Package leaflets
50.—(1) If it is not reasonably practicable to have all the required information on the immediate packaging or all of this information on the outer packaging, there must be a package leaflet supplied with the product, containing all the required information except for the batch number and the expiry date, and including the name of both the marketing authorisation holder and, if different, the name of the distributor named in the marketing authorisation.
(2) If there is a package leaflet, the immediate packaging and the outer packaging must both refer the user to it.
(3) A package leaflet must relate solely to the veterinary medicinal product with which it is included.
(4) It must be written in plain English.
(5) Only a package leaflet approved in the marketing authorisation may be included with the veterinary medicinal product.