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T: +27(0) 12 394 3200 / 3320 F: +27(0) 12 394 0166 E: ccsa@compcom.co.za W: www.compcom.co.za DTI Campus, Mulayo (Block C) 77 Meintjies Street, Sunnyside, Pretoria Private Bag X23, Lynnwood Ridge
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What is remedy form adverse effect?
A remedy form adverse effect is a document used to report negative side effects or adverse reactions caused by a product, particularly in the context of pharmaceuticals or medical devices.
Who is required to file remedy form adverse effect?
Manufacturers, healthcare professionals, and consumers who experience or observe adverse effects related to a product are typically required to file the remedy form.
How to fill out remedy form adverse effect?
To fill out a remedy form, you generally need to provide detailed information regarding the product, the specific adverse effect experienced, the affected individual's details, and any relevant medical history.
What is the purpose of remedy form adverse effect?
The purpose of the remedy form is to ensure that adverse effects are reported to regulatory authorities, so they can monitor product safety, investigate claims, and take appropriate actions to protect public health.
What information must be reported on remedy form adverse effect?
Key information includes product details, description of the adverse effect, dates of occurrence, patient demographics, and any previous medical conditions or medications.
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