MHRA Publishes Updated Guide on Defective Medicinal Products
In February 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a new edition of “A Guide to Defective Medicinal Products”, providing updated guidance for patients, healthcare professionals, manufacturers, distributors and licence holders on the reporting, investigation and recall of suspected defective medicinal products .
Although primarily focused on medicinal products, the guidance is highly relevant for manufacturers and licence holders operating in the UK market, particularly those responsible for complaint handling, quality defect investigations and recall management.
Scope of the Guidance
The guide applies to:
All medicinal products for human use, including licensed and unlicensed products (such as specials and imported unlicensed medicines)
Substances used in their manufacture or packaging
It does not apply to:
Medical devices
Veterinary medicinal products
Suspected adverse drug reactions (ADRs)
Medication errors or near-miss incidents
The document clearly differentiates between:
Quality defects
Adverse drug reactions
User errors
Incidents involving medical devices
This distinction is critical for manufacturers when classifying complaints and determining reporting pathways.
The Role of the Defective Medicines Report Centre (DMRC)
The Defective Medicines Report Centre (DMRC), part of the MHRA, is responsible for:
Receiving and assessing reports of suspected defective medicinal products
Advising and monitoring actions taken by the responsible licence holder
Communicating recall information when necessary
The DMRC operates during business hours with emergency out-of-hours contact procedures. Where recalls are required, decisions are taken in consultation with the relevant licence holder.
Importantly, the responsibility for carrying out a recall remains with the licence holder.
Statutory Obligations for Manufacturers
The guidance reiterates key legal obligations under:
The Human Medicines Regulations 2012 (SI 2012/1916)
Directive 2003/94/EC (GMP Directive)
EU and UK Good Manufacturing Practice (GMP) requirements
Manufacturers must:
Implement systems for recording and reviewing complaints
Maintain an effective recall system
Investigate all complaints concerning quality defects
Immediately inform the licensing authority of any defect that could result in a recall
Ensure compliance with Good Distribution Practice (GDP) when distributing products
Notably, the guide states that manufacturers who notify the MHRA only after a recall has already commenced are in breach of the regulations.
Where uncertainty exists as to whether a recall is required, the guidance instructs manufacturers to contact the DMRC for advice.
Recall Classification System
The MHRA uses an internationally agreed classification system:
Class 1 (National Patient Safety Alert – NatPSA)
Risk of death or serious disabilityClass 2
Risk of mistreatment or harm (non-life-threatening)Class 3
Unlikely to cause harm (e.g. specification non-compliance)Class 4 (Caution in Use)
Minor defects not likely to impair product efficacy
All Class 1 recalls are issued as National Patient Safety Alerts (NatPSA) and published via the Central Alerting System (CAS).
For manufacturers, this means recall strategy must consider:
Risk classification
Level of recall (wholesale, pharmacy, or patient level)
Whether an MHRA Recall Notification will support the action
Potential need for Direct Healthcare Professional Communications (DHPCs)
New Digital Reporting Requirements for Licence Holders
Appendix 7 introduces detailed guidance on the online Defective Medicines Reporting Form, which must be used by licence holders via the MHRA ICSR submissions portal .
The reporting system:
Is aligned with the E2B R3 ICSR structure
Uses MedDRA terminology for defect classification
Requires structured data entry including:
Impact assessment
Risk evaluation
Proposed market action
Root cause analysis
CAPA information
In urgent cases (critical or major defects), telephone notification remains mandatory.
For manufacturers, this increases expectations around:
Documentation quality
Timeliness of reporting
Traceability of batches
Robust risk assessments
Follow-Up and Closure Requirements
Investigations remain open until the DMRC issues a formal closing response.
Licence holders must:
Provide regular updates
Submit a final report (normally within 12 weeks unless otherwise agreed)
Provide reconciliation data for recalled stock
Agree timelines with the DMRC where extensions are required
The guidance also confirms that information relating to reported defects feeds into the MHRA’s Risk-Based Inspection (RBI) process.
What This Means for Manufacturers
For UK marketing authorisation holders and manufacturers, this updated guidance reinforces:
Immediate reporting obligations
Clear recall governance
Structured digital submission requirements
Formalised risk classification criteria
Regulatory scrutiny of complaint handling systems
Integration of defect investigations into GMP inspection oversight
Manufacturers should ensure that:
Their quality systems clearly differentiate ADRs, errors and quality defects
Recall procedures are aligned with MHRA classification criteria
Staff are trained on DMRC reporting pathways
Digital reporting capabilities are fully operational
Risk assessments are defensible and well documented
Final Remarks
The February 2026 update consolidates the MHRA’s expectations for the management of defective medicinal products in the UK and reinforces the central role of licence holders in safeguarding patients through robust complaint handling, investigation and recall systems .
Manufacturers supplying the UK market should review the full guidance and assess alignment with their existing quality and pharmacovigilance frameworks.
Read the full document below.
