Ensuring MHRA Compliance and Cost Efficiency
Customer Requirement
A pharmaceutical company developing a generic product for the UK market required preparation of the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) in compliance with MHRA regulations. The product was available in two strengths.
In line with UK regulatory requirements, two separate SmPCs were prepared, one for each strength. For the PIL, regulatory guidance allows the use of a single leaflet when indications and dosing requirements are identical across strengths. However, review of the UK reference product revealed that separate PILs were listed for each strength, creating uncertainty regarding whether a single consolidated PIL would be acceptable for the generic submission.
The client sought regulatory clarity and expert guidance to ensure MHRA acceptance while avoiding unnecessary duplication, cost escalation, and delays in market entry.
Problem Statement
The client faced regulatory ambiguity related to PIL strategy:
- Uncertainty around MHRA acceptance of a single PIL where the reference product listed separate leaflets
- Risk of regulatory queries or rejection due to perceived misalignment with reference labelling
- Potential increase in labelling costs and complexity if separate PILs were maintained
- Concern over delayed market entry if a conservative or incorrect approach was adopted
Without regulatory clarity, the client risked inefficiencies, higher costs, and unnecessary delays.
Key Objective
To ensure MHRA-compliant SmPC and PIL preparation for a UK generic product while enabling a consolidated PIL strategy that reduced labelling costs and supported timely market entry.
DDReg Solutions & Regulatory Outcome
DDReg supported the client by applying regulatory expertise to address the ambiguity surrounding PIL consolidation. The engagement focused on ensuring that patient safety, clarity, and regulatory expectations were fully met while avoiding unnecessary duplication.
A consolidated PIL was prepared that appropriately addressed dosing considerations for both strengths within a single document, maintaining consistency with UK regulatory principles. This approach was reviewed and accepted by the MHRA, confirming regulatory compliance.
Business Impact
Through DDReg’s regulatory support:
- A single consolidated PIL was successfully approved by the MHRA
- Labelling duplication was avoided, reducing long-term printing and maintenance costs
- Lifecycle management across strengths was simplified
- The product entered the UK market in under 9 months
- Regulatory uncertainty was resolved without compromising compliance
Key Learning
UK Regulatory Services Outcomes can often be optimized when guidance is interpreted with practical insight and risk awareness. Addressing regulatory ambiguity with informed judgment enables compliant, cost-efficient labelling strategies and faster market access.
Read more case studies from DDReg: Structured Product Labeling (SPL) for US FDA Generic Drug Submission