# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 78


In regulation 101 (amendment of regulation 108 (application for renewal of certificate)) for “for “European Union”” to the end substitute—
“for “must be established in the European Union” substitute—
“, where it is applying for renewal of—
(a) a COR(NI) and originally granted—
(i) in accordance with Chapter 4 of Title III of the 2001 Directive, must be established in the European Union;
(ii) on any other basis, must be established in the United Kingdom;
(b) a COR(GB) and originally granted—
(i) under the unfettered access route, must be established in Northern Ireland;
(ii) other than under the unfettered access route, must be established in the United Kingdom;
(c) in the whole United Kingdom, must be established in the United Kingdom.”.”.

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Source: https://www.legislation.gov.uk/ukdsi/2020/9780348213980/schedule/2/paragraph/78 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-78
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.