radiopharmaceutical
as defined in Directive 2001/83/EC of the European Parliament and of the Council of 6…, Article 1, point (6)
Any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medicinal purpose.
Install the extension for EUR-Lex
Also defined in
- Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on… 32014R0536, Article 2(1)
set out in points (2), (6), (11), (12), (23) and (24), respectively, of Article 1 of Directive 2001/83/EC apply