2017–18 year to date performance overview

Between 1 July 2017 and 30 September 2017, the APVMA:

  • finalised 27 applications for pre-application assistance
  • received 622 new product, active and permit applications for preliminary assessment
  • commenced assessment/evaluation of 704 product, active and permit applications
  • finalised 1058 product, active and permit applications
  • overall timeframe performance was 58 per cent for product, active and permit applications types with:
    • 36 per cent of applications for pesticides completed in timeframe
    • 76 per cent of applications for veterinary medicines completed in timeframe
    • 82 per cent of applications for actives completed in timeframe
    • 52 per cent of applications for permits completed in timeframe
  • 74 per cent of the 1303 applications in progress are within timeframe
  • 38 per cent of applications requiring major assessment for pesticides were completed within timeframe
  • 26 per cent of applications requiring major assessment for veterinary medicines were completed within timeframe
  • 35 per cent of non-technical applications for pesticides were completed within timeframe
  • 97 per cent of non-technical applications for veterinary medicines were completed within timeframe

Summary of activities related to regulatory decisions July 2017 – September 2017 

Types of regulatory decisions*

Commenced

Finalised/issued

In progress

Pre-application assistance

27

30

35

Product registration—pesticides

275

403

542

Product registration—veterinary medicines

224

310

301

Actives

103

177

299

Permits

102

168

161

Items 8L, 8M, 8P

230

241

6

Item 25

5

5

14

Notifiable variations

216

124

160

Import consents

194

182

28

Certificates of export

122

94

28

Total

1498

1734

1574

*See description of application types.

Glossary of terms

Product applications—applications made for the registration of pesticides (substances or mixtures of substance intended for preventing, destroying, repelling or mitigating any pest) and veterinary medicines (substances or mixtures of substances intended for treating diseases or conditions in animals). Product applications include applications within item numbers 1–14. It excludes notifiable variations and items 8L, 8P, 8M and 25.

Major assessments have assessment periods over three months and require one or more technical assessments. Includes item numbers 1, 2, 3, 4, 5, 6, 10, 11 and 14.

Non-technical assessments have assessment periods of three months or less and have no technical assessment. Includes item numbers 7, 8, 9, 10A, 12, 13 and 13A.

Actives—the component of a pesticide or veterinary medicine product that is responsible for its physiological or pharmacological action. Applications for active constituents are covered under items 15–18, plus a number of applications in items 1 and 2.

Permits—applications to use or possess an unregistered pesticide or veterinary medicine or for an off-label use of a registered pesticide or veterinary medicine. Covers items 19–23.

8L, 8M and 8P—applications to either change the holder or nominated agent of an approval or registration or nominate a nominated agent for an approval or registration

Item 25—are technical assessments used to determine that a data package addresses the safety, efficacy and trade criteria. An outcome of a technical assessment can be used by an applicant as part of a future application.

Notifiable variations—minor change to the details of a registered product, actives or labels without having to register a new product. This process commenced on 1 January 2015. There is no statutory timeframe for the APVMA to process these, they are considered to be accepted upon lodgement by the applicant after some checks of the information.

Import consents—consents to import are permits that allow unregistered or unapproved chemicals into Australia when a legitimate reason exists for a person or company to have possession of the chemicals in Australia, e.g. for research, chemical trials or special veterinary applications in zoos. There is no statutory timeframe for the APVMA to process these but the APVMA aims to process import consents within 14 days.

Certificates of export—before accepting exports of a chemical product from Australia, many countries require an assurance from the government authority responsible for regulating the product in Australia. This is provided by the APVMA in the form of a certificate of export. There are no statutory timeframes for the APVMA to process these.

 

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