You are here

Annual performance statistics report: July 2018 to June 2019

21 October 2019

Book pagination

2. Over-the-counter medicines

Over-the-counter (OTC) medicine applications are categorised as new medicine (N) or change (C) applications and are further categorised by risk (N1 and C1 are low risk, N5 and C4 are highest risk). The OTC application categorisation framework outlined on the following page defines the different OTC medicine application levels and the key application criteria.

Table 11 Categorisation of OTC medicine applications
Application category Definition Timeframe in days
N1 An application submitted as a 'clone'. 45 working days
N2 An application which complies with an OTC medicine monograph. 55 working days
N3 New application for a 'generic' medicine other than those 'generic' applications in levels N1, N2 or N4. 150 working days
N4

An application for a 'generic' medicine where the medicine:

  • requires supporting safety and/or efficacy (clinical/toxicological) data or a justification for not providing such data; and/or
  • requires a higher level of assessment due to the umbrella branding segment of the product name; and/or
  • has not been previously registered as an OTC medicine following down-scheduling.
170 working days
N5 An application for a new product that is an extension to a 'generic category' product or an application for a product containing a new chemical entity as an active ingredient. 210 working days
CN

'Notification' changes, where their implementation would not impact the quality, safety or efficacy of a medicine. Includes quality and non-quality changes classified as 'negligible risk'.

- Implemented 1 July 2017

N/A

(Automated validation and approval)

C1 Quality and non-quality changes classified as 'negligible risk'. 20 working days
C2 Quality and non-quality changes classified as 'low risk' - no safety and/or efficacy data required; quality data may be required. 64 working days
C3

Quality and non-quality changes classified as 'low risk' - safety and/or efficacy data required unless justified; quality data may be required.

Umbrella branding segment of new name requires a higher level of assessment.

120 working days
C4 Non-quality changes classified as 'moderate risk' - safety and/or efficacy data required unless justified. 170 working days
B1 Request for advice in relation to a registered OTC medicine for the purpose of listing the medicine as a pharmaceutical benefit that does not contain clinical data. 20 working days
B3 Request for advice in relation to a registered OTC medicine for the purpose of listing the medicine as a pharmaceutical benefit that contains clinical data or a justification as to why such data is not needed. 120 working days
Requests for consent under section 14/14A of the Act Request for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard. N/A

2.1. Approval times

We aim to have 80% of applications completed within target timeframes. The following target timeframes apply to OTC medicine applications:

Table 12 Median approval time for OTC medicine applications
2017-18 2018-19
July to June
New medicine applications (days)
N1 25 30
N2 35 48
N3 74 95
N4 55 97
N5 162 121
Change applications (days)
C1 4 4.5
C2 31 36
C3 72 84
C4 95 109
Table 13 OTC medicine approval time against target time by application category for July 2018 to June 2019
Application type Number completed (% of Total) Range Mean Median % within target
New medicines
N1 129 (58%) 0-66 29 30 87
N2 18 (8%) 28-55 45 48 100
N3 52 (24%) 8-188 92 95 94
N4 13 (6%) 18-217 101 97 85
N5 9 (4%) 81-198 126 121 100
Total 221 (100%)
Change applications
C1 182 (25%) 0-88 7 4.5 96
C2 549 (74%) 0-121 37 36 89
C3 8 (1%) 33-214 87 84 88
C4 2 (0.2%) 82-136 109 109 100
Total 741 (100%)

2.2. Applications

2.2.1 New OTC medicine applications

Table 14 Applications received for new OTC medicines and changes to existing medicines
2017-18 2018-19
July to June
Number (% of Total)
New medicine applications
N1 169 (60%) 100 (40%)
N2 16 (6%) 18 (7%)
N3 64 (23%) 70 (28%)
N4 23 (8%) 39 (16%)
N5 8 (3%) 23 (9%)
Total 280 (100%) 250 (100%)
Change applications
CN 171 (21%) 197 (18%)
C1 190 (24%) 197 (18%)
C2 438 (54%) 675 (62%)
C3 7 (0.8%) 7 (0.6%)
C4 3 (0.4%) 6 (0.6%)
Total 809 (100%) 1082 (100%)

2.2.2 Completed applications

Table 15 New OTC medicine applications completed and outcomes
2017-18 2018-19
July to June
Number (% of Total)
N1
Approved 144 (96%) 129 (98%)
Rejected 0 0
Withdrawn by sponsor 7 (4%) 3 (2%)
Returned/failed screening 0 0
Total 151 (100%) 132 (100%)
N2
Approved 5 (45%) 18 (82%)
Rejected 0 0
Withdrawn by sponsor 6 (55%) 4 (18%)
Returned/failed screening 0 0
Total 11 (100%) 22 (100%)
N3
Approved 37 (81%) 52 (81%)
Rejected 0 0
Withdrawn by sponsor 1 (2%) 0
Returned/failed screening 8 (17%) 12 (19%)
Total 46 (100%) 64 (100%)
N4
Approved 19 (76%) 13 (65%)
Rejected 1 (4%) 0
Withdrawn by sponsor 3 (12%) 3 (15%)
Returned/failed screening 2 (8%) 4 (20%)
Total 25 (100%) 20 (100%)
N5
Approved 8 (73%) 9 (90%)
Rejected 0 0
Withdrawn by sponsor 2 (18%) 0
Returned/failed screening 1 (9%) 1 (10%)
Total 11 (100%) 10 (100%)
Table 16 OTC change applications completed and outcomes
2017-18 2018-19
July to June
Number (% of Total)
C1
Approved 202 (99%) 182 (97%)
Rejected 0 0
Withdrawn by sponsor 2 (1%) 6 (3%)
Returned/failed screening 0 0
Total 204 (100%) 188 (100%)
C2
Approved 386 (97%) 549 (99%)
Rejected 0 0
Withdrawn by sponsor 11 (3%) 7 (1%)
Returned/failed screening 2 (0.5%) 0
Total 399 (100%) 556 (100%)
C3
Approved 5 (83%) 8 (80%)
Rejected 0 0
Withdrawn by sponsor 0 1 (10%)
Returned/failed screening 1 (17%) 1 (10%)
Total 6 (100%) 10 (100%)
C4
Approved 4 (100%) 2 (100%)
Rejected 0 0
Withdrawn by sponsor 0 0
Returned/failed screening 0 0
Total 4 (100%) 2 (100%)

2.2.3 Other applications

Other application types that we process include requests for advice for the purpose of listing a medicine as a pharmaceutical benefit. In accordance with the legislation, registered goods must comply with numerous standards at the time they are registered and throughout their lifecycle. Following an appropriate application and review of the scientific data and safety considerations, we may grant an exemption from a particular standard for a product.

Table 17 Number of other OTC medicine applications
2017-18 2018-19
July to June
Number (% of Total)
Requests for advice for the purpose of listing a medicine as a pharmaceutical benefit
B1 0 2 (100%)
B3 0 0
Total 0 2 (100%)
Requests for consent under section 14/14A of the Act to import, export or supply therapeutic goods not complying with an applicable standard
Approved 10 (100%) 21 (95%)
Rejected 0 1 (5%)
Total 10 (100%) 22 (100%)

Book pagination