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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.
[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 Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
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.
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 ]
Our EU-GMP audit was completed on November 18th. ... We averaged 131 grams per plant in fiscal 2022, 158 grams in fiscal 2023, 175 grams in fiscal 2024, and are pleased to report a record-breaking ...
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially 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). [3]
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