This content applies to human and veterinary medicines.
Competent Authorities should ensure that information concerning the recall of medicinal products is notified rapidly to other Member States, if the nature of the defect presents a serious risk to public health. This information is communicated using the Rapid Alert Procedure.
The aim of the Rapid Alert Procedure is to transmit only those alerts whose urgency and seriousness cannot permit any delay in transmission. 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).
Every holder of a Manufacturing Authorisation in accordance with Article 40 of Directive 2001/83/EC and Article 44 of Directive 2001/82/EC is required under Article 13(1) of Directive 2003/94 and Article 13 of Directive 91/412/EC to report to the Competent Authorities (European Medicines Agency and/or Supervisory Authority) any defect in a medicinal product under their authorisation that could result in a recall or abnormal restriction on supply.
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