Consent to import, supply or export goods that do not comply with standards
Therapeutic goods (including medicines) which are supplied in Australia must comply with certain standards. In exceptional circumstances and only when it does not negatively affect the safety, quality and efficacy of the goods, the TGA can consent to the importing, supplying or exporting of particular therapeutic goods that are not compliant with a standard. This consent may be subject to appropriate conditions.
In all other circumstances it is an offence under section 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to import, supply or export therapeutic goods that do not comply with the applicable standards.
These databases provide information about the therapeutic goods that the TGA has given consent to import, supply, or export therapeutic goods that are not compliant with standards.
Review of conditions on consent given by Secretary
Under section 60 of the Act, a person whose interests are affected by a decision to impose a condition can, within 90 days, request an internal review of the decision by the Minister for Health. They can also seek a review by the Administrative Appeals Tribunal (AAT) of the decision by the Minister on the internal review.
The Secretary is required under the Act to publish any decision by the delegate of the Minister that overturns a decision to impose conditions or makes a substituted decision for the decision to impose conditions. Information about any such reviews is shown in the database under 'Decision status'.
Records of individual decisions
The databases contain records of regulatory decisions that the Secretary is required under the Act to publish. In the event that a decision is revoked or substituted, the information about both the initial and review decision are required to remain available to the public. It is for this reason that details about both decisions will remain in the databases.
Information about the review decision is shown in the database under 'Decision status'.