CBG-MEB (College ter Beoordeling van Geneesmiddelen, the Medicines Evaluation Board)

Who regulates medicines in the Netherlands?

In one sentence

The CBG-MEB is the Netherlands' medicines regulator: an independent board of experts that licenses medicines and runs Dutch pharmacovigilance.

It sits under the Ministry of Health, Welfare and Sport. A board of up to 17 members decides, an agency of some 500 staff prepares, and an independent foundation, Lareb, collects the side-effect reports on the board’s behalf. It also takes a large share of the European Union (EU) assessment work for the European Medicines Agency (EMA).

Where it sits

MinistryHealth, Welfare and Sport (VWS)
Independent boardCollege ter Beoordeling van Geneesmiddelen
AgencyAgentschap CBG, which prepares and implements the decisions
Reporting centreBijwerkingencentrum LarebSuspected reactions land here

Think of it like this

Think of a jury of specialists who meet once a month to decide. A clerk’s office does the reading all year, and a neighbourhood hotline takes the calls and tells the jury what it hears.

Key insights

A jury, not a bureauTiger balm was number oneThe hotline is a foundationA big EU desk

The decisions are taken by a board of up to 17 medical specialists, hospital pharmacists and professors, appointed by the Minister for four years and sitting alongside their day jobs. Every meeting gets a public report. Chapter 1 tells how that came to be.

The board was founded in 1963, and the first Dutch marketing authorisation number went to tiger balm. Sixty years on, the agency handles about 20,000 cases a year.

Reports of suspected side effects do not go to the board but to Lareb, an independent foundation funded by the board and the Ministry. It collects about 30,000 reports a year and sends its signals to the board. Chapter 2 sets the clocks.

In 2025 the board took 23 rapporteurships for medicine assessment and 15 for pharmacovigilance in the EU procedures, ran signal detection for 100 active substances in EudraVigilance, and was the safety rapporteur for 197 centrally authorised products.

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

Chapter 1

Which three moments made the CBG-MEB what it is?

Pick a year. Each shaped the split between board, agency and hotline.

1963Tiger balm gets number one2007A new Act for an independent board2021Two hundred thousand reports

Tiger balm gets number one

The College was founded in 1963, when packaged, factory-made medicines first had to be assessed before sale in the Netherlands. The very first Dutch marketing authorisation number, the RVG number still printed on every pack, went to tiger balm.

The shape was set then: not a department but a college of outside experts, judging each dossier and leaving the paperwork to a secretariat.

What it left behind: tens of thousands of registrations later, a board that still decides as a jury of peers.

A new Act for an independent board

The Geneesmiddelenwet of 8 February 2007 replaced the 1958 law. Its second article says simply “Er is een College ter beoordeling van geneesmiddelen”, and puts the College under the framework law for independent administrative bodies. At most 17 members, appointed for four years at a time; decisions on authorisations; and, in article 76, charge of pharmacovigilance.

The same Act splits the work three ways. The Minister must foster bodies that collect side-effect data, which is Lareb’s legal footing, and supervision of the Act goes to the Health and Youth Care Inspectorate, not to the College.

What it left behind: a regulator that decides but does not inspect, and a hotline that is not a government office.

Two hundred thousand reports

Lareb normally collects about 30,000 reports of suspected adverse reactions a year from doctors, pharmacists and patients. In 2021 the coronavirus vaccines pushed that to almost 200,000.

The chain held: Lareb analyses, the board reviews, and for vaccines Lareb also informs the National Institute for Public Health and the Environment. The board’s own EU role grew with it; by 2025 it ran signal detection for 100 active substances in EudraVigilance and discussed 32 Lareb analyses in the year.

What it left behind: proof that a foundation outside government can carry a national reporting system through its busiest year.

Chapter 2

Your report, their clock

A case has reached your company. The EU directive, carried into the Geneesmiddelenwet, 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 not a company at all: a doctor or pharmacist with a serious case or a patient in the Netherlands

Every serious suspected reaction, in the EU or a third country, goes to EudraVigilance within 15 days of the day you learned of it. The Dutch Act makes you register all of them, whatever system they came from. Directive 2001/83/EC, Article 107(3); Geneesmiddelenwet, artikel 78

A non-serious suspected reaction in the Union goes to EudraVigilance within 90 days. Directive 2001/83/EC, Article 107(3)

A non-serious reaction outside the Union is not on the 15 or 90 day list. It is registered in your pharmacovigilance system, which must connect to the board’s own. Geneesmiddelenwet, artikel 76a and 78

