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Frequently asked questions about the new OTC business process (commenced April 2013)

29 November 2015

These frequently asked questions have been incorporated into updated guidance.

This page will be removed on 1 March 2016.

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Staged implementation

The new OTC BPR process commenced on the 15 April 2013. The new process and requirements are being implemented in stages over 12 months, with full implementation in April 2014. The staged implementation is intended to allow sponsors to become familiar with the new process.

The ARGOM: Guidelines on the Pre-market application and evaluation process for OTC Medicines and the Staged implementation plan specify the aspects of the new process and requirements that are subject to staged implementation. If a requirement of the new process is not subject to staged implementation then it is applicable from April 2013. There is no option to apply the old process during staged implementation.

During staged implementation sponsors will be able to correct some errors in their applications, as detailed in the Staged implementation plan. From April 2014, applications that do not meet the requirements set out in the Australian Regulatory Guidelines for OTC Medicines may not be accepted, as described in the ARGOM: Guidelines on the Pre-market application and evaluation process for OTC Medicines.

The Staged implementation plan details further information and key implementation dates.

Format of the submission dossier

Between April 2013 and April 2014, you are required to provide the submission dossier in both hard and electronic copy. Screening of applications will not commence until both hard and electronic copies of the submission dossier have been provided. This requirement applies to all application levels.

The electronic copy of the dossier needs to be provided on CD ROM, CD-R, DVD-R or 'data stick'. The cover letter should state the form of the electronic submission dossier (e.g. CD-R, DVD-R) and provide an assurance that the hard and electronic copies are identical.

You are strongly encouraged to follow the ARGOM: Guidelines on electronic OTC dossiers in order to submit electronic dossiers that best facilitate evaluation of the application.

From April 2014, when the ARGOM: Guidelines on electronic OTC dossiers come into effect, hard copies of applications will not be required.

Please refer to the Staged implementation plan and ARGOM: Guidelines on the Pre-market application and evaluation process for OTC Medicines for further details.

From September 2013, all dossiers must be in Common Technical Document (CTD) format. You are strongly encouraged to follow the ARGOM: Guidelines on electronic OTC dossiers in order to submit electronic dossiers that best facilitate evaluation of the application. These guidelines will come into effect in April 2014.

A separate electronic submission dossier (on a separate storage device) is required for each application submitted and is required for all application levels.

Please refer to ARGOM: Guidelines on electronic OTC dossiers for full details.

Payment of fees

If paying by cheque or credit card authorisation, forward payment together with a copy of the relevant invoice directly to the TGA Finance section in the Regulatory Business Services Branch by separate postage. Indicate that payment has been forwarded directly to the TGA Finance section in the application cover letter. Do not include cheque/credit card details with the hard copy of the submission.

Cheques and credit card authorisations should be sent directly to:

Regulatory Business Services Branch
PO Box 100
WODEN ACT 2606
Australia
Fax: 02 6232 8222

Cover letters

Your cover letter should state the following:

  • The nature and scope of the application.
  • The application level (as per the OTC application categorisation framework)
  • The reasons for selecting the application level, how the application meets the criteria for the application level and any relevant background information.
  • For applications to change an OTC medicine, a description of the change(s) and the reason for the change. It is not sufficient to just restate the information contained in the applicable change codes.
  • Where multiple changes are proposed, the information should be presented in table format comparing the current and proposed product details that are subject to change and giving the reason for the change. For example, a suitable table format would include the following headings; current registration, proposed registration, reason for change, reference to supporting documentation and change code/application level. This is necessary for all change applications, including C1 applications.
  • Other relevant information including:
    • The format of the electronic dossier and an assurance that the hard and electronic copies of the submission dossiers are identical.
    • Confirmation that payment of fees has been forwarded directly to TGA finance.
    • Details of any requests made to the TGA for extensions to GMP certification/clearance.
    • Relevant assurances. For example, the assurances required to accompany N1 level applications.

When screening applications, the TGA relies on the cover letter to accurately describe the scope of the application and detail any factors that may impact the application level.

If your cover letter does not include the required information you will be requested to provide an updated letter during screening.

It is not sufficient to state only the application level in the cover letter. Your cover letter needs to clearly document how the application meets the criteria for the application level and should include;

  • The nature and scope of the application.
  • The reasons and criteria that you considered when selecting the application level.
  • For medicines with an 'umbrella segment' in the product name; how you applied the guideline on the OTC application route for umbrella branded medicines to determine the application level.
  • Any other information that may be relevant to the application level. 

Confirmation of the application level is made during screening on the basis of the information provided in your application form and cover letter. Screening does not involve any assessment of data or in-depth scrutiny of documents, including labels or formulation details, to verify your assessment of the application level.

If the cover letter omits information that is critical to determining the application level, it may not be possible to detect, during screening, an application that has been submitted at an incorrect level.

Application level

It is the sponsor's responsibility to determine the correct application level. During screening, the TGA confirms that the application has been submitted at the correct level based on the information in the cover letter and application form. No assessment of data or in-depth scrutiny of documents, including labels or formulation details, is undertaken during screening to verify your assessment of the application level.

The consequences for applications that are submitted at an incorrect level prior to April 2014 are detailed in the Staged implementation plan. After April 2014, applications that are submitted at the incorrect application level will not be accepted and the application fee will be forfeited.

If the cover letter omits information that is critical to selecting the correct application level, it may not be possible to detect an incorrectly levelled application during screening. However, the incorrect application level may be detected during the closer scrutiny of the evaluation phase. In this case, if your application has been accepted for evaluation at a lower application level, you will be informed that the application will be restricted to conform to the requirements of the accepted application level and advised of the changes needed to meet the relevant criteria detailed in the OTC application categorisation framework. If this is not possible, the application cannot proceed and will need to be resubmitted at the correct level.

Example

During evaluation, an application accepted at the N3 level is noted to have labels that include an extension of target population and directions for use, which were not raised in the cover letter and therefore not detected during screening. Due to the extended target population and directions for use, the application fails to meet the criteria for an N3 level application. In this case, the sponsor would be informed that the target population and directions for use will be restricted to those that meet the criteria for an N3 level application.

GMP certification/clearance

Application level GMP clearance: sufficient duration before expiry is a minimum of:
C1 2 months
N1 3 months
C2 & N2 4 months
N3, N4, N5, C3 & C4 6 months

If the GMP clearance expires before an OTC medicine application is completed this can cause delays as the application cannot be finalised without current and valid GMP clearance. Therefore, an OTC medicine application needs to be accompanied by GMP clearance with sufficient duration before expiry to allow for completion of the application. The duration until expiry will be checked during screening.

For lower application levels, the minimum sufficient duration until expiry is based on the expected time to complete an application, including target evaluation days and time allowed for requests for information (RFIs). For all higher applications levels the minimum duration until expiry is six months from the time you submit the application.

If you need to renew the clearance or obtain an extension to the expiry this should be requested, and preferably obtained, from the Manufacturing Quality Branch before application lodgement. Applying to renew the clearance before application lodgement is particularly important for the application levels that have target evaluation times exceeding six months, as an extension to the expiry is unlikely to cover the full period to completion of the application. If you have requested an extension or applied to renew the clearance, state this in the application cover letter.