UK Regulatory Context
Medical information is a regulated function in the UK. Every marketing authorisation holder must be able to respond to enquiries from healthcare professionals and the public with accurate, balanced, non-promotional scientific information. The MI function is also a key intake channel for pharmacovigilance: any enquiry containing a potential adverse event or product quality complaint must be identified, documented, and promptly forwarded to the PV or quality system, a major focus of inspections.
In the UK, MI activities are governed by the Human Medicines Regulations 2012, the MHRA’s advertising and promotional requirements, and the ABPI Code of Practice (2024 edition, fully in force from 1 January 2025). The ABPI Code is not law, but compliance is a condition of ABPI membership, and most non-member companies follow it as evidence of good practice. The PMCPA administers the Code independently.
What the ABPI Code Requires for MI
The 2024 ABPI Code reinforces the distinction between medical information and promotional activity. MI responses must be accurate, balanced, and consistent with the Summary of Product Characteristics (SmPC). Off-label enquiries must be handled with particular care: responses should be factual and scientific, never promotional, and documented with full traceability.
What We Handle Locally
We run MI services for UK MAHs as a fully outsourced function or as an extension of internal MI teams. Our MI specialists answer the phone, handle the emails, write the responses, triage the adverse events, and maintain the documentation. This is operational delivery, not advisory work.
Enquiry handling across all channels.
We manage telephone, email, webform, and written enquiries from healthcare professionals, patients, distributors, and internal teams. All enquiries are logged in our validated medical information database with full audit trails. Response timelines are tracked and reported.
Standard response library and governance.
We develop, review, and maintain pre-approved standard responses aligned with the SmPC, scientific literature, and internal company positions. Responses are subject to an annual review cycle with documented sign-off and cross-functional alignment across medical affairs, regulatory, and safety teams.
Adverse event and product quality triage.
Medical information is a primary intake channel for safety data. Our team is trained to identify potential adverse events, product quality complaints, and special situations within enquiries. Reportable information is documented and forwarded to pharmacovigilance or quality systems within defined timelines. Reconciliation between MI logs and safety databases is performed routinely.
ABPI Code compliance built into responses.
All responses are reviewed against the 2024 ABPI Code requirements. Non-promotional positioning is verified, and off-label enquiry handling procedures are applied. Staff are trained to maintain a clear boundary between medical information and promotional activity.
Enquiry trend monitoring and insights.
We track enquiry volumes, topics, and trends, and report these to the MAH. This provides visibility on recurring questions, product-related issues, and emerging patterns relevant to medical affairs, regulatory strategy, and safety functions.
Product shortage and crisis communications.
In situations involving product shortages or safety actions, we draft and deliver medical information communications to healthcare professionals. Communications are clear, factual, and aligned with the MAH’s regulatory position.
How MI Connects to Pharmacovigilance
MI and PV are operationally linked. An enquiry that starts as a clinical question can contain a reportable adverse event. A product complaint reported through the MI line may be a PQC that needs to reach the quality system. Getting this triage right is a regulatory obligation, not an operational nicety.
Our MI team sits within the same UK PV operation. MI specialists are trained in adverse event recognition and product quality complaint identification. Enquiries containing reportable information are forwarded to the PV team within defined timescales. Reconciliation between the MI and safety teams runs on a defined schedule. This integration is documented in SOPs and inspected by the MHRA during GVP inspections.
For the full PV system, including QPPV services, case management, and signal detection, see Pharmacovigilance & Device Vigilance. For UK QPPV and NCP services specifically, see UK: QPPV.
Need an MI Service for Your Marketing Authorisations?
Tell us about your product portfolio, enquiry volumes, and current setup, and we will outline what we can provide.
Speak with an ExpertKey UK Regulations
The regulatory and industry frameworks governing medical information in the UK.
Frequently Asked Questions (FAQ)
Can you run our entire MI function as an outsourced service?
Yes. We manage enquiry intake, response development, adverse event triage, documentation, quality control, and trend reporting as a fully outsourced medical information service. We represent your MAH and act as your MI function for healthcare professionals and patients. We can also support hybrid models, working alongside internal teams to handle overflow, out-of-hours coverage, or specific product portfolios.
How do you handle off-label enquiries?
Off-label enquiries are handled strictly within the boundaries of the ABPI Code and are reported to pharmacovigilance where required. Responses are factual, balanced, and based on published scientific evidence, clearly separated from promotional activity. We document the enquiry, response, references, and rationale. Off-label response templates are subject to formal review and approval before use.
What happens when an enquiry contains a potential adverse event?
Our MI specialists are trained to identify adverse events, product quality complaints, and special situations. When identified, relevant information is documented and forwarded to the pharmacovigilance or quality team within defined timelines, typically within 24 hours. MI and safety databases are reconciled routinely to ensure completeness. The process is governed by SOPs and is audit-ready.
Do you handle enquiries for products marketed in Ireland as well?
Yes. We support medical information activities for products marketed in Ireland, including responses aligned with HPRA requirements and the IPHA Code of Practice. For products marketed across the UK and Ireland, we operate a coordinated service ensuring consistent scientific content while respecting national regulatory and industry code differences.
What MI database do you use?
We operate a validated medical information database with full audit trail, case tracking, reference management, and GDPR-compliant data handling. The system can be configured to meet client-specific requirements. Where organisations already use an internal MI platform, we can work within that system. The setup is defined based on your infrastructure and reporting needs.
How do you stay current with ABPI Code changes?
We monitor updates to the ABPI Code and review PMCPA case reports and rulings to ensure our interpretations remain aligned with current enforcement practice. This is integrated into training, response review processes, and ongoing quality oversight.
How do you provide a personalised and integrated MI service?
We operate using client-specific workflows and align with your preferred communication channels and escalation pathways, maintaining close coordination with pharmacovigilance and quality teams. Our MI database is tailored to your requirements, with configurable fields and reporting metrics. Integration with pharmacovigilance services can be included where needed.