Get Adverse Drug Reaction Reporting Form
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How to fill out the Adverse Drug Reaction Reporting Form online
Filing an adverse drug reaction report is a vital step in ensuring the safety and efficacy of health products. This comprehensive guide will walk you through the process of filling out the Adverse Drug Reaction Reporting Form online, ensuring clarity and accuracy at every step.
Follow the steps to successfully complete the form.
- Press the ‘Get Form’ button to access the Adverse Drug Reaction Reporting Form and open it in your preferred online editor.
- Begin with section A, Patient Information. Fill in the identifier that allows you to easily reference the case if contacted for further details. Avoid using the patient's name.
- Next, complete section B, Adverse Reaction. Indicate the suspected health product name, strength, and manufacturer, if known. Fill in the reaction date and document the nature of the adverse reaction.
- In the same section, specify outcomes attributed to the adverse reaction by checking the applicable boxes. Include details regarding whether the reaction ceased after stopping or reducing the dosage.
- Proceed to provide the relevant health product details including dosage, frequency, and route of administration in section C.
- Conclude section C by detailing any concomitant health products, relevant tests, and other medical history that may provide context to the adverse reaction.
- In section D, Reporter Information, provide your name, address, and contact number. Indicate if you are a health professional.
- Review all provided information for accuracy and completeness. You may use this section to confirm if the report was also submitted to the manufacturer.
- Finally, save your changes, download a copy, or print the form for submission. Ensure it is sent to the appropriate Adverse Reaction Centre to finalize your report.
Begin your report now to contribute to the safety monitoring of health products.
FDA Form 3500 and FDA Form 3500B are for voluntary reporting; FDA Form 3500A is for mandatory reporting. * The majority of the indirect, mandatory reports were not received by Agency on a paper version of form 3500A [by mail or fax] but via an electronic submission route.
Fill Adverse Drug Reaction Reporting Form
Use this form to report suspected adverse reactions to vaccines and prescription, over the counter and complementary medicines. Please return the completed form to: Food and Drugs Authority, P. O. Box CT 2783, Cantonments - Accra, Ghana. Suspected adverse reaction may be reported through any of the following: • Mail or Direct submission to: FOOD AND DRUG ADMINISTRATION. Please report especially: • adverse drug reactions to newly marketed products. • serious reactions and interactions with all products. Please report especially: • adverse drug reactions to newly marketed products. • serious reactions and interactions with all products. Purpose of collection: Health Canada requires this information to assess adverse reaction reports, monitor the safety of health. ➢ Report non-serious, known or unknown, frequent or rare adverse drug reactions due to Medicines,. Vaccines and Herbal products etc.
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