Cooperation in the Netherlands

The MEB is working to ensure high quality and reliable medicines in the Netherlands. We cannot do this alone. That is why we are working closely with various national chain partners and (patient) organisations.

The Central Committee for Research Involving Human Subjects (CCMO)

The CCMO is responsible for protecting research subjects involved in medical-scientific research. As part of this work the Committee is assessing, together with the medical-ethical review committees in our country, whether the research fulfils the statutory requirements. The MEB is working in a pilot on joint scientific advice together with the CCMO.

The National Health Care Institute

The National Health Care Institute (ZiN) starts its work after the MEB has issued a market authorisation for a particular medicine. It advises the Minister for Medical Care and Sport as to whether a medicine is eligible for the Medicine Reimbursements Scheme. In doing so it assesses whether the price of medicine is justifiable. Currently, the MEB and ZiN are working on, among other things, reducing the time between the authorisation and the reimbursement of a medicine in the pilot entitled 'Parallel MEB-ZIN Procedures'. The MEB is also providing scientific advice, together with the ZiN, whenever a company has questions about the authorisation of, and the reimbursement procedure for, medicines.

Health and Youth Care Inspectorate

The Health and Youth Care Inspectorate (IGJ) supervises the safety and quality of medicines in daily practice. This means that, among other things, it performs checks on medicine manufacturers. The MEB and the IGJ collaborate intensively whenever there are problems relating to the quality of medicine. For example, the IGJ can decide, based on recommendations from the MEB, whether a medicine has to be recalled if the pharmaceutical ingredient is contaminated. We also cooperate on resolving medicine shortages and on the dissemination of risk communications and urgent, new information about medicines.

Netherlands Pharmacovigilance Centre Lareb

On the instructions of the MEB, Netherlands Pharmacovigilance Centre Lareb manages the national spontaneous reports system. Lareb collects and analyses reports of suspected adverse reactions passed on by healthcare providers, patients, and marketing authorisation holders. If necessary, the Lareb informs the MEB. The Board then decides whether any action has to be taken. For example, the MEB can amend the patient information leaflet or warn care providers about risks. The Lareb can also publish information independently.

The National Institute for Public Health and the Environment (RIVM)

The National Institute for Public Health and the Environment (RIVM) investigates, among other things, medicine safety and use. RIVM also advises organisations such as the MEB. The MEB and RIVM are also collaborating on the non-animal testing patient-safe development of medicines.

National consultations

The MEB regularly consults with patients (representatives), care providers and representatives from the pharmaceutical industry. In the Medical Practice Committee, the MEB is in discussion with doctors, pharmacists, pharmacy assistance and nurses. In addition to that there are periodical consultations with patient and consumer organisations. For example, the MEB keeps a close eye on experiences with medicines in practice. The subjects discussed include the patient information leaflet, repeat prescriptions, over-the-counter medicines and medicines for children, medicine shortages and patient information on important safety issues.

The MEB consults with chain partners about the development of ATMPs in the Advanced Therapy Medicinal Products (ATMP) Committee. ATMPs include products for tissue manipulation and gene and somatic cell therapy. In the Contact Committee on Authorisation (CCR), a dialogue takes place between the MEB and representatives from the pharmaceutical industry. During these meetings the participants discuss current and new developments and, where possible, they make arrangements on how to resolve shared problems.