# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 68


For regulation 91 (omission of regulation 94A (offences relating to Commission Regulation 2016/161)) substitute—
“Amendment of regulation 94A (offences relating to Commission Regulation 2016/161)
91. In regulation 94A—
(a) for paragraph (1) substitute—
“(1) A person who is—
(a) the holder of a UKMA(NI), UKMA(UK) or parallel import licence, or
(b) a parallel distributor,
is guilty of an offence if the holder fails to comply with a requirement or obligation contained in a provision of Commission Regulation 2016/161 listed in paragraph (2).”;
(b) for paragraph (3) substitute—
“(3) In this regulation “parallel distributor” means a person who imports into Northern Ireland from an EEA state a product which has been granted a marketing authorisation under Regulation (EC) No 726/2004 and in relation to which that person is not the holder of a UKMA(NI), UKMA(UK), Article 126a authorisation, COR(NI), COR(UK), THR(NI) or THR(UK).”.”.

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Source: https://www.legislation.gov.uk/ukdsi/2020/9780348213980/schedule/2/paragraph/68 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-68
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.