# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 3: Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019


For regulation 17 (amendment of regulation 36 (requirement for authorisation to manufacture or import investigational medicinal products)) substitute—
“17. In regulation 36(2), after “marketing authorization” insert “or marketing authorisation issued by the competent authority of an EEA State in accordance with Directive 2001/83/EC”.”.

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Source: https://www.legislation.gov.uk/ukdsi/2020/9780348213980/schedule/1/paragraph/3 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-1/paragraph-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.