Published: 15 March 2013

Outcome of Consultation on Over-the-counter (OTC) Medicines Business Process Reform

15 March 2013

This section of the website provides a summary and describes the outcomes of the OTC medicines business process reform consultation, which included:

OTC medicines business process reform consultation

In September 2012, Medsafe and the TGA sought comments from interested parties on proposed reforms to the business processes for the evaluation of OTC medicines.

A consultation paper was published on the Medsafe and TGA websites on 13 September 2012 with a deadline for submission of 7 November 2012.

A total of 21 submissions were received - including 4 from industry associations, 12 from individual pharmaceutical companies, and the remaining 5 submissions from professional body representatives or advocacy groups.

Medsafe and the TGA would like to thank those who took the time to prepare a submission and provide helpful comments and suggestions.

The submissions received from both Australian and New Zealand submitters were jointly considered by Medsafe and the TGA for any changes to the proposed OTC medicines business process reforms.

Risk based approach to the categorisation of OTC medicines

The majority of submissions supported the proposed risk-based approach for categorising OTC medicine applications.

One submission suggested that the risk rating for OTC medicine applications should be based on the characteristics of the medicine in terms of risk to patients (e.g. indication, side effects) rather than the data requirements.

Regulator's Comment:

The risk-based categorisation was established using the inherent risk associated with different OTC medicines. The risk rating is based on the risk to patients and the data requirements are proportional to the risk rating.


Risk categorisation framework - new medicine applications

The majority of submissions supported the proposed risk categories for new medicines. Two submissions did not.

Regulator's comment:

The submissions that did not agree with the risk categorisation framework represent particular groups of products that include toothpastes, mouth washes, anti-acne face washes, hand sanitisers etc. Medsafe and the TGA consider that these types of products can be appropriately included in the proposed framework by further exploring the use of categories such as the monograph category.


Risk categorisation framework - changed medicine applications

There was mixed support for the proposed risk categories for changed medicines and a number of queries about the proposed change tables.

Several submitters requested that the current changes tables be retained or that change categorisation be aligned with the EU (e.g. IA, IB, II). Submitters also requested that all types of changes are reviewed to extend the notified and self-assessable categories further.

New Zealand specific comments included a reduction in the timeframes for the C4 category and reinstating two 'requests for information' for the C1 category.


Five-phase process

Of the submissions that responded directly to this question, there was general support for the process and the principles applied in developing a five-phase process.

A high proportion of submissions requested further definition of each phase of the proposed process including defined timelines. The screening phase was the subject of extensive comment, with particular emphasis on how to avoid refusal of applications and forfeit of the application fee. There was also extensive comment on the proposed timelines, and a request for statutory timelines.

A number of submissions requested that further clarification, on the detail of the process, be documented in guidance and that this guidance is subject to a separate consultation prior to implementation.



In general, the submissions from companies and industry bodies representing 'branded products' did not support monographs without the ability for inclusion of umbrella branded products. But the 'non-branded product' (i.e. 'house brand') companies and industry bodies did express some level of support.

Several submitters noted that the list of proposed monographs would have very limited uptake by applicants and suggested expanding the list would increase the utility. In particular, submitters requested adoption of international monographs to reduce the regulator's development costs. Others asked for the ability to submit abbreviated module 3 data that was similar to a monograph application, where applicable, in a submission of an application at a higher classification.


Umbrella branding

The majority of submitters agreed with the objective of reducing potential harm to consumers by developing clear guidance for managing the higher risk associated with umbrella branded products.

Clear guidance will be required alongside additional tools to ensure a consistent approach between regulators. This guidance should be developed within the implementation plan, noting that there is a labelling and packaging review currently under way in Australia that includes matters related to umbrella branding.



The majority of submissions felt that the proposed implementation date of April 2013 did not allow enough time to develop, consult and validate the required guidance documents and application tools.