assessments

The assessment of application dossiers is done by the Botanicals and Novel Foods unit.

The Botanicals department of the MEB assesses the application on the basis of criteria laid down in the Dutch Medicines Act (Geneesmiddelenwet). Once it has finished the assessment, the Botanicals department provides the Board with a recommendation. The MEB then decides whether the traditional herbal medicinal product can be used safely and whether it meets the
quality standards for the preparation of a medicinal product. Part of the criteria is specific for the demonstration of the traditional nature of the medicinal product. Efficacy is assessed on the basis of a simplified procedure.

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. 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 MEB also decides on the legal status of the medicinal product, indicating whether it can only be obtained with a GP's prescription or can be purchased without a prescription from a drugstore, for example.

Applicants have the choice between two forms of marketing authorisation for a medicinal product: a national marketing authorisation and a European marketing authorisation.