public assessment reports on homeopathy

The MEB publishes national assessment reports containing a brief discussion of data from the marketing authorisation dossier. The reports indicate the data which served as a basis for granting marketing authorisation or which caused the product information to be changed at a later stage. This information can promote good pharmacotherapy on the part of doctors, pharmacists and other healthcare professionals and students.

The content of a marketing authorisation dossier is regarded as confidential. To this end, the MEB has established a covenant with the pharmaceutical companies in the Netherlands on the issue of public reports. It contains general agreements on publication and the role of companies in the production of the report.

The MEB produces national public assessment reports on products authorised in the Netherlands that contain a new active ingredient and are assessed for the first time in Europe by the Netherlands. Following this national marketing authorisation, a mutual recognition procedure can be started in other European Union countries.

European public assessment reports are also drawn up by other European Union countries. This happens when a product is first assessed in another European Union country and is granted marketing authorisation in the Netherlands under a mutual recognition procedure. These public assessment reports are published on the HMA website, under Product Index.

The MEB’s national public assessment reports contain a brief discussion of data from the marketing authorisation dossier. The reports indicate the data which served as a basis for granting marketing authorisation or which caused the product information to be changed at a later stage. This information may contribute to good pharmacotherapy by doctors, pharmacists or others involved with medicinal products for professional or study reasons.