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The Veterinary Medicines Regulations 2005
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49.—(1) If it is not reasonably practicable to have all the information in paragraph 47 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 information in paragraph 47 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 shall relate solely to the veterinary medicinal product with which it is included.
(4) It must be written in terms that are comprehensible to the general public.
(5) Only a package leaflet approved in the marketing authorisation may be included with the veterinary medicinal product.
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