The Act uses one word: “onmiddellijk”. A health professional reports every suspected serious reaction immediately to the reporting centre, Lareb. Geneesmiddelenwet, artikel 78, derde lid

You report to Lareb when you like. The board must register every Dutch report from professionals and patients and report it on, and Lareb sends the board an overview of all signals at least every three months. Geneesmiddelenwet, artikel 78, tweede en vierde lid

Beroepsbeoefenaren melden onmiddellijk elke vermoedelijke ernstige bijwerking.
Geneesmiddelenwet, artikel 78: health professionals report every suspected serious adverse reaction immediately

Volume gives the sentence its weight. Lareb collects about 30,000 reports in an ordinary year, and almost 200,000 in 2021. In 2025 the board and Lareb discussed 32 analyses of those reports; most fed into procedures already running.

Chapter 3

What does the Netherlands add to the EU rules?

The directive sets the floor. Five places where the Dutch set-up is its own.

	The EU rule	The Dutch layer
Who decides	The European Commission, on the EMA’s opinion, for centralised medicines	Nationally, a board of up to 17 outside experts appointed by the Minister, meeting monthly, with public reports of each meeting
Reports from the public	Member States encourage patients and professionals to report	An independent foundation, Lareb, collects and analyses them on the board’s behalf, funded by the board and the Ministry
A serious case seen by a doctor	Reporting is encouraged	The Act says “onmiddellijk”: immediately, to Lareb
Who inspects you	The national competent authority, in cooperation with the EMA	The Health and Youth Care Inspectorate, not the board; it is also the Dutch member of the inspectors’ network PIC/S
Signals	Assessed at the EMA’s safety committee	Lareb sends the board an overview of all signals at least every three months; the board was safety rapporteur for 197 centrally authorised products in 2025

Show the legal references

Who decides: Regulation (EC) No 726/2004, Article 10(1); Geneesmiddelenwet, artikelen 2, 3 and 9; the MEB page on the Board.
Reports: Directive 2001/83/EC, Article 102(a); Geneesmiddelenwet, artikel 76, derde lid; Lareb, About Lareb.
Professionals: Geneesmiddelenwet, artikel 78, derde lid.
Inspections: Directive 2001/83/EC, Article 111(1); Geneesmiddelenwet, artikel 100; PIC/S membership list.
Signals: Geneesmiddelenwet, artikel 78, vierde lid; CBG Jaarverslag 2025.

Three doors, one house: in the Netherlands the board decides, the inspectorate checks, and a foundation listens.

The facts, in one place

What it is	An independent administrative body under the Ministry of Health, Welfare and Sport, created by article 2 of the Geneesmiddelenwet; the framework law for such bodies applies.
Since	1963; the present Act dates from 8 February 2007.
Who decides	The board, up to 17 members appointed by the Minister for four years. The agency, 537 employees at the end of 2025, prepares and implements the decisions.
Seat	Utrecht, Graadt van Roggenweg.
2025 in numbers	23 rapporteurships for assessment and 15 for pharmacovigilance; 126 periodic safety report assessments for Europe; about 20,000 cases a year at the agency.
Pharmacovigilance	Reports go to Lareb, about 30,000 a year; the board runs signal detection for 100 active substances in EudraVigilance and sits on the Pharmacovigilance Risk Assessment Committee (PRAC) as rapporteur for 197 centrally authorised products.
Member of	The International Coalition of Medicines Regulatory Authorities (ICMRA). In the Pharmaceutical Inspection Co-operation Scheme (PIC/S) the Netherlands is represented by the inspectorate, a scheme member since November 1995.

Don’t confuse it with: Lareb

CBG-MEB

The regulator

Decides: whether a medicine may be sold, and whether its licence changes
Answers: to the Minister, as an independent administrative body
Example: reviews a Lareb signal and changes the product information

Lareb

The reporting centre

Collects: the reports from professionals and patients, on the board’s behalf
Is: an independent foundation, funded by the board and the Ministry
Example: spots twelve reports of nightmares with one antihistamine and tells the board

Chapter 4

Test yourself

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

“The CBG-MEB inspects Dutch companies’ pharmacovigilance systems.”

MythTruth

MythYou got it.Not quite.

Supervision of the Geneesmiddelenwet belongs to the Health and Youth Care Inspectorate. The board decides on authorisations and runs pharmacovigilance; it does not inspect.

“A Dutch doctor must report a suspected serious reaction immediately.”