Guidance

Format and content of applications for agreement or modification of a Paediatric Investigation Plan

Also covering requests for waivers or deferrals and concerning the operation of the compliance check.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 31 December 2020

Documents

Guideline on the format and content of applications for agreement or modification of a Paediatric Investigation Plan and requests for waivers or deferrals and concerning the operation of the compliance check

PDF, 241 KB, 33 pages

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Details

This guidance provides detailed information on:

• the required format and content of applications for agreement on or modification of a PIP
• requests for waiver and deferrals
• the operation of the compliance check in accordance with the HMRs.

The legal requirements for UK-PIPs are set out in the Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (HMRs), including transitional provisions (see in particular regulations 50A to 50D).

This document should be read in conjunction with:

• Guidance on procedures for UK-PIPs
• User reference guides on using the MHRA Submissions homepage for PIP-related submissions (available from the MHRA Submissions homepage

PIPs, waivers, annual reports, and compliance checks should be submitted via the MHRA Submissions homepage

Submission of a Paediatric Investigation Plan must be made to the MHRA no later than the completion of the human pharmaco-kinetic studies in adults in relation to the medicinal product to which the plan relates, unless the MHRA agrees to accept a later request. This is according to regulation 50B of the HMRs. It is our intention to update these Regulations to reflect the change of implementation dates following the Transition Period.

Applications for marketing authorisations to MHRA to which the PIP provisions apply should contain either:

• the results of all studies of an agreed PIP with details of all information collected in compliance with this PIP
• a decision granting a deferral on an agreed PIP (subject to compliance check)
• a decision granting a product specific waiver
• the European Medicines Agency (EMA) decision number granting a class waiver, and if the applicant has requested it, the confirmatory letter from the EMA and/or MHRA confirming the medicinal product for the intended condition falls under the class waiver

For guidance on the submission, see processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs).

UK paediatric requirements webinar recording which took place on 29 October 2020:

UK paediatric requirements webinar recording which took place on 29 October 2020.

Contact

For further information, please email our Customer Services Centre at [email protected] or call 020 3080 6000. You can also email [email protected] with urgent questions. Alternatively, contact your Trade Association by emailing:

• Association of the British Pharmaceutical Industry (ABPI): [email protected]
• British Generic Manufacturers Association (BGMA): [email protected]
• BioIndustry Association (BIA): [email protected]
• Clinical & Contract Research Association (CCRA): [email protected]
• Ethical Medicines Industry Group (EMIG): [email protected]
• Health Food Manufacturers’ Association (HFMA): [email protected]
• The National Pharmacy Association (NPA): [email protected]
• Proprietary Association of Great Britain (PAGB): [email protected]

Published 31 December 2020