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  2. 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]

  3. Drug labelling - Wikipedia

    en.wikipedia.org/wiki/Drug_Labelling

    The details of label includes the name of preparation, quantity of drugs, instructions for patients, patient's name and the date of dispensing. Drug labelling, also referred to as prescription labelling, is a written, printed or graphic matter upon any drugs or any of its container, or accompanying such a drug. Drug labels seek to identify drug ...

  4. CLP Regulation - Wikipedia

    en.wikipedia.org/wiki/CLP_Regulation

    The CLP Regulation [1] (for "Classification, Labelling and Packaging" [2]) is a European Union regulation from 2008, which aligns the European Union system of classification, labelling and packaging of chemical substances and mixtures to the Globally Harmonised System (GHS).

  5. Medication package insert - Wikipedia

    en.wikipedia.org/wiki/Medication_package_insert

    The list of 1997 drug labelling changes can be found on the FDA's website, here. The first patient package insert required by the FDA was in 1968, mandating that isoproterenol inhalation medication must contain a short warning that excessive use could cause breathing difficulties.

  6. European Directorate for the Quality of Medicines & HealthCare

    en.wikipedia.org/wiki/European_Directorate_for...

    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 ...

  7. Regulation of therapeutic goods - Wikipedia

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

    EU legislation requires that each Member State operates to the same rules and requirements regarding the authorisation and monitoring of medicines. [20] 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 ...

  8. 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 ...

  9. Directive 67/548/EEC - Wikipedia

    en.wikipedia.org/wiki/Directive_67/548/EEC

    The appropriate standard phrases must appear on the packaging and label of the product and on its MSDS. Annex I specifies the standard phrases to be used for substances that are listed there: these are obligatory. The lists of standard phrases were updated in 2001, and Directive 2001/59/EC provides a consolidated list in all EU languages. [8]