Guidance on the GMP clearance of overseas medicine manufacturers

17th edition

16 May 2011

The Therapeutic Goods Act 1989 (the Act) requires that the standard of manufacture, and quality control of therapeutic goods manufactured outside Australia, be taken into consideration for the registration or listing of those therapeutic goods on the Australian Register of Therapeutic Goods (ARTG), unless the goods are exempt from this requirement by the Act.

A sponsor applying to the Therapeutic Goods Administration (TGA) for registration or listing of a therapeutic good manufactured outside Australia, must provide an acceptable form of evidence to show that the manufacture of the goods is of an acceptable standard. This is referred to as Good Manufacturing Practice (GMP) clearance of overseas manufacturers.

The purpose of this guidance document is twofold. It is intended to provide information to sponsors and manufacturers on the acceptable form of evidence of GMP compliance for overseas manufacturers, and, outline how to submit such evidence to the TGA for assessment. It is not intended to provide a definitive list of the forms of evidence that are considered acceptable or unacceptable.

The Australian Regulatory Guidelines Good Manufacturing Practice (GMP) Clearance for Overseas Manufacturers (17th edition) will be phased in over the next 3 months. During this period, submitted applications for GMP Clearance may the requirements of either the preceding 16th or 17th edition. At the conclusion of the phase-in period (15 August 2011) the preceding 16th edition of the guidelines will be retired. Subsequent applications after this date will be required to meet the requirements of the 17th edition of the guidance.

How to access a pdf or Word document

*Large file warning: Attempting to open large pdf files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.

• Guidance on the GMP clearance of overseas medicine manufacturers, 17th edition, May 2011 (pdf,545kb)
• Guidance on the GMP clearance of overseas medicine manufacturers, 17th edition, May 2011 (Microsoft Word,5.41Mb)*