is a legislative act
A legislative act is a formal written enactment produced by a legislature or by a legislative process. It may be contrasted with a non-legislative act which is adopted by an executive or administrative body under the authority of a legislative act or for implementing a legislative act....
of the European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
that becomes immediately enforceable as law in all member states simultaneously. Regulations can be distinguished from directives which, at least in principle, need to be transposed into national law
The incorporation of international law is the process by international agreements become part of the municipal law of a sovereign state. A country incorporates a treaty by passing domestic legislation that gives effect to the treaty in the national legal system....
. Regulations can be adopted by means of a variety of legislative procedures
The legislatureof the European Union is principally composed of the European Parliament and the Council of the European Union. Competencies in scrutinising and amending legislation are usually divided equally between the two, while the power to initiate laws is held by the European Commission...
depending on their subject matter.
The legal basis for the enactment of regulations is Article 288 of the Treaty on the Functioning of the European Union (formerly Article 249 TEC).
- Article 288
- To exercise the Union's competences, the institutions shall adopt regulations, directives, decisions, recommendations and opinions.
- A regulation shall have general application. It shall be binding in its entirety and directly applicable in all Member States.
- A directive shall be binding, as to the result to be achieved, upon each Member State to which it is addressed, but shall leave to the national authorities the choice of form and methods.
- A decision shall be binding in its entirety upon those to whom it is addressed.
- Recommendations and opinions shall have no binding force.
The Council can delegate legislative authority to the Commission and, depending on the area and the appropriate legislative procedure, both institutions can make laws. There are Council regulations and Commission regulations. Article 288 does not clearly distinguish between legislative acts and administrative acts, as is normally done in national legal systems.
Regulations are in some sense equivalent to "Acts of Parliament", in the sense that what they say is law and do not need to be mediated into national law by means of implementing measures. As such, regulations constitute one of the most powerful forms of European Union law
European Union law is a body of treaties and legislation, such as Regulations and Directives, which have direct effect or indirect effect on the laws of European Union member states. The three sources of European Union law are primary law, secondary law and supplementary law...
and a great deal of care is required in their drafting and formulation.
When a regulation comes into force, it overrides all national laws dealing with the same subject matter and subsequent national legislation must be consistent with and made in the light of the regulation. While member states are prohibited from obscuring the direct effect of regulations, it is common practice to pass legislation dealing with consequential matters arising from the coming into force of a regulation.
- Directive (European Union)
:Category:European Union regulations
- Law of the European Union
EUR-Lex is a service providing legal texts of the European Union on its official website europa.eu. Replacing the earlier service CELEX, EUR-Lex provides direct free access to European Union law. The system makes it possible to consult the Official Journal of the European Union and it includes...
EudraLex is the collection of rules and regulations governing medicinal products in the European Union.-Volumes:EudraLex consists of 10 volumes:*Concerning Medicinal Products for Human use:**Volume 1 - Pharmaceutical Legislation....