EU Community law for medicinal products

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Useful links:

http://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm

http://www.emea.europa.eu

Hierarchy of the laws in European Communities

The law is community acts adopted by the Community institution. According to their legal effects, they are classified as follows:

1. Legally binding acts - can be adopted by the European Parlament acting jointly with the Council, the Council, or the Commission:

• Regulation - is an act binding in its entirety and directly applicable in all Member States. It does not require any transposition by the national authorities.

• Directive - is an legal act binding upon the Member States to which it is addressed, as far as the results to be achieved are concerned; leaving the National Authorities the choice of form and methods

A Directive always leads to complementary nation measures. In order to take effect a Directive must be transposed into legal order of the Member States.

• Decision - is a legal act binding entirety upon those to who it is addressed ( Member State or legal or natural person).

2. “Soft Law”

• Resolution - is a declaratory act not provided for by the EC Treaty that is published by the Council and the European Parliament in order to inform of their positions on a specific subject, and, where necessary, that invites the Commission to propose the appropriate measures.

A resolution is rather a political than a legal act, it does not create a legal obligation.

• Communication - is an act not provided for by the EC Treaty, which is without binding legal effect.

It indicates governments and economic actors how the Commission is planning to apply or wishes to see applied a give Community rule.

The Court of Justice of the European Communities often supports its interpretation of legally bindings acts with Commission Communications.

• Guidelines- are texts covering technical topics, their legal status may differ:

Guidelines resulting from a formal request laid down in a Community Directive or Regulation are binding when those acts so provide, and must be complied with when the corresponding Directive or Regulation is implemented.

Guidelines spontaneously drawn up by the scientific committees are not legally binding; they present the best or more appropriate way to fulfill an obligation laid down in the Community rules.

• Notice to applicants - is guidance adopted pursuant to Article 6 of Regulation (EC) no 726/2004 and Annex I of Directive 2001/83/EC. The Commission publishes this guidance in “ The rules governing medicinal products in the European Union”, Volume 2 “Notice to applicants human medicinal product”. Volume 2 is divided in:

Volume 2A Procedures for marketing authorisarion

Volume 2B Prsentation and content of the dossier

Volume 2C Regulatory Guidelines