If you do not know which department is competent, please send your question :

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, Xavier De Cuyper	management@fagg-afmps.be
Press questions	comm@fagg-afmps.be + 32 2 528 40 12 Spokesperson (Ann Eeckhout) + 32 495 23 71 69
Complaints	Complaint form
Reporting of irregularities within the areas of competence of the FAMHP by whistleblowers	whistleblowers@fagg-afmps.be
Questions concerning legislation and disputes	ius@fagg-afmps.be
Questions about customer invoicing (invoices from the FAMHP) Questions about supplier invoicing (invoices for the FAMHP)	fin@fagg-afmps.be purchases@fagg-afmps.be
Questions and comments about the FAMHP website	webmaster@fagg-afmps.be
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	prelicensing@fagg-afmps.be postlicensing@fagg-afmps.be
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 marketing authorisations; parallel imports; clinical trials; publicity and promotion; distribution.	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: 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	innovationoffice@fagg-afmps.be
Questions about publicity, notification and visas	advertising@fagg-afmps.be
Questions on clinical trials submitted under Directive 2001/20/EC	ct.rd@fagg-afmps.be
Questions on clinical trials submitted under the CTR pilot project	CTRPilot@fagg-afmps.be
Questions on clinical trials submitted under Regulation 536/2014 (CTR)	CTR@fagg-afmps.be
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 (medicines for human use) Reporting adverse reactions (medicines for veterinary use)	vig@fagg-afmps.be adr@fagg-afmps.be www.eenbijwerkingmelden.be (NL) www.notifieruneffetindesirable.be (FR) www.eenbijwerkingmelden-dieren.be (NL) www.notifieruneffetindesirable-animaux.be (FR)
Questions about inspections and controls	inspection@fagg-afmps.be
Questions on illegal practices (Special Investigation Unit)	medicrime@fagg-afmps.be

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	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.)	NB.meddev@fagg-afmps.be
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: (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
Questions about the Central Traceability Register	RCT-CTR.meddev@fagg-afmps.be
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	inspection.meddev@fagg-afmps.be
Questions about fraud, prosecution dossiers, violations of the legislation on medical devices and IVDs by non-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
All technical questions relating to the online applications and the web portal (except questions about EUDAMED)	support.portal@fagg-afmps.be +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 the implementation of Regulations (EU) 2017/745 and (EU) 2017/746	recast.meddev@fagg-afmps.be
Questions about SARS-CoV-2 antigen tests	antigen@fagg-afmps.be
Questions about about SARS-CoV-2 serological tests	serology@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	borderline.hum@fagg-afmps.be borderline.vet@fagg-afmps.be
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)	Biovigil@fagg-afmps.be