Regulation 17 Amendment of regulation 19 (exemptions from requirement for wholesale dealer's licence)I1

Regulation 19 M1 is amended as follows.

For paragraph (1)(a) substitute—

“(a)

the holder of—

(i)

in the case of a product for sale or supply in Great Britain, a UKMA(GB), a UKMA(UK), a COR(GB), a COR(UK), a THR(GB) or a THR(UK) (an “authorisation”) which relates to the product, or

(ii)

in the case of a product for sale or supply in Northern Ireland, a UKMA(NI), a UKMA(UK), a COR(NI), a COR(UK), a THR(NI), a THR(UK), an EU marketing authorisation or an Article 126a authorisation (an “authorisation”) which relates to the product,

including a holder of an authorisation who manufactured or assembled the product; or”.

In paragraph (1)(b), after “or assembled the product” insert “ in the United Kingdom ”.

At the end insert—

“(6)

Regulation 18 does not apply to a person (“P”) who imports a medicinal product into Great Britain from an approved country for import for administration to P or to any other person who is a member of P’s household.”.