# 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)

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

All information, which is relevant to the evaluation of the medicinal product concerned, shall be included in the application, whether favourable or unfavourable to the product. In particular, all relevant details shall be given of any incomplete or abandoned pharmaco-toxicological or clinical test or trial relating to the medicinal product and/or completed trials concerning therapeutic indications not covered by the application.

---
Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/division/1/division/7 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/division-1/division-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.