Edition VMT010
- Directors update: Dr Donald Sibanda, Dr Valerie Villiere and Dr Sam Beckett
- New product registrations
- Welcome to Dr Sam Beckett, Director, Veterinary Medicines
- New module descriptors from 1 February 2023
- International and overseas assessments – possible timeframe and fee savings
- Guidance for active constituent applications
- Useful information for industry
- List of new, suspended or cancelled manufacturer licences
- Q&A
Directors update: Dr Donald Sibanda, Dr Valerie Villiere and Dr Sam Beckett
Welcome to the March 2023 edition of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) Veterinary Medicines Regulatory Newsletter. In this edition, we have included information on several regulatory topics, including the introduction of new module descriptors following the release of the APVMA Cost Recovery Implementation Statement (CRIS), and our review of guidelines for immunobiologicals.
Since our last newsletter, we have welcomed Dr Sam Beckett as a Director in the Veterinary Medicines Team, who oversees Manufacturing Quality and Licencing (MQL) and Assurance, including Adverse Experience Reporting (AERP), Hormonal Growth Promotants (HGPs) and product recalls.
We continue to encourage applicants to participate in the APVMA stakeholder meetings, which are conducted from February to October. These meetings are a valuable forum for applicants, industry, and the APVMA Veterinary Medicines Team to discuss current and future applications and priorities, and to work through any concerns. These meetings can be organised through your case manager. If at any time you require assistance with matters related to the registration of veterinary medicines, please reach out to the Veterinary Medicines Team.
If you have any suggestions or requests for content to be included in future editions of the APVMA’s Veterinary Medicines Regulatory Newsletter, please send them to the APVMA Communications Team.
New product registrations
The APVMA publishes a fortnightly Gazette, which includes information about new product registrations and variations to current registered products, particulars, or conditions of registration.
Table 1 lists a new registration of veterinary product based on a new active constituent published in the Gazette during the last quarter.
|
Application no. |
Product name |
Active constituent/s |
Applicant name |
Description of the application and its purpose |
Date of registration |
Product registration no. |
|---|---|---|---|---|---|---|
|
128490 |
Aservo EquiHaler |
30 mg/mL (343 μg/actuation) ciclesonide
|
Boehringer Ingelheim Animal Health Australia Pty Ltd |
Registration of a 30 mg/mL ciclesonide inhalation solution product for the management of clinical signs associated with equine asthma in horses, in conjunction with approval of ciclesonide |
19 October 2022 |
90307 |
Welcome to Dr Sam Beckett, Director, Veterinary Medicines
We are delighted to welcome Dr Sam Beckett back to the Veterinary Medicines Team as a Director overseeing MQL, the AERP, recalls and HGP. Some of our stakeholders may remember Dr Beckett from when he held the position of APVMA Portfolio Director for Veterinary Medicines several years ago.
Dr Beckett is a veterinary epidemiologist and has held a range of regulatory, consulting and research roles in Australia and overseas, including senior management positions with the Department of Agriculture, Fisheries and Forestry (DAFF).
Dr Beckett’s technical specialities span quantitative epidemiology, biosecurity, pest and disease modelling and risk management, with a focus in arbovirus diseases, antimicrobial resistance and many of Australia’s key invasive pests and biosecurity threats.
Dr Beckett is pleased to have re-joined the APVMA and is looking forward to meeting our stakeholders and supporting the Veterinary Medicines Team and the regulatory services we provide.
New module descriptors from 1 February 2023
Following the release of the APVMA Cost Recovery Implementation Statement (CRIS), which came into effect on 1 February 2023, the APVMA has introduced new lower-cost and shorter timeframe modules for some assessment areas.
These changes aim to capture assessment types where a reduced timeframe and fee are considered appropriate.
The full overview of updated module descriptors is included in a separate attachment: Risk assessment module descriptors 1 February 2023.
Changes to the module descriptors include:
- Toxicology and Work Health and Safety modules have been combined and renamed as Health.
- There are additional modules for Chemistry and Environment where a reduced timeframe and fee were deemed appropriate.
- Changes to the Residues modules include the removal of permit-specific modules, with the work redistributed across the 5 modules.
- Relabelling the modules from numbers to more meaningful names.
The changes also include timeframe and fee reductions for applications where appropriate overseas assessments are submitted, along with supporting data. Pre-application assistance and a project plan are required to use this pathway. See our specific note on international assessments in this newsletter for further information.
