The FAMHP has moved: from 1 March 2021, you will be able to find our departments at the following address.
Federal Agency for Medicines and Health Products - FAMHP
Avenue Galilée 5/03
1210 BRUSSELS
All our telephone numbers and e-mail addresses remain the same.
+32 2 528 40 00 (from 8 AM to 5 PM on working days)
welcome@fagg-afmps.be
EORI number BE0884579424
| Send your questions to the FAMHP by e-mail. If you don’t know which is the appropriate department send it simply to the general e-mail address at FAMHP: welcome@fagg-afmps.be. Your question will then be passed on to the relevant department. |
Authorisations and certificates
- Certificates of Pharmaceutical Products (CPP) and related documents - certificates@fagg-afmps.be
- Authorisations (MIA/WDA), certificates (GMP/GDP), registrations (API REG) - eudragmdp@fagg-afmps.be
Billing – purchases@fagg-afmps.be
Borderline products whose status is unclear - borderline.hum@fagg-afmps.be - borderline.vet@fagg-afmps.be
Chief Executive Officer, Xavier De Cuyper - management@fagg-afmps.be (Secretariat)
Complaints - Complaints about the FAMHP?
Herbal Medicines - phyto@fagg-afmps.be
Homeopathic medicines - homeo@fagg-afmps.be
Human body material (MCH-MLM) - mch-mlm@fagg-afmps.be
Information on the proper use of medicines and health products - info.medicines@fagg-afmps.be
Inspection and control – General - inspection@fagg-afmps.be
Inspection and control – Pharmacies - pharmacy@fagg-afmps.be
Inspection and control – Distribution of medicines - distribution@fagg-afmps.be
Inspection and control – Industry - industry@fagg-afmps.be
Inspection and control - Medical devices - inspection.meddev@fagg-afmps.be
Inspection and control – Special Investigation Unit - medicrime@fagg-afmps.be
Inspection and control - Pharmacovigilance - phvinsp@fagg-afmps.be
Inspection and control - Publicity - General - publicity@fagg-afmps.be
Inspection and control - Human Body Material - inspection.hbm@fagg-afmps.be
Legal Affairs - ius@fagg-afmps.be
Marketing Authorisation - Variations and Renewals - postlicensing@fagg-afmps.be
Medicines for veterinary use - infovet@fagg-afmps.be
National Innovation Office - innovationoffice@fagg-afmps.be
Narcotics and psychotropics - narcotics@fagg-afmps.be
Precursors - drugprecursor@fagg-afmps.be
Press (For journalists only) - comm@fagg-afmps.be
Ann Eeckhout, spokesperson of the FAMHP
phone +32 2 528 40 12
mobile +32 495 23 71 69
Publicity – Notification and visum - advertising@fagg-afmps.be
Research and Development (R&D) - ct.rd@fagg-afmps.be
Scientific-Technical Advice (STA) - sta@fagg-afmps.be
Supply problems and commercialisations - supply-problems@fagg-afmps.be
Vigilance of medicines for human use - vig@fagg-afmps.be
Webmaster - webmaster@fagg-afmps.be
Medical devices
All current e-mail addresses dedicated to the medical devices and in-vitro diagnostics (IVDs) will be reorganised in order to ensure a better management of the incoming emails and to increase efficiency in processing them.
From the 15th of March 2021, the following e-mail addresses will be phased out and eventually disappear completely:
• meddev@fagg-afmps.be
• IVD@fagg-afmps.be
• ALCL@fagg-afmps.be
• notifications@fagg-afmps.be
• contributions@fagg-afmps.be
These general e-mail addresses will be replaced by more specific ones. All new e-mail addresses will be used for enquiries related to medical devices and medical devices for in-vitro diagnostics (IVDs).
| For all enquiries about the following topics | Contact |
| - Clinical investigations - Performance studies - Serious adverse events |
CT.RD@fagg-afmps.be |
| - Scientific-technical advice on innovative devices - Requests for advice from a Notified Body (Transmissible Spongiform Encephalopathies (TSE)...) |
STA.meddev@fagg-afmps.be |
| - Notified Bodies and Notified Body certificates (withdrawal, suspension ...) - Questions related to Notified Bodies |
NB.meddev@fagg-afmps.be |
| Applications for certificates of free sale and questions related to those certificates | FSC.meddev@fagg-afmps.be |
| - Compassionate use - Derogations - Appeals |
derogation.meddev@fagg-afmps.be |
| 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 |
| Central traceability register | RCT-CTR.meddev@fagg-afmps.be |
| - Inspection related files - Advertising and promotion of medical devices - Self-checking guide (Good distribution practices) - My control/Self-checking form section on the Portal - Violations of the medical devices and IVD legislations by registered actors |
inspection.meddev@fagg-afmps.be |
| - Fraud - Prosecution files - Violations of the medical device and IVD legislations by non-registered actors |
medicrime@fagg-afmps.be |
| - Marketing and distribution notifications - Registration of actors - Business questions related to online applications (except the Autocontrol application) - Registration in EUDAMED |
notifications.meddev@fagg-afmps.be |
| All technical questions regarding the online applications and the web portal (except EUDAMED) | support.portal@fagg-afmps.be |
| Technical issues with EUDAMED | SANTE-EUDAMED-SUPPORT@ec.europa.eu |
| Contributions | Contributions.meddev@fagg-afmps.be |
| The implementation of Regulations (EU) 2017/745 and (EU) 2017/746 | Recast.meddev@fagg-afmps.be |
| - Qualification - Classification - Invitations for European/national meetings - All other enquiries that are not related to topics of the other email boxes |
Info.meddev@fagg-afmps.be |
| All enquiries about SARS-CoV-2 antigen tests | Antigen@fagg-afmps.be |
| All enquiries about SARS-CoV-2 serological tests | Serology@fagg-afmps.be |