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  2. EudraLex - Wikipedia

    en.wikipedia.org/wiki/EudraLex

    EudraLex is the collection of rules and regulations governing medicinal products in the European Union. Volumes. EudraLex consists of 10 volumes:

  3. List of European Union directives - Wikipedia

    en.wikipedia.org/wiki/List_of_European_Union...

    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]

  4. Validation (drug manufacture) - Wikipedia

    en.wikipedia.org/wiki/Validation_(drug_manufacture)

    FDA, or any other food and drugs regulatory agency around the globe not only ask for a product that meets its specification but also require a process, procedures, intermediate stages of inspections, and testing adopted during manufacturing are designed such that when they are adopted they produce consistently similar, reproducible, desired results which meet the quality standard of product ...

  5. Regulation of therapeutic goods - Wikipedia

    en.wikipedia.org/wiki/Regulation_of_therapeutic...

    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:

  6. Regulation (European Union) - Wikipedia

    en.wikipedia.org/wiki/Regulation_(European_Union)

    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 Pages displaying short descriptions of redirect targets

  7. European Medicines Agency - Wikipedia

    en.wikipedia.org/wiki/European_Medicines_Agency

    The Rules Governing Medicinal Products in the European Union (EudraLex) Health-EU Portal official public health portal of the European Union

  8. Category:European Union law - Wikipedia

    en.wikipedia.org/wiki/Category:European_Union_law

    EudraLex; EUR-Lex; Eurodac; European Arrest Warrant; European Authorized Representative; European banking union; European Case Law Identifier; European Centre of Tort and Insurance Law; European civil code; European Communities Act 1972 (Ireland) European Communities Act 1972 (UK) European Competition Law Review; European contract law; European ...

  9. Directive 75/318/EEC - Wikipedia

    en.wikipedia.org/wiki/Directive_75/318/EEC

    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.