There are no changes to fixed fee applications or to levies or other charges.
For veterinary medicine product and active constituent applications, the following new modules have been introduced for applications submitted from 1 February 2023 onwards:
- Chemistry 4 and Chemistry 5 modules now have reduced timeframe and assessment fees, compared to previous Chemistry level 1 to 3 modules.
- A new Health 6 module has been included, with a reduced timeframe and assessment fee (noting previous Toxicology and Work Health and Safety modules have been combined and renamed as Health).
- Inclusion of Residues 3 and Residues 5 modules as part of the redistribution of work – these modules previously only applied to permit applications.
- A new Environment 4 module with a reduced timeframe and fee.
The module descriptors document is intended to be read from the top down when looking at which modules apply. Once your application meets a module-level descriptor, the intent is that your application should be submitted with that module and level. If no module level has been described for the application type, it is likely that module is not necessary. All applicants are encouraged to apply for pre-application assistance (PAA) to ensure they have the right modules for their application.
Note, only applications submitted after 1 February 2023 will be able to be assessed under the new module descriptors. Applicants are requested to note the modules they would like to include in the Executive Summary of their application if they are not available to choose on the application form. For application forms drafted (but not submitted) prior to 1 February 2023, the new modules will not appear.
Note, for Item 17 and 18 applications, applicants are required to mention the preferred module, Chemistry 4 or Chemistry 5, in the Executive Summary, if applicable.
A summary of timeframes and fees, including for the new modules, is available on our website.
International and overseas assessments – possible timeframe and fee savings
As part of the regulatory process, the APVMA acknowledges the work of trusted overseas regulators and international scientific bodies. The APVMA recognises that by using assessments from these bodies, the regulatory burden for both the applicant and the APVMA can be eased.
As part of the APVMA Cost Recovery Implementation Statement, timeframe and fee reductions have now been passed on to applicants for certain scenarios relating to international assessments. On the APVMA website, applicants have access to information relating to fee and timeframe savings, an example veterinary application, and the APVMA’s PAA.
Guidance for active constituent applications
New chemistry and health modules were introduced on 1 February 2023 for some categories of active constituent applications, which have lower fees and timeframes. For further information on the modules and application types, please see the module descriptors.
What do these new modules mean for me?
Prior to 1 February 2023, applicants had the choice of an Item 17 or Item 18 application to approve a new source of active constituent or vary the relevant particulars of an approved active, respectively. These application types have a fixed fee and timeframe and do not allow use of the new lower fee and timeframe chemistry modules.
From 1 February 2023, applicants can now access an Item 24 application to utilise the new modules.
What is an Item 24?
An Item 24 is a modular application item made under section 10 or 27 of the Agvet Code and requires a technical assessment, other than those covered by Items 1 to 18. An Item 24 can be used for applications of active constituent approvals or variations to existing approvals. For existing approvals, it is also referred to as an Item 24V. While Item 24 is effectively a miscellaneous application item to cover situations not picked up by others, it can now be used more widely for active constituent approvals.
There are a number of scenarios where an Item 24 and 24V will be appropriate for your active constituent application. Some example scenarios are included in Table 2.
|
Situation |
Modules |
Fees |
Expected timeframe |
|---|---|---|---|
|
Approval of a new source or variation of an approval for an active complying with a BP, Ph Eur or USP monograph. |
Preliminary Assessment
|
$902 $480 $1 730 (total $3 112) |
4 months |
|
Variation of an active approval where active does not comply with a monograph in BP, Ph Eur or USP to add a new manufacturing site with no change in manufacturing process or specifications. |
Preliminary Assessment
|
$902 $970 $1 730 (total $3 602) |
5 months |
|
Approval of a new source of an existing active constituent where a toxicological assessment is required for new impurities. |
Preliminary Assessment Health 6
|
$902 $1 954 $2 000 $3 090 (total $7 946) |
8 months |
How do I submit an Item 24?
The decision tree and Online Services Portal have now been updated to include the ability to submit both Item 24 and Item 24V applications. You will see in the decision tree several new questions for active constituents under both the approval and variation pathway to give an Item 24 a decision ID. These questions are labelled with Item 24 in addition to providing examples of what is submitted under an Item 24 to make them easy to differentiate.
The same application form is used for both Item 24 and 24V applications and our administration staff will correctly assign them as Item 24 or 24V applications. If you are submitting a variation, please make sure to include the active number of the active constituent you wish to be varied as part of your submission.
