registration in EUDAMED

notifications.meddev@fagg-afmps.be

recast.meddev@fagg-afmps.be

Questions about products in the "grey area" of which the status is unclear

for human use

for veterinary use

borderline.hum@fagg-afmps.be

borderline.vet@fagg-afmps.be

Biovigil@fagg-afmps.be