FAMHP (Federal Agency for Medicines and Health Products)

Who regulates medicines in Belgium?

In one sentence

FAMHP is Belgium's medicines regulator: a public body under the Minister of Public Health that authorises, inspects and watches over medicines.

Agence fédérale des médicaments et des produits de santé (AFMPS) in French, Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) in Dutch. Its Vigilance Division records every suspected reaction reported in Belgium and passes it to the European Union (EU) database, EudraVigilance.

Where it sits

MinisterThe Minister of Public Health, whose hierarchical authority it is under
Public bodyFederal Agency for Medicines and Health Products (AFMPS, FAGG)
PillarDirectorate-General (DG) Post-authorisation, one of three pillars since 2009
UnitVigilance DivisionSuspected reactions land here

Think of it like this

Think of an alarm company that may keep its control room abroad, as long as a local number answers at three in the morning. Belgium treats your safety expert the same way.

Key insights

Carved out of a ministrySomeone on call, 24/7Patients report tooFunded by fees, priced elsewhere

A 2006 law created the agency; on 1 January 2007 it took over the files, duties and staff of the ministry’s medicines directorate. Since 2009 it works in three pillars. Chapter 1 tells the story.

Your qualified person for pharmacovigilance may live anywhere in the EU. If that person does not physically work in Belgium, the royal decree wants a contact person on Belgian territory who is reachable 24 hours a day, 7 days a week. Chapter 2 sets the clocks.

Doctors, pharmacists, dentists, nurses, midwives and patients all report on the same online portal, in Dutch or French. Professionals have reported online since late 2010; patients since July 2012, when the EU package took effect.

The agency lives on budget credits plus a yearly charge on turnover, flat contributions from authorisation holders and fees per act, all fixed by its law. The price of a medicine is someone else’s job: the Minister of Economic Affairs sets the ceiling, the Minister of Social Affairs decides reimbursement.

Jump to: 1 Three moments 2 Your report, their clock 3 What Belgium adds to the EU rules 4 Test yourself

Chapter 1

Which three moments made the FAMHP what it is?

Pick a year. Each changed who decides, who reports, and how openly.

2007One agency, out of a ministry2013Europe’s package, Belgium’s decree2021A weekly bulletin on vaccines

One agency, out of a ministry

The law of 20 July 2006 created the agency as a public interest body with legal personality under the Minister of Public Health. From 1 January 2007 the Federal Public Service (FPS) Public Health was discharged of the work: the agency took over every file and the rights, obligations and staff of the Directorate-General Medicines.

A chief executive on a six-year mandate runs it. Since 1 February 2009 the work sits in three pillars: DG Pre-authorisation, DG Post-authorisation and DG Inspection.

What it left behind: one federal body for the whole life of a medicine, from clinical trial to pharmacy shelf.

Europe’s package, Belgium’s decree

The EU pharmacovigilance package took effect in July 2012. Belgium answered with a law published on 3 August 2012 amending its Medicines Act of 25 March 1964, and with the royal decree of 28 May 2013, in force from 20 June 2013, which rewrote the pharmacovigilance title of the royal decree of 14 December 2006.

That title holds the Belgian clocks that still run: the company records every suspected reaction and sends serious ones to EudraVigilance within 15 days, non-serious EU ones within 90; the agency records every suspected reaction on Belgian territory reported by a professional or a patient and passes it on within the same 15 or 90 days. Patients had been able to report since July 2012; professionals had reported online since late 2010, when 43 percent of the following year’s reports already came in on the web form.

What it left behind: one decree for every Belgian deadline, and the contact person who must answer around the clock.

A weekly bulletin on vaccines

When the pandemic came, the agency started with the hospitals: from 1 April 2020 its experts sent the pharmacovigilance contact points of Belgian hospitals a weekly report on the reactions seen with coronavirus disease 2019 (COVID-19) treatments in the European database. By 17 June 2020 Belgium had 18 such reports.

Then it turned to the public. From 7 January 2021 the agency published, every week, a cumulative overview of the adverse reactions reported after a COVID-19 vaccination in Belgium, in its own words to increase confidence through full transparency. Vaccines and advanced therapy medicinal products (ATMPs) are the two fields it calls its spearheads.

What it left behind: the habit of showing the reports, not just collecting them.

Chapter 2

Your report, their clock

A case has reached your company. Article 67 of the 2006 decree sets the deadline for a suspected adverse drug reaction (ADR) with two questions: is it serious, and was it in the EU? Pick a cell.

