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Australian regulatory guidelines for OTC medicines (ARGOM) (Nov 2012)

Version 1.4

9 November 2012

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8. Post marketing surveillance

The current Australian Regulatory Guidelines for Over-the-counter Medicines (ARGOM) is being reviewed and updated by the TGA.

Selected chapters have been removed and replaced with references to the appendices. This document will remain as the guidance document until it can be fully replaced by the updated ARGOM, i.e. chapters such as Chapter 2, 3, 7, 8, 10 and 11 will remain in effect until such time it is replaced.

Products which are already being marketed are subject to a number of levels of surveillance by the TGA.

The sampling program

The TGA Laboratories undertake a continuous sampling program in all states of Australia. Products are purchased in the marketplace, or obtained from manufacturers or sponsors, and subjected to analysis and regulatory scrutiny. Products not meeting the required standards may be subject to corrective action, recall or removal from the register.

Good Manufacturing Practice (GMP) audits

Manufacturers of therapeutic goods in Australia are subject to regular inspections by the TGA's Manufacturer Assessment Section. Details of requirements for manufacture are specified in the Australian Code of Good Manufacturing Practice for medicinal products.

The evaluation committees may request that particular problems encountered during the evaluation process be followed up with the manufacturer during subsequent GMP audits.

See also Post-registration requirements in Chapter 4E, Stability testing.

'Grandfathered' products

Those products entered in the ARTG under the 'grandfather' provisions of the Act may be subject to future evaluation to determine whether they should remain on the Register. If you are the sponsor of such a product, you should ensure that you hold evidence to substantiate the quality, safety and efficacy of the product. You should also ensure that an ongoing stability testing program is in place for each product under your control.

The Surveillance Unit

The Surveillance Unit investigates breaches of the legislation and coordinates prosecutions.

Problem reporting and recall

Recalls of therapeutic goods are coordinated by the TGA's Recalls Section. Information can be obtained from the TGA website.

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