SCHEDULES
SCHEDULE 6Manufacturer's and wholesale dealer's licences for exempt advanced therapy medicinal products
PART 1Manufacturer's licences
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—
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.