Transparency of information
The MEB aims to be transparent. Transparency contributes to good information and provides insight into the decision-making process surrounding the admission of medicinal products. However, not all the data present at the MEB can be disclosed. Therefore, an overview has been provided about which information is accessible.
The MEB discloses the agendas and the minutes of its meetings and the decisions that it has taken. Minority views and particulars about votes and rationale are included. In addition, there are Public Assessment Reports (PARs). The marketing authorisation, the package leaflet and the summary of product characteristics of a medicinal product are also publicly accessible. This information can be consulted via the MEB Medicines Information Bank.
Information about reports of possible adverse events can be found on the website of the Netherlands Pharmacovigilance Centre Lareb. At a European level regarding possible adverse events, the agendas and reports of the Pharmacovigilance Committee PRAC are published by the European Medicines Agency (EMA).
Passive transparency: request for information
The MEB regularly receives requests for more and different information than provided on the website. Examples include information from submitted authorisation files, the accompanying “Risk Management Plans” (RMPs) and/or the Periodic Safety Update Reports (PSURs). However, the information from these documents and the reports that the MEB writes about this information cannot all be disclosed. For example, the Freedom of Information Act states that this applies if:
- The information contains company and manufacturing data or confidential data.
- A manufacturer would be unfairly impeded from a competition perspective by the disclosure of the data.
- This could harm the good cooperation with another country involved in the assessment.
Consultation with the MEB following a request for information
Have you submitted a request for information? Then you can also ask the MEB for a meeting. If possible, the questions can be answered in this meeting. The MEB can also provide a further explanation, for example about why the MEB has ruled a certain way on a medicinal product.
Information for scientific research
Universities or research institutes can also request information for scientific research. The MEB concludes separate agreements on the research and the exchange of information. You can contact the Scientific Bureau of the MEB about the options, via e-mail address: _DienstpostbusWeten@cbg-meb.nl.
Submitting a request for information
The MEB considers each request for information as a FIO request. Such a request can be submitted both in writing and via e-mail. Always state your name and address details.
Medicines Evaluation Board
f.a.o. the Policy, Governance and Regulatory Affairs unit
P.O. Box 8275
3503 RG Utrecht
By e-mail: BRI@cbg-meb.nl.