Edition VMT002
- Directors update
- APVMA news
- Performance report
- New product registrations
- Making changes to veterinary sites of