Primary source: EMA - What's new RSS
New reporting timelines have been established: a 15 calendar day submission timeline for newly authorized medicinal products, starting upon receipt of positive XEVPRM ACK; and a 30 calendar day timeline for notifying the EMA following a transfer of marketing authorization.
These changes will require marketing authorization holders to adapt their workflows to ensure compliance with the new timelines for submissions, thereby impacting their operational capacity and regulatory adherence.
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.
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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.
The European Medicines Agency (EMA) has provided an updated guidance document addressing the electronic submission of Article 57(2) data, which includes important timelines for submission and specific obligations for marketing authorization holders.
What changed: New reporting timelines have been established: a 15 calendar day submission timeline for newly authorized medicinal products, starting upon receipt of positive XEVPRM ACK; and a 30 calendar day timeline for notifying the EMA following a transfer of marketing authorization.
Why it matters: These changes will require marketing authorization holders to adapt their workflows to ensure compliance with the new timelines for submissions, thereby impacting their operational capacity and regulatory adherence.
Practical implication: 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.
Published from the regulator source ingestion pipeline after PV impact triage.
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.
