PV Bulletin

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Gov.uk

publicMHRA · UK · Updated Sep 4, 2026

Change to the definition of regulated activity with children from 1 September 2026

Urgency: High

Organizations must re-evaluate roles related to children's activities and prepare to request Enhanced DBS checks including access to the Children’s Barred List check starting from 1 September 2026.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicUK Health Security Agency · UK · Updated Sep 7, 2026

Low Flu Vaccination Rates Among Primary School Children

Urgency: High

Parents are reminded to complete and return flu vaccination consent forms promptly as vaccination sessions in schools are set to start this week, aiming for completion by late November.

Signal ManagementPV Quality Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: PV Quality Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicUK Health Security Agency · UK · Updated Sep 3, 2026

Invasive mosquito species detected in east London

Urgency: High

UKHSA has implemented control measures to destroy larvae and is monitoring the area closely for further mosquito activity.

Signal ManagementLiterature SurveillanceMedical Safety Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Medical Safety Lead, Signal Management Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMHRA · UK · Updated Sep 3, 2026Translated From French

Field Safety Notices: 24 to 28 August 2026

Urgency: High

Healthcare professionals must act on the issued FSNs as outlined by MHRA, ensuring compliance to address any safety concerns associated with the listed medical devices.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Devices
Read impact briefarrow_forward
publicVeterinary Medicines Directorate (VMD) · UK · Updated Sep 3, 2026

VMD updates guidance on QR codes for veterinary medicinal product packaging

Urgency: High

Marketing Authorization Holders must update packaging and compliance processes to incorporate QR codes linked to educational materials as per the new guidelines.

LabelingRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Labeling Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicYouth Justice Board for England and Wales · UK · Updated Sep 3, 2026

YJB response to the PAVA rollout extension

Urgency: High

Monitor compliance practices regarding PAVA use in youth custody settings and assess alignment with the YJB's concerns and evidential claims on efficacy and safety.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMHRA · UK · Updated Sep 2, 2026

MHRA and Manchester NHS partner on health innovation sandbox

Urgency: High

The program will implement collaborative processes for the evaluation of technologies, enhancing real-world evidence integration into signal management and impacting regulatory compliance workflows.

Signal ManagementCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMHRA · UK · Updated Sep 1, 2026

UK accelerates support for efforts to stop Ebola outbreak at source

Urgency: High

Operational support will now be increased for disease surveillance, health worker assistance, and community outreach based on the new funding and response framework.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMHRA · UK · Updated Sep 2, 2026

Filters should be used during the administration of Parenteral Nutrition for patients in all care settings DSI/2026/011

Urgency: High

Update local protocols to ensure parenteral nutrition is administered with filters in compliance with the new requirements.

Signal ManagementCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMHRA · UK · Updated Sep 1, 2026

MHRA Suspends Use of Avacopan Vifor to New Patients

Urgency: High

Healthcare professionals should not initiate treatment with Avacopan Vifor for new patients and must review existing patients' treatment plans to ensure safe transitions to alternative therapies.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Latest
Read impact briefarrow_forward
publicMHRA · UK · Updated Aug 28, 2026

Record Ketamine Seizures Indicate Safety Concerns

Urgency: High

Monitor and evaluate the drug misuse trends and health impacts associated with ketamine, focusing on the increase in seizures as part of public health and law enforcement strategies.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicUK Health Security Agency · UK · Updated Aug 27, 2026

UK Salmonella Outbreak Linked to Imported Eggs

Urgency: High

Implement enhanced surveillance and tracking of Salmonella cases linked to imported eggs, potentially increasing ICSR submissions related to these infections.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicUK Health Security Agency · UK · Updated Aug 27, 2026

Vaccination Guidance to Improve Childhood Immunization Rates

Urgency: High

Parents are encouraged to ensure their children receive timely vaccinations according to the NHS schedule to increase overall immunization rates and adherence to WHO guidelines.

Country ComplianceMedical Safety Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMHRA · UK · Updated Aug 26, 2026

Increased risk of wear and corrosion identified with certain cobalt chrome modular neck hip replacements

Urgency: High

Healthcare providers must implement a follow-up process for patients with identified cobalt-chrome modular neck components, monitoring for new or unexpected symptoms including pain, stiffness, or instability.

Signal ManagementMedical Safety Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMHRA · UK · Updated Aug 25, 2026

Changes to Regulated Activity with Children Effective September 2026

Urgency: High

Organisations should review their DBS checking arrangements, especially prioritizing checks that include the Children's Barred List for those working with children, as part of their compliance with the new definition from September 2026.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMHRA · UK · Updated Aug 25, 2026

APHA Strengthens Bluetongue Disease Response

Urgency: High

Submit bluetongue samples to APHA with forms attached securely on the outside of the parcel to facilitate rapid booking into their digital sample handling system.

Signal ManagementCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMHRA · UK · Updated Sep 1, 2026

MHRA Regulatory Reform Amendments Tabled in Government’s Health Bill

Monitoring

Organizations involved in medical device compliance should prepare for potential future changes requiring MHRA-issued licenses for devices entering the market.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMHRA · UK · Updated Sep 3, 2026Translated From French

AI Sleep Data Could Provide One-Week Early Warning of Flu and COVID-19

Monitoring

Health agencies should integrate and evaluate passive digital monitoring data, such as cough signals from sleep apps, alongside traditional surveillance systems to enhance early warning capabilities.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceMedium
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward

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