# 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 5.2.1: Reports of bio-pharmaceutics studies

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

Bio-availability study reports, comparative bio-availability, bio-equivalence study reports, reports on in vitro and in vivo correlation study, and bio-analytical and analytical methods shall be provided.
In addition, an assessment of bio-availability shall be undertaken where necessary to demonstrate bio-equivalence for the medicinal products referred to in Article 10 (1) (a).

---
Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/I/division/5/division/5.2/division/5.2.1 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-5/division-5.2/division-5.2.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.