For authorised medicinal products, the MA holder is required to keep the product information up to date with current scientific knowledge. The operational part of this is ongoing pharmacovigilance.
Among the tasks of pharmacovigilance are the management of Individual Case Safety Reports (ICSRs) both those received from the market and those collected by the regulatory authorities. Moreover, the QPPV should be available on a 24/7 basis and have extensive knowledge of all aspects of pharmacovigilance.
New safety advice for excipients demands improved labelling information The European Medicines Agency (EMA) and the European Commission have updated the annex to the European Commission’s guideline on ’Excipients in the label and package leaflet of medicinal products [...]