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A national Adverse Drug Reaction (ADR) reporting form is used for collecting information about a suspected adverse event for analysis at a national pharmacovigilance centre. This document will help you design a user-friendly form and ease the process of submitting reports.
ADR reporting - patient guideline. Did you. know? You can report side effects yourself. As a patient, you have the right to report unwanted side effects of medicines directly to the authorities. You can also report a side effect on behalf of someone in your care, such as a child or relative.
provides public access to reports of suspected side effects submitted to the EudraVigilance system by national medicines regulatory authorities and pharmaceutical companies that hold marketing authorisations for medicines in the European Economic Area (EEA).
Online access to suspected side-effect reports. On this website you can view data on suspected side-effects, also known as suspected adverse drug reactions, for authorised medicines in the European Economic Area (EEA).
ADR to report • Pre-paid, addressed postcard (or fax sheet) pre-printed with all reporter’s details, with tick-box ‘I have an ADR to report’ • Direct telephone line to NC • Mechanism for providing ABSOLUTE minimum info (e.g. ADR, suspected drug, patient sex and age)
The feedback led to the following updates: Date fields to prompt three values (day, month and year) to highlight the need for a full date. Medicine dose field was improved with the addition of frequency and route of administration. Clearer ADR outcome options were added, per reaction, rather than overall outcome.
Download, complete and print the Serious adverse drug reaction reporting form for hospitals. Send by fax at: 1-866-678-6789. Mail it to the Canada Vigilance National Office.
