Paragraph 3 ManufactureI1

the holder of a manufacturing authorisation if manufactured in the United Kingdom;

the holder of a manufacturing authorisation issued under Directive (EC) No. 2001/82 if manufactured in another member State;

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;

in the case of any other country, a manufacturer whose premises have been inspected and approved by an officer of the Secretary of State.