The Human Medicines Regulations 2012

26.  The licence holder must ensure that the package leaflet of the exempt advanced therapy medicinal product shall include the following particulars—

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

(b) the intended effect of the medicinal product if correctly used, applied, administered or implanted;

(c) 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, where such cells or tissues are of animal origin, their specific origin;

(d) where the product contains a medical device or an active implantable medical device, a description of that device and, where that device contains cells or tissues of animal origin, their specific origin;

(e) any necessary instructions for use, including—

(i) the posology,

(ii) the method of use, application, administration or implantation and, if appropriate, the route of administration,

(iii) a description of symptoms of overdose,

(iv) action to be taken in the event of overdose, including any emergency procedures,

(v) action to be taken if one or more doses have been missed, and

(vi) a recommendation to consult the doctor or pharmacist for any clarification on the use of the product;

(f) where adverse reactions are known, a description of those which may occur under recommended conditions of use of the product and, if appropriate, an indication of action to be taken in such a case;

(g) an instruction that the patient report any adverse reaction not specified in the package leaflet to the doctor or pharmacist;

(h) the expiry date in clear terms and a warning against using the product after that date;

(i) any special storage precautions;

(j) a description of any visible signs of deterioration;

(k) a complete qualitative and quantitative composition;

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

(m) the date on which the package leaflet was last revised.