In the EUOutside the EUSeriousSerious, in the EUSerious, outside the EUNot seriousNot serious, in the EUNot serious, outside the EU

Or you are someone else: a doctor, nurse or patient in Belgium or the company’s contact person in Belgium

Every serious suspected reaction, in the EU or a third country, electronically to EudraVigilance within 15 days of the day you learned of the event. Arrêté royal du 14 décembre 2006, article 67 §3

A non-serious suspected reaction in the EU within 90 days of the day you learned of the event. Arrêté royal du 14 décembre 2006, article 67 §3

A non-serious reaction outside the EU is recorded, like every suspected reaction you hear of, but it is not on the article 67 sending list. Arrêté royal du 14 décembre 2006, article 67 §1 and §3

No deadline for you. Every medicine’s product information invites professionals to report to the national system, and patients may report directly: online, in Dutch or French. The agency then sends a serious case to EudraVigilance within 15 days and a non-serious one within 90. Arrêté royal du 14 décembre 2006, articles 7 and 67bis

Not a deadline but a duty: if the qualified person for pharmacovigilance does not physically work in Belgium, the company appoints a contact person who works on Belgian territory, has the language skills, and is reachable 24 hours a day, 7 days a week. Arrêté royal du 14 décembre 2006, article 66 §2

Elle doit être joignable 24 heures sur 24 et 7 jours sur 7.
Arrêté royal du 14 décembre 2006, article 66 §2: the contact person must be reachable 24 hours a day, 7 days a week

The Vigilance Division assesses every report with internal and external experts. A medicine assessed nationally goes to Belgium’s Commission for Medicinal Products for Human Use; the rest to the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA). It can then change the product information, restrict an indication or warn prescribers.

Chapter 3

What does Belgium add to the EU rules?

The EU directive sets the floor and the EMA runs the shared database. Five places where Belgium built its own layer on top.

	The EU rule	Belgium’s own layer
Reports from professionals	Member States encourage patients and professionals to report	The product information invites professionals to report; professionals and patients use one online portal, in Dutch or French
The company’s cases	Every serious case goes to EudraVigilance within 15 days	The same clocks, in article 67 of the 2006 decree; the agency sends on the reports it receives itself within 15 or 90 days
The company’s people	A qualified person for pharmacovigilance, resident in the EU	If that person does not work in Belgium, a contact person on Belgian soil, with the language skills, reachable 24 hours a day
Who pays	Pharmacovigilance funds stay under the authority’s control, to keep it independent	Budget credits plus a yearly charge on turnover, flat contributions and fees per act, set by the 2006 law; a Transparency Committee with sector seats sees how the money is used
Who sets the price	Prices stay national; the EU only sets deadlines and transparency	Not the agency: the Minister of Economic Affairs sets the maximum price; the Minister of Social Affairs decides reimbursement, advised by the National Institute for Health and Disability Insurance (NIHDI)

Show the legal references

Reports: Directive 2001/83/EC, Article 102(a); Arrêté royal du 14 décembre 2006, articles 7 and 67bis §1.
Cases: Regulation (EC) No 726/2004, Article 24(1); Arrêté royal du 14 décembre 2006, article 67 §3 and article 67bis §4.
People: Directive 2001/83/EC, Article 104(3)(a); Arrêté royal du 14 décembre 2006, article 66 §1 and §2.
Funds: Directive 2001/83/EC, Article 105; Loi du 20 juillet 2006, articles 12, 13, 14/2, 14/9, 14/13 and 14/14.
Price: Council Directive 89/105/EEC; NIHDI, Belgium: pharmaceutical pricing and reimbursement policies (2024); the NIHDI’s Commissie Tegemoetkoming Geneesmiddelen.

Same Europe, one local switchboard: someone must answer a Belgian phone day and night, and the agency sends on the reports it receives itself.

The facts, in one place

What it is	A public interest body with legal personality under the Minister of Public Health, reporting yearly to the minister and Parliament.
Since	1 January 2007, under the law of 20 July 2006 (Moniteur belge of 8 September 2006).
Who decides	A Chief Executive Officer on a six-year renewable mandate; three directorates-general; a Consultative, a Scientific and a Transparency Committee beside the agency.
Seat	Avenue Galilée 5/03, 1210 Brussels.
Safety system	The Vigilance Division; one online portal for professionals and patients; national products advised by the Commission for Medicinal Products for Human Use, the rest through the PRAC.
Inspects	Manufacturers, distributors, trial sites, the pharmacovigilance systems of authorisation holders, and advertising; a Special Investigation Unit for illegal medicines.
Member of	The Pharmaceutical Inspection Co-operation Scheme (PIC/S) since February 1997; the Heads of Medicines Agencies (HMA), which it chaired in the first half of 2024; the EMA committees.

Don’t confuse it with: the Federal Public Service (FPS) Public Health

FAMHP

The regulator

Grants: clinical trial approvals and national marketing authorisations
Runs: the Vigilance Division and forwards each Belgian case to EudraVigilance
Example: inspects a company’s pharmacovigilance system; its inspectors’ names are not public

FPS Public Health

The ministry’s administration

Was: home of the Directorate-General Medicines until 2007, when the agency took its files and staff
Shares: a joint Health Service Centre with the agency and the NIHDI
Example: the minister, not the agency, signs a suspension or withdrawal of a marketing authorisation

Chapter 4

Test yourself

Myth or Truth? Pick an answer to see the explanation.

“A doctor in Belgium has a legal deadline, in days, to report a suspected reaction.”

MythTruth

MythYou got it.Not quite.

The 2006 decree invites professionals to report and gives the clocks to the company and the agency: 15 days for a serious case, 90 for a non-serious one.

“If a company’s qualified person works outside Belgium, it needs a contact person in Belgium reachable 24 hours a day.”