OTC business process improvements

23 December 2015

A number of agreed business process improvements for registered over the counter medicines are now nearly concluded and will be implemented shortly, consistent with timeframes previously agreed with industry.

Improved target times for OTC evaluations

As at 1 November 2015, the target total evaluation times for N2 applications will be 55 working days. This has been reduced from 75 working days as part of the ongoing review and refinement of the OTC business processes. During the first half of 2016 we aim to introduce target times for the screening and initial evaluation phase, which will provide greater transparency and predictability for applicants.

Updated guidance material

A package of new and updated guidance has been developed in consultation with the OTC Industry Working Group, to better support the OTC business process and provide clarity for applicants. The new guidance does not introduce changes to the current process or requirements.

The package of guidance was published on 30 November 2015. The existing process guidelines will continue to be available until 1 March 2016. We strongly encourage applicants to make themselves familiar with, or start using, the new guidance as soon as is it published. Please note, that the information regarding fees in the new guidance describes the current fee structure. This will be updated as at 1 January 2016 to reflect the new fee structure, but otherwise the guidance remains consistent and relevant for existing processes and processes post 1 January 2016.

Revised fees commencing 1 January 2016

A new fee structure will apply to applications received on or after 1 January 2016. The new fee structure replaces the current fees based on page count with fees that are aligned with the application level. Fees will be set by amendments to the Therapeutic Goods Regulations 1990. Information on the proposed fees was published within the cost recovery implementation strategy for over the counter medicines on the TGA website in July 2015.

We would also like to draw your attention to the way the wording of section 9D application fees will differ slightly from section 23 applications. For section 9D applications the application fees and evaluation fees will appear as one fee, with a provision to refund the portion of the fee corresponding to the fee for evaluation, if the application does not proceed to the evaluation phase. Please note that the total submission cost for change applications (under section 9D or section 23) is not affected by this difference in wording. For example, the total submission cost of a C2 application made under section 23 of the Act is $5310 ($1530 application fee plus $3780 evaluation fee), which is the same cost as a C2 application made under section 9D of the Act.

The new fee structure will be reflected in the summary of fees and charges as published on the TGA website and is shown in the tables below. Currently, the application portal splits the total submission cost into application fees and evaluation fees regardless of the section of the Act they are prescribed under. We will work to amend the portal to consistently reflect the language in the fees table and regulations, however this portal modification may not be in place by 1 January 2016.

Table 1. Fees for section 23 applications
Application level Application fee Concurrent Application fee Evaluation fee Concurrent evaluation fee
N1 $1530 $765 $3780 N/A
N2 $1530 $765 $5360 N/A
N3 $2450 $1225 $8270 $4185
N4 $3575 $1225 $13700 $4185
N5 $5310 $1225 $20300 $4185
C1 $1530 N/A N/A N/A
C2 $1530 N/A $3780 N/A
C3 $1530 N/A $6330 N/A
C4 $2450 N/A $8270 N/A
Table 2. Fees for section 9D applications
Application level Application fee Refund if application doesn't proceed to evaluation
C1 $1530 N/A
C2 $5310 $3780
C3 $7860 $6330
C4 $10720 $8270