Forms for manufacturers of therapeutic products

• Application for a licence to manufacture therapeutic goods
  <http://www.tga.gov.au/docs/html/gmpapp.htm>
  To be completed by or for each Australian manufacturer, who is not exempted from the requirement to hold a licence, of medicines, other therapeutic goods, or existing listed or registered therapeutic devices
• GMP audit of overseas manufacturer application form
  <http://www.tga.gov.au/docs/html/gmpaudit.htm>
  To be completed by or for each overseas manufacturer of therapeutic goods who, if based in Australia, would not be exempted from the requirement to hold a licence
• Medical device adverse event reporting by medical device manufacturers and sponsors
  <http://www.tga.gov.au/docs/html/forms/iris_mdir.htm>
  To be used by medical device manufacturers or authorised representatives for mandatory reporting of adverse events associated with a medical device.
• Request form for GMP or Quality Systems certificates
  <http://www.tga.gov.au/docs/html/forms/gmpcert.htm>
  Use to request GMP Certificate of Compliance, Certified copy of GMP Certificate of Compliance, Quality Systems Certificate, Certified copy of Quality Systems Certificate, Mutual Recognition Certificate (MRA)
• Medical devices essential principles checklist
  <http://www.tga.gov.au/devices/epcheck.htm>
  It is the manufacturer's responsibility to demonstrate compliance with the essential principles for their medical devices
• Client details form
  <http://www.tga.gov.au/docs/html/forms/clientdt.htm>
  To be completed by or for each client involved with the supply of the therapeutic goods in Australia for which the TGA requires address details
• Report of the manufacture of exempt therapeutic goods
  <http://www.tga.gov.au/pmeds/forms/exempttg.htm>
  Used by sponsors of exempt therapeutic goods to inform the TGA of the details of the supply of such goods on a quarterly basis