# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 153: Amendment of regulation 193 (harmonisation of PSUR frequency or date of submission)


(1) Regulation 193 is amended as follows.
(2) Omit paragraph (1)(a).
(3) For paragraph (2) substitute—
“(2) Where one or more of the grounds in paragraph (3) is met, the holder may submit a request in writing to the licensing authority, or the licensing authority may in any event decide, to—
(a) determine a UK reference date from which submission dates are calculated in respect of products that fall under paragraph (1); or
(b) change the frequency and date of submission of the PSUR.”.
(4) For paragraph (4) substitute—
“(4) Where the licensing authority makes a decision under paragraph (2) following a written request from a holder, it must notify that holder in writing of its decision to approve or refuse the request.”.
(5) In paragraph (5)—
(a) for “Article 107c(4) or Article 107c(6) of the 2001 Directive” substitute “paragraph (2)”; and
(b) for “EMA” substitute “licensing authority”.
(6) For paragraph (6) substitute—
“(6) Subject to paragraph (6A), in this regulation, “UK reference date” means a date determined by the licensing authority under paragraph (2)(a) in respect of medicinal products containing the same active substance or the same combination of active substances.
(6A) Until the licensing authority makes a decision under paragraph (2), any—
(a) Union reference date in respect of medicinal products containing the same active substance or the same combination of active substances; or
(b) date of submission and frequency of periodic safety reports in respect of such products,
published by the EMA under Article 107c(7) of the 2001 Directive, is deemed to be the UK reference date or, as the case may be, the required date or frequency of PSUR submission, in respect of those medicinal products.”.
(7) After paragraph (6A) insert—
“(7) The licensing authority must publish a list of—
(a) UK reference dates it determines under paragraph (2); and
(b) the required date of submission and frequency for PSURs in respect of medicinal products containing the same active substance or the same combination of active substances.
(8) Any change to the date of submission and frequency of PSURs as a result of the application of this regulation is to take effect after a 6 month period, such period beginning with the day after the licensing authority publishes that change under paragraph (7).”.

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Source: https://www.legislation.gov.uk/ukdsi/2019/9780111179185/regulation/153 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-153
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.