# The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994, Paragraph 7


A person required to maintain the records mentioned in paragraph 6 shall—
(a) notify the licensing authority of any suspected adverse reaction such as is mentioned in head (e) of that paragraph which is a serious adverse reaction; and
(b) make available for inspection at all reasonable times by the licensing authority the records mentioned in that paragraph.

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Source: https://www.legislation.gov.uk/uksi/1994/3144/schedule/1/paragraph/7 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-1/paragraph-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.