If you do not know which department is competent, please send your question to the joint Health Service Centre of the FAMHP, the FPS Public Health and the NIHDI:
- to the FAMHP general email address: welcome@fagg-afmps.be;
- or by phone + 32 2 528 40 00 (available on working days from 8 a.m. to 1 p.m.).
Please contact us preferably by e-mail.
Your question will be forwarded to the relevant department.
Send your questions to a single email address of the FAMHP. Below you will find the correct contact address for each type of question.
General contacts
Type of question |
Contact |
Reception desk or questions for which you cannot find specific contact information | welcome@fagg-afmps.be + 32 2 528 40 00 (available on working days from 8 a.m. to 1 p.m.) |
Questions for the secretariat of the Chief Executive Officer, Hugues Malonne | management@fagg-afmps.be |
Press questions |
comm@fagg-afmps.be Spokesperson (Ann Eeckhout) |
Complaints | Complaint form |
Reporting of irregularities within the areas of competence of the FAMHP by whistleblowers |
Agreement on whistleblowers |
Questions concerning legislation and disputes | ius@fagg-afmps.be |
Specific question regarding the identity of controllers and inspectors staff |
secretary_DGINSP@fagg-afmps.be |
Questions about customer invoicing (invoices from the FAMHP) Questions about supplier invoicing (invoices for the FAMHP) |
|
Questions and comments about the FAMHP website | webmaster@fagg-afmps.be |
Hospital audit questions | Federal supervision and audit of hospitals |
Urgent medical questions | Contact your doctor or pharmacist Contact the Antipoison Centre (available 24/7 on + 32 70 245 245) |
Medicines
Type of question |
Contact |
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 |
sta@fagg-afmps.be |
Applications for Certificates of Pharmaceutical Products (CPP), certified copies, SEEN certificates and other related documents |
certificates@fagg-afmps.be |
Application for manufacturing/importation authorization for medicinal products (MIA), for wholesale distributor authorization for medicinal products (WDA) and for registrations of active substances (API) | eudragmdp@fagg-afmps.be |
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 | info.medicines@fagg-afmps.be |
Questions about distribution activities of Active Pharmaceutical Ingredients or medicines |
distribution@fagg-afmps.be |
Questions about the pharmaceutical activities (storage, preparation and delivery of human and veterinary medicines) in pharmacies open to the public or hospital pharmacies | pharmacy@fagg-afmps.be |
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 |
industry@fagg-afmps.be |
Questions about pharmacovigilance inspections and the tasks and responsibilities of the marketing authorisation holder for a medicine |
phvinsp@fagg-afmps.be |
Questions about inspections of publicity and other promotional activities for medicines | publicity@fagg-afmps.be |
Questions about homeopathic medicines | homeo@fagg-afmps.be |
Questions about veterinary medicines including questions on
|
infovet@fagg-afmps.be |
Questions about the availability and commercialisation of medicines | supply-problems@fagg-afmps.be |
Questions for the National Innovation Office such as:
|
innovationoffice@fagg-afmps.be |
Questions about publicity, notification and visas | advertising@fagg-afmps.be |
Questions on submitted clinical trials |
|
Safety-related questions on clinical trials submitted under Regulation 536/2014 (CTR) |
|
Questions about Compassionate Use and Unmet Medical Need programmes | umn@fagg-afmps.be |
Questions about narcotics and psychotropic substances | narcotics@fagg-afmps.be |
Questions about pharmacovigilance Questions about adverse reactions Reporting adverse reactions Reporting adverse reactions |
www.eenbijwerkingmelden.be (NL) www.eenbijwerkingmelden-dieren.be (NL) |
Questions about inspections and controls | inspection@fagg-afmps.be |
Questions on illegal practices (Special Investigation Unit) |
Medical devices
Type of question | Contact |
Questions on
All other questions and enquiries about subjects that do not qualify for other email addresses |
info.meddev@fagg-afmps.be |
Questions about clinical trials Questions about performance studies Questions about serious adverse events |
CT.RD@fagg-afmps.be |
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 |
STA.meddev@fagg-afmps.be |
Questions about Notified Bodies and Notified Body certificates (withdrawal, suspension, etc.) | |
Questions for and about certificates of free sale | FSC.meddev@fagg-afmps.be |
Questions about Compassionate Use Questions about derogations Questions about appeals |
derogation.meddev@fagg-afmps.be |
All vigilance related documents and questions:
|
|
Questions about the Central Traceability Register | RCT-CTR.meddev@fagg-afmps.be |
Questions about:
|
inspection.meddev@fagg-afmps.be |
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) |
+32 2 528 48 56 |
Technical issues with EUDAMED | SANTE-EUDAMED-SUPPORT@ec.europa.eu |
Questions about contributions | contributions.meddev@fagg-afmps.be |
Questions about inspections and controls | inspection@fagg-afmps.be |
Questions about illegal practices (Special Investigation Unit) | medicrime@fagg-afmps.be |
Special products
Type of question | Contact |
Questions about inspection and control of human body material | inspection.hbm@fagg-afmps.be |
Questions about human body material | mch-mlm@fagg-afmps.be |
Questions about drug precursors | drugprecursor@fagg-afmps.be |
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 | Hemovigil@fagg-afmps.be |
Questions and documents about the vigilance of human body material (cells and tissue) |
Address
Federal Agency for Medicines and Health Products
Avenue Galilée 5/03
1210 BRUSSELS
The building is open from 8 a.m. till 7 p.m.
Map: PNG - PDF
Google Maps
Welcome to the Galilee building
More information on car park, accessibility and facilities