# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 17: Amendment of regulation 19 (exemptions from requirement for wholesale dealer's licence)

Extent: E+W+S+N.I.

(1) Regulation 19 is amended as follows.
(2) 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”.
(3) In paragraph (1)(b), after “or assembled the product” insert “ in the United Kingdom ”.
(4) 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.”.

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Source: https://www.legislation.gov.uk/uksi/2019/775/regulation/17 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-17
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.