# 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: Module 5

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

Clinical information generated from clinical studies using on the precursor itself is not considered to be relevant in the specific case of a radio-pharmaceutical precursor intended solely for radio-labelling purposes.
However, information demonstrating the clinical utility of the radio-pharmaceutical precursor when attached to relevant carrier molecules shall be presented.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/III/division/2/division/2.2/division/3 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-III/division-2/division-2.2/division-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.