Regulation of prescription medicines
You need a doctor's prescription to buy these from a pharmacist. Otherwise, only authorised health care professionals can supply them, such as in a hospital setting. Examples include contraceptive pills, antibiotics and strong painkillers.
If you have an enquiry about prescription medicines that is not answered by this website, please see the contact details below.
Regulatory guidelines & standards
- Australian regulation of prescription medical products
<http://www.tga.gov.au/docs/html/pmeds_reg.htm> - Australian regulatory guidelines for prescription medicines (ARGPM)
<http://www.tga.gov.au/pmeds/argpm.htm> - European Union guidelines
<http://www.tga.gov.au/docs/html/euguideh.htm> - Risk management plans for prescription medicines
<http://www.tga.gov.au/pmeds/rmplans.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> - Common technical document (CTD)
<http://www.tga.gov.au/docs/html/eugctd.htm> - Enforcement guidelines
<http://www.tga.gov.au/legis/enfguidelines.htm> - Guideline on product discontinuations
<http://www.tga.gov.au/meds/proddiscont.htm> - Literature-based submissions - points to consider
<http://www.tga.gov.au/docs/html/litbsubs.htm> - Pharmacovigilance & reporting adverse drug reactions
<http://www.tga.gov.au/safety/monitoring.htm> - Best practice guideline on prescription medicine labelling
<http://www.tga.gov.au/pmeds/pmbestpractice.htm> - How long does it take to evaluate a prescription medicine?
<http://www.tga.gov.au/docs/html/evaltime.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 prescription medicines
If your enquiry is not specifically about prescription medicines, see: Contact the TGA <http://www.tga.gov.au/contact.htm>
Enquiries about prescription medicines
- Email: info@tga.gov.au
- Phone:
- 1800 020 653 (freecall within Australia)
- 02 6232 8101
- 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 8140
- Post: Office of Prescription Medicines, TGA, PO Box 100, Woden ACT 2606, Australia