# 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 (2): Herbal Medicinal Products

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

With respect to the formulation development, a brief summary describing the development of the herbal medicinal product should be provided, taking into consideration the proposed route of administration and usage. Results comparing the phyto-chemical composition of the products used in supporting bibliographic data and the herbal medicinal product applied for shall be discussed, where appropriate.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/III/division/4/division/1/division/2 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-III/division-4/division-1/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.