How Janssen Complies with Legislation Across the EMEA Region

Janssen EMEA follows all legislation that is applicable to each part of the region as we are committed to the highest levels of integrity and trust in the healthcare solutions we provide.

Complying with EC Legislation and beyond in each country of the region

In the diverse region of Janssen EMEA, countries have similar but different legislation with regard to the distribution of pharmaceutical products. Local operating companies work within the parameters of these local regulations.

For the 28 countries belonging to the European Union there is some uniform legislation also in the form of both Regulations and Directives.

This legislation covers the following:

• Procedures to obtain a marketing authorisation for a new or enhanced medicine within EU Members States, including a pan-EU marketing authorisation
• Classification of medicines in different categories
• Manufacturing and importation
• Labelling and packaging
• Wholesale distribution of medicines
• Advertising of medicines
• Pharmacovigilance

EC Regulations apply directly to EU Member States, whilst EC Directives need to be enacted into local legislation first.

Some important example rules are:

• Prescription medicines can never be promoted to the general public
• The promotion of medicines to Healthcare Professionals must be in line with the approved label for that medicine
• There is strict regulation of hospitality to Healthcare Professionals at medical or scientific conferences.

Countries outside of the European Union in Europe, Africa and the Middle East have similar legislation.

For more information please don’t hesitate to contact us via our online form.