This section has no associated Explanatory Memorandum
6. Where the holder of a manufacturer's licence distributes by way of wholesale dealing any exempt advanced therapy medicinal product manufactured or assembled pursuant to the licence that person must comply with—U.K.
(a)the requirements of paragraphs 15, 16, 18 and 19; and
(b)the guidelines on good distribution practice published by the European Commission in accordance with Article 84 of the 2001 Directive;
as if that person were the holder of a wholesale dealer's licence.