# 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 4

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

It is appreciated that toxicity may be associated with a radiation dose. In diagnosis, this is a consequence of the use of radio-pharmaceuticals; in therapy, it is the property desired. The evaluation of safety and efficacy of radio-pharmaceuticals shall, therefore, address requirements for medicinal products and radiation dosimetry aspects. Organ/tissue exposure to radiation shall be documented. Absorbed radiation dose estimates shall be calculated according to a specified, internationally recognised system by a particular route of administration.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/III/division/2/division/2.1/division/2 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-III/division-2/division-2.1/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.