INOPP Forum
Rapid Alert System in the European Union
Quote from VigiServe Admin on March 7, 2021, 8:27 AMThe aim of the Rapid Alert System is to transmit only those alerts whose urgency and seriousness cannot permit any delay in transmission. To ensure its effectiveness, the system must not be saturated by the transmission of less urgent information. In each case a professional assessment must be made of the seriousness of the defect, its potential for causing harm to the patient or (in the case of a veterinary product) harm to animals, consumers, operators and the environment, and the likely distribution of the affected batch(es). Appendix 1 provides guidance on the classification of the urgency of the recall of defective medicinal products.
Class I defects are potentially life-threatening. A rapid alert notification must be sent to all contacts of the rapid alert notification list irrespective of whether or not the batch was exported to that country.
Class II defects could cause illness or mistreatment but are not Class I. A rapid alert notification should be sent to all contacts of the rapid alert notification list as it might be difficult to know where a batch has been distributed. If the product distribution is known, the notification should be only sent to the contacts concerned.
Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons. These are not normally notified through the Rapid Alert System.
Where appropriate, the rapid alert system may be used for notification to authorities concerned of the recall of products or an embargo on the distribution of products following suspension or withdrawal of a manufacturing / wholesale authorisation.
The aim of the Rapid Alert System is to transmit only those alerts whose urgency and seriousness cannot permit any delay in transmission. To ensure its effectiveness, the system must not be saturated by the transmission of less urgent information. In each case a professional assessment must be made of the seriousness of the defect, its potential for causing harm to the patient or (in the case of a veterinary product) harm to animals, consumers, operators and the environment, and the likely distribution of the affected batch(es). Appendix 1 provides guidance on the classification of the urgency of the recall of defective medicinal products.
Class I defects are potentially life-threatening. A rapid alert notification must be sent to all contacts of the rapid alert notification list irrespective of whether or not the batch was exported to that country.
Class II defects could cause illness or mistreatment but are not Class I. A rapid alert notification should be sent to all contacts of the rapid alert notification list as it might be difficult to know where a batch has been distributed. If the product distribution is known, the notification should be only sent to the contacts concerned.
Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons. These are not normally notified through the Rapid Alert System.
Where appropriate, the rapid alert system may be used for notification to authorities concerned of the recall of products or an embargo on the distribution of products following suspension or withdrawal of a manufacturing / wholesale authorisation.