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European Data Protection Board; ... EudraLex is the collection of rules and regulations governing medicinal products in the European Union. Volumes
EudraPharm (European Union Drug Regulating Authorities Pharmaceutical Database) was the database of medicinal products authorised in the European Union, and included the information contained in the Summary of Product Characteristics, the patient or user package leaflet and the information shown on the labelling.
EUR-Lex is the official online database of European Union law and other public documents of the European Union (EU), published in 24 official languages of the EU.The Official Journal (OJ) of the European Union is also published on EUR-Lex.
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]
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:
EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines or devices which have received marketing authorisation or are actively being studied in clinical trials in the European Economic Area (EEA).
The database serves as a quick reference for checking the good manufacturing practice (GMP) of a potential contract manufacturer. One can search by the “company name, location, or certificate number and find details on the types of products or activities that the company conducts and the date of the most recent GMP inspection.” [ 3 ]
Cover of the European Pharmacopoeia, 11th Edition. The European Pharmacopoeia [1] (Pharmacopoeia Europaea, Ph. Eur.) is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them. [1]