Welcome to the Australian Adverse Drug Reaction Reporting System.
In this system, you can report a case of a suspected adverse reaction in association with a medicine (including complementary, OTC or prescription) or a vaccine.
Personal information in this report about a patient is collected and used for the purpose of assessing the safety of medicines under the Therapeutic Goods Act 1989 (the Act). All reports are assessed and entered into the TGA's Australian Adverse Drugs Reactions System (the ADRS). That information in this report is only disclosed: (i) under subsection 61(3) of the Act to State and Territory Health Departments (if the information relates to vaccine events); or (ii) where the disclosure is otherwise required by, or authorised under, a law. For example, the Secretary of the Department of Health and Ageing can release information from this report under subsection 61(7) of the Act if it is necessary to do so to ensure the safe use of the medicine, including to the company responsible for its supply in Australia. The reporter's details are recorded in the ADRS so that they can be contacted if further information is required about the reported adverse event. Personal information about a reporter is only disclosed: (i) under subsection 61(3) of the Act to State and Territory Health Departments (if the information relates to vaccine events); or (ii) where the disclosure is otherwise required by, or authorised under, a law.
Adverse event information:
Specified kinds of information about reported adverse events can be released to the public by the Secretary under subsection 61(5C) of the Act. The information includes such details as the medicine reported to have been involved in an adverse event, and statistics such as the number of cases of reported adverse events relating to a medicine for any particular period of time. This information does not include any "personal information" within the meaning of the Privacy Act 1988 - that is, information from which an individual's identity might be apparent or reasonably ascertainable. Further information about how the TGA uses adverse event information that is reported to it is available at http://www.tga.gov.au/safety/problem.htm.
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