If you have an unpaid draft application currently in progress in the Online Services Portal as an Item 17 or item 18 application that meets the Item 24 criteria, please clearly state in the Executive Summary that you want your application to be an Item 24 application and list the modules required. If you have submitted an application and it has not passed preliminary assessment, please forward the request for consideration as an Item 24 or 24V to the APVMA Enquiries Team. The APVMA will shortly update our tailored guidance pathways with information about all options to approve or vary an active constituent. In the interim, if you have any further questions, please contact the APVMA Enquiries Team.
Useful information for industry
In this edition, we’ve included an update on several regulatory topics, including our review of s 6A guidelines, tips on how to avoid disclosing Confidential Commercial Information (CCI) in application summaries, and an overview of the issues and trends we’ve identified for Item 13A (Prescribed Variation) applications.
Review of s 6A guidelines
Section 6A of the Agricultural and Veterinary Chemicals Code 1994 (Agvet Code) provides that the APVMA may make written guidelines for performing its functions and exercising its powers under the Code.
Section 6A Guidelines are intended to assist APVMA staff in making decisions in a consistent and transparent way. They are therefore not guidelines intended for applicants; however, applicants may find them useful in preparing their applications, to understand what our staff will consider when making their decisions. The Agvet Code stipulates that all s 6A guidelines must be published.
Section 6A Guidelines are specific in that if the APVMA makes an s 6A guideline, APVMA decision-makers must have regard to it in performing the functions and exercising the powers of the APVMA under the Agvet Code.
The APVMA is currently reviewing its suite of 6A guidelines, to ensure the guidelines are relevant to the decision-making process of APVMA staff and are suitable as an s 6A guideline compared with information and guidance for applicants.
Current section 6A guidelines can be found on the APVMA website, nothing they will be progressively updated in the coming months. An additional update will be provided in the next newsletter to detail all changes made.
New official paper for certificates and manufacturing licences
On 1 March 2023, the APVMA introduced new official paper for APVMA Certificates of Exports, Certificates of Good Manufacturing Practice compliances issued under the Mutual Recognition Agreements (MRA), and APVMA manufacturing licences. The paper is 160 GSM (grams per square meter), heavier than standard paper, with a light green background print and a watermark visible under ultraviolet (UV) light.
Tips to avoid disclosure of CCI in ‘the application purpose and description of use’ field in application summaries
Division 2.1 and Division 2.2 of the Agricultural and Veterinary Chemicals Code Regulations 1995 require the APVMA to publish certain information about an application. These application summaries can be found on the APVMA website. Summaries appear after an application has passed preliminary assessment into evaluation, and are removed 2 weeks after an application is finalised.
Divisions 2.1 and 2.2 do not apply to applications for pre-application assistance (PAA) and requests for technical advice (Item 25). Summaries are also not produced for Item 13A (Prescribed Variation) applications or for Notifiable Variations that do not undergo preliminary assessment.
‘Application purpose and description of use’
One of the fields in an application summary is the ‘application purpose and description of use’ field. The APVMA system extracts the contents of this field from the information entered by the applicant in the Executive Summary of the application form. An example image from the Online Service Portal is featured below with additional text in red showing what information is placed in the application summary, and what is not included.
Confidential Commercial Information (CCI) entered in the top field in the Executive Summary will automatically be published in the application summary on the APVMA website, should the application pass preliminary assessment.
APVMA staff will inform applicants if CCI is identified at preliminary assessment and can amend the application form if consent is provided. However, there is a risk that APVMA administration officers may not identify the information as CCI. Examples of CCI that have been identified by APVMA staff include product shelf-life details, formulation information, and the names and addresses of manufacturers.
The description should include all requested changes to be made in the application but should only include details that are known, or will become known, to the public. Sample text is provided on the application form for applicants to amend. Other examples of appropriate text are outlined below:
- Registration of a 10 g/L active X spot-on product and approval of a label for the treatment of fleas on cats.
- Variation to the relevant particulars of a registered chemical product and label approval to add an additional use in sheep and extend the shelf-life.
- Application to approve a new source of the active constituent X.
- Variation of active approval to add a new manufacturing site.
Common questions and answers relating to application summaries can be found on the APVMA website.
