Directive 75/319/EEC
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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 The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been de ...
sought to bring the benefits of innovative pharmaceuticals to patients across
Europe Europe is a large peninsula conventionally considered a continent in its own right because of its great physical size and the weight of its history and traditions. Europe is also considered a subcontinent of Eurasia and it is located entirel ...
by introducing the mutual recognition, by Member States, of their respective national marketing authorisations. The Directive says 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 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. **Volume 2 - ...
* Directive 75/318/EEC * Directive 65/65/EEC1 * Directive 93/41/EEC *
Directive 2001/83/EC Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relates to medicinal products for human use in mainly countries that are part of the European Union. The Directive dealt with the disparitie ...
*
Regulation of therapeutic goods The regulation of therapeutic goods, defined as 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 reg ...
* European Medicines Agency


References


Second Council Directive 75/319/EEC of 20 May 1975
{{DEFAULTSORT:Directive 75 319 EEC Pharmaceuticals policy 75 319 1975 in law 1975 in the European Economic Community