# 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, Part II: SPECIFIC MARKETING AUTHORISATION DOSSIERS AND REQUIREMENTS

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

Some medicinal products present specific features which are such that all the requirements of the marketing authorisation application dossier as laid down in Part I of this Annex need to be adapted. To take account of these particular situations, an appropriate and adapted presentation of the dossier shall be followed by applicants.

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