The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

3.—(1) Subject to the following sub-paragraphs, regulation 3(1) shall not apply to anything done—

(a) by a doctor or dentist which relates to a relevant medicinal product specially prepared by him, or to his order, for administration to one or more patients of his or, where that doctor or dentist is a member of a group of doctors or dentists working together to provide general medical or dental services, to one or more patients of any other doctor or dentist of that group, and consists of procuring the manufacture or assembly of a stock of the product with a view to administering the product to such patients; or

(b) in a registered pharmacy, a hospital or health centre and is done there by or under the supervision of a pharmacist, and consists of procuring the manufacture or assembly of a stock of relevant medicinal products with a view to dispensing them in accordance with paragraph 1.

(2) The exemption conferred by sub-paragraph (1) shall not apply to procuring the manufacture of relevant medicinal products unless those products are to be manufactured by the holder of a manufacturer’s licence which relates specifically to the manufacture or assembly of relevant medicinal products to which paragraph 1 applies.

(3) The exemption conferred by sub-paragraph (1) shall not apply to anything done by a doctor or dentist in relation to a stock held by him of such relevant medicinal products in excess of a total of 5 litres of fluid and 2.5 kilograms of solids of all relevant medicinal products to which that sub-paragraph relates.