# The Human Medicines Regulations 2012, Regulation 50C: Deferral of initiation or completion of measures in paediatric investigation plan


(1) At the same time as the paediatric investigation plan is submitted under regulation 50B(1), the person requesting agreement of it may request the agreement of the licensing authority to a deferral of the initiation or completion of some or all of the measures set out in the plan.
(2) If the licensing authority is satisfied that a deferral of the initiation or completion of some or all of the measures set out in a paediatric investigation plan can be justified on scientific and technical grounds, or on grounds related to public health, it may—
(a) agree to a request by the applicant to grant a deferral; or
(b) decide of its own motion to grant a deferral.
(3) If the licensing authority is satisfied as set out in paragraph (2), it must decide to grant a deferral where it is satisfied that—
(a) it is appropriate to conduct studies in adults prior to initiating studies in the paediatric population; or
(b) studies in the paediatric population will take longer to conduct than studies in adults.
(4) If the licensing authority grants an application to which regulation 50A applies, it must, if it also grants a deferral in accordance with this regulation—
(a) record that fact in the product's summary of product characteristics, and, if it considers that it would be appropriate to do so, in the package leaflet; and
(b) specify in the document notifying the applicant of the grant of the deferral the time limits for the initiation or completion of the measures to which the deferral relates.
(5) Schedule 11 makes provision about advice and representations in relation to proposals to grant, or to refuse to grant, a deferral under paragraph (2) or (3).

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/50C (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-50C
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.