Freedom of information
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. 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, patient information leaflet and summary of product characteristics are also published. This information can be consulted via the MEB Medicines Information Bank.
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 in connection with possible adverse effects by the European Medicines Agency (EMA).
Passive disclosure: information request
The MEB regularly receives requests for more and other information than can be found on the website. Examples include information from submitted registration dossiers, the accompanying 'Risk Management Plans' (RMP's) and/or the Periodic Safety Update Reports (PSURs). However, not all the details in these documents and the related reports drawn up by the MEB can be published. The Government Information (Public Access) Act states that the above applies, for example:
- In the event of company and manufacturing data or privacy-sensitive data.
- If, from the competition perspective, a manufacturer would experience disproportional disruption from publication of the data.
- If the good collaboration with another country involved in the assessment would be damaged.
Consultation with the MEB after an information request
Has an information request been submitted? If so, you can request a meeting with the MEB. It may then even be possible to answer the questions you have during that meeting. 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: regulatoryscience@cbg-meb.nl.
Submitting an information request
Information requests can be submitted in writing and via email. Always state your name and address details.
In writing to:
Medicines Evaluation Board
Attn the Policy, Regulatory and International Affairs (PRI) unit
PO Box 8275
3503 RG Utrecht
Via e-mail:
BRI@cbg-meb.nl.
Are you a journalist? If so, you should contact the Communications unit via the press page.