Issues and trends in applications in Item 13A (Prescribed Variation) applications
Following a legislative change in 2019, the APVMA has received an increased number of Item 13A applications. The graph below shows a breakdown of application numbers and outcomes by program year since 1 July 2019. It includes the 2022–23 year-to-date figure as of 31 January 2023.
The graph demonstrates there has also been an increase in the percentage of applications failing to meet the requirements of the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 (the Instrument) and either being refused or voluntarily withdrawn by the applicant.
The allowed changes
This Instrument allows for variations to the names and addresses of manufacturers of veterinary chemical products. These variations can be the addition, removal, or substitution (delete old and add new) of manufacturers in specific situations.
This Instrument also allows for a change of excipient in a chemical formulation for agricultural and veterinary chemical products in certain situations. However, applicants should be aware that the Instrument is very restrictive on the type of situation where an excipient change could be approved under an Item 13A application.
Further information about varying manufacturers, with links to start an application, is available on the APVMA website, as well as information about varying a chemical formulation.
Withdrawn Item 13A applications
Reasons why Item 13A applications have been refused include, but are not limited to, applicants requesting:
- changes that are not needed,e.g., the applicant or a former holder has already made the change
- changes to the steps of manufacture where there is no change to the name and/or address of the manufacturer performing the step(s)
- the addition of an Australian-based manufacturer, which is not licensed to perform the proposed steps of manufacture for that product type
- the addition of an overseas-based manufacturer performing primary steps of manufacture, where that manufacturer was not assessed for another product held by that same holder (i.e. the APVMA had not assessed the original addition of that manufacturer under an Item 12, 14 or 27V).
Additional information about sites of manufacture is available on our website.
Delays in processing Item 13A applications
Reasons why some Item 13A applications have been delayed include, but are not limited to, applicants:
- not including details of the old site to be removed when adding the new site for a change of manufacturer address
- choosing the ‘all steps’ option on the application form and not listing the individual steps of manufacture performed by that manufacturer
- requesting changes to multiple products where the same change is not required for each product.
To avoid applications being refused, applicants are requested to check their registration records before submitting an application to ensure the same change is required for each of the products included in the application.
Getting information
Which manufacturer is on my product?
Registrants can submit an Agvet Code request to request a record of the manufacturers listed for their product. Currently, the APVMA may not be able to release information for repacked products where the manufacturer details are CCI. In these situations, the registrant may wish to consult with the holder of the original reference product and/or discuss options with the APVMA prior to lodging an Item 13A application.
Where can I find the licence details for Australian-based manufacturers?
Australian-based manufacturers will have a printed copy of their licence in their possession. In addition, the APVMA publishes a list of all licences held by Australian-based manufacturers on our website. This alphabetical list includes details about the approved site, licence number, licence category, and steps of manufacture.
Applicants are asked to check this list or confirm with the manufacturer before proposing the addition of an Australian-based manufacturer to a veterinary chemical product.
APVMA 2023 Stakeholder Survey
The APVMA conducts surveys of our stakeholders to determine their level of satisfaction with our performance and services. The results of the survey will provide us with an updated benchmark to assist with measuring our performance and provide insights into what is working well and identify opportunities for improvement.
The 2023 Stakeholder Survey will be deployed next month, and if you are subscribed to our mailing list you will receive an invitation to participate in the anonymous survey. Alternatively, you can access the Client and Stakeholder survey from our website once the survey is live. The survey will take approximately 5 minutes to complete.
The APVMA remains committed to improving our performance and services, and the responses from the 2022 survey were used to identify 4 key areas of opportunities to progress.
If you have any questions, please contact us on +61 2 6770 2300 or email our Enquiries Team.
List of new, suspended or cancelled manufacturer licences
The APVMA’s Manufacturing Quality and Licensing (MQL) Team gazettes a list of licences for new manufacturers issued under subsection 123(1) of the Agvet Code and licences suspended or cancelled under subsection 127(1) the Agvet Code.
Tables 3 to 5 list the new licences and licences suspended or cancelled since 22 September 2022.
