# 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 2.2: Radio-pharmaceutical precursors for radio-labelling purposes

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

In the specific case of a radio-pharmaceutical precursor intended solely for radio-labelling purposes, the primary objective shall be to present information which would address the possible consequences of poor radio-labeling efficiency or in vivo dissociation of the radio-labeled conjugate, i.e. questions related to the effects produced in the patient by free radio-nuclide. In addition, it is also necessary to present relevant information relating to occupational hazards, i.e. radiation exposure to hospital staff and to the environment.
In particular, the following information where applicable shall be provided:

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