TITLE V

LABELLING AND PACKAGE LEAFLET
Article 66
1
The outer carton and the container of medicinal products containing radionuclides shall be labelled in accordance with the regulations for the safe transport of radioactive materials laid down by the International Atomic Energy Agency. Moreover, the labelling shall comply with the provisions set out in paragraphs 2 and 3.
2
The label on the shielding shall include the particulars mentioned in Article 54. In addition, the labelling on the shielding shall explain in full, the codings used on the vial and shall indicate, where necessary, for a given time and date, the amount of radioactivity per dose or per vial and the number of capsules, or, for liquids, the number of millilitres in the container.
3
The vial shall be labelled with the following information:
- the name or code of the medicinal product, including the name or chemical symbol of the radionuclide,
- the batch identification and expiry date,
- the international symbol for radioactivity,
- the name and address of the manufacturer,
- the amount of radioactivity as specified in paragraph 2.
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.