# 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: Module 4

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

The provisions of Module 4 shall apply to the simplified registration of homeopathic medicinal products referred to in Article 14(1) with the following specifications.
Any missing information must be justified, e.g., justification must be given why demonstration of an acceptable level of safety can be supported although some studies are lacking.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/III/division/3/division/2 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-III/division-3/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.