By Medicines and Healthcare Products Regulatory Agency
Pharmacovigilance is the technology of gathering, tracking, learning, assessing and comparing info from healthcare prone and sufferers at the antagonistic results of medicines, organic items, herbalism and standard drugs on the way to determining new information regarding dangers linked to medications and fighting damage to sufferers. Pharmacovigilance is very excited about adversarial drug reactions.The MHRA has pointed out a necessity for writing and publishing a consultant to "Good Pharmacovigilance Practice". this article enhances present laws and tips, and gives sensible suggestion approximately attaining a suitable method of pharmacovigilance.
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Additional info for Good Pharmacovigilance Practice Guide
Example text
The QPPV should assess whether the response provided to one Competent Authority, following a request for information necessary for the evaluation of benefits and risks, should also be provided to other Competent Authorities. This assessment should be documented. Although not a legal requirement, the MAH/QPPV should consider implementing a system to capture and track requests for information from Competent Authorities, and the information provided in response to such requests. The documentation associated with a Competent Authority request and with the MAH’s response to the request should be retained.
5 What Other Tasks Might the Qualified Person for Pharmacovigilance Perform? 1 states that the QPPV should also act as the MAH’s contact point for pharmacovigilance inspections or should be made aware by the MAH of any inspection that may impact the pharmacovigilance system, in order to be available as necessary. MAH procedures should describe the communication process to be followed when an inspection notification is received. The QPPV should be kept informed concerning the inspection arrangements.
Personnel within the pharmacovigilance function must maintain adequate records of all pharmacovigilance data received. 1 Reconciliation When transfer of pharmacovigilance data occurs, the mechanism should be such that there is confidence that all notifications are received, in that a confirmation and/or reconciliation process is undertaken. This is appropriate for both internal transfers, such as that between the medical information and the pharmacovigilance departments, and external transfers, such as that with licence partners.