Regulation 50D Waiver of production of information in a paediatric investigation planF1

(1)

The applicant making an application to which regulation 50A applies is exempt from the obligation to provide to the licensing authority the results of all studies performed, and details of all information collected, in compliance with an agreed paediatric investigation plan, if a waiver is granted in accordance with this regulation.

(2)

The licensing authority may grant a waiver in accordance with this regulation if it is satisfied that there is evidence showing that—

(a)

the medicinal product or class of medicinal products is likely to be ineffective or unsafe in all or part of the paediatric population;

(b)

the disease or condition for which the medicinal product or class of medicinal products is intended occurs only in adult populations; or

(c)

the medicinal product does not represent a significant therapeutic benefit over existing treatments for patients in the paediatric population.

(3)

The licensing authority may grant a waiver in accordance with this regulation—

(a)

in respect of the entire paediatric population, or a subset of it;

(b)

in respect of all of the therapeutic indications for the medicinal product concerned, or only some of them;

(c)

of its own motion, or at the request of the applicant; or

(d)

in respect of a specific product or a class of medicinal products.

(4)

A person who requests a waiver in accordance with this regulation must submit the request to the licensing authority not later than upon completion of the human pharmaco-kinetic studies in adults in relation to the medicinal product concerned, as specified in section 5.2.3 of Part I of Annex I to the 2001 Directive, unless the licensing authority agrees to accept a later application.

(5)

The licensing authority must maintain and publish a list of waivers which are granted under this regulation in respect of a class of medicinal products.

(6)

The licensing authority may review a waiver which it has granted under this regulation and may revoke it if it considers it appropriate, having regard to the matters specified in paragraph (2).

(7)

If the licensing authority revokes a waiver granted under this regulation, the holder of the UK marketing authorisation to which the waiver relates must, at the end of the period of 36 months beginning with the date of publication of the decision to revoke the waiver, submit the information referred to in regulation 50A(3) to the licensing authority.

(8)

If the licensing authority grants an application to which regulation 50A applies, it must, if it also grants a waiver in accordance with this regulation, 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.

(9)

Schedule 11 makes provision about advice and representations in relation to proposals to grant, or to refuse to grant, a waiver in response to a request made in accordance with paragraph (4) and to revoke a waiver under paragraph (6).

Annotations

Textual amendments

F1: Regs. 50A-50J inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 53 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 40(a)-(g)); 2020 c. 1, Sch. 5 para. 1(1)