# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 68: Amendment of regulation 61 (conditions of UK marketing authorisation)


(1) Regulation 61 is amended as follows.
(2) For paragraph (4), substitute—
“(4) The obligation in this paragraph is—
(a) to conduct a post-authorisation safety study; or
(b) to comply with such other conditions or restrictions as the licensing authority considers essential for the safe and effective use of the medicinal product.”.
(3) For paragraph (6) substitute—
“(6) If concerns as described in paragraph (2) apply to more than one medicinal product, the licensing authority—
(a) must, where the obligation is to conduct a post-authorisation safety study, encourage the UK marketing authorisation holders concerned to conduct a joint study; and
(b) may, where the obligation is to comply with any other conditions or restrictions, encourage the UK marketing authorisation holders concerned to take co-ordinated action to comply with the conditions or restrictions.”.
(4) For paragraph (7) substitute—
“(7) The obligation under paragraph (5) must—
(a) be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive; and
(b) take into account the scientific guidance that applies under regulation 205B in relation to post-authorisation efficacy studies
(7A) The Ministers may by regulations make provision specifying the situations in which post-authorisation efficacy studies may be required by virtue of the obligation under paragraph (5).
(7B) Paragraph (7)(a) ceases to apply on the coming into force of regulations made under paragraph (7A).”.
(5) Omit paragraph (13).

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Source: https://www.legislation.gov.uk/ukdsi/2019/9780111179185/regulation/68 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-68
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.