# The Human Medicines (Amendment etc.) (EU Exit) (No. 2) Regulations 2021, Regulation 6: Amendment of regulation 43 (obligations of licence holder)


In regulation 43(6)(d)—
(a) at the end of sub-paragraph (i), omit “or”;
(b) in sub-paragraph (ii), for “import.” substitute “import; or”; and
(c) at the end insert—
“(iii) from the United Kingdom to a person in an EEA State, if the distribution is specifically for purposes of placing the product on the market in that State and the medicinal product has—
(aa) a marketing authorisation,
(bb) Article 126a authorisation,
(cc) certificate of registration, or
(dd) traditional herbal registration for that EEA State.”

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Source: https://www.legislation.gov.uk/ukdsi/2021/9780348228755/regulation/6 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-no-2-regulations-2021/regulation-6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.