Division 6 The following particulars shall appear on the immediate and the outer packaging:

name of the main contact;

name of the medicinal product, followed by its strength and pharmaceutical form;

statement of the active substances expressed qualitatively and quantitatively per dosage unit;

batch or code number identifying the contents and packaging operation;

clinical trial reference code allowing identification of the clinical trial site, investigator and subject;

directions for use (reference may be made to a leaflet or other explanatory document intended for the subject or person administering the product);

’For clinical trial use only’ or similar wording;

the storage conditions; and

period of use (expiry date or retest date as applicable).