3.—(1) The product must be manufactured in the United Kingdom, another member State or in Australia, Canada, New Zealand, or Switzerland (1).
(2) The product must have been manufactured by—
(a)the holder of a manufacturing authorisation if manufactured in the United Kingdom;
(b)the holder of a manufacturing authorisation issued under Directive (EC) No. 2001/82 if manufactured in another member State;
(c)in the case of Australia, Canada, New Zealand, or Switzerland, the holder of an authorisation from the competent authority permitting him to manufacture medicinal products.
(3) This paragraph shall not apply until 1st November 2007.
Australia, Canada, New Zealand and Switzerland are the only countries outside the European Union that have mutual recognition agreements on the manufacture of veterinary medicinal products with the European Union.