31Label

31 Label

(1) If the variation proposed affects an approved label, the application must contain, or be accompanied by, the following information to the extent that the information is affected by the variation: (a) the particulars prescribed for paragraph 21(a) of the Code that are appropriate to be stated on the label; and (b) any instructions proposed to be stated on the label; (c) any information required by regulation 18E of the Regulations to be stated on the label. (2) The information must be presented in a way that shows how the variation affects the information (for example, all additions and deletions must be clearly identified).