Federal Agency for Medicines and Health Products - FAMHP
Avenue Galilée 5/03

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+32 2 528 40 00 (from 8 AM to 4 PM on working days)

EORI number BE0884579424

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:
Your question will be forwarded to the competent department.


General contacts

Type of question

Reception desk or questions for which you cannot find specific contact information
0032 2 528 40 00
Questions for the secretariat of the Chief Executive Officer, Xavier De Cuyper
Press questions
0032 2 528 40 12

Spokesperson (Ann Eeckhout)
0032 495 23 71 69

Complaints Complaint form
Questions concerning legislation and disputes
Questions about invoicing
Questions and comments about the FAMHP website



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 authorisations for manufacturers and certificates
Applications for Certificate of Pharmaceutical Product (CPP) and related documents
Applications for Manufacturing and Importation Authorisation (MIA), Wholesale Distributor Authorisation (WDA) and registrations for Active Pharmaceutical Products (API REG)

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

Questions on the proper use of medicines

Questions about distribution activities of Active Pharmaceutical Ingredients or medicines
Questions about the pharmaceutical activities (storage, preparation and delivery of human and veterinary medicines) in pharmacies open to the public or hospital pharmacies

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 inspections of publicity and other promotional activities for medicines
Questions about homeopathic medicines

Questions about veterinary medicines including questions on

  • marketing authorisations;
  • parallel imports;
  • clinical trials;
  • publicity and promotion;
  • distribution.
Questions about the availability and commercialisation of medicines
Questions for the National Innovation Office such as:
  • 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 about publicity, notification and visas

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

Questions about the CTR pilot project

Questions about Compassionate Use and Unmet Medical Need programmes
Questions about narcotics and psychotropic substances

Questions about pharmacovigilance and adverse reactions

Reporting adverse reactions
(medicines for human use)

Reporting adverse reactions
(medicines for veterinary use) (NL) (FR) (NL) (FR)

Questions about inspections and controls
Questions on illegal practices (Special Investigation Unit)


Medical devices

Type of question Contact

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
Questions about Notified Bodies and Notified Body certificates (withdrawal, suspension, etc.)

Questions for and about certificates of free sale

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

Questions about the Central Traceability Register
Questions about:
  • 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
Questions about fraud, prosecution dossiers, violations of the legislation on medical devices and IVDs by non-registered actors

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

All technical questions relating to the online applications and the web portal (except questions about EUDAMED)
Technical issues with EUDAMED
Questions about contributions
Questions about the implementation of Regulations (EU) 2017/745 and (EU) 2017/746

Questions about SARS-CoV-2 antigen tests
Questions about about SARS-CoV-2 serological tests
Questions about inspections and controls
Questions about illegal practices (Special Investigation Unit)


Special products

Type of question Contact
Questions about inspection and control of human body material
Questions about human body material
Questions about drug precursors

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

for human use

for veterinary use

Questions and documents about the vigilance of blood and blood products
Questions and documents about the vigilance of human body material (cells and tissue)

Last updated on 09/11/2021