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

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.

• 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 (http://www.tga.gov.au/pdf/euguide/ich555202en.pdf) 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.

• 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.

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.

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.

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.

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.