20: Granting licences and issuing certification

Once we have decided to grant your licence or issue your GMP certification, the official Decision Letter and GMP Licence or Certificate will be sent via email as a PDF document. No hard copies will be sent in the mail.

All Licences and Certificates of GMP Compliance issued by the TGA will be signed "electronically" and will no longer contain a wet ink signature.

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.

On this page: Licence | GMP certification

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.

A copy of the Licence to Manufacture and the Schedule of Conditions must be displayed 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 on the TGA website.

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

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

Please note that we will not accept a TGA issued certificate as evidence for a GMP clearance desktop application if you have declined to contribute to the cost of the inspection without justification. Refer to the GMP Clearance Guidance for more information.

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:

• request extra copies
• pay an additional fee

Please note: GMP Certificates of Compliance for Australian manufacturers are not automatically issued after each inspection. You must request and pay for a certificate before it can be issued and/or notarised.

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