Regulation of over-the-counter (OTC) medicines
You can buy over-the-counter (OTC ) medicines for self-treatment from pharmacies, with selected products also available in supermarkets, health food stores and other retailers. Examples include cough and cold remedies, anti-fungal treatments, sunscreens, non-prescription analgesics such as aspirin and paracetamol.
If you have an enquiry about OTC medicines that is not answered by this website, please see the contact details below.
Regulatory guidelines & standards
- Australian regulatory guidelines for OTC medicines (ARGOM)
<http://www.tga.gov.au/docs/html/argom.htm> - Approved terminology for medicines
<http://www.tga.gov.au/docs/html/aan.htm> - Colourings permitted in medicines for oral use
<http://www.tga.gov.au/meds/colourings.htm> - Enforcement guidelines
<http://www.tga.gov.au/legis/enfguidelines.htm> - Guideline on product discontinuations
<http://www.tga.gov.au/meds/proddiscont.htm> - Guidelines for levels and kinds of evidence to support indications and claims
<http://www.tga.gov.au/docs/html/tgaccevi.htm> - European Union guidelines
<http://www.tga.gov.au/docs/html/euguideh.htm> - Pharmacovigilance & reporting adverse drug reactions
<http://www.tga.gov.au/safety/monitoring.htm> - How do I determine whether my product is a therapeutic product?
<http://www.tga.gov.au/docs/html/determine.htm>
Contact details for enquiries about OTC medicines
If your enquiry is not specifically about OTC medicines, see: Contact the TGA <http://www.tga.gov.au/contact.htm>
Enquiries about OTC medicines
- Email: OTC.Medicines@tga.gov.au
- Web: OTC Medicines Section
- Phone:
- 02 6232 8652
- 1800 020 653 (freecall within Australia)
- Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
- TTY or computer with modem users phone 1800 555 677 then ask for 1800 020 653
- Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653
- Fax: 02 6232 8659
- Post: OTC Medicines, TGA, PO Box 100, Woden ACT 2606, Australia