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Australian manufacturing licences and overseas GMP certification

A step-by-step guide

19 March 2019

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22: Keeping us up-to-date and making requests

Both sponsors and manufacturers have responsibilities. One of your responsibilities as a manufacturer (for licences) or sponsor (for GMP certification) is to notify us of any significant changes in the manufacturer's business or operations. This enables us to evaluate the impact of such changes.

Please notify us before making any change, because some changes require prior approval.

We can usually process any changes to the scope of licence or certification as part of the ongoing inspection program.

You can find more information about sponsor responsibilities in Sponsor responsibilities related to GMP clearance and certification. It is the sponsor's responsibility to request recertification, when required.

Requesting recertification

Sponsors should maintain evidence of GMP compliance for all sites used in the manufacture of their registered or listed medicines and are responsible for these nominated sites at all times.

When GMP certification expires, it ceases to have effect. Sponsors do not need to submit applications for routine reinspections-the TGA Business Services will automatically generate an application for re-inspection based on the frequency recommended following the inspection.

If evidence is available from other regulators, or a GMP clearance has been applied for or granted for the same scope for a site, we will consider this. If a GMP clearance has been granted, or evidence is available to support a GMP clearance application, we will not schedule an on-site inspection.

To request recertification, make a GMP certification application using TGA Business Services-for example, where a GMP clearance was obtained via MRA or CV pathway previously, but there is no current evidence available prior to the GMP clearance expiry.

Licence holder responsibilities

Details of licence holder responsibilities can be found in Responsibilities of manufacturers of medicines and biologicals and include the following.

Comply with the manufacturing principles

Licence holders should maintain an effective quality system and comply with the principles of GMP in the manufacture of therapeutic goods. It is critical that the quality system and resources are appropriate for the manufacturing operations performed.

Implement corrective and preventative actions as agreed

Licence holders are required to implement all corrective and preventative actions as agreed with the TGA. If you are unable to meet a specific commitment or deadline, you should email the Lead Inspector.

Pay your annual charge

Pay the annual charge for your TGA manufacturing licence.

If you don't pay the annual fee, we can revoke your licence.

Declarations

For TGA licences you need to make a declaration on Certificate S40(6) regarding specific convictions and financial penalties in the 10 years prior to the application when:

  • the licence changes hands, such as when the company is sold to a new owner (see guidance on the transfer of licences)
  • OR
  • an individual in your company described in Section 38(1)(g)-(h) of the Therapeutic Goods Act 1989 does not meet its requirements.

Submit the declaration form to the TGA manufacturing enquiry email address.

Variation applications

To make a variation application, refer to the guidance on making a variation to a manufacturing licence.

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