Paragraph 3 Manufacture
(1)
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 2001/82/EC 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;
(d)
in the case of any other country, a manufacturer whose premises have been inspected and approved by an officer of the Secretary of State.
(2)
This paragraph does not apply until 1st November 2007.