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EudraLex is the collection of rules and regulations governing medicinal products in the ... Guidelines on Good Distribution Practice of Medicinal Products for Human ...
Within the EU, EudraLex maintains the collection of rules and regulations governing medicinal products in the European Union, and the European Medicines Agency acts to regulate many of these rules and regulations. Amongst these rules and regulations are:
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 distribution of medications has special drug safety and security considerations. [1] Some drugs require cold chain management in their distribution. [2]The industry uses track and trace technology, though the timings for implementation and the information required vary across different countries, with varying laws and standards.
The Rules Governing Medicinal Products in the European Union (EudraLex) Health-EU Portal official public health portal of the European Union
EudraLex, Volume 4, Chapter 1) The QP is typically a licensed pharmacist, biologist or chemist (or a person with another permitted academic qualification) who has several years' experience working in pharmaceutical manufacturing operations, and has passed examinations attesting to his or her knowledge. The requirement for QP oversight has been ...
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.
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.