# 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 (6)

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

In case where starting and raw materials, active substance(s) or excipient(s) are described neither in the European Pharmacopoeia nor in the pharmacopoeia of a Member State, compliance with the monograph of a third country pharmacopoeia can be accepted. In such cases, the applicant shall submit a copy of the monograph accompanied by the validation of the analytical procedures contained in the monograph and by a translation where appropriate.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/I/division/3/division/3.2/division/6 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-3/division-3.2/division-6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.