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  2. EudraLex - Wikipedia

    en.wikipedia.org/wiki/EudraLex

    Download as PDF; Printable version; ... Free Trade Agreements; ... EudraLex is the collection of rules and regulations governing medicinal products in the European Union.

  3. Directive 2001/83/EC - Wikipedia

    en.wikipedia.org/wiki/Directive_2001/83/EC

    Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relates to medicinal products for human use in mainly countries that are part of the European Union. [1]

  4. EUR-Lex - Wikipedia

    en.wikipedia.org/wiki/EUR-Lex

    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.

  5. European Pharmacopoeia - Wikipedia

    en.wikipedia.org/wiki/European_Pharmacopoeia

    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]

  6. List of European Union directives - Wikipedia

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

    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 ...

  7. 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.

  8. Qualified person (European Union) - Wikipedia

    en.wikipedia.org/wiki/Qualified_person_(European...

    EudraLex, Volume 4, Chapter 1) The QP is typically a licensed pharmacist, biologist or chemist (or a person with another permitted academic qualification) who has several years' experience working in pharmaceutical manufacturing operations, and has passed examinations attesting to his or her knowledge. The requirement for QP oversight has been ...

  9. Help:Download as PDF - Wikipedia

    en.wikipedia.org/wiki/Help:Download_as_PDF

    In the Print/export section select Download as PDF. The rendering engine starts and a dialog appears to show the rendering progress. When rendering is complete, the dialog shows "The document file has been generated. Download the file to your computer." Click the download link to open the PDF in your selected PDF viewer.