Edition VMT001
- Directors update
- APVMA news
- Performance report
- New product registrations
- Useful information for industry
- Guidance material for applicants
- Compliance and Monitoring
- Adverse Experience Reporting Program
- Chemical Review
Directors update: Dr Martin Ilott and Dr Donald Sibanda
Welcome to the first edition of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) quarterly Veterinary Medicines Regulatory Newsletter.
The purpose of this newsletter is to establish a more tailored communication stream for our stakeholders, with updates and information relevant to the veterinary industry.
The APVMA Veterinary Medicines Team has had a busy year so far. Our team is now established in Armidale and has been working hard to provide strong timeframe performance and maintain open communication channels with our stakeholders.
We continue to encourage applicants to participate in regular APVMA stakeholder meetings, which have continued online throughout COVID-19 restrictions. These meetings are a valuable forum for both industry and the APVMA Veterinary Medicines Team to discuss current applications and work through any concerns. These meetings can be organised through our Case Management and Administration Unit (CMAU) by emailing casemanagement@apvma.gov.au.
Our next newsletter is scheduled for release in September 2020, and if you have any suggestions or requests for future editions please send them through to communications@apvma.gov.au.
Please reach out to the Veterinary Medicines Team if you require assistance for issues related to the registration, access and use of veterinary medicines.
APVMA news
Like the broader veterinary industry, the APVMA has had to adjust the way we work these past few months, to ensure we can continue to deliver efficient, effective, timely, and science-based agvet chemical regulation throughout the COVID-19 pandemic.
The APVMA has published a number of updates to assist our stakeholders during this period:
- APVMA update—COVID-19
- Advice for veterinary medicine manufacturers and holders
- APVMA COVID-19 update—industry advice
- Importation of veterinary chemicals
If you have specific enquiries or questions pertaining to COVID-19, please contact the APVMA via email at enquiries@apvma.gov.au.
We’ve also published important information and key dates for renewal applications, which can be found on our website.
The APVMA’s revised cost recovery arrangements will take effect from 1 July 2020, and further information about the revised fee schedule is available on our website.
Performance report
The Veterinary Medicines Team delivered another strong quarter of timeframe performance at the end of March 2020.
- Product applications completed within timeframe for the March quarter 2020 increased to 87 per cent, up from 82 per cent in the December quarter 2019.
- Major applications completed within timeframe for the March quarter 2020 increased to 79 per cent, up from 69 per cent in the December quarter 2019.
- Work in progress has remained steady at 320.
The full performance report for the March quarter 2020 is available on our website, and the next report will provide statistics for the full 2019–20 financial year.
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 active constituents, published in the Gazette to date for 2020.
| Application no. | Product name | Active constituent/s | Applicant name | Applicant ACN | Summary of use | Date of registration | Product registration no. | Label approval no. |
|---|---|---|---|---|---|---|---|---|
| 115018 | Pracetam 400 mg/mL Oral Solution For Pigs | 400 g/L paracetamol | Ceva Animal Health Pty Ltd | 002 692 426 | For the treatment of clinical signs of fever in pigs | 11 March 2020 | 86212 | 86212/115018 |
| 115696 | Galliprant 100 MG Flavoured Tablets For Dogs | 100 mg/tablet grapiprant | Elanco Australasia Pty Ltd | 076 745 198 | For the treatment of pain and inflammation associated with osteoarthritis in dogs | 7 April 2020 | 86405 | 86405/115696 |
| 115698 | Galliprant 20 MG Flavoured Tablets For Dogs | 20 mg/tablet grapiprant | Elanco Australasia Pty Ltd | 076 745 198 | For the treatment of pain and inflammation associated with osteoarthritis in dogs | 7 April 2020 | 86407 | 86407/115698 |
| 115700 | Galliprant 60 MG Flavoured Tablets For Dogs | 60 mg/tablet grapiprant | Elanco Australasia Pty Ltd | 076 745 198 | For the treatment of pain and inflammation associated with osteoarthritis in dogs | 7 April 2020 | 86408 | 86408/115700 |
