Paediatric Investigation Plans in the UK

Our UK team supports the UK-specific aspects of paediatric obligations for medicines submitted through UK regulatory routes. Since Brexit, the UK has established its own PIP framework under the MHRA, separate from the EU PDCO process. For the full description of our PIP methodology (EU framework, PDCO procedure, waivers, deferrals, incentives), see Regulatory Strategy & Operations.

UK Regulatory Landscape

The MHRA manages a separate but largely aligned PIP process under the Human Medicines Regulations 2012 (as amended, regulation 50B). The UK framework introduces specific requirements for companies submitting marketing authorisations through UK national routes.

UK PIP Requirements

For medicines submitted via UK national routes, the applicant must provide either an agreed UK PIP, a UK waiver, or confirmation that the EU PIP can be relied upon. The choice depends on the submission route and the product’s regulatory history.

EU PIP Reliance

Where a product has an agreed EU PIP (approved by the PDCO), the UK allows reliance on this for UK submissions under certain conditions. This avoids duplicating the paediatric development programme. However, early clarification with the MHRA is essential to confirm whether reliance is accepted for the specific product and submission route, or whether a standalone UK PIP application is required.

UK PIP Applications

Where a standalone UK PIP is needed, the application is submitted to the MHRA. The process is similar in structure to the EU PDCO process but managed entirely by the MHRA. The MHRA assesses the proposed paediatric studies, waiver justifications, and deferral requests against the same scientific principles but within the UK regulatory context.

UK Incentives

Paediatric incentives in the UK mirror the EU framework in principle: completion of an agreed PIP may qualify for a Supplementary Protection Certificate extension. The specific UK SPC rules apply post-Brexit and should be confirmed on a product-by-product basis.

What We Handle Locally

Our UK team delivers the following within the UK paediatric regulatory framework. For our full PIP methodology (EU PDCO procedure, waivers, deferrals, incentives), see the central Regulatory Strategy & Operations page.

  • Assess whether a standalone UK PIP is required or whether EU PIP reliance is accepted for the planned UK submission route. Engage with the MHRA early to clarify the position before submission planning is committed.
  • Prepare and submit standalone UK PIP applications to the MHRA, including the development rationale, proposed paediatric studies, waiver justifications, and deferral requests.
  • Manage UK PIP reliance documentation: prepare the confirmation of reliance on the EU PIP, including any MHRA-required supporting documentation.
  • Coordinate UK and EU paediatric strategy so that the UK PIP position is consistent with the EU PDCO-agreed plan. Where the UK and EU positions need to differ (due to regulatory divergence), we manage both tracks.
  • Advise on UK SPC extension eligibility following PIP compliance, including the specific UK rules that apply post-Brexit.
  • Track UK PIP compliance milestones and manage updates as the development programme evolves.

Our UK Team

UK paediatric regulatory work is managed by our regenold UK regulatory team, who coordinate with our central regulatory strategy specialists for EU PDCO procedures and cross-jurisdictional paediatric planning.

For the full team, see Our Teams.

Planning a UK Submission that Involves Paediatric Obligations?

Tell us about your product and your EU PIP status. We will clarify whether a standalone UK PIP is needed and outline the next steps.

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Frequently Asked Questions (FAQ)

Does the UK still require PIPs after Brexit?

Yes. The UK maintains paediatric obligations under the Human Medicines Regulations 2012 (regulation 50B). The requirement applies to all new marketing authorisation applications submitted through UK routes. The options are an agreed UK PIP, a UK waiver, or confirmed reliance on an EU PIP.

Can we rely on an EU PIP for a UK submission?

In many cases, yes. The MHRA accepts reliance on EU PIPs under certain conditions, avoiding duplication. However, acceptance is not automatic. Early MHRA engagement is recommended to confirm whether reliance applies to your specific product and submission route.

How does the UK PIP process differ from the EU?

The scientific principles are similar, but the UK PIP is assessed by the MHRA rather than the PDCO. The procedural timelines, documentation format, and authority interactions are managed separately. For companies developing products for both UK and EU markets, we coordinate the two processes to maintain consistency.