13. The requirements in paragraphs 14 to 20 apply to a wholesale dealer’s licence insofar as it relates to exempt advanced therapy medicinal products.
14. The licence holder must obtain supplies of exempt advanced therapy medicinal products only from—
(a)the holder of a manufacturer’s licence in respect of those products; or
(b)the holder of a wholesale dealer’s licence in respect of those products.
15. The licence holder must distribute an exempt advanced therapy medicinal product by way of wholesale dealing only to—
(a)the holder of a wholesale dealer’s licence in respect of those products; or
(b)a person who—
(i)may lawfully administer those products, and
(ii)solicited the product for an individual patient.
16. The licence holder must establish and maintain a system ensuring that the exempt advanced therapy medicinal product and its starting and raw materials, including all substances coming into contact with the cells or tissues it may contain, can be traced through the sourcing, manufacturing, packaging, storage, transport and delivery to the establishment where the product is used.
17. The licence holder must inform the licensing authority of any adverse reaction to any exempt advanced therapy medicinal product supplied by the holder of the wholesale dealer’s licence of which the holder is aware.
18. The licence holder must, subject to paragraph 44 of Schedule 4, keep the data referred to in paragraph 16 for a minimum of 30 years after the expiry date of the exempt advanced therapy medicinal product.
19. The licence holder must secure that the data referred to in paragraph 16 will, in the event that—
(a)the licence is suspended, revoked or withdrawn; or
(b)the licence holder becomes bankrupt or insolvent,
be held available to the licensing authority by the holder of a wholesale dealer’s licence for the period described in paragraph 18 or such longer period as may be required pursuant to paragraph 44 of Schedule 4.
20. The licence holder must not import or export any exempt advanced therapy medicinal product.