Division 1 Qualitative particulars

‘Qualitative particulars’ of all the constituents of the medicinal product shall mean the designation or description of:

• active substance(s),

• the constituents of the excipients, whatever their nature or the quantity used, including colouring matter, preservatives, adjuvants, stabilisers, thickeners, emulsifiers, flavouring and aromatic substances,

• the constituents, intended to be ingested or otherwise administered to animals, of the outer covering of the veterinary medicinal products, such as capsules, gelatine capsules.

These particulars shall be supplemented by any relevant data concerning the immediate packaging and if relevant the secondary packaging and, where appropriate, its manner of closure, together with details of devices with which the medicinal product will be used or administered and which will be supplied with the medicinal product.