# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 119


In regulation 152 (amendment of regulation 192 (obligation to submit periodic safety reports: derogation from general requirements))—
(a) in paragraph (3), for “for “EMA” to the end substitute “after “EMA” insert “and the licensing authority or, in the case of a holder of a UKMA(GB), to the licensing authority only,”;
(b) for paragraph (4) substitute—
“(4) In paragraph (9), after “paragraph (3)(a)” insert “from the holder of a UKMA(UK), UKMA(NI), THR(UK), THR(NI) or Article 126a authorisation”.”.

---
Source: https://www.legislation.gov.uk/ukdsi/2020/9780348213980/schedule/2/paragraph/119 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-119
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.