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 - external site.
Revocation, suspension or restriction of licence
Section 41 of the Therapeutic Goods Act 1989 - external site 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 - external site].
Section 40 of the Therapeutic Goods Act 1989 - external site allows us to add new conditions to the licence, or to vary or remove existing conditions on a manufacturing licence.