CRED ERP 25

01/07/2025

Types of secondary legislation (1/2)

Some types are binding, others are not. Some apply to all EU countries, others to just a few. Regulations: binding legislative act. It must be applied in its entirety across the EU. Directives: legislative act that sets out a goal that all EU countries must achieve. However, it is up to the individual countries to derive their own laws on how to reach these goals. Decisions: is only binding on those to whom it is addressed (e.g. an EU country or an individual company) and is directly applicable.

Recommendations / opinions: both non-binding instruments.

The Organisation for Professionals in Regulatory Affairs

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Types of secondary legislation (2/2)

Non-legislative acts e.g. Variation Regulation EC/1234/2008

Miscellaneous e.g Commission Communication on the Community marketing authorisation procedures for medicinal products (98/C 229/03): definition same MAH

The Organisation for Professionals in Regulatory Affairs

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