Openness ensures good quality information and provides an insight into the decision-making process relating to the organisation of medicines. Not all data present at the MEB can be made public. That is why an overview has been created showing which information is public.

Active disclosure

The MEB publishes the agendas and minutes of its meetings and the decisions taken (only in Dutch). This includes minority opinions and issues relating to voting and arguments. Public Assessment Reports (PARs) are also available. What is more, a medicine's marketing authorisation, package leaflet and summary of product characteristics are also published. This information can be consulted via the MEB Medicines Information Bank.

The Open Government Act (Wet open overheid, or Woo) requires the MEB to actively publish specific categories of information. Our page in the Register of Government Organisations (only available in Dutch), under the heading 'Woo documents locations', lists the references to all available categories of information. 

Information on notifications of possible adverse reactions can be found on the website of the Netherlands Pharmacovigilance Centre Lareb. At European level the agendas and reports of the Pharmacovigilance Risk Assessment Committee (PRAC) are published by the European Medicines Agency (EMA) in connection with possible adverse reactions.

Passive disclosure: information request

The MEB regularly receives requests for additional information beyond what is already on the website. Examples include data from submitted authorisation dossiers, accompanying Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs).

For each request, the MEB assesses what information may be disclosed.

Requests under the Open Government Act

Some data from these documents and from the MEB's reports may not be disclosed. According to the Woo (Articles 5.1 and 5.2), this is the case, for example, when:

  • it concerns business or manufacturing data, or privacy-sensitive information;
  • disclosure would cause a manufacturer disproportionate harm in terms of competition;
  • collaboration with another country involved in the assessment would be harmed as a result.

These exceptions ensure that transparency through the Woo remains in balance with protecting vital State interests and fair treatment of companies and other stakeholders.

Code list of Woo requests

The premise of the Open Government Act (Woo) is that information at an administrative authority is public. The Woo has a number of grounds for exceptions in this respect. These exceptions are listed in Articles 5.1 and 5.2 of the Woo. The MEB has elaborated these grounds for exceptions in a code list. This list is in line with the 2024 European guideline of the Heads of Medicines Agencies (HMA) and EMA, among others.

The MEB updated the code list on 14 October 2024. With regard to policy views, we will from now on apply this tightened policy to assess for each passage whether it concerns objective factors (such as general facts and policy alternatives) or subjective views (such as a personal experience or feeling of the person expressing them). We will only mark the latter subjective views in the document as personal views (on policy or otherwise). The policy views to be objectified on the administrative matter in the document will remain public.

With this adjustment, the MEB aims to ensure a more transparent and consistent implementation of the Woo.

Consultation with the MEB after an information request

Has an information request been submitted? If so, you can request a meeting with the MEB. During that meeting, it may even already be possible to answer any questions you may have. The MEB can also provide clarification, for example about why the MEB issued a certain opinion about a medicine.

Information for scientific research

Universities or research institutes can also request information for scientific research. The MEB will then make separate agreements about the research and the exchange of information. If you would like to find out more about the possibilities, please contact the MEB's Science Unit via the email address: science@cbg-meb.nl.

Submitting an information request

A request can be submitted in writing, either by post or by email. Always state your name and address details.

In writing to:
Medicines Evaluation Board
Attn department JIP (Legal Affairs, Records Management and PAR)
PO Box 8275
3503 RG Utrecht

Via e-mail:
BBR@cbg-meb.nl. 

Journalists can contact the Corporate Communications unit via our press page.