national partners and as part of a
European regulatory network, the MEB is permanently responsible
for the evaluation and monitoring of authorised products for the
entire lifecycle. Any time there is a change in the clinical
benefit-risk ratio, for example due to new insights, data on
potential risks or changes to product specifications,
(re)evaluation takes place.
Synergy is pursued within these national and EU
- between scientific and clinical, toxicological and
- in the distribution of tasks;
- in creating greater efficiency and public confidence in the
The contribution to the team effort of creating the European
marketing authorisation and pharmacovigilance system is a key
strategic priority for the MEB. The MEB actively contributes on a
European level through participation in a large number of platforms
both within the European Medicines Agency (EMA) and beyond.
The MEB works closely with national
partners IGZ, RIVM and the Central Committee on Research inv. Human
Subjects (CCMO) and Lareb.
The MEB has collaborative
agreements with the Pharmacoepidemiology Department of Utrecht
University (UU) in the field of pharmacovigilance and the
University of Rotterdam (Erasmus MC). On the basis of this
collaboration, the MEB now plays a prominent role within Europe in
the assessment of
risk management plans (RMPs) for medicinal products. The
Netherlands Pharmacovigilance Centre Lareb runs the national
spontaneous reporting system on behalf of the MEB. Lareb collects
and analyses reports of suspected adverse events that are reported
by healthcare providers, patients and marketing authorisation
holders. Where necessary Lareb sends a signal to the MEB so that it
can take the matter further.
In the field of oncology the Board has
for some time been cooperating with the Dutch Cancer Institute
(NKI) in Amsterdam, while collaborative agreements have been
concluded with diabetes centres at the VU University Medical Centre
in Amsterdam and St Radboud UMC in Nijmegen.
Psychiatry, neurology and
Collaborations are being discussed with
Utrecht University in the fields of psychiatry, neurology and
vaccines. To strengthen the assessment of medicinal products for
children, the MEB has set up a group of
specialists in paediatric medicine.
This alliance is stimulating a fruitful exchange of information and
knowledge between the organisations, allowing for an even better
assessment of the balance between the risks and efficacy of
Many of the clinical
assessors are also working as specialists at a university hospital,
meaning that their knowledge and personal networks remain
Patient and consumer organisations
maintains contact with consumers/patients through patient and
consumer organisations. The MEB organises
meetings with patient and consumer organisations four times a
year to exchange information and hold discussions. This is
importand for these organisations because it keept them up to date
on information about new developments in medicines. For the MEB
this exchange is important because the contact with the
organisations provides a good insight into the use of medicines.
Topics of discussion include the package leaflet, repeat
prescriptions, over-the-counter medicines (medicines available
without a prescription) and medicines for children.
Authorisation Contact Committee (CCR)
Authorisation Contact Committee (CCR) is a consultation between the
Medicines Evaluation Board and umbrella organisations for the
pharmaceutical industry. During the meetings, topics of mutual
interest are discussed and where possible agreements are made in
order to solve shared problems. The CCR consists of representatives
BioFarmind represents the interests of the biotech, pharmaceutical
and life science industry – in short, the medical biotechnology
industry in The Netherlands.
Bogin – The Union of the Netherlands Generic Medicinal Product
industry – represents the interests of manufacturers of generic
Centraal Bureau Drogisterijbedrijven (Central Office for Chemists).
The CBD represents their members that are also marketing
Nefarma, the association for innovative medicinal products in The
Netherlands, represents pharmaceutical companies involved in the
development and marketing of new and innovative medicinal
Neprofarm is the Dutch Association of the Pharmaceutical Industry
of Self-Care Medicines and Health Products, and represents the
interests of manufacturers and importers of authorised medicines
available without prescription.
Association of Euro Specialités. The VES represents applicants for
parallel marketing authorisations.
There are two different CCR meetings: during the Regular CCR,
topics of discussion are primarily policy-related, such as new
legislation and regulations and internal projects. Issues such as
backlogs are also addressed. The Practice CCR is the place for
discussing practical issues surrounding review of
applications. The status of the discussions of the CCR are
laid down in
this document (only available in Dutch).
The reports of the CCR minutes (in Dutch) are publicly
accessible via the website
Over CBG > Publicaties > Agenda's & Verslagen.
The European system for the marketing authorisation of medicinal
products is unique in the world. Each EU Member State has its own
experience, medical culture and expertise. In order to consolidate
these resources as far as possible, the regulatory authorities have
built up a network, which receives assistance and support from the
European Medicines Agency (EMEA). Thanks to this network, national
regulatory authorities are able to share the workload and exploit
each others’ expertise to the full.
Co-ordination group for Mutual recognition and
Decentralised procedures (CMD)
Within the network, the
marketing authorisation agencies cooperate in several different
ways. Via the Co-ordination group for Mutual recognition and
Decentralised procedures (CMD human/veterinary) the nationally
responsible agencies cooperate in assessing medicinal products. Ms
Truus Janse-de Hoog is, on behalf of the Netherlands, chair of CMD
(human) and drs. Kora Doorduyn is a member of CMDh. For the
centralised procedure, medicinal products are assessed by the
European scientific committee (CHMP/CVMP). Within this committee,
the reporter and co-reporter coordinate the nationally available
expertise for a European assessment. EMeA primarily has a
supportive role in this area. On behalf of the Netherlands, Dr
Barbara van Zwieten is a member of CHMP, and Prof. Pieter de Graeff
is an acting member.
The Committee for Orphan Medicinal Products
The Committee for Orphan Medicinal Products
(COMP) operates in a similar manner. Each country is also
represented by a member in the group, who, together with the
coordinator from EMeA is responsible for assessing whether a
certain product can be awarded the status orphan medicinal product.
Dr Bettie Voordouw is, on behalf of the Netherlands, a member of
Scientific Advice Working Party (SAWP)
Members of the Scientific Advice Working Party (SAWP) are chosen on
the basis of expertise. Not all 27 EU countries are represented, Dr
Christine Gispen-de Wied and Dr Hans Ovelgönne are the Dutch
members of the SAWP.
No agency has all of the requisite expertise in-house and few
regulatory authorities can provide the highly specialised knowledge
that is needed in order to resolve every problem directly. However,
the European network ensures that the available knowledge is
consolidated, and that each Member State makes its own
contribution. The Netherlands plays an important role in Europe by
actively participating in the network and through its efforts on
many committees. The Netherlands is represented in many commitees,
including the Pharmacovigilance Working Party, the Efficacy Working
Party, the Quality Working Party and the Safety Working Party.