Regulation 9 Amendment to regulation 39 (further requirements for manufacturer’s licence)

In regulation 39^f1, substitute paragraph (8) with—

“(8)

In distributing a medicinal product by way of wholesale dealing, the licence holder must comply with the following as if they are a holder of a wholesale dealer’s licence—

(a)

regulations 43(1), (2) and (5), 43ZA and 44(5) and (6), and

(b)

regulation 43A, if applicable, where the product is being distributed in NI.”.