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 products for human use.

The main changes can be found in the following sections:

Labelling of pharmaceutical products:
• 5.1.3. Packaging for more than one country
• Layout: image and text
   o 6.1 Introduction
   o 6.3. Assessment criteria
   o 6.4.4 Safety features

Nomenclature of pharmaceutical products
• 4. Purpose and scope
   o No name confusion
   o Not for promotional purposes
• 5.3 Name of the marketing authorisation holder
• 10.1 Combination packages and combination products
   o Combination packaging
   o Combination product

The new policy comes into effect immediately.


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