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publications

The MEB publishes a variety of documents. Below you can find an overview of publications regarding human medicines:

Most of the publications can be read online. You will need Adobe Acrobat Reader to read the PDF files. Download Acrobat Reader.

Newsletter
The MEB publishes the e-newsletter for marketing authorisation holders.

Click here to subscribe and for an overview of all newsletters.

Agendas and Minutes
As part of its drive for greater transparency, the MEB publishes agendas and minutes of MEB meetings covering non-confidential aspects of its work. These reports do not contain any (commercially) confidential information. Much of the information relating to European applications (via the centralised procedure, the mutual recognition procedure and the decentralised procedure) and national applications is regarded as commercially sensitive. That is why published reports only contain a limited amount of information, such as the role played by the Netherlands in a particular procedure (for example, that it is acting as (co-)rapporteur or as a Reference Member State).

The agendas and minutes can be accessed from ‘ About MEB/News'. On the right-hand side of this page is a grey section headed 'Agendas and Minutes' from which you can download the documents.

Public Assesment Reports
In Europe, marketing authorisations for medicinal products are issued after a review according to one of the four following procedures:

  1. a centralised procedure requesting one marketing authorisation for the entire European Union;
  2. a Mutual Recognition Procedure (MRP) requesting  marketing authorisation in one or more member states (Concerned Member States, CMSs) based on a marketing authorisation that has been issued in another member state (Reference Member State, RMS);
  3. a Decentralised Procedure (DCP) with two or more member states concurrently requesting a marketing authorisation, whereby one of these member states (Reference Member State, RMS) leads the approval process;
  4.  a national procedure requesting only a marketing authorisation in the Netherlands.

Marketing authorisations issued after these procedures have been successfully completed are published along with the assessment report (from which commercially confidential information has been deleted). Following the centralised procedure, the European Medicines Agency (EMEA) published the European Public Assessment Report (EPAR). The member states publish the other Public Assessment Reports (PARs) in the Product Index on the website of the Heads of Agencies (HMA).

For transparency purposes, the MEB publishes the agendas and reports of its meetings (after commercially confidential information has been deleted). The agendas and reports only include a small proportion of the decisions regarding applications because assessments of requests are not discussed in MEB meetings when they are performed exactly in accordance with previously determined MEB guidelines.

A Public Assessment Report (PAR) is drawn up once the MEB has made a decision on a medicinal product. The MEB publishes the public report of the discussions of the medicinal product at the same time as the PAR is published on its website. Please find this information on the ‘ Public Assessment Reports' page.

List of pharmaceutical products
The publishing firm Sdu Uitgevers publishes a list of pharmaceutical products once a quarter. The publication is edited by the Medicines Evaluation Board. It contains a summary of all the pharmaceutical products that are authorised for sale in the Netherlands. It is divided into four parts:

  • medicinal products ordered alphabetically by name;
  • medicinal products ordered by their RVG number;
  • medicinal products that have received marketing authorisation since the previous edition;
  • medicinal products that have been withdrawn since the previous edition.

The list of pharmaceutical products is published by SDU of The Hague.

List of homeopathic pharmaceutical products
Since 2010 the MEB has annually published a full overview of all homeopathic pharmaceutical products that are authorised for marketing in the Netherlands: the list of homeaopathic pharmaceutical products (in Dutch).

All homeopathic medicinal products lawfully on the market as of 1 July 2010 are listed in deze lijst. For each homeopathic product, the following particulars are given:

  • RVH number
  • Product name
  • Pharmaceutical administration form
  • Marketing authorisation holder
  • In preparations (if applicable): Mother tincture (Ø) or Mother tincture (MT)
  • Decimal potencies
  • Centesimal potencies
  • Korsakov potencies
  • LM potencies

All authorised medicinal products can also be found at the Database Human Medicines with extensive product information.

Geneesmiddelenbulletin
The MEB publishes articles on the latest changes in the field of Dutch and European marketing authorisations in the monthly-published journal Geneesmiddelenbulletin (Gebu).

View a list of meb articles published in GeBu (in Dutch)

The Geneesmiddelenbulletin (GeBu) is a Dutch-language journal published periodically by the Geneesmiddelenbulletin Foundation. The bulletin provides information about independent research into the action and composition of new and existing medicinal products and any adverse events associated with them. It is independent of the pharmaceutical industry and therefore a neutral source of information about medicinal products for Dutch doctors.

Direct Healthcare Professional Communication (DHPC)
In the case of urgent and/or important safety issues, Direct Healthcare Professional Communications are used to notify healthcare professionals. The MEB publishes DHPCs in the news section and in summary form in the Side effects & DHPCs section.

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