The Human Medicines Regulations 2012

25.  The licence holder must ensure that the immediate packaging of an exempt advanced therapy medicinal product is labelled to show the following particulars—

(a) the name of the exempt advanced therapy medicinal product;

(b) the expiry date in clear terms including the year and month and, if applicable, the day;

(c) a description of the active substance, expressed qualitatively and quantitatively;

(d) where the product contains cells or tissues of human or animal origin—

(i) a statement that the product contains such cells or tissues, and

(ii) a short description of the cells or tissues and of their specific origin;

(e) the pharmaceutical form and the contents by weight, volume or number of doses of the product;

(f) a list of excipients, including preservative systems;

(g) the method of use, application, administration or implantation and, if appropriate, the route of administration, with space provided for the prescribed dose to be indicated;

(h) any special storage precautions;

(i) specific precautions relating to the disposal of the unused product or waste derived from the product and, where appropriate, reference to any appropriate collection system;

(j) the name and address of the holder of the manufacturer’s licence;

(k) the manufacturer’s licence number;

(l) the manufacturer’s batch number;

(m) the unique donation code referred to in Article 8(2) of Directive 2004/23/EC; and

(n) where the exempt advanced therapy medicinal product is for autologous use, the unique patient identifier and the words “for autologous use only”.