Information for manufacturers

In most cases manufacturers of therapeutic goods must hold a licence. To obtain a licence to manufacture therapeutic goods, a manufacturer must demonstrate, during a factory audit, compliance with manufacturing principles which include codes of good manufacturing practice.

If you have an enquiry about manufacturing medicines or medical devices that is not answered by this website, please see the contact details below.

Information for all manufacturers of therapeutic products

General information for manufacturers of therapeutic products

• Good manufacturing practice for therapeutic goods
  <http://www.tga.gov.au/manuf/gmptg.htm>
• Australian codes of good manufacturing practice - current status
  <http://www.tga.gov.au/docs/html/gmpcodes.htm>
• Australian code of good wholesaling practice for therapeutic goods for human use
  <http://www.tga.gov.au/docs/html/gmpgwp.htm>
• Legislation
  <http://www.tga.gov.au/legis/index.htm>
  • Manufacturing principles
    <http://www.tga.gov.au/legis/manufp.htm>
• PIC/S explanatory notes for industry on the preparation of a site master file
  <http://www.tga.gov.au/docs/html/siteinfo.htm>
• TGA guidelines for sterility testing of therapeutic goods
  <http://www.tga.gov.au/docs/html/sterilit.htm>
• Transmissible spongiform encephalopathies (TSEs)
  <http://www.tga.gov.au/docs/html/tse.htm>

Contact details for enquiries about manufacturing therapeutic products

If your enquiry is not specifically about manufacturing therapeutic products, see: Contact the TGA <http://www.tga.gov.au/contact.htm>

Enquiries about manufacturing therapeutic products

• Email:
  • General & Australian manufacturing enquiries: gmp@tga.gov.au
  • Overseas manufacturing enquiries: gmpclearance@tga.gov.au
• Phone:
  • 1800 446 443 (freecall within Australia)
  • 02 6232 8156
  • 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 8426
• Post: Manufacturers Assessment Branch, TGA, PO Box 100, Woden ACT 2606, Australia

Top of page