2. Legislative documents governing medicines regulation


1. Legislative documents governing medicines regulation

1.1. Regulations and directives

    • “Regulations” are legal acts that apply automatically and uniformly to all EU countries as soon as they enter into force, without needing to be transposed into national law. They are binding in their entirety for all EU member states (MS), but certain provisions may apply.
      For example, the Clinical Trials Regulation (CTR) ( Clinical Trial Regulation EU No. 536/2014 ) aiming at harmonizing and simplifying the conduct of Clinical Trials was adopted and entered into force in 2014. The timing of its application depends on confirmation of full functionality of a Clinical Trials Information System (CTIS). The Regulation becomes applicable six months after the European Commission publishes notice of this confirmation. When the Regulation becomes applicable, it will repeal the currently effective EU Clinical Trial Directive (EC) No. 2001/20/EC and national legislation that was put in place to implement the Directive (see next paragraph)

  • A “directive” is a legislative act that sets out a goal that all EU countries must achieve. The member states must introduce the requirements of the directive into their national legislation. However, it is up to the individual countries to devise their own laws on how to reach these goals, as long as they do not weaken the overall goal of the directive.
    For example, Directive 2001/83/EC states that you cannot market a medicine in the EU without having a MA. This requirement is now in the national law of each MS.

You can find all regulations and directives on the website of the European Commission https://ec.europa.eu/health/medicinal-products/eudralex/eudralex-volume-1_en