# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 158: Amendment of regulation 198 (post-authorisation safety studies: general provisions)

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

(1) Regulation 198 is amended as follows.
(2) In paragraph (2),
(a) “the competent authorities” to the end becomes sub-paragraph (a);
(b) in sub-paragraph (a), at the end insert “and the licensing authority, where the product is subject to a marketing authorisation, traditional herbal registration or Article 126a authorisation for sale or supply in Northern Ireland;”
(c) after sub-paragraph (a) insert—
“(b) the licensing authority, where the product is subject to a marketing authorisation or traditional herbal registration for sale or supply in Great Britain only.”.
(3) In paragraph (3)—
(a) in sub-paragraph (c),
(i) “for “the relevant competent authorities” substitute—
“(i) “for “the relevant competent authorities” substitute—
“(i) the relevant competent authorities and the licensing authority, where paragraph (2)(a) applies;
(ii) the licensing authority where paragraph (2)(b) applies,”
(ii) “any new information” to the end becomes full-out words;”
(b) in sub-paragraph (d),
(i) “the competent authorities of the EEA States in which the study was conducted” becomes paragraph (i);
(ii) in paragraph (i), after “the study was conducted” insert “and the licensing authority, where paragraph (2)(a) applies;”
(iii) after paragraph (i) insert—
“(ii) the licensing authority, where paragraph (2)(b) applies,”;
(iv) “before the end of the period” to the end becomes full-out words.

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Source: https://www.legislation.gov.uk/uksi/2019/775/regulation/158 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-158
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.