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AUSTRALIAN GUIDELINE FOR PHARMACOVIGILANCE RESPONSIBILITIES OF SPONSORS OF REGISTERED MEDICINES REGULATED BY DRUG SAFETY AND EVALUATION BRANCH July 2003 Amended 31 May 2005 ABOUT THIS GUIDELINE is

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What is australian guideline for pharmacovigilance?

The Australian guideline for pharmacovigilance is a set of standards and instructions that govern the reporting and monitoring of adverse effects and safety issues related to pharmaceutical products.

Who is required to file australian guideline for pharmacovigilance?

All pharmaceutical companies operating in Australia are required to file the Australian guideline for pharmacovigilance.

How to fill out australian guideline for pharmacovigilance?

The Australian guideline for pharmacovigilance can be filled out by following the specific instructions provided by the regulating authority. The guideline typically requires the reporting of adverse events, safety information, and other relevant data related to pharmaceutical products.

What is the purpose of australian guideline for pharmacovigilance?

The purpose of the Australian guideline for pharmacovigilance is to ensure the safety and quality of pharmaceutical products in the Australian market. It aims to monitor and mitigate any potential risks and adverse effects associated with these products.

What information must be reported on australian guideline for pharmacovigilance?

The Australian guideline for pharmacovigilance requires the reporting of adverse events, safety information, product quality issues, and any other relevant information that may impact the safety and efficacy of pharmaceutical products.

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