Standards applying to therapeutic goods - information for consumers

11 March 2016

Therapeutic goods (including medicines) which are supplied in Australia must comply with certain standards, for example, about what information must be included on a medicine label. Many of these standards are international standards. Ongoing compliance with standards ensures the therapeutic goods are of the appropriate quality, safety and efficacy.

Importing, supplying or exporting therapeutic goods that do not comply with the applicable standards is an offence under the Therapeutic Goods Act 1989.

However, in exceptional circumstances and only when the scientific and medical experts in the TGA are satisfied that the safety, quality and efficacy of the goods are not adversely affected, the TGA can consent to the importing, supplying or exporting of particular therapeutic goods that are not compliant with a standard.

This may involve a minor or technical non-compliance and supply of a needed medicine would be interrupted if the consent were not given. The consent is usually subject to conditions designed to minimise any risk and will usually be limited to nominated batches of the goods or be of limited duration.

For instance, consent has been given to the supply of specified batches of a medicine where the batch number and expiry date prefixes printed on blister foils on a blister pack for the medicine are present but do not immediately precede the respective batch number and expiry date. In this example, a condition was imposed by the TGA that a 'Dear Pharmacist' letter was required to be supplied with affected batches setting out the circumstances of the consent to supply that reminded patients to keep the blister strips with the outer carton.

The person seeking the consent must make an application to the TGA and provide relevant information, including an explanation of the reasons for the non-compliance.

The TGA minimises any risk associated with the granting of the consent by considering:

  • the clinical need for an uninterrupted supply of the goods and the extent to which suitable alternatives are available,
  • the extent to which the imposition of appropriate conditions will sufficiently mitigate any risks,
  • whether it is appropriate to limit the consent by reference to time and or number of batches, and
  • whether the issue giving rise to the lack of compliance was foreseeable or avoidable.

Where any such risk cannot be appropriately mitigated, the consent will not be granted.

The TGA is required under the Act to publish particulars of all decisions to consent as soon as practicable after the decision is made. Information includes:

  • the name of the person in relation to whom the consent has been granted,
  • the name of the relevant product and the type,
  • duration of the consent/batches to which the consent applies,
  • the standard in relation to which the consent is being granted,
  • a description of how the product does not meet that standard, and
  • any conditions imposed.

Information about consents granted prior to 1 February 2016 is available on the ComLaw website.

Further information (including consents granted since 1 February 2016) is available from the database.