The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

Amendment of regulation 59 (conditions of UK marketing authorisation or parallel import licence: general)

65.—(1) Regulation 59(1) is amended as follows.

(2) For paragraph (3) substitute—

“(3) An obligation to conduct such studies as are referred to in paragraph (2)(f) 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.”.

(3) After paragraph (3), insert—

“(3A) The Ministers may by regulations make provision specifying the situations in which post-authorisation efficacy studies may be required by virtue of the condition referred to in paragraph (2)(f).

(3B) Paragraph (3)(a) ceases to apply on the coming into force of regulations made under paragraph (3A).”.

(4) In paragraph (4), insert “UK” before “marketing authorisation”.

(5) After paragraph (4), insert—

“(4A) Where the application is one to which regulation 50A, 50E or 50F (applications to which paediatric-specific provisions apply) applies, the licensing authority must, if it considers that there is a particular cause for concern, grant the UK marketing authorisation subject to a condition that—

(a) a risk management system be set up comprising a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those interventions; or

(b) specific post-marketing studies be performed and submitted for review.

(4B) The licensing authority may request the holder to submit, in addition to the assessment required to be submitted pursuant to Part 9 of Schedule 12A (post-authorisation safety studies), a report assessing the effectiveness of any risk management system, and the results of any studies performed, in compliance with a condition imposed under paragraph (4A).

(4C) If the licensing authority grants a conditional marketing authorisation—

(a) it must impose, as a condition of the conditional marketing authorisation, an obligation on the holder of the authorisation to complete ongoing studies, or to conduct new studies, with a view to confirming the that the positive therapeutic effects of the product outweigh the risks to the health of patients or the public associated with the product, and to provide the additional data referred to in regulation 50I(3)(a);

(b) it may impose, as a condition of the conditional marketing authorisation, an obligation on the holder of that authorisation in relation to collection of pharmacovigilance data.

(4D) If the licensing authority grants a UK marketing authorisation in relation to an advanced therapy medicinal product, it must, if it considers that there is a particular cause for concern, grant the UK marketing authorisation subject to a condition that—

(a) a risk management system be set up which is designed to identify, characterise, prevent or minimise risks related to advanced therapy medicinal products, including an evaluation of the effectiveness of that system; or

(b) that specific post-marketing studies be carried out and submitted for review by the licensing authority.

(4E) The licensing authority may request the holder to submit, in addition to the assessment required to be submitted pursuant to Part 9 of Schedule 12A, a report assessing the effectiveness of any risk management system, and the results of any studies performed, in compliance with a condition imposed under paragraph (4D).”.

(6) Omit paragraph (5).

(1)

Regulation 59 was amended by S.I. 2014/1878.