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Submissions and TGA response: Australian Regulatory Guidelines for Over-The-Counter Medicines (ARGOM) - Stage 1

12 October 2012

The TGA would like to thank the organisations who have submitted written comments or made submissions in response to the consultation: Australian Regulatory Guidelines for Over-The-Counter Medicines (ARGOM) - Stage 1.

Submissions received

Submissions were received from the following industry group and organisations:

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Summary of broad issues reported and TGA's Response

The following sets out in brief the broad issues identified from the submissions received and the TGA's response.

Appendix 1: Efficacy and safety

Topic Summary of issue TGA response
Inclusion of substance on list of active ingredients in section 11. It was proposed that fluconazole should be included in the list of active ingredients for which bioequivalence data are not required.

The list has been determined in accordance with the guidelines outlined in Section 6.1. The TGA will update this list when submissions of acceptable justification have been received by the TGA.

The TGA will amend the document to clarify the requirement.

Appendix 2: Quality

Topic Summary of issue TGA response
Qualifications to write for CTD Module 2.3 and requirements for all application types.
  • Concern was raised on what qualifications the TGA will recognise as acceptable to write the Module 2.3. It was noted that registered Qualified Person (QP) is required in Europe. However, in Australia no equivalent qualification exists. Typically experienced Regulatory or Quality personnel have prepared the quality expert reports.
  • Concern was also raised that the wording implies the Module 2.3 will be required for all application types.
  • The TGA considers that there is no requirement for the summaries in Module 2 to be written by someone authorised for that purpose. The answer to question 2 in the Q&A document ( indicates that this is a Europe-specific requirement. The TGA does not intend to change the current Australian practice of summaries being written by experienced Regulatory or Quality personnel.
  • The TGA will amend the document to clarify the requirements for different application types.
Module 1.6 of the Australian CTD It was requested that clarification be made that the Australian CTD Module 1.6 has been specifically drafted for prescription medicines. In the process of review, it was determined that it would be more appropriate if the document is amended to refer to a letter of access rather than referring to the Australian CTD.
Inclusion of Section 14 of Therapeutic Goods Act It has been proposed that information relating to seeking exemption through Section 14 of the Therapeutic Goods Act is included where a standard cannot be met for a reason. The TGA believes that the addition of information relating to Section 14 of Therapeutic Goods Act may mislead the purpose of section 14 as an alternative and may falsely encourage sponsors to submit an application for exemption rather than comply with the standard. The Standard should be complied with under all circumstance and only exceptional cases will require the need for section 14.
Measuring devices and dose delivery devices A number of respondents identified that there was insufficient guidance on medical devices that are used with OTC medicines, whether they are packaged together or separately supplied. Furthermore it was pointed out that the information provided was confusing and inaccurate and the examples given in the guideline did not appear to be consistent with ARGMD. It was proposed that the guideline should cite sections of the Australian Regulatory Guideline for Medical Devices (ARGMD) where appropriate. The TGA will undertake further consultation with the Office of Device Authorisation and will revise the section to be consistent with the ARGMD.
Unclear requirements for licensing of active ingredients. It was felt that the information in the revised guidelines were not as clear as the current document with regard to this requirement. The respondent claims that the revised wording used can be construed to indicate a change in TGA's requirement for evidence to confirm approval. The TGA considers that the revised wording does not introduce a new change to the process or impose a new requirement. The revised text is considered to be clearer regarding the requirements as compared to the information in the current ARGOM 2003 document which can be misleading as it implies that GMP is not required.

Appendix 3: Presentations

Topic Summary of issue TGA response
Updating of guideline A respondent queried why the guidance on umbrella branding and professional endorsement have not been updated even though the issue has been subject to significant discussion. The consultation document advises in the information box under Section 2 Product name that the section will be revised pending the outcomes of the labelling and packaging review that is currently undertaken by the TGA.
Restricted representation
  • It was considered that it would be useful to include some information on the need to obtain an exemption for inclusion of a restricted representation on labelling, which is a separate process from seeking approval for use of a restricted representation in advertising.
  • It has been proposed that additional guidance is provided with regards to potential for restricted representation issues relating to sponsorships.
  • The inclusion of information on the need to obtain exemption for restricted exemption may mislead sponsors into thinking that an application seeking approval for use of restricted representation is a matter of routine rather than in exceptional cases. It is also out of the scope of the guideline to provide this information. In addition, there already exists a guidance document on the TGA website regarding restricted representation which sponsors can refer to.
  • The TGA will amend the document to provide some guidance with regards to potential for restricted representations relating to sponsorships.

Appendix 4: New substances

Topic Summary of issue TGA response
Information relating to data requirements for new substance applications The information contained in Section 4 providing guidance on data requirements is unclear with respect to the various strategies that are available to generate the data necessary to support a new substance application. The TGA will undertake further consultation with the Toxicology section to revise the entire section 4.

