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Australian manufacturing licences and overseas GMP certification

A step-by-step guide

19 March 2019

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1: Determining whether licensing or certification is required

You need a TGA manufacturing licence to manufacture in Australia certain therapeutic goods for supply in or export from Australia under the Therapeutic Goods Act 1989 (the 'Act') and the Therapeutic Goods Regulations 1990.

GMP certification is how we determine that certain therapeutic goods manufactured overseas and intended for import and supply to Australia comply with GMP requirements.

The goods must be therapeutic

TGA only regulates therapeutic goods for human use. For more information, see:

Medical devices

The TGA regulates medical devices under Chapter 4 of the Therapeutic Goods Act 1989. Medical devices must comply with the Essential Principles.

The TGA manufacturing licence and GMP certification processes are not applicable to medical devices. For more information, see:

Goods exempt from manufacturing principles

Some therapeutic goods are exempt from complying with the manufacturing principles. Check Schedule 7 of the Therapeutic Goods Regulations 1990 to find out if your therapeutic good is exempt from the manufacturing principles.

We recommend you seek independent legal advice to ensure you comply with the legislation.

Persons exempt from manufacturing principles

Some persons are exempt from the manufacturing principles. Check Schedule 8 of the Therapeutic Goods Regulations 1990 to find out if the person manufacturing the goods is exempt from the manufacturing principles.

We recommend you seek independent legal advice to ensure you comply with the legislation.

Country of manufacture

If your manufacturing site is in Australia, you manufacture therapeutic goods (excluding medical devices), and neither you nor the goods are exempt, then you need a manufacturing licence from the TGA.

If your manufacturing site is overseas, you manufacture therapeutic goods (excluding medical devices), and neither you nor the goods are exempt you need GMP clearance. This can be obtained by an Australian sponsor who:

  • can use the MRA or CV pathways to GMP clearance instead of requesting TGA certification
  • can obtain GMP certification from the TGA if the MRA and CV pathways are not appropriate

The MRA and CV pathways to GMP clearance are only available if the relevant overseas regulator has recently inspected the manufacturing site to a GMP code equivalent to the TGA's for the type of therapeutic good produced there.

It is often not possible to obtain GMP clearance using evidence from another regulator because of differences in the regulatory frameworks and GMP standards for:

  • listed medicines including sunscreens
  • biologicals, blood and blood components and haematopoietic progenitor cells

GMP clearance or certification is not necessarily required unless the manufacturing step is recorded on the Australian Register of Therapeutic Goods (ARTG). If you are unsure whether you need GMP certification or clearance, contact the relevant product regulatory area before you submit your application.

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