You can view the complete list of currently licenced Australian manufacturers on our website.
|
Company name |
Licence number |
Company ACN |
Address |
Product types |
Steps of manufacture |
Date issued |
|---|---|---|---|---|---|---|
|
Acura Bio Pty Ltd |
1086 |
074 656 509 |
2806 Ipswich Road Darra, QLD 4076 |
Category 1 (Immunobiologicals and sterile veterinary preparations) – Vaccine (Low Bioburden processing) |
Quality assurance (QA) of raw materials, cell propagation, virus cultivation, bacterial fermentation, low bioburden filling, packaging, labelling, microbiological reduction treatment (heat, filtration, chemical), freeze drying, analysis and testing (physical, chemical), release for supply, storage. |
22 September 2022 |
|
Pia Pharma Pty Ltd |
6243 |
150 999 974 |
Unit 1, 148 Tennyson Memorial Avenue Tennyson QLD 4105 |
Category 6 (Single-step manufacture) – all dosage forms |
Analysis and testing (physical and chemical) |
11 November 2022 |
|
David Gray & Co. Pty Limited |
3003 |
008 671 127 |
2 Rawlinson Street O'Connor WA 6163 |
Category 3 (Ectoparasiticides) – Liquids, sprays and powders. |
Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, aerosol filling from bulk, analysis and testing (physical and chemical), storage and release for supply. |
6 December 2022 |
|
DHL Supply Chain (Australia)
|
6071 |
071 798 617 |
16 Picrite Close Greystanes NSW 2145 |
Category 6 (single-step manufacture) – all product dosage forms |
Secondary packaging, secondary/supplementary labelling, storage, and release for supply. |
7 December 2022 |
|
Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific |
1073 |
072 147 561 |
53–57 Oatley Court Belconnen ACT 2617 |
Category 1 (Immunobiologicals and sterile products) – Terminally sterilised products for injection (powder, solution and diluent). |
Formulation including blending, filling, packaging, labelling, sterilisation (heat), microbiological reduction treatment (heat, and filtration), analysis and testing (physical, and chemical), storage and release for supply. |
13 December 2022 |
|
Australian Life Sciences Pharma Pty Ltd |
2250 |
604 520 532 |
Unit 2-3, 4 Endeavour Road Caringbah NSW 2229 |
Category 2 (Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements) – Pastes, powders, creams/lotions and ointments Category 4 (Premixes and supplements) – premixes – powders, supplements - powders |
Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, analysis and testing (chemical, physical), storage, and release for supply. |
4 January 2023 |
|
Complementary Medicines Group Pty Ltd |
6246 |
146 924 343 |
5A/5B Jubilee Avenue Warriewood NSW 2102 |
Category 6 (Single-step manufacture) – non-sterile all dosage forms |
Packaging, secondary packaging, labelling, secondary/supplementary labelling, repackaging and relabelling, storage and release for supply. |
12 January 2023 |
|
Costar Pharm Laboratory Pty Ltd |
2275 |
132 907 138 |
171-177 Woodpark Road Smithfield NSW 2164 |
Category 2 – tablets, capsules soft; capsules hard; powders, granules, solid unit dosage forms, liquids Category 4 – powder, liquids |
Quality assurance of raw materials, formulation including blending, dry milling, wet milling, granulation, filling, tableting, tablet coating, capsule filling from bulk, packaging, repackaging, strip, blister, sachet packaging, labelling, relabelling, analysis and testing (physical and chemical), storage and release for supply |
19 January 2023 |
|
Chemcert Limited |
6244 |
072 731 894 |
Room 104, Building 485 Biyal Place Charles Sturt University Wagga Wagga NSW 2678 |
Category 6 – all dosage forms |
Storage only |
8 February 2023 |
|
Company name |
Licence number |
Company ACN |
Address |
Date cancelled |
|---|---|---|---|---|
|
Pia Pharma Pty Ltd |
2232 |
150 999 974 |
Unit 3, 46 Buffalo Road Gladesville NSW 211 |
23 September 2022 |
|
Eurofins ams Laboratories Pty Limited |
6139 |
075 467 757 |
8 Rachael Close Silverwater NSW 2128 |
23 September 2022 |
|
Pia Pharma Pty Ltd |
6242 |
150 999 974 |
Unit 3, 46 Buffalo Road Gladesville NSW 2111 |
10 January 2023 |
|
Abbey Laboratories Pty Ltd |
6223 |
156 000 430 |
16 Voyager Circuit Glendenning NSW 2761 |
31 January 2023 |
|
COMPLEMENTARY MEDICINES GROUP PTY LIMITED |
6232 |
146 924 343 |
1/9 Apollo Street Warriewood NSW 2102 |
14 February 2023 |
|
Company name |
Licence number |
Company ACN/ABN |
Address |
Period of suspension |
|---|---|---|---|---|
|
The State of NSW Department of Industry trading under the business name of Department of Primary Industries (Elizabeth Macarthur Agricultural Institute). |
1120 |
20 770 707 468 |
Woodbridge Road Menangle NSW 2568 |
From 2 December 2022 to 2 December 2024 |
Any questions about these licenses can be directed to the MQL Team.