Appendix 5: Specific products

Topic Summary of issue TGA response
Aspartame Query the need to include the warning statement "PHENYLKETONURICS: CONTAINS PHENYLALANINE" for OTCs containing aspartame, and recommends that this requirement be removed from ARGOM (and subsequently from the proposed RASML 6 update).

As indicated, warning statements marked with an (*) which are being included in the current updating of the RASML document will be removed once the updated version of RASML document is implemented.

A response to submission is available on the TGA website regarding the inclusion of a warning statement for Aspartame in the RASML document: RASML updates 5 & 6: Submissions & TGA response to submissions.

Hyoallergenicty of topical preparations

Respondents argued that appropriately designed Repeat Insult Patch Testing (RIPT) is becoming the standard test method everywhere. That in Europe and the Middle East the RIPT is accepted by regulatory authorities for sensitisation and irritation testing. Therefore it should be accepted as a suitable substitute test for hypoallergenicity claims. Further, the RIPT tends to be applied to finished products, whereas the Kligman Maximisation Test (KMT) is applied to raw materials. Respondents also noted that the Australian laboratories are no longer providing the KMT.

It was requested that the TGA reconsider this position on RIPT or provide advice on acceptable internationally recognised alternative tests.

Although the RIPT is internationally recognised and accepted by overseas regulatory agency for testing irritation or sensitisation potential, nevertheless it is not used for claiming hypoallergenicity. RIPT are performed on normal and healthy subjects and not in sensitive subjects unless sensitive subjects are specifically selected in the study. Therefore the TGA considers that a negative result in a routine RIPT cannot be used as the basis for claiming hypoallergenicity.

The TGA asserts that hypoallergenicity claim should be restricted to products that have been shown not to cause sensitisation reactions in hypersensitive subjects.

Paediatric products containing sedating antihistamines The information provided for this section is ambiguous in that it implies, by omission, that sedating antihistamines may be given to children between 2 and 6 years of age. It would also appear to be contrary to the outcomes of the recent cough and cold medicine review. The TGA will revise the section to further clarify the requirements for paediatric products containing sedating antihistamines.
The use of the term health care professional

Stakeholders expressed a concern that the term 'healthcare professional' appears to be no longer be acceptable for cough and cold medicine labels, and the need to replace it with 'pharmacist, doctor or nurse practitioner'. It is argued that:

  • The term 'health(care) professional' has been used for a long time with no adverse outcomes
  • The term 'nurse practitioner' is not well known or understood by consumers and may cause confusion
  • There is already limited space on labels

In addition, there would be a significant regulatory and cost impact if sponsors were directed to change their labelling to implement this wording across all warning statements.

The TGA has identified that there were two warning statements that requires the use of the term "health care professional" and "health professional" in the guidance document. The two warning statements only apply to head lice treatment and Nonoxinol. The rest of the warning statements in the guidance document as well as those in the RASML document, for OTC medicines, have always referred to a doctor and/or pharmacist.

In the review of the cough and cold medicines for use in children, it was identified that the meaning of health care professional encompasses a number of professions who are not qualified to give advice for medicines for use in children. To ensure the safe use of cough and cold medicines in the paediatric population, the advisory statement identifies doctor, pharmacist and nurse practitioners to ensure there is no ambiguity as to who can give this advice.

The guidance document advises on the warning statement that is applicable for specific products. The evaluation of an application happens on a case by case basis taking into account all the elements which constitute the safe and effective use of the medicines including working with space on labels.

Process related issues

The following issues have been identified as being process related issues. These will be referred to the OTC BPR project team for consideration.

Appendix 1: Efficacy and safety

Topic Summary of issue
Justification for not providing bioequivalence data Members have expressed concern where justifications should be included in applications. It is vital for industry to know where to include this information in the application so it is not overlooked and the application considered being deficient.

Appendix 2: Quality

Topic Summary of issue
OTC specific Module 1 Footnote 11 provides a link to Module 1 contains Australian-specific requirements and details regarding the physical aspects of a prescription medicine submission dossier. It has been developed as part of the Prescription Medicines BPR project. It would be preferable to be able to provide a link to an OTC-specific Module 1. This should be prepared as part of the OTC BPR project.
GMP Clearance

The process for obtaining clearance of overseas OTC medicine manufacturers is more stringent and inconsistent with that for prescription medicines. Prescription applications are able to be submitted for evaluation prior to receiving overseas GMP clearance, but for OTCs the process is more onerous as GMP clearance must be obtained prior to submitting applications. ASMI suggests this should be discussed as part of the OTC BPR project.

The process for GMP Clearance within electronic submission needs review as part of BPR project.

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