OpenLegislation

Article 7

United Kingdom

Original text. Later amendments are not shown.

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, F1kits or radionuclide precursors in accordance with the manufacturer's instructions.

Annotations

Textual amendments

F1

Substituted by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.