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PV teams must update workflows and SOPs to include the requirement of contacting member state contact points prior to the launch of QR code content, specifically when it contains non-statutory information.

PV teams need to update SOPs and workflows related to user safety risk assessments and ensure that procedures are aligned with the new draft guidelines prior to its implementation following the consultation.

PV teams must engage in the public consultation by preparing comments on the draft guideline. Additionally, update any related SOPs and compliance controls to align with the new structured signal management framework once finalized.

PV teams must ensure that their workflows, SOPs, and compliance controls are updated to reflect the new pharmacovigilance recommendations issued by the EMA for 2026. Attention should be given to the monthly updates for product-specific implications.

PV teams must review and update their workflows related to regulatory intelligence monitoring to align with the new PMF submission timelines and ensure compliance with upcoming guidelines specified in the 3-year work plan.

Update workflows and SOPs related to Country Compliance and PMF submission processes to ensure timely response to the newly defined 60-day timelines.

PV teams should update their Standard Operating Procedures (SOPs) related to QT/QTc evaluation methods, integrate new assessment frameworks based on the revised guidelines, and consider the necessity for training on these updates.

PV teams must update their workflows and SOPs to align with the new PSUR requirements, increasing the frequency and detail of safety monitoring and adverse event reporting. Staff training may be necessary to ensure compliance with these changes.

PV teams should update workflows related to Inspection Readiness and adjust compliance controls to emphasize reliance on inter-authority inspections as part of their preparation strategies.

PV teams must revise SOPs for inspection readiness to incorporate increased collaboration and risk-based planning protocols, ensuring that workflows align with the new inspection resource allocation strategies.

PV teams must update their SOPs to incorporate new timelines and reporting requirements related to PSUSAs. Ensure workflows related to regulatory intelligence and signal management are aligned with the new EMA guidelines to maintain compliance.