TGA labelling and packaging regulatory framework

May 2011

The legislative framework

Legal requirements

The Therapeutic Goods Act 1989 (the Act) specifies that therapeutic goods must not be imported, supplied or exported if they do not meet applicable standards. A number of Therapeutic Goods Orders (Orders) specify standards relating to the labelling and packaging of therapeutic goods (see Attachment 1).

The Standard for the Uniform Scheduling of Drugs and Poisons (the Poisons Standard) is also adopted by state and territory legislation in relation to poisons labelling and other Commonwealth regulatory authorities, such as the Office of Chemical Safety. In relation to the regulation of therapeutic goods, the Poisons Standard applies to decisions about whether a medicine should be listed or registered on the Australian Register of Therapeutic Goods (ARTG) and decisions relating to the advertising code.

The Required Advisory Statements for Medicine Labels (RASML) document was developed to enable the transfer of all mandatory label advisory statements from the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) and the Therapeutic Goods Regulations 1990 (the Regulations) to a new document, separate from but linked to TGO 69 - General requirements for labels for medicines (the Labelling Order).

The Labelling Order makes it mandatory for medicine labels to include any label advisory statements specified in RASML. By physically separating the documents, the advisory statements can be updated at regular intervals to reflect decisions of the Advisory Committee on Medicines Scheduling, without issuing an entirely new Labelling Order each time.

Guidance documents and codes of practice

The TGA, as a Commonwealth regulatory authority has an obligation to provide explanatory material to assist the regulated community in understanding their legal obligations. Each legislative instrument therefore has an associated guidance or explanatory document. As a result of the tampering crises in the consumer medicines industry in 2000, the Therapeutic Goods Administration (TGA) established an Industry Government Crisis Management Committee (IGCMC). This Committee developed strategies aimed at preventing, or minimising the effect of, similar occurrences in the future. This included the development of an industry code of practice that sets out the requirements for tamper evident packaging, the Code of Practice for the Tamper-Evident Packaging of Therapeutic Goods (the TEP Code of Practice). This code of practice was adopted on a voluntary basis by the Australian Self Medication Industry Association (ASMI), Medicines Australia (MA), the Complementary Healthcare Council (CHC) and the Medical Industry Association of Australia (MIAA) in December 2000.

The TGA also provides detailed information to sponsors in relation to applications to register a therapeutic good on the ARTG. In the case of prescription medicines, this includes the Australian Regulatory Guidelines for Prescription Medicines and detailed instructions about information that must be included in the Common Technical Document (CTD). A CTD is an internationally harmonised application package to register a therapeutic good on the ARTG. This facilitates the preparation of preclinical pharmacology and clinical data in a format that can be submitted to therapeutic goods regulators around the world. Module 1 of the CTD requires a sponsor to supply information elements that reflect local legislative requirements. In Australia, this is where specific labelling and packaging information is provided. Detailed guidance about labelling and packaging requirements, in addition to the guidance documents shown in Attachment 1, is provided by on the TGA internet site.

TGA regulation of product labelling and packaging

Pre-market regulatory processes

The TGA pre-market evaluation process includes an assessment of the product against mandatory labelling and packaging requirements and those requirements documented in the TEP Code of Practice. Evaluators provide their assessment and appropriate recommendations to the clinical delegate with responsibility for the product application. Before a therapeutic good can be approved for marketing, the delegate must be satisfied that all legislative requirements, including those relating to labelling and packaging, have been met.

In relation labelling, the TGA evaluators check that the label contains information specified by the legislation, including:

  • the product name;
  • name(s) of all active ingredients and their quantity;
  • in some cases, excipient information;
  • batch number;
  • expiry date;
  • relevant warning/advisory statements;
  • storage conditions;
  • directions for use;
  • in most cases the indications for which the product is used; and

that the information is in the English language and in durable, legible lettering that is not less than 1.5 millimetres in height (except for the ARTG number which must be no less than 1 millimetre in height).

TGA evaluators also assess:

  • the scientific evidence that is provided in support of the proposed shelf life (expiry dates);
  • whether the product name looks or sounds like another ARTG entry;
  • the content of the Patient Information (also known as Consumer Medicines Information) documents against the requirements specified in Schedule 12 and regulation 9A of the Regulations;
  • ensure that medicines containing active ingredients listed in TGO80 are packaged in a manner that is designed to be resistant to opening by children; and
  • that the elements of the TEP Code of Practice have been met.

Please note that the above is not intended to be a complete listing of legislative requirements in relation to medicine labelling and packaging. Non-mandatory specifications, such as space for Pharmacy dispensing labels and packaging colour and design are also considered and changes recommended to the sponsor of the therapeutic good.

Post-market regulatory processes

Once a therapeutic good has been entered on the ARTG, it becomes subject to TGA's ongoing post-market monitoring and surveillance processes, which include the following activities:

Adverse event monitoring: The TGA assesses adverse event information to identify risks that may come to light only after more people use the therapeutic good, and takes appropriate action. This may include product recalls, safety alerts, revision of contra-indications and advisory statements.

Audits of manufacturing sites: To ensure the ongoing quality of the approved therapeutic good, the TGA conducts regular inspections of sites where they are manufactured, including overseas manufacturers. The frequency of the audits is based on product risk (see Risk based approach to audit frequency).

Product testing: The TGA conducts random and targeted laboratory testing of approved therapeutic goods.

Problems reporting: The TGA provides an on-line facility for consumers and health professionals to report problems related to therapeutic goods. This may include information about problems relating to labelling or packaging issues. Information received is assessed and appropriate follow up or compliance action taken.

The TGA is also closely engaged with other therapeutic goods regulators. This is particularly important as potential problems may be detected first in larger populations or in countries where a therapeutic good is approved for marketing earlier.

The TGA has a range of compliance and enforcement powers to take appropriate action should any potential non-compliances with labelling and packaging requirements be detected.

Reviewing the TGA labelling and packaging framework

As with any regulatory framework, there is a need for ongoing review to ensure it keeps up with technical developments and continues to be able to manage emerging risks.

The TGA is currently conducting a scoping exercise in relation to a review of the labelling and packaging regulatory framework. Once the scope and priorities have been determined, the TGA will engage with relevant stakeholders. It is anticipated that this will include consumer, professional and industry representative bodies, other government agencies and the jurisdictions.

It is a requirement of Australian Government agencies that a Regulatory Impact Statement (RIS) is prepared for any proposed changes to Commonwealth legislative instruments that are likely to impact on business or the not-for-profit sector, unless that impact is of a minor or machinery of government nature and does not substantially alter existing arrangements. The primary role of the RIS is to improve government decision-making processes by ensuring that all relevant information is presented to the decision maker.

The Office of Best Practice Regulation in the Department of Finance and Deregulation is responsible for the quality control of RISs and must clear the RIS before it is submitted to the decision maker.

Attachment 1: Diagram of the TGA labelling and packaging framework

Labelling Packaging
Therapeutic Goods Act 1989
Legislative instruments
  • TGO80 (Child resistant packaging)
    If reclosable package, relevant International, British, Canadian, Australian Standards and US Code of Federal Regulations also apply. These are specified in TGO80.
Other mandatory requirements
  • Required Advisory Statements of Medicines Labelling
    Mandated by TGO69
    Prescription, non-prescription, complementary and exempt medicines
  • Nil
TGA guidance documents

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