Julphar will transmit all Individual Case Safety Reports (ICSRs) requiring expedited reporting promptly and no later than 15 calendar days from receipt. This applies to initial and follow-up information. 
 
The clock for expedited reporting starts as soon as one or more of the following has received the minimum information (an identifiable patient, an identifiable reporter, a suspected reaction, and a suspected drug) required for the submission of an adverse reaction report:
 
  • Any personnel of Julphar – including sales representatives.
  • The Qualified Person responsible for Pharmacovigilance (QPPV) or persons working for or with this person.
  • Where Julphar has entered into relationships with a second company for the marketing of, or research on, the suspected product, the clock starts as soon as any personnel of Julphar receives the minimum information. However, wherever possible, the time frame for regulatory submission should be no longer than 15 calendar days from first receipt by the second company and explicit procedures and detailed agreements will exist between Julphar and the second company to facilitate achievement of this objective.
  • In the case of relevant world-wide scientific literature, the clock starts with awareness of the publication by any personnel of Julphar; Julphar will maintain awareness of possible publications by accessing a widely used systematic literature review and reference database, no less frequently than once a week, or by making formal contractual arrangements with a second party to perform this task; Julphar will also ensure that relevant publications are appropriately reviewed.
  • Expedited reporting of serious adverse reaction will be reported as soon as possible, but in no case later than 24 hours of initial receipt of information by the healthcare provider.
 
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