network

Together with 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 relationships:

• between scientific and clinical, toxicological and pharmaceutical expertise;
• in the distribution of tasks;
• in creating greater efficiency and public confidence in the system.

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.

NATIONAL NETWORK
The MEB works closely with national partners IGZ, RIVM and the Central Committee on Research inv. Human Subjects (CCMO) and Lareb.

Pharmacovigilance
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.

Oncology
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 vaccines
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 medicinal products.

Scientific integration
Many of the clinical assessors are also working as specialists at a university hospital, meaning that their knowledge and personal networks remain up-to-date.

Patient and consumer organisations
The MEB 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)
The 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 from:

• Biofarmind
  BioFarmind represents the interests of the biotech, pharmaceutical and life science industry – in short, the medical biotechnology industry in The Netherlands.
• Bogin
  Bogin – The Union of the Netherlands Generic Medicinal Product industry – represents the interests of manufacturers of generic medicinal products.
• CBD
  Centraal Bureau Drogisterijbedrijven (Central Office for Chemists). The CBD represents their members that are also marketing authorization holder.
• Nefarma
  Nefarma, the association for innovative medicinal products in The Netherlands, represents pharmaceutical companies involved in the development and marketing of new and innovative medicinal products.
• Neprofarm
  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.
• VES
  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.

EUROPEAN NETWORK

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 (COMP)
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 COMP.

Scientific Advice Working Party (SAWP)
All 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.