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  • Writer's pictureFarbridge Pharma Consulting

What is the difference between a Directive and a Regulation in the EU?

Updated: Aug 9, 2018

This is an interesting topic for QA auditors and companies planning to work with Europe or opening an European Affiliate.

A "Regulation" is defined as a binding legislative act. It is immediately applicable in its entirety in all Member States and it overrules national laws.

A "Directive" is a legislative act setting objectives that all EU countries must reach and translate into their national legislation within a defined time frame. However, it is up to the individual countries to define how to achieve these goals by implementing them in their local laws. They are free to add stricter requirements. As a consequence, a Directive may be enforced in different manners in the EU Member States.

Therefore, Quality Professionals should be aware that when their audits or activities falls under the scope of an EU Directive, they should also consider the relevant national legislation in order to have a comprehensive understanding of all the applicable requirements.


#farbridge #pharma #directive #regulation #europeanunion #blog #consulting

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