# The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024, Regulation 82: Amendment to regulation 191

Extent: E+W+S+N.I.

In regulation 191 (obligation on holder to submit periodic safety update reports: general requirements)—
(a) in paragraph (1)—
(i) after “and the licensing authority” insert “in the case of a holder of a UKMA(NI) or a UKMA(UK)(Category 2)”;
(ii) after “UKMA(GB”) insert “or a UKMA(UK)(Category 1)”;
(b) in paragraph (4A), after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”;
(c) in paragraph (7)—
(i) after “and the licensing authority” insert “in the case of a holder of a UKMA(NI) or a UKMA(UK)(Category 2)”;
(ii) after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”;
(d) in paragraph (8A), after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”;
(e) in paragraph (10)—
(i) in sub-paragraph (b)(i), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”;
(ii) in sub-paragraph (b)(ii)—
(aa) after “a UKMA(GB)” insert “or a “UKMA(UK)(Category 1)”;
(bb) for “Great Britain”, in both places, substitute “the United Kingdom”;
(iii) in sub-paragraph (c)—
(aa) in paragraph (i), in the opening words, for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”;
(bb) in paragraph (ii), for the opening words substitute—
“in relation to a product authorised under a UKMA(GB) or a UKMA(UK)(Category 1), the product has been placed on the market in the United Kingdom”.

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Source: https://www.legislation.gov.uk/uksi/2024/832/regulation/82 (the official version)
Page: https://openlegislation.uk/human-medicines-amendments-relating-to-the-windsor-framework-regulations-2024/regulation-82
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.