Edition VMT008
- Directors update: Dr Donald Sibanda and Dr John Owusu
- Performance report
- New product registrations
- Have your say: Overseas GMP compliance assessment fee
- Useful information for industry
- Item 10 application options
- Q&A – ‘combined Item 10’ applications
Directors update: Dr Donald Sibanda and Dr John Owusu
Welcome to the June 2022 edition of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) quarterly Veterinary Medicines Regulatory Newsletter. In this edition, we have included information on a range of regulatory topics, including new requirements for voluntary recalls, product registrations and concurrent approval of a new source of active, and a deep dive into Item 10 applications.
The Veterinary Medicines Team has continued to focus our efforts on ensuring Australians are provided with timely access to safe and effective products that support improved animal health, completing 100% of veterinary medicines product applications within timeframe in March quarter 2022. More information is available in the Performance report section of this newsletter.
Since our last newsletter, we have also welcomed Dr John Owusu as a Director of the Veterinary Medicines Team.
We continue to encourage applicants to participate in 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 by emailing casemanagement@apvma.gov.au. Please reach out to the Veterinary Medicines Team if you require assistance for issues related to the registration of veterinary medicines.
If you have any suggestions or requests for future editions of the APVMA’s Veterinary Medicines Regulatory Newsletter, please send them through to communications@apvma.gov.au.
Performance report
The Veterinary Medicines Team delivered another strong quarter of timeframe performance in March quarter 2022.
We completed:
- 100% of veterinary medicines product applications within timeframe
- 100% of applications requiring major assessment for veterinary medicines within timeframe
- 100% of non-technical veterinary medicine applications within timeframe.
298 veterinary medicine product applications remained in progress at the end of March quarter 2022.
The full performance report for March quarter 2022 is available on our website.
New product registrations
The APVMA publishes a fortnightly Gazette, which includes information about new product registrations and variations to currently registered particulars or conditions for registration.
The following table lists the new registrations of veterinary products based on new combinations of active constituents, new formulations, and new active constituents 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. |
|---|---|---|---|---|---|---|
|
124578 |
SOLENSIA Solution for Injection for Cats |
7 mg/mL frunevetmab per vial |
Zoetis Australia Pty Ltd |
Registration of a 7 mg/mL frunevetmab liquid product for the alleviation of pain associated with osteoarthritis in cats
|
14 March 2022 |
89387 |
|
130059 |
Prevomax 10 mg/mL Solution for Injection |
10 mg/mL maropitant as maropitant citrate |
Dechra Veterinary Products (Australia) Pty Ltd |
Registration of a 10 mg/mL maropitant, parenteral solution product for the prevention and treatment of nausea and emesis in dogs and cats
|
29 March 2022 |
90801 |
|
131885 |
Feliway Friends Diffuser |
16.2 mg/mL Synthetic Analogue Naturally Occurring Cat Appeasing Pheromone |
Ceva Animal Health Pty Ltd |
Registration of the product ‘FELIWAY FRIENDS DIFFUSER’ which contains the active, synthetic analogue of feline facial pheromone, at a concentration of 16.2 mg/mL to aid in alleviating signs associated with tension and conflict between cats in the home |
24 March 2022 |
91337 |
Have your say: Overseas GMP compliance assessment fee
The APVMA is seeking input from registered holders and stakeholders regarding the proposed change to the overseas good manufacturing practice (GMP) compliance assessment fee process, to be payable for all overseas sites on the APVMA register from FY2023–24.
Registered holders and other stakeholders are encouraged to provide their feedback about the proposed change by 18 August 2022.
More information about the consultation, including how to make a submission, is available on our website.
Useful information for industry
New requirements for voluntary recalls
On 7 March 2022, new legislation commenced for voluntary recalls described under Part 11 of the Agricultural and Veterinary Chemicals Code Act 1994.
The new legislation requires persons who take action voluntarily to recall an agvet product to notify the APVMA within 2 days of taking the action. The APVMA must also publish notice of the recall on our website.
More information about these obligations is available on our website.
If you become aware of an issue with a product that you suspect may require recall, you may seek advice from the APVMA by contacting recalls@apvma.gov.au.
To be notified of recalls via email, please complete our subscription form and select ‘Recall notices’.
Sites of manufacture on product registrations
Recent GMP audits have highlighted differences between the sites of manufacture recorded on the Register and in the information provided in pre-audit notification forms. Registered holders are encouraged to check all sites of manufacture on their product registrations to ensure the information provided is correct.
