# Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, Division (5)

Extent: E+W+S+N.I.

With respect to the quality part (chemical, pharmaceutical and biological) of the dossier, all monographs including general monographs and general chapters of the European Pharmacopoeia are applicable.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/division/1/division/5 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/division-1/division-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.