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Australian manufacturing licences and overseas GMP certification

A step-by-step guide

19 March 2019

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4: Compiling documentation

To apply for a licence or GMP certification, you will need to collect the following minimum information:

Client details

You will need to provide us with:

  • the applicant's details
  • the manufacturer's details

Primary and secondary sites

A manufacturing licence or GMP certification may cover multiple manufacturing sites where all of the criteria are satisfied, as outlined in the S38 guidelines for Australian manufacturing licences covering multiple manufacturing sites.

Primary site

The primary manufacturing site is the main premises where manufacturing occurs. You will need to provide the:

  • manufacturing site address
  • contact name and contact details for primary site
  • name and resume of the person in charge of quality control
  • name and resume of the person in charge of production
  • name of authorised person for release for supply
  • details of the items manufactured. You can select these from drop-down menus in the application form. They include:
    • manufacturing type
    • sterility
    • manufacturing class
    • dosage form
    • product code
    • manufacturing steps
  • Refer to the code tables available on the TGA Business Services page if you need assistance in selecting the manufacturing items.

Secondary site

You can combine your applications for a primary and secondary site provided you satisfy the criteria outlined in the S38 guidelines for Australian manufacturing licences covering multiple manufacturing sites. Secondary sites are normally ancillary sites that support the primary site-for example, warehouses.

You will need to provide the:

  • site address(es)
  • contact name and contact details for the secondary site
  • name of the person in charge of quality control
  • name and resume of the person in charge of production
  • details of the items manufactured. You can select these from drop-down menus in the application form. They include:
    • manufacturing type
    • sterility
    • manufacturing class
    • dosage form
    • product code
    • manufacturing steps

Supporting documents

To make a valid application you need to provide us with:

  • for manufacturers of APIs, medicines, or biologicals containing or comprising animal cells, tissues or organs a Site Master File (SMF) or, if the site is a testing laboratory, a Quality Manual
  • for blood, blood components, haematopoietic progenitor cells manufacturing, and biologicals that comprise, contain or are derived from human cells and tissues a copy of the Quality Manual. In addition, the Technical Master File (TMF) must also be lodged prior to, or with, the licence application. The licence application is not considered effective until it is confirmed that the TMF has been submitted to the TGA biological science section or with the licence application.
  • for new manufacturing licences, make a statutory declaration on Certificate 38(1)(g)
  • for GMP certification applications where the manufacturer does not currently supply to Australia, the Australian sponsor must submit a Declaration of intent to supply

All documents supplied to the TGA must be in English or accompanied by an English translation.

Documents should be provided in an electronic format.

We prefer you to attach an electronic copy of each document to the application, but you may also email them to the Manufacturing Quality Branch. Your application will not be considered effective until all required evidence has been submitted to us.

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