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Eudralex,The Rules Governing Medicinal Products in the European Union, European Communities Commission. Directorate-General for Industry, Pharmaceuticals and Cosmetics. Vol. 1: Pharmaceutical legislation: medicinal products for human use. ISBN 92-828-2032-7; Vol. 2: Notice to applicants: medicinal products for human use. ISBN 0-11-975780-X
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 ...
European Union Directive 2001/82/EC [4] and Directive 2001/83/EC, [5] (as amended) state the legally binding character of European Pharmacopoeia texts for Marketing Authorisation Applications (MAA). All manufacturers of medicines or substances for pharmaceutical use therefore must apply the European Pharmacopoeia quality standards in order to ...
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 European Directive on Traditional Herbal Medicinal Products (THMPD), formally the Directive 2004/24/EC amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use, was established by the European Parliament and Council on 31 March 2004 to provide a simplified regulatory approval process for traditional ...
Many medications your doctor might recommend are available over the counter. They may include: Products that numb your skin, such as lidocaine. Ibuprofen (Advil) or other anti-inflammatory drugs.
The directive applies since 2 January 2013. The European Commission Delegated Regulation, (EU) 2016/161, supplements Directive 2001/83/EC with rules regarding safety features for the packaging of medicinal products for human use. The regulation was adopted in October 2015.