Edition VMT007
- Director’s update: Dr Donald Sibanda
- Performance report
- New product registrations
- Useful information for industry
- Q&A
- Manufacturing Quality and Licensing update
Director’s update: Dr Donald Sibanda
Welcome to the March 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 agvet chemical legislation and preliminary assessment tips.
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 99.1% of veterinary medicines product applications within timeframe in the December quarter 2021. More information is available in the Performance report section of this newsletter.
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 with 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 the December quarter 2021.
We completed:
- 99.1% of veterinary medicines product applications within timeframe
- 95.6% of applications requiring major assessment for veterinary medicines within timeframe
- 100% of non-technical veterinary medicine applications within timeframe.
240 veterinary medicine product applications remained in progress at the end of December quarter 2021, down from 249 in September quarter 2021.
The full performance report for the December quarter 2021 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 |
Date of registration |
Product registration no. |
Description of the application and its purpose |
|---|---|---|---|---|---|---|
|
105496 |
Improvac LV Vaccine for Male Pigs |
≥300 µg GnRF-protein conjugate |
Zoetis Australia Pty Ltd |
Registration of a 300 μg GnRF-protein conjugate (gonadotropin releasing factor analog-diphtheria toxoid conjugate), injectable product for use in the control of boar taint and behavioural modification in male pigs |
3 December 2021 |
82356 |
Useful information for industry
New agvet chemical legislation
The Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Bill 2019 (Improvements Bill) passed through Parliament on 1 December 2021. On 7 December 2021, the Improvements Bill received the Royal Assent and is now the Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Act 2021 (Improvements Act).
The Improvements Act includes measures to:
- establish a governance board for the APVMA
- allow for prescribed approvals and registrations for chemicals of low regulatory concern
- provide for extensions to limitation periods and protection periods as an incentive for chemical companies to register certain new uses of chemical products (limited to agricultural chemical products only at this time)
- allow for computerised decision-making by the APVMA
- simplify industry reporting requirements for annual returns.
Implementation of the measures will be staggered and you can subscribe to receive email news updates from the APVMA as implementation occurs.
More information about the Improvements Act is available on our website.
Generic product applications
We receive a number of applications to register generic veterinary chemical products. Some generic applications (typically submitted under Items 5 and 10) require efficacy and safety data to satisfy the efficacy and safety criteria. Applicants are encouraged to submit relevant scientific information or data to support efficacy and target animal safety of the product.
Guidance is available to assist applicants to submit relevant data, including demonstration of equivalence with a registered reference chemical product. In determining whether a proposed product is equivalent to a registered reference product, we will generally consider whether the proposed product:
- and reference product have the same use pattern
- and reference product are pharmaceutically and/or biologically equivalent
- complies with applicable quality standards.
If specific published literature is cited, applications should provide a legible copy of the whole article, in English. Abstracts are generally not acceptable. It is the responsibility of the applicant to make sure only relevant scientific literature is submitted. Applicants should clearly state the relevance of the information in their Part 8 summary. Articles that are not clearly linked to the summary will generally not be relied on during assessment of the efficacy and safety data. Pre-application assistance is also available for further advice on the data requirements.
Issues that may cause delays at preliminary assessment
A preliminary assessment (PA) is conducted on certain applications under subsections 11(2) (registrations) and 28(2) (variations) of the Agvet Code. The PA is designed to ensure applications are complete and meet the application requirements outlined in the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014.
The PA is conducted by officers in the Veterinary Medicines Administration Team and delays can occur if, after an initial assessment, the application is found not to meet the application requirements. The Veterinary Medicines Administration Team will initially contact applicants to advise the application does not appear to pass PA and request confirmation of the application details.
The Team has identified some common issues that have caused delays at PA in recent months. Examples of these issues are outlined below:
Confidential Commercial Information (CCI) contained in the Executive Summary of the application form
The Executive Summary field of the application contains 2 ‘boxes’. The first box is provided to describe the purpose of the application. This field should include a brief description of the intent of the application, for example, “Registration of a XX g/L Active product for use on (target animals) to address (parasites)”, “Variation of the chemical product relevant particulars to amend the formulation” or “Variation of approved label particulars to align with the Veterinary Labelling Code”.
For some applications, this description is automatically published on the APVMA website as part of the application summary. Applicants are reminded not to include CCI in this field.
