Manufacturer's Information System (MIS)

The Manufacturer's Information System (MIS) allows for electronic application for:

• Manufacturing licences for medicinal products
• Certification by audit of overseas medicines manufacturers
• Variations to each of the above
• Clearance Certification of overseas medicines manufacturers by assessment of GMP evidence provided by an overseas regulatory body

If you have an enquiry about MIS that is not answered by this website, please see the contact details below.

MIS

• Manufacturer's Information System for GMP audits and manufacturer's clearances
  <http://www.tga.gov.au/manuf/mis.htm>
• TGA online services Internet site
  <http://www.tgasime.health.gov.au>
• Other online services
  <http://www.tga.gov.au/sime/sime.htm>

Contact details for enquiries about MIS

• Email: gmp@tga.gov.au
• Phone: 1800 446 443 (freecall within Australia)
• Fax: 02 6232 8426
• Post: Manufacturers Assessment Branch, TGA, PO Box 100, Woden ACT 2606, Australia