Changes to product information policy

Changes to product information policy

The Netherlands The Medicines Evaluation Board (MEB) recently revised 2 policy documents relating to the requirements for product information: “labelling of pharmaceutical products” and “Nomenclature of pharmaceutical products”. The revision only applies to medicinal...
Public consultations on labeling and naming policy

Public consultations on labeling and naming policy

The Netherlands The Medicines Evaluation Board (MEB) invites interested parties and stakeholders to comment on 2 amended policy documents on the labeling of medicines for humans (MEB 6) and the naming of pharmaceutical products (MEB 13). The most important changes are...

Policy adjustment of patient information on the MEB website

The Netherlands The Medicines Evaluation Board (MEB) will no longer publish full product information about the active substance of generic medicines on its website if there is still a patent on one of the indications. A generic drug may not be sold for indications...

New Advisory Group for borderline medicinal products

The Netherlands An ‘Advisory Group on the Status Determination of Medicinal Products has been established in the Netherlands. This Advisory Group is composed of expert representatives from IGJ, NVWA, MEB and CCMO. The ‘Advisory Group’ advises on...