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Australian manufacturing licences and overseas GMP certification

A step-by-step guide

19 March 2019

Book pagination

20: Granting licences and issuing certification

Once we have decided to grant your licence or issue your GMP certification, we will send it to you in the mail. If there are changes to your licence we will reissue it, but if there are no changes to the licence there is no need for this.

As a manufacturer with a licence or GMP certification, you have ongoing responsibilities. For GMP certification, the sponsor also has responsibilities.

You shall not in any way use the fact that a licence has been granted or certification has been issued to provide customers with misleading information regarding applicability of the licence or certification outside the scope for which it has been issued.

All licences and certificates remain the property of the TGA. You must return a licence or certificate upon request. This usually happens when we revoke, suspend or vary a licence.

Licence

The Licence to Manufacture includes:

  • licence number
  • licence holder name
  • manufacturing site addresses
  • description of the types of products and manufacturing steps authorised

A Schedule of Conditions usually accompanies the Licence to Manufacture. Some of these conditions are common across licences, but some may be specific to a particular licence.

  • You must display a copy of the Licence to Manufacture and the Schedule of Conditions where the general public can view them [Regulation 20(a)].
  • We must publish (as soon as practicable) the decision to grant a licence [section 38(4), Therapeutic Goods Act 1989]. We also publish a list of licensed Australian manufacturers.

A licence commences on the day specified in the licence and remains in force until revoked or suspended.

Legislation underpinning manufacturing licences
Process Legislation
Application for a licence Section 37 Therapeutic Goods Act 1989
Granting a licence Section 38 Therapeutic Goods Act 1989
Term of the licence Section 39 Therapeutic Goods Act 1989
Conditions of the licence

Section 40 Therapeutic Goods Act 1989

Regulation 19 and 20 Therapeutic Goods Regulations 1990

Variations by the Secretary Section 40A Therapeutic Goods Act 1989
Variations at the request of the licence holder Section 40B Therapeutic Goods Act 1989
Revocation or suspension of licence Section 41 Therapeutic Goods Act 1989
Transfer of licences

Section 41AAA Therapeutic Goods Act 1989

Regulation 22 Therapeutic Goods Regulations 1990

GMP certificate of compliance for licence holders

Once you have been granted a licence, you can request a certificate of GMP compliance if you need one.

GMP certification

Following successful inspection of an overseas manufacturer we issue:

  • a GMP certificate to the manufacturer
  • GMP clearance to the sponsor who made the application and/or who contributed to the costs of the inspection

The GMP certificate includes:

  • the certificate number
  • manufacturing site address
  • a description of the types of products and manufacturing steps inspected
  • the expiry date, which reflects the intended reinspection frequency and is based on the risk category of the products manufactured and the compliance rating determined at closeout

There may be conditions on a GMP certificate, some of which are common across certificates and some specific to that particular certificate.

Extra copies

We can provide you with notarised copies of manufacturing licences or GMP certificates of compliance for Australian manufacturers if you:

We do not provide notarised copies of GMP certificates issued to overseas manufacturers.

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