Item 7 applications require an approved active constituent
All Item 7 applications require the proposed product to have an approved source of the active constituent, as defined in Clause 2.1, Schedule 6, of the Agricultural and Veterinary Chemicals Code Regulations 1995. If the active source is not approved, an Item 17 must be approved prior to submission of the Item 7 application.
As a cost-effective alternative, applicants can consider an Item 5, Item 6 or Item 10 application option if they wish to apply for both the registration of a new chemical product and approval of a new source of an approved active in the one application. Item 5 and Item 6 applications are appropriate when the active is of a pharmacopeia standard. Further information on ‘combined’ applications, including short-cuts to start applications is available on our website.
Active and manufacturers of active constituents
An application to register a new chemical product must contain details of the APVMA approved source for the active constituent(s) in that product. Importantly, details of the approval number, company name, and site address must match APVMA records for the active constituent(s). Applicants are requested to confirm these details with the manufacturing companies prior to submission of the application and to encourage manufacturers to advise the APVMA of any updates or changes to their details.
After registration, holders of registered products may change to another APVMA-approved source of that active without the need for an application to the APVMA. However, they should advise the APVMA in writing if they wish the change to be recorded on the APVMA product register. Details of approved actives can be obtained from the APVMA’s PubCRIS database. Written requests may be sent to Enquiries@apvma.gov.au and marked for the attention of the Veterinary Medicines Administration Team.
Manufacturers of proposed products and manufacturing steps
Applicants should ensure the manufacturers’ details listed on the application form match the same details contained in supporting evidence, including Certificates of Analysis and Good Manufacturing Practice Certificates.
In addition, the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 requires applicants for veterinary products to list all the proposed steps of manufacture that each manufacturer will conduct. Applicants are asked to avoid the use of the ‘all steps’ option in the application form.
The difference between a nominated agent and an authorised agent for application correspondence
Applications can be lodged by registrants, authorised agents, or nominated agents depending on the situation.
Some applicants who are not nominated agents are incorrectly choosing the ‘nominated agent’ option when selecting the application contact. Please note, a nominated agent is appointed under section 8M of the Agvet Code Act to legally represent the registrant of a product in Australia. Nominated agents can only be appointed by overseas-based registrants.
An authorised agent is appointed to manage a registered product or application and can be appointed by an Australian-based or overseas-based registrant, or appointed by a nominated agent.
More information about the difference between a nominated agent and an authorised agent is available on our website.
Q&A
Our ‘Question and Answers’ (Q&A) section in this edition covers the Adverse Experience Reporting Program and review rights.
What is the Adverse Experience Reporting Program?
The Adverse Experience Reporting Program (AERP) is a post-registration program that assesses reports of adverse experiences associated with the use of a registered chemical product (or those on permit). Reports of adverse experiences are closely monitored by the APVMA.
It is vital to record, assess and classify adverse experiences to detect uncommon events not evident during the initial registration process of a product.
How do I report an adverse experience?
Anyone can report a problem with a chemical product.
Holders are required to report relevant information to the APVMA, in accordance with the legislation.
The AERP is not intended to replace a consumer’s right or responsibility to complain to the registration holder or manufacturer about an adverse experience involving an agricultural or veterinary chemical product.
What should I do if I am not satisfied with a decision made by the APVMA?
If you are not satisfied with a decision made by the APVMA under the Agvet Code or the Agvet Code Regulations, you may be able to:
- request that the APVMA review the decision (that is, seek internal review) within 42 days from the date the decision was made (pursuant to section 166)
- apply to the Administrative Appeals Tribunal for review of the decision in accordance with the provisions of the Administrative Appeals Tribunal Act 1975 (pursuant to section 167).
When we review a decision, we must confirm, vary or set aside the original decision and make a new decision in substitution for the original decision. We must then notify the person who made the request of our decision on the review as soon as practicable.
More information about how to seek review of a decision is available on our website.
Manufacturing Quality and Licensing update
The APVMA’s Manufacturing Quality and Licensing Team continues to work through a backlog of audits that were deferred due to the COVID-19 pandemic.
To ensure audits are conducted in accordance with COVID-safety requirements, the APVMA has employed several COVID-safe strategies, including:
- remote auditing of low-risk sites of manufacture
- a hybrid audit with increased remote auditing and face to face verification.
With restrictions easing, the APVMA is reintroducing face-to-face audits where government and health advice allows.
Auditors are reminded to consider the COVID Safety Plan of a manufacturing site, including relevant state or territory government requirements and health advice, before organising or attending an audit.
Questions about the APVMA’s MQL audits can be directed to mls@apvma.gov.au.