Labelling of outer/immediate packaging referred to in Article 11
ANNEX IIISupplementary provisions
ANNEX III Labelling of outer/immediate packaging referred to in Article 11 (a) The name of the medicinal product and, if appropriate, an indication of whether it is intended for babies, children or adults; the international non-proprietary name (INN) shall be included, or, if the product has no INN, the common name; (b) A description of the active substance(s) expressed qualitatively and quantitatively, including, where the product contains cells or tissues, the statement ‘This product contains cells of human/animal [as appropriate{] origin’ together with a short description of these cells or tissues and of their specific origin, including the species of animal in cases of non-human origin; (c) The pharmaceutical form and, if applicable, the contents by weight, by volume or by number of doses of the product; (d) A list of excipients, including preservative systems; (e) The method of use, application, administration or implantation and, if necessary, the route of administration. If applicable, space shall be provided for the prescribed dose to be indicated; (f) A special warning that the medicinal product must be stored out of the reach and sight of children; (g) Any special warning necessary for the particular medicinal product; (h) The expiry date in clear terms (month and year; and day if applicable); (i) Special storage precautions, if any; (j) Specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, where appropriate, as well as reference to any appropriate collection system in place; (k) The name and address of the marketing authorisation holder and, where applicable, the name of the representative appointed by the holder to represent him; (l) Marketing authorisation number(s); (m) The manufacturer’s batch number and the unique donation and product codes referred to in Article 8(2) of Directive 2004/23/EC; (n) In the case of advanced therapy medicinal products for autologous use, the unique patient identifier and the statement ‘For autologous use only’.