European Union

Ensure all sites listed in marketing authorization applications are ready for inspection upon submission, and adhere to the new timelines for inspection requests and report submissions.

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.

Ensure that all labeling and safety information reflects the updated product name 'Prasugrel Viatris' instead of 'Prasugrel Mylan'.

Applicants must adhere to new timelines: submit a rapporteurs' allocation request 9 months prior to the intended MAA submission date, and submit their Letter of Intent at least 2 months before the MAA submission.

Stakeholders must express interest in the pilot by submitting an application form prior to the full submission of data, with the pilot set to run through 2027.

Manufacturers must now incorporate expert panel feedback into their conformity assessment processes, ensuring timely integration of provided expert advice into their evaluation and regulatory submissions.

Companies must ensure compliance with the Irish language requirements and complete mandatory OMS registration before regulatory submissions to prevent delays.

Developers of NAMs are encouraged to participate in early dialogues with EMA and are now able to submit NAM-derived data for independent evaluation under a voluntary data submission pilot.

Manufacturers must familiarize themselves with the new procedure, including creating an EMA account and understanding the timelines for submitting the required briefing documents according to the established timetable for 2025 and 2026.

Review and update labeling processes in accordance with the newly published safety-related changes for affected products.

MAHs must allocate resources to develop and maintain SPPs, ensuring they meet the new regulatory requirements and are ready for submission within two days upon request in crisis situations.

Implement the updated product information by November 5, 2026, ensuring that all labeling and documentation includes the new warnings and risk profiles.

Implement new labeling requirements for choline salicylate products by November 5, 2026, including specific warnings as outlined.

The marketing authorization holder must submit amended product information reflecting the new safety guidelines by October 9, 2026, with translations due by August 10, 2026.

Veterinary practitioners must now adjust their prescribing practices in accordance with the AMEG guidelines and monitor compliance with the new restrictions as outlined in the EMA's directive.

Annual reviews of new information will be conducted to update the summary, requiring continuous monitoring and data submission in response to findings.

Marketing authorization holders (MAHs) must review and potentially update their product labeling to align with the new regulations by 11 April 2029 for products authorized before 11 May 2024.

Regulatory teams should integrate the new labeling information into their literature surveillance processes to ensure compliance and accurate communication surrounding Spikevax usage.

Regulatory requirements for daratumumab will need to be reviewed in light of the orphan designation status granted by the EMA.

Regulatory Intelligence teams must monitor updates regarding the ongoing CHMP evaluation and potential implications for existing marketing authorizations.

Update all internal and external communications, labels, and marketing materials to reflect the new product name, Svariya, instead of Rivaroxaban Koanaa.

Marketing Authorisation Holders (MAHs) and applicants must register new sites and organisations in the OMS before any regulatory submission and ensure alignment of their submission documents with the latest guidelines.

Regulatory Intelligence Leads must incorporate the new reporting requirements and deadlines into their monitoring activities for affected products.