Product information: Reference documents and guidelines

This page lists the reference documents and guidelines on the quality of product information for centrally authorised human medicines, including style, terminology, use of abbreviations and the translations of standard terms into European Union (EU) languages.

In light of the United Kingdom's (UK) withdrawal from the EU, several QRD reference documents are revised to reflect the provision that as of 1 January 2021, EU law applies in the UK only to the territory of Northern Ireland to the extent foreseen in the Protocol on Ireland / Northern Ireland. For more information see Brexit-related guidance for companies

Reference documents

Committee for Medicinal Products for Human Use (CHMP) scientific guidelines

Topics

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