Holders are required to notify the APVMA of any changes to the information entered in the Record, Register or Record of Permits. To vary the details for the sites of product manufacture, a variation can be made by submitting a prescribed variation (Item 13A) or a non-technical fixed fee application (Item 12). More information about making a variation is available on our website.
Item 10 application options
Item 10 applications can be used for the following situations:
- Registration of a new product that has an existing approved source of the active constituent
- Registration of a new product where the applicant has a separate application in progress for approval of a new source of the approved active constituent
- Both the registration of a new product and a new source of the approved active constituent
The third option is colloquially termed a ‘combined Item 10’, as the request is for approval of both the product and active source. One application can be used for the product and multiple active sources.
Combined Item 10 applications have a modular assessment with modular fees. Preliminary assessment (Module 1.0), Finalisation (Module 11) and Data protection (Module 12.0) are applied to the product application along with relevant assessment modules. An additional Module 2.3 (Chemistry) is applied for each of the active sources.
Combined Item 10 applications may require more than one Chemistry (Module 2.3) assessment; however, applicants cannot currently select multiple Module 2.3 assessments when lodging their applications. Instead, applicants are requested to include an outline of the proposed approvals in the Executive summary on the application form. For example, “This application is to register a new product with X number of approvals for the active(s). Two of the active sources (X & Y) will require one active approval”. The relevant fees will be applied at preliminary assessment.
Before applying for an Item 10, applicants should consider if a ‘combined Item 5’ or ‘combined Item 6’ application would be more appropriate for any product that has pharmacopoeia standard actives. Item 5 and Item 6 applications have set fees of $7,566.00 and $6,406.00 respectively, regardless of the number of active sources.
If you have any questions about the Item 10 options available, please contact enquiries@apvma.gov.au.
Q&A – ‘combined Item 10’ applications
Our ‘Question and Answers’ (Q&A) section in this edition covers ‘combined Item 10’ applications.
Is the fee for a ‘combined Item 10’ less than a separate application for the active approval?
In most cases, yes. Applicants applying to approve a new source of active constituent would normally submit an Item 17 application with a current prescribed fee of $5,442.00. The charge for the active approval within a ‘combined Item 10’ is currently $1,954.00 (Module 2.3). Please note, however, if there are three or more assessment modules on the combined Item 10, the fee may be higher for a combined Item 10 due to the assignment of the 11.1 Finalisation module (not 11.2). Applicants should consult the APVMA’s Timeframe and fees page when considering options.
Can I apply to have 2 sources of active in the one active approval number?
Provided the composition and purity of the active from the 2 sources is sufficiently similar and that one set of specifications can cover both sources, the 2 sources can be considered under a single additional Module 2.3 for the active for the Item 10, and approved under a single approval number. If the composition and purity are not sufficiently similar, then 2 separate active approvals and 2 Module 2.3 charges would apply.
Can I use a ‘combined Item 10’ for a product that is ‘closely similar’ to a registered product?
Yes. A chemistry assessment Module 2.3 would not apply to the proposed product in this situation, as long as the proposed product is found to be ‘closely similar’ under clause 1.2 of Schedule 6 of the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Regulations). In these situations the applicant should still select Module 2.3 as an assessment module for the application and this module will be applied to the active.
Why can’t I submit an Item 7 application and a separate Item 17 application instead of a ‘combined Item 10’?
Under Schedule 6 of the Regulations, an Item 7 application is used to register a proposed product that has an approved source of active. If the active source is not approved, the Item 7 application would not pass preliminary assessment and would be considered for refusal under section 14(2) of the Agvet Code.
Can I have a ‘combined Item 10’ with secondary product applications?
Yes; however, please be aware if the active approval fails, all product applications will also fail. Fee waivers for ‘primary/secondary’ applications are only available for applications that have modular assessments, are for the same item number and submitted on the same day. Applicants should identify the proposed primary and secondaries in the Executive summary section of the applications. More information about primary and secondary applications is available on our website.
How do I order my datalist (information list) for a ‘combined Item 10’?
APVMA systems allow applicants to submit one datalist with the application. When entering their data items, applicants should use the data ‘sub-type’ to distinguish between ‘active’ or ‘product’ data. If there is more than one active, applicants should use the reference number system to distinguish between the actives. For example, ‘Attachment 2.1 M for meloxicam’ or ‘Att2.2 Ivermectin’.
Do I need to use the decision tree to obtain a decision ID to apply for a ‘combined Item 10’?
No. You can use our guidance material instead, which includes a direct link to lodge an application.