Q&A
Our Question and Answers (Q&A) section in this edition covers frequently asked questions related to defect notices.
Defect notices can now be issued at preliminary assessment.
In line with the Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Act 2021, the APVMA has now introduced defect notices for registration and variation applications at preliminary assessment that do not appear to meet the application requirements in Section 8A of the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code). Previously, defect notices could only be issued during preliminary assessment of applications for minor use permits.
Defect notices, referred to as 11(3), 28(3) and 110A(3) ‘Notices of defects in application’ – provide applicants with an opportunity to address errors or missing information in cases when the issue(s) can be reasonably rectified within the one-month preliminary assessment timeframe.
Further information about updating or clarifying application defect notices is available on our website.
I have received a defect notice, what does it mean for me?
The APVMA is committed to working with applicants to progress applications to register new products, approve active constituents, and approve variations to registered products. However, in some situations, applications can have error(s) that need to be fixed before the application can be assessed.
As part of standard processes, the APVMA conducts an initial check of incoming applications, and this is called a preliminary assessment. This check is to confirm if, upon lodgement, your application meets the application requirements as outlined in Section 8A of the Agvet Code and, in particular, the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014. As part of this check, the APVMA will also confirm that other key legislative requirements are met from other parts of the agvet legislation, for example, if it is the correct item number.
If you receive a defect notice, it will be because an error has been identified in your application but the APVMA believes the error can be corrected within a reasonable period (one month).
What types of errors can be corrected?
The APVMA will email you to clarify small errors, such as spelling mistakes or errors in contact details. A defect notice will be issued for such issues as the following:
- The manufacturer details listed in Section 13 (Active Constituent Manufacturers) of the application form do not match an approved source of that active constituent – particularly for Item 7 applications which otherwise fail Schedule 6 of the Agricultural and Veterinary Chemicals Code Regulations 1995 (Agvet Code Regulations)
- The license details, including approved steps of manufacture, for Australian manufacturers producing veterinary chemical products that are not up to date with the list of APVMA licensed Australian manufacturers
- The data list does not contain a brief description of each piece of information provided for the assessment
- A Certificate of Analysis issued in the last 2 years has not been provided for a product registration
- The application has missing information that is required under the Application Requirements Instrument
What types of applications cannot be corrected?
You will receive an email from the APVMA advising if your application does not pass preliminary assessment and must be refused, in situations including where:
- The application is an incorrect item number as defined under Schedule 6 of the Agvet Code Regulations
- a proposed variation does not involve a change of relevant particulars.
If I receive a notice, what happens next?
The defect notice allows you one month to provide the requested information to the APVMA. Once the information is provided, we will then reassess your application to see if it passes preliminary assessment.
If the information is not provided within the one-month period, or the APVMA finds the response unsatisfactory, the application will be refused. There is no right of review for this refusal decision.
What should I do if I don’t understand the defect or what I need to do?
Please contact the APVMA and ask to speak to the officer named on your defect notice. It is important the defect is corrected as quickly as possible. Extensions to the one-month period are not permitted.
How do I provide the requested information?
Information that is less than 10 MB can be emailed to the APVMA Enquiries Team. Applicants are asked to contact the APVMA if the size of the data exceeds 10 MB so we can arrange alternative data transfer methods.
Please note, you will not be able to upload or submit the information through your online user registration account or update your original submitted application.
Will this delay my application?
Not necessarily, but it will depend on the circumstances and when the defect(s) are rectified. The assessment period for the application only commences once the application has passed preliminary assessment and all fees are paid. The APVMA will invoice for outstanding fees once an application passes preliminary assessment.
Can I withdraw the application and receive a refund of fees paid?
You can withdraw your application at any time after the application is made and before it is determined, under Section 8D of the Agricultural and Veterinary Chemicals Code Act 1994. Any withdrawal request should be submitted to the APVMA. Any request for a refund would be considered by an APVMA financial delegate on a case-by-case basis after withdrawal of the application.
Any additional questions can be referred to the APVMA Enquiries Team or your case manager.