Transparent and careful decision-making
The MEB intends to ensure maximum transparency with respect to viewpoints adopted and decisions taken, and to make the information at the MEB available to patients and health care professionals (physicians and/or pharmacists). The main objective of creating transparency is to ensure that the MEB can be externally evaluated.
Public access to the agenda and minutes of MEB meetings and decisions
The MEB attaches considerable importance to the principles of transparency and openness towards the public. In addition, this basic rule is enshrined in specific legislation and regulations with which the MEB is obliged to comply, such as the Government Freedom of Information Act (Wob) and the Personal Data Protection Act (Wbp). Pursuant to these Acts, data which can be traced back to individual persons and which represents commercial interests is confidential.
Co-operation within the European network likewise obliges the MEB to exercise restraint with respect to disclosure in current procedures in which dossiers and (preliminary) assessment reports are exchanged within the European Union. The agenda and minutes of MEB meetings are available to the public by law, and the MEB publishes assessment reports which are likewise available to the public. National licenses are published in the Medicines Data Bank, which can be accessed on the MEB website. If the licenses in question are European, the MEB refers users to the European Medicines Agency website (EMA).
Reporting procedure recorded in an electronic documentation system
The MEB’s decisions are recorded under each product or group of products in an electronic documentation system. Since the MEB is responsible for the entire life cycle of a medicinal product, this task also includes the registration of irregularities or unforeseen occurrences varying from hitches in the application procedure to integrity violations, and decision-making on such matters.
The MEB takes minutes of the meetings, including items on the agenda, decisions made and points for action. These minutes also include decisions concerning policy, strategy, guidelines and posts on the website. The agenda and minutes of the MEB meetings are published on our website.
The General Administrative Law Act (Awb) stipulates that a governing body such as the MEB must prepare its decisions carefully. This means that the MEB must collect all relevant data and documents to make a decision. A number of conditions must be met to guarantee a careful decision-making process.
For example, data and documents added to the application must be checked to ensure that they are complete. If the MEB intends to pass a negative judgement on an application ("reject" the application), then the applicant must first be given the opportunity to give their opinion on this proposed judgement. If the MEB intends to make a ruling on e.g. suspension, withdrawal or amendment of dispensing status, then the marketing authorisation holder must again be given the opportunity to give their opinion on this proposal. Only then can the MEB make a ruling. In addition, any party listed as a third-party affected party can submit their opinion on a proposed judgement before the MEB makes its ruling.
These opinions can be submitted either in writing or verbally. Verbally presented opinions can be presented during a hearing. This allows for clarification and explanation of the opinion and allows for MEB questions to be answered. A written opinion will suffice if the party does not want a hearing. The opinions will be evaluated at the MEB by a dedicated Advisory Committee.