Get the free Module II Pharmacovigilance system master file (Rev 2) - ema europa
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28 March 2017 EMA/816573/2011 Rev 2×Guideline on good pharmacovigilance practices (GAP) Module II Pharmacovigilance system master file (Rev 2)Date for coming into effect of first version2 July 2012Date
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What is module ii pharmacovigilance system?
Module II pharmacovigilance system is a regulatory requirement for companies involved in the pharmaceutical industry to monitor and report the safety and effectiveness of their products.
Who is required to file module ii pharmacovigilance system?
All pharmaceutical companies and manufacturers are required to file module II pharmacovigilance system.
How to fill out module ii pharmacovigilance system?
Module II pharmacovigilance system can be filled out by submitting relevant safety data, adverse drug reaction reports, and other related information to the regulatory authorities.
What is the purpose of module ii pharmacovigilance system?
The purpose of module II pharmacovigilance system is to ensure the safety and effectiveness of pharmaceutical products, detect and report any adverse drug reactions or safety concerns, and take appropriate measures to minimize risks to patients.
What information must be reported on module ii pharmacovigilance system?
Module II pharmacovigilance system requires the reporting of adverse drug reactions, product quality issues, and any other safety-related information pertaining to pharmaceutical products.
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