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