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Australian manufacturing licences and overseas GMP certification
A step-by-step guide
19: Making a decision
We will review the findings and recommendations of our inspection report. Following this review, we will make a decision regarding the licence or certification, where relevant.
We need to be satisfied that:
- you have achieved the requirements for a licence or GMP certification
- all deficiencies have been, or are being, satisfactorily addressed
- all fees have been paid
We will decide to either:
- for new applications:
- for licences or certifications that are in force:
- reissue a Licence to Manufacture or GMP certification, with or without conditions
- recommend that no changes be made to the licence or certification that is in force
- revoke, suspend or vary a licence, where relevant
- recommend an existing GMP clearance be cancelled
Refusal to grant licence or issue certification
If we decide to refuse to grant a licence or issue certification, we will write to you about:
- our decision
- the reasons for our decision
- how to seek a review of our decision
We can grant or refuse to grant a manufacturing licence under Section 38 of the Therapeutic Goods Act 1989.
Revocation, suspension or restriction of licence
Section 41 of the Therapeutic Goods Act 1989 allows us to revoke or suspend a manufacturing licence. For more information, see Suspending, revoking and varying conditions of manufacturing licences.
We must publish (as soon as practicable) a decision to revoke or suspend a licence [section 41(6), Therapeutic Goods Act 1989].
Section 40 of the Therapeutic Goods Act 1989 allows us to add new conditions to the licence, or to vary or remove existing conditions on a manufacturing licence.