| 105030 | Dermcare Barazone 0.25 g/L Budesonide Leave-On Conditioner | 0.25 g/L budesonide | Dermcare-Vet Pty Ltd | 010 280 010 | For the symptomatic treatment of canine atopic dermatitis, contact allergy and other pruritic conditions of the dog | 15 April 2020 | 82108 | 82108/105030 |
| 105036 | Dermcare Barazone 0.125 g/L Budesonide Leave-On Conditioner | 0.125 g/L budesonide | Dermcare-Vet Pty Ltd | 010 280 010 | For the symptomatic treatment of canine atopic dermatitis, contact allergy and other pruritic conditions of the dog | 15 April 2020 | 82113 | 82113/105036 |
| 116464 | Arthramid Vet | 25 mg/mL cross-linked polyacrylamide hydrogel | IMS Vet Pty Ltd | 620 774 094 | For the treatment of lameness in horses | 15 April 2020 | 86728 | 86728/116464 |
| 118251 | Neptra Otic Solution For Dogs | 16.7 mg/mL florfenicol, 14.8 mg/mL terbinafine (as terbinafine hydrochloride), 2.2 mg/mL mometasone furoate | Bayer Australia Ltd (Animal Health) | 000 138 714 | For the treatment of Otitis externa in dogs | 4 May 2020 | 87389 | 87389/118251 |
| 115249 | Eryvac E-Oral (Live) Vaccine For Pigs | Erysipelothrix rhusiopathiae strain 31 (≥ 1.0 x 108.08 CFU/dose) | Zoetis Australia Pty Ltd | 156 476 425 | For in-water administration to healthy pigs 11 weeks of age or older as an aid in the prevention of disease caused by Erysipelothrix rhusiopathiae | 6 May 2020 | 86289 | 86289/115249 |
Useful information for industry
The APVMA offers assistance for applicants and future registrants before they begin the applications process, and also provides guidelines to clarify the requirements for the registration of generic veterinary chemical products, and the submission of international data, standards and assessments.
Pre-application assistance
The APVMA offers assistance for applicants before they submit their applications. This technical advice, known as pre-application assistance (PAA), is offered on a fee-for service basis, and applicants or future registrants are encouraged to apply for this assistance.
PAA provides applicants with the opportunity to reduce uncertainty for a specific prospective application, with assistance provided via a written response and a face-to-face meeting, or a teleconference if requested.
PAA can also be used to obtain an appraisal on a trial protocol, and is required for the submission of a project plan for a Global Joint Review.
Registering generic veterinary chemical products
The APVMA receives a significant number of applications to register generic veterinary chemical products. A guideline is available to assist applicants in submitting data that will satisfy the safety, efficacy and trade criteria for this application.
Applicants are encouraged to submit a request for pre-application assistance if the guidelines do not provide sufficient information for a specific product.
Additional guidance for applications involving reference products and bioequivalence is available on our website.
International assessments
The APVMA collaborates internationally to assess specific applications. During the assessment, we may use international assessment reports in work-sharing arrangements to support independent national risk assessments.
We also accept trusted international data, standards and assessments for use in our assessments of veterinary chemical applications. We will require additional data only to meet specific legislative requirements, or to enable us to fully consider the risk under Australian environmental conditions and use patterns.
For us to accept an international assessment, the active constituent or product that was the basis of the overseas assessment must be the same as the active constituent or product intended for approval or registration in Australia. Examples of products that may be able to use international efficacy/safety assessments includes analgesics and anti-inflammatories.
Guidance for the submission of international data, standards and assessments is available on our website.
Guidance material for applicants
The APVMA develops and publishes guidance material on our website to guide applicants through the requirements for each application type. This guidance provides for a variety of veterinary medicine applications, including manufacturing site transfers for immunobiologicals and autogenous vaccine permits.
Vaccine efficacy claim guidelines
The requirement for clear vaccine efficacy claims guidance emerged from the vaccine industry, who expressed a desire for a harmonised and standardised approach for supporting label claims in veterinary vaccine submissions to the APVMA.
Following consultation through the Veterinary Immunobiological Working Group (VIWG), we have developed new guidance material to provide clarity on label efficacy claims for veterinary vaccines.
The efficacy claims for a veterinary vaccine should be substantiated through the generation of data from laboratory and/or field studies in the target species. The following standard efficacy claims should be used where relevant on the label for an immunobiological product.
For active immunisation or passive immunisation of the target species to:
- prevent mortality, clinical signs and/or lesions of the disease
- prevent infection
- reduce mortality, clinical signs and/or lesions of the disease
- reduce infection.
In addition, the onset and the duration of immunity should be included with the information on the expected protection, unless justified.
Data from laboratory and field efficacy studies may also be used to support additional efficacy claims on the nature of the protection. For example:
- The nature of immunological response and action.
- The extent of prevention/reduction of replication of the pathogen in vaccinated animals.
- The extent of prevention/reduction of dissemination of the pathogen through the body of vaccinated animals.
- The extent of persistence (percentage or duration) of the pathogen in the body of vaccinated animals (ie carrier status).
- The transmission of the pathogen from the vaccinated animal to eggs, embryos and/or foetuses.
The move towards a more data driven claims structure removes the uncertainty and confusion regarding more traditional claims, such as ‘as an aid to prevent disease’, and provides additional information on the onset and duration of immunity expected from a veterinary vaccine.
Manufacturing site transfers for immunobiologicals
New guidance for this application has been developed in consultation with the VIWG, to provide clarity on data requirements for the transfer of veterinary immunobiologicals.
The new guidance also makes clearer the data requirements for moving production and testing of veterinary immunobiological to alternative sites, both within Australia or to overseas sites.
In addition, the new guidance focuses on the demonstration of consistency of production and testing, removing the need for additional animal tests for safety and efficacy. This reduces animal usage and respects the 3Rs (replace, reduce and refine) in animal testing.
Revised guidance for autogenous vaccine permits
The APVMA has recently sought feedback via public consultation in relation to technical data requirements for autogenous vaccine applications for minor use. The consultation ran from 4 May to 4 June 2020.
The revised guidance seeks to clarify and simplify the data requirements for autogenous vaccine applications, to improve the time lines for approval. Autogenous vaccines fill an important niche where there are no existing registered vaccines or products to prevent or treat the disease, or in the case new serotypes or strains emerge such that existing vaccines fail to protect animals.
The APVMA will review any comments from the consultation, and update the new guidance taking account of relevant concerns and comments.
Autogenous vaccines are also seen as an effective tool to reduce antibiotic usage, and are an important tool in ongoing initiatives against antimicrobial resistance (AMR).
Guidance on registration of a product and new source of active
Applicants can seek approval of a new source of an existing active constituent in conjunction with a product registration under application Items 5, 6 and 10.
Updated guideline on active constituents for veterinary products
Following targeted industry consultation, the APVMA has updated its guideline on active constituents for veterinary products. The guideline has been updated to ensure it is consistent with legislative requirements for the approval of individual sources of veterinary active constituents, and to provide clearer information on the data required for new sources of pharmacopoeial and non-pharmacopoeial active constituents.
Updated tailored guidance for alteration of shelf life/expiry date, in-use shelf life and/or storage conditions
Applicants can seek approval to vary the shelf life details or storage conditions for registered products under application Items 12 and 14.
Updated tailored guidance for amendment of a restraint, contraindication, precaution or side effect statement
For registration, veterinary chemical products must be shown to be safe and effective when used in accordance with any approved directions for use. Product labels must adequately reflect these directions, including restraints, contraindications, precautions and side effects of the product where applicable.
Updated guidance material for amendment of a restraint, contraindication, precaution or side effect statement is available on our website.
Compliance and Monitoring
The APVMA’s Compliance and Monitoring function sits within the Office of the Chief Regulatory Scientist, and plays an important role in the agvet scheme through post-market monitoring, managing the adverse experience program, audits, recalls, investigations and enforcement.
Compliance and Monitoring recently issued a number of recall and stop supply notices, with many relating to unregistered veterinary products which the Victorian Board kindly published on its website.
The APVMA considers unregistered agvet products to be of great risk, as a result of the products not being assessed. Stakeholders can subscribe to receive email notifications when a new recall is published on our website.
APVMA Compliance Investigators recently concluded an investigation into a company selling unregistered veterinary products, and issued a $26,250 fine. A previous attempt to engage with the company Director and address the non-compliance was unsuccessful. Information about the conduct has been reported to the relevant Veterinary Board.
A referral was made recently to the NSW Veterinary Practitioners Board (NSW VPB) about claims made by a practitioner in relation to a complementary animal health treatment. The APVMA advice letter resulted in the relevant webpage being locked, however we believe the NSW VPB was successful in resolving the issue. The collaboration on this matter proved to be of great benefit to the APVMA and we look forward to working closely with Veterinary Surgeons and Practitioners Boards around Australia.
Adverse Experience Reporting Program
The APVMA’s Adverse Experience Reporting Program (AERP) is a post-registration program that assesses reports of adverse experiences associated with the use of a registered veterinary medicine or agricultural chemical.
The APVMA defines an adverse experience as an unintended or unexpected effect on animals, human beings or the environment, or a lack of efficacy associated with the use of a registered agricultural or veterinary chemical product.
The reporting of off-label adverse experiences is also important, as these have resulted in the APVMA resolving potential issues with registered products.
Lack of efficacy for registered products (when used according to label directions) remains an area of interest to the APVMA, particularly when lack of efficacy correlates to serious disease in animals. As we head towards the season for paralysis ticks for instance, it is important that label directions for parasiticide products are read and understood to ensure optimum efficacy.
The AERP continues to monitor trends in the reporting incidence of all registered products, including lack of efficacy, and encourages veterinarians in particular to submit reports or concerns through the program via email at AERP@apvma.gov.au, or using the online reporting form.
Veterinarians and product holders are also encouraged to contact the AERP with any concerns or questions.
Chemical Review
The APVMA’s Chemical Review function hosts public consultations during its review process, and encourages input from stakeholders who may wish to provide information or relevant data.
Questions about current reviews or consultations may be directed to Chemical Review by email at chemicalreview@apvma.gov.au, or telephone on +61 2 6770 2400.
Information on the scope and work plans of ongoing chemical reviews can be found on our website.
Anticoagulant rodenticides
On 7 April 2020 the APVMA opened a public consultation on use patterns of anticoagulant rodenticide products in Australia. The consultation focuses on registered products containing the following active constituents:
First-generation anticoagulant rodenticides (FGARs):
- Warfarin
- Coumatetralyl
- Diphacinone
Second-generation anticoagulant rodenticides (SGARs):
- Brodifacoum
- Bromadiolone
- Difenacoum
- Difethialone
- Flocoumafen
The APVMA welcomes submissions by 3 July 2020 on matters related to:
a. the need for anticoagulant rodenticide products to be used in home garden or domestic settings
b. the need for anticoagulant rodenticide products to be used in residential or suburban settings, for example, for public health or public sanitation programs
c. the need for anticoagulant rodenticide products to be used in or around buildings, including those used to house livestock, or in or around on-farm buildings (including homesteads)
d. the need for anticoagulant rodenticide products to be formulated as powders, gels, liquids, pellets, grains or pastes
e. the likelihood of compliance with post-application sanitisation instruction (eg the timely collection of poisoned rodent carcasses, and the appropriate disposal of carcasses)
f. the label instructions, particularly the adequacy of instructions to prevent inadvertent exposure to the product
g. critical uses for anticoagulant rodenticide products, particularly in primary production; and
h. other relevant matters related to the use of anticoagulant rodenticide products.