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Download as PDF; Printable version; In other projects ... EudraLex is the collection of rules and regulations ... Guidelines on Good Distribution Practice of ...
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.
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 ...
The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...
Under this legislation, all applications for marketing authorisation of new medicinal products, or variations to existing authorisations, have to either include data from paediatric studies previously agreed with the PDCO, or obtain a PDCO waiver or a deferral of these studies. [23]
Finally, in 1997 a web version was launched and named EUR-Lex, hosted by the Publications Office of the European Union. The EUR-Lex website was opened to the public in 2001, while CELEX still existed as a separate database until the end of 2004. Subsequently, steps were undertaken to merge the two services and to make them completely free of ...
EudraLex – EU laws on medicinal products; EUR-Lex – Official website of EU Law and documents; European Union law – System of rules within the European Union; Framework decision – Former EU law on criminal justice; List of European Union directives; List of European Union regulations
EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice.The EudraGMP system was launched in April 2007, for use by European Medicines Regulators.