TGA Office of Medicines Safety Monitoring

The TGA Office of Medicines Safety Monitoring receives reports of suspected adverse reactions to prescription medicines, vaccines, over-the-counter medicines and complementary medicines. All reports are reviewed by professional and medical staff. Reports involving serious reactions or recently marketed drugs are reviewed by the Advisory Committee on the Safety of Medicines (ACSOM) <http://www.tga.gov.au/committee/acsom.htm>.

The Office of Medicines Safety Monitoring has adopted performance standards with respect to the processing of reports of suspected adverse reactions:

• All reports are reviewed by professional staff within 3 working days of receipt.
• All reports are entered into the database within 2 working weeks of receipt.

Contact details

The TGA Office of Medicines Safety Monitoring can be contacted by:

• Email: adr.reports@tga.gov.au
• Phone: 1800 044 114
• Fax: 02 6232 8392