Directive 2001/83/EC of the European Parliament and of the CouncilDangos y teitl llawn

Article 7 U.K.

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, [F1 kits] or radionuclide precursors in accordance with the manufacturer's instructions.

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.