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.
Source: https://www.cbg-meb.nl/actueel/nieuws/2020/03/23/wijzigingen-in-beleid-productinformatie