# 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 7: MIXED MARKETING AUTHORISATION APPLICATIONS

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

Mixed marketing-authorisation applications shall mean marketing-authorisation application dossiers where Module 4 and/or 5 consists of a combination of reports of limited non-clinical and/or clinical studies carried out by the applicant and of bibliographical references. All other Module(s) are in accordance with the structure described in Part I of this Annex. The competent authority shall accept the proposed format presented by the applicant on a case by case basis.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/II/division/7 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-II/division-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.