# 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, Article 7

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

A marketing authorization shall not be required for a radiopharmaceutical prepared at the time of use by a person or by an establishment authorized, according to national legislation, to use such medicinal products in an approved health care establishment exclusively from authorized radionuclide generators, kits or radionuclide precursors in accordance with the manufacturer's instructions.

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