public assessment reports

The MEB publishes public assessment reports (PAR) containing a brief discussion of data from the marketing authorisation dossier. The report indicates 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 MEB publishes PARs for national ánd European procedures submitted and approved áfter October 2005.

The MEB also compiles a public assessment report when a medicine is  suspended and withdrawn because it is of importance to public health.

National marketing authorisation
The MEB produces national public assessment reports on products authorised in the Netherlands and are assessed for the first time in Europe by the Netherlands and which are not assessed in the mutual recognition procedure. Following this national marketing authorisation, a mutual recognition procedure can be started in other European Union countries.

European public assessment reports
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. 

Confidentiality
The information in an application dossier is considered confidential.