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This glossary gives definitions for the main regulatory terms used on this website and in European Medicines Agency (EMA) documents.

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English (Monolingual)

Not a glossary as much as a resource for templates for pharmaceutical information, package leaflets and product summaries for medical products in the EU.
"The Working Group on the Quality Review of Documents (QRD) was established in June 1996 and is composed of representatives from Member States' national authorities, the European Commissio... View more

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Many languages