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EudraLex is the collection of rules and regulations governing medicinal products in the European Union. Volumes. EudraLex consists of 10 volumes: Concerning Medicinal ...
EudraLex; Directive 65/65/EEC1, requires prior approval for marketing of proprietary medicinal products; Directive 75/318/EEC; Directive 75/319/EEC, requires marketing authorization requests to be drawn up only by qualified experts; Directive 93/41/EEC; Directive 2001/20/EC; Regulation of therapeutic goods; European Medicines Agency
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 implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use) is a European Union directive that aimed at ...
Commission Directive 66/683/EEC of 7 November 1966 eliminating all differences between the treatment of national products and that of products which, under Articles 9 and 10 of the Treaty, must be admitted for free movement, as regards laws, regulations or administrative provisions prohibiting the use of the said products and prescribing the use of national products or making such use subject ...
Regulation (EC) No 536/2014; European Union regulation: Title: Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance
The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
The "Yellowstone" Season 5 finale just left viewers wanting more and they may just get their wish.On Dec. 15, the popular series wrapped up its fifth season with an explosive finale that killed ...
Directive 65/65/EEC; Directive 75/318/EEC; Directive 75/319/EEC; Directive 93/41/EEC; Directive 2001/83/EC; Medicare Part D coverage gap; Drug Efficacy Study Implementation; Drug labelling; Drug nomenclature; Drug Quality and Security Act; Drug utilization review; Drugs controlled by the German Narcotic Drugs Act; Durham–Humphrey Amendment