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Marketing authorization holders must prepare to submit any relevant pre-clinical and clinical data pertaining to amoxicillin's dosing regimens in pigs during the review.

Regulatory teams must integrate the new guidelines into clinical development plans for migraine treatments, particularly focusing on designing studies that consider high placebo response rates in children and the new early intervention protocol.

Ensure that all inspection readiness protocols are updated to align with the new guidelines from revision 2 of Module III and incorporate implementation regulations effective from 12 February 2026.

Ensure that only the current national adverse event reporting details for HR and CZ are displayed on veterinary product packaging, as per the updated guidelines.

Review the updated guidance to incorporate the new compliance procedures starting from 1 January 2026, specifically regarding the electronic submission process.

Marketing authorization holders must implement processes to ensure timely submissions of required data within the defined 15 and 30 calendar day timelines, including details of the Qualified Person responsible for Pharmacovigilance and the submission of Pharmacovigilance System Master File information.

Update labeling materials for Gardasil 9 to incorporate new safety and efficacy data as per the revised EPAR.

The pharmacovigilance department must increase reporting obligations for any adverse effects related to Rezolsta as part of ongoing safety monitoring.

Healthcare professionals must administer Kavigale in a monitored clinical environment to manage potential severe allergic reactions, including anaphylaxis.

Implement resource allocation for increased monitoring of reported adverse reactions specific to Vislyfa as per the new safety evaluation requirements.

Stakeholders must review and update the labeling of Benlysta in accordance with the new indications highlighted in the EPAR.

Monitor the supply chain developments and prepare to adjust inventory management practices as the end of the shortage approaches.

Monitor for changes in labeling requirements and risk management strategies as a result of the ongoing review by PRAC.

Signal management teams need to prepare for potential updates in labeling, usage guidelines, and monitoring requirements for injectable iron-containing medicines.

Regulatory compliance workflows involving the Dengue Tetravalent Vaccine outside the EU need to incorporate the EMA's positive opinion concerning its use in individuals aged 4 to 60.

Regulatory intelligence processes must update reporting timelines and workflows to incorporate the new PSUSA findings for exemestane.

MAHs of products containing phenobarbital must monitor new cases of AHS and submit yearly updates to IRIS. The annual statement submission deadline is set for the end of November each year.

Sponsors must prepare for training on the new module and transition to its use for ASR submissions while ensuring all trial authorizations align with the timeline.

Regulatory intelligence should be updated to reflect the new PSUSA, and signal management processes may require reviews based on new safety information.

Stakeholders must familiarize themselves with the new data elements for Individual Case Safety Reports (ICSRs) as per the revised EudraVigilance access policy effective immediately.