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ARGOM Appendix 2: Guidelines on quality aspects of OTC applications

Version 1.1

30 May 2014

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3. Description and composition of the medicine (finished product)

The application should include a brief description of the finished product and its composition, as specified under CTD module 3.2.P.1. In particular, the application should include:

  • a visual description
  • table(s) of the ingredients and quantities, including overages (if any)
  • details of the function of the ingredients in the product (e.g. disintegrant, antimicrobial preservative)

Sponsors should use Australian Approved Name (AAN) terminology. For those ingredients without an AAN, an Application form for proposing a chemical name, should be completed and either included with the application or submitted separately to the TGA (to the attention of the 'The Secretariat, Australian Approved Names Committee'). The Australian Register of Therapeutic Goods (ARTG) entry can only be finalised using AANs.

Any processing solvents should be included in the electronic application form under the category ‘starting materials not present in the final product’; however this information will not be included on the ARTG record for the product.

Note 1: Where the form has been submitted separately, it is recommended that the application letter include a statement alerting the evaluator to this fact.

Note 2: Other data requirements for new substances are detailed in ARGOM Appendix 4 Guidelines on OTC application for new substances.

3.1 Colouring ingredients permitted in medicines for oral use

The colours allowed by the TGA in medicines for oral use are included in the TGA document Colours permitted in medicines for topical and oral use, available on the TGA website. This restriction does not apply to dermal products or medicated lipsticks.

3.2 Proprietary ingredients

The term 'proprietary ingredient' means a formulated ingredient obtained from another manufacturer for which the formulation details are not known to the sponsor (flavouring and fragrance ingredients, for instance, are often sourced as proprietary ingredients).

If a proprietary ingredient is included in the product the sponsor should ensure that either:

  • the formulation details have already been disclosed to the TGA (in which case the  reference number of the ingredient should be stated in the application form)
  • the manufacturer of the proprietary ingredient has been requested to provide the TGA with details of the formulation on a Notification of a proprietary ingredient form, available from the TGA website.

If the label contains a negative disclosure (e.g. 'sugar free' or 'alcohol free'), the sponsor should check with the manufacturer or supplier that the substance is not contained in any proprietary ingredient included in the formulation. The sponsor should also check with the manufacturer or supplier whether the proprietary ingredient contains any ingredients that must be disclosed on the label, as listed in the First Schedule of the TGO 69.

For details of requirements relating to the control of proprietary ingredients see 'Section 6 Control of excipients'.

3.3 Ingredients of human or animal origin

Any materials of human or animal origin used as ingredients, excipients or during manufacture (e.g. fermentation medium) need to be assessed for viral and prion safety, including the risk of transmissible spongiform encephalopathies (TSEs) from ruminant-derived materials.

Therefore, when an electronic application is submitted to the TGA the sponsor must state whether each ingredient is of animal origin and if this is the case provide details regarding the material.

Guidance on the requirements for minimising the risk of TSEs in therapeutic goods is available on the TGA website. This guidance classifies materials of animal origin into three categories (A, B and C) depending on the animal species and tissues that they are derived from.

Ruminant-derived raw materials that are classified as Category A (high infectivity) and Category B (lower infectivity) tissues or fluids will be subject to full TGA viral and prion safety evaluation.

Category C materials are those currently classified as having no detectable infectivity, as described in the TGA guidelines. These materials may be eligible for self-assessment. The TGA website contains a questionnaire designed to help sponsors collect the data needed in order to self-certify therapeutic goods against the TGA requirements.

As part of the electronic application process sponsors are required to agree to the following statutory declaration:

'Any Category C ruminant ingredients included in this product have been 'self-assessed' in accordance with the TGA's 'Supplementary requirements for therapeutic goods for minimising the risk of transmitting transmissible spongiform encephalopathies (TSEs)', aand comply with those requirements.'

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