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EudraGMP is part of the EU telematics strategy, which has been conceived in order to meet the strategic objectives of the European Commission, the European Medicines Agency and the Member State competent authorities. EudraGMP is part of a larger database known as EudraGMDP, which contains information on: “Manufacturing and import authorisations
Similarly, The Rules Governing Medicinal Products in the European Union, Volume 4, Annex 11: Computerised Systems applies to all forms of computerized systems used as part of a GMP regulated activities and defines Computer System Validation Elements [2]
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.
Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use. Many countries have legislated that manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.
[1] [2] The initial members comprised the 10 member countries of EFTA at that time. In the early 1990s it was realized that because of an incompatibility between the Convention and European law, it was not possible for new countries to be admitted as members of PIC. European law did not permit individual EU countries that were members of PIC to ...
The European Committee for Food Contact Materials and Articles (CD-P-MCA) [37] is tasked with developing and strengthening harmonised measures that supplement EU and national legislation to ensure the safety of packaging, containers, utensils and other materials and articles for food contact. It is supported by two subordinate bodies: the ...
The European Union reached a blockbuster free trade agreement Friday with Brazil, Argentina and the three other South American nations in the Mercosur trade alliance, capping a quarter-century of ...
This list of European Union Directives is ordered by theme to follow EU law. For a date based list, see the Category:European Union directives by number. From 1 January 1992 to 31 December 2014, numbers assigned by the General Secretariat of the Council followed adoption, for instance: Directive 2010/75/EU. [1]