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Regulatory change: How the TGA legislation and guidelines are amended
Amending delegated or subordinate legislation
In addition to the TG Act and the Charges Act, the TGA is also responsible for administering the Therapeutic Goods Regulations 1990, the Therapeutic Goods (Charges) Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002. Delegates of the Minister or the Secretary within the TGA also from time to time make or amend a range of legislative instruments, such as Therapeutic Goods Orders which set out standards for therapeutic goods, and Listing Notices which require that specified therapeutic goods be included in the part of the Australian Register of Therapeutic Goods for listed goods.
Regulations, including regulations that amend other regulations, are approved by the Governor-General at a meeting of the Federal Executive Council, and are tabled in Parliament.
Meetings of the Executive Council are scheduled throughout the year. Proposed amendment regulations are prepared ahead of such meetings, so that the amendment regulation can be provided for the Governor-General's consideration and approval.
Once a proposal to amend the regulations has undergone all the necessary preliminary steps of consultation, completion of best practice requirements and policy refinement and approval, the TGA will ask OPC to draft the amendment regulation and work with them to settle the amendment regulation.
TGA officers will also prepare an Explanatory Memorandum (EM) and a separate description of any consultation undertaken in relation to the proposed amendments, to accompany the settled amendment regulation. The settled amendment regulation and the EM must then be provided to the Federal Executive Council Secretariat for review.
The EM explains the purpose and effect of each of the proposed amendments. Once an amendment regulation has become law, persons accessing online versions of the amendment regulation will not be able to view the EM but rather an Explanatory Statement (ES). The ES is identical to the EM except that tense is slightly different. The ES explains the amendments on the basis that they are already in place (e.g. "this amendment does x"), whereas the EM uses the future tense and explains the effect that the amendments would have if they were approved (e.g. "this amendment would do x").
The ES will also incorporate a Statement of Compatibility with Human Rights. Such Statements have been required under the Human Rights (Parliamentary Scrutiny) Act 2011 (the HR (PS) Act) since January 2012 and should assess whether the amending regulation is considered compatible with Australia’s human rights obligations as identified in the HR(PS) Act.
Once any feedback of the Secretariat has been reflected in the documents, the Executive Council liaison officer within the Department will prepare additional supporting documents to accompany the amendment regulation and the EM. The total package will then be submitted to the Parliamentary Secretary for review and approval ahead of the Executive Council meeting which the amendment regulation is being progressed towards.
Once the Governor-General approves an amendment regulation, it will need to be registered on the Federal Register of Legislation (FRL) before it can become law. In relation to the commencement of an amendment regulation, this will be set out in the amendment regulation itself. Often amendment regulations commence the day after they are registered on FRL, but in some cases they may commence on a specific date. For example, amendments to regulations to effect an increase TGA fees and charges usually commence on 1 July, to coincide with the start of each new financial year.
Making or amending legislative instruments other than regulations
The TG Act provides for a range of legislative instruments that may be made by the Minister or Secretary (or a respective delegate), such as manufacturing principles or the Therapeutic Goods Advertising Code.
Such instruments will, in most cases, be prepared by TGA officers, once all of the necessary consultations, policy approvals and regulatory impact assessments have been satisfactorily completed. TGA officers will also prepare an ES to accompany the instrument, and a Statement of Compatibility with Human Rights.
As with regulations, the TGA's legislative instruments must be registered on FRL to have legal effect.