Directive 75/319/EEC

Directive 75/319/EEC

Directive 75/319/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products. This directive of the European Union sought to bring the benefits of innovative pharmaceuticals to patients across Europe by introducing the mutual recognition, by Member States, of their respective national marketing authorisations.

The Directive states that Member States shall take all appropriate measures to ensure that the documents and particulars for marketing authorization requests are drawn up by experts with the necessary technical or professional qualifications before they are submitted to the competent authorities.

See also

* EudraLex
* Directive 75/318/EEC
* Directive 65/65/EEC1
* Directive 93/41/EEC
* Directive 2001/83/EC
* Regulation of therapeutic goods
* European Medicines Agency

References

* [http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31975L0319:EN:HTML Second Council Directive 75/319/EEC of 20 May 1975]


Wikimedia Foundation. 2010.

Игры ⚽ Нужно решить контрольную?

Look at other dictionaries:

  • Directive 93/41/EEC — of 14 June 1993 on the approximation of national measures relating to the placing on the market of high technology medicinal products, particularly those derived from biotechnology. The Directive offered two routes for authorising medicinal… …   Wikipedia

  • Directive 75/318/EEC — of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products. This directive of the European Union …   Wikipedia

  • Directive 2001/20/EC — or Clinical Trials Directive of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, Regulations and administrative provisions of the Member States relating to implementation of good clinical practice in… …   Wikipedia

  • Directive 2001/83/EC — of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. The Directive dealt with the disparities between certain nationalprovisions, in particular between provisions… …   Wikipedia

  • Directive 2005/28/EC — The Directive 2005/28/EC or Good Clinical Practice Directive, of 8 April 2005 of the European Parliament and of the Council, lays down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for …   Wikipedia

  • Clinical Trials Directive — The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to… …   Wikipedia

  • List of European Union directives — The following is an incomplete thematic list of European Union directives :Anti discrimination measures*Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic… …   Wikipedia

  • EudraLex — is the collection of rules and regulations governing medicinal products in the European Union.VolumesEudraLex consists of 10 volumes: *Concerning Medicinal Products for Human use: **Volume 1 Pharmaceutical Legislation. **Volume 2 Notice to… …   Wikipedia

  • Regulation of therapeutic goods — The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are… …   Wikipedia

  • Dexfenfluramine — La dexfenfluramine, commercialisée par les laboratoires Servier sous le nom d Isoméride ou de Redux, est une substance active médicamenteuse aux propriétés anorexigènes (effet « coupe faim ») qui agit directement sur les récepteurs… …   Wikipédia en Français

Share the article and excerpts

Direct link
Do a right-click on the link above
and select “Copy Link”