# 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 5.2.7: Case reports forms and individual patient listings

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

When submitted in accordance with the relevant Guideline published by the Agency, case report forms and individual patient data listings shall be provided and presented in the same order as the clinical study reports and indexed by study.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/I/division/5/division/5.2/division/5.2.7 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-5/division-5.2/division-5.2.7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.