how are medicinal products brought to the market?

Medicinal products have to be granted marketing authorisation by the Medicines Evaluation Board (MEB) before they can be placed on the market.

Pharmaceutical companies that are applying for marketing authorisation for a medicinal product have to submit a dossier to the MEB. In particular, this dossier must contain chemical-pharmaceutical, pharmacological, toxicological and clinical information. This is data obtained from scientific research that the applicant has had carried out by contract research companies or in-house.

The MEB concentrates on the efficacy, safety and quality of the medicinal product when performing its assessment. Homeopathic medicinal products are assessed for safety and quality, but not for efficacy.

The MEB grants marketing authorisation to a medicinal product once examination of the data submitted by the applicant has shown that:

• the risk-benefit ratio is favourable;
• the medicinal product has the claimed therapeutic effect;
• the medicinal product has the qualitative and quantitative composition stated; and
• the data and documents submitted in support of the application comply with provisions laid down in or by virtue of this law.

Once the MEB has given a positive assessment of the medicinal product, the manufacturer receives marketing authorisation. The medicinal product is then added to the Register of Medicinal Products and given a marketing authorisation number or RVG number. The 'Summary of Product Characteristics' or product information is part of the marketing authorisation. This is the scientific text which contains all the key data about the product. Package leaflets are based on this text. Manufacturers submit a draft for these texts but the final version is drawn up by the MEB.

The work of assessing medicinal products is carried out by MEB staff working in Pharmaco Therapeutic groups I to IV. They keep their skills and knowledge up to date by maintaining strong, close links with universities, hospitals, the European Medicines Agency (EMA) and evaluation boards of the EU member states.

Chemical-pharmaceutical data and pharmacological and toxicological data are assessed on behalf of the MEB agency by experts at the National Institute for Public Health and the Environment (RIVM).