Australian manufacturing licences and overseas GMP certification

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A step-by-step guide

4 August 2017

This step-by-step guide is for:

  • Australian manufacturers of therapeutic goods (medicines, active pharmaceutical ingredients (APIs) and biologicals, human blood and blood components and haematopoietic progenitor cells) applying for a manufacturing licence for an Australian manufacturing site
  • Australian sponsors of therapeutic goods manufactured overseas applying for GMP certification of the overseas manufacturer
  • overseas manufacturers inspected by the TGA

This guidance is not intended for:

Only Australian manufacturing sites can obtain a manufacturing licence.

Overseas manufacturers can instead obtain GMP certification following a successful on-site inspection by the TGA.

GMP certification applications are required to be submitted by the Australian sponsor or an agent acting on the Australian sponsor's behalf.

GMP certification is usually only requested if it is not possible to obtain GMP clearance via the Mutual Recognition Agreement (MRA) or Compliance Verification (CV) pathways, for example due to lack of evidence. The TGA reserves the right to undertake an audit of an overseas manufacturing site, irrespective of any other evidence supplied. For example, this may be where TGA has other regulatory information, has concerns regarding compliance.

Ensure that GMP clearance cannot be obtained via the MRA or CV pathways before applying for GMP certification.

Step 1 will help you determine if this process is appropriate for you.

Responsibilities

Both manufacturers and sponsors need to be aware of their responsibilities. For more information, see:

Information about fees and charges can be found in the Summary of fees and charges.

Supplying manufactured goods to Australia

No batch of product (including validation batches) manufactured prior to licensing or certification can be sold or supplied within Australia, or exported from Australia, unless prior approval has been obtained.

Do not commence manufacturing for supply to Australia until a manufacturing licence or certification has been granted, unless prior approval has been obtained.

Confidentiality

We treat information about applications and manufacturers as official information. Find out more about confidentiality at TGA approach to disclosure of commercially confidential information.

We publish a list of licensed Australian manufacturers.

Timeframes

Consider the timeframes involved in the licensing or certification process to ensure you allow sufficient time to apply for and obtain your manufacturing licence or GMP certification.

From application to completion, the process (including the on-site inspection) can take:

  • up to 12 months for a manufacturing licence for an Australian manufacturing site
  • up to 15 months for GMP certification of an overseas manufacturing site

APVMA-TGA cooperation

The TGA and the Australian Pesticides and Veterinary Medicines Authority (APVMA) have a Memorandum of Understanding (MoU) for cooperation on medicinal products manufactured in Australia for veterinary use.

Manufacturers holding both TGA and APVMA licences may elect to the APVMA to have routine inspections conducted by the TGA. The licence holder must notify the APVMA of this decision. The TGA will not inspect aspects of the manufacturing facility that are dedicated to veterinary products only.

Australia has a mutual recognition agreement (MRA) with the European Community (EC) and the European Free Trade Association (EFTA). Manufacturers licensed by the APVMA who wish to export veterinary medicines to Europe must be inspected by the TGA. This inspection must be requested by the APVMA, not by the manufacturer. The APVMA will assess the TGA inspection results and can then issue a GMP certificate to the manufacturer. Under the MRA, the EC recognises the TGA as the authority for inspecting veterinary premises in Australia.

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