Regulation 262 Labelling requirements for radionuclides

(1)

Where a medicinal product contains radionuclides—

(a)

the carton and the container of the product must be labelled in accordance with the regulations for the safe transport of radioactive materials laid down by the International Atomic Energy Agency; and

(b)

the labelling on the shielding and the vial must comply with the remaining provisions of this regulation.

(2)

The label on the shielding must—

(a)

include the information specified in Part 1 of Schedule 24;

(b)

explain in full the codings used on the vial;

(c)

indicate, where necessary, for a given time and date, the amount of radioactivity per dose or per vial; and

(d)

indicate the number of capsules or, for liquids, the number of millilitres per container.

(3)

The label on the vial must include—

(a)

the name or code of the medicinal product, including the name or chemical symbol of the radionuclide;

(b)

the batch identification and expiry date of the product;

(c)

the international symbol for radioactivity;

(d)

the name and address of the manufacturer; and

(e)

the amount of radioactivity; as mentioned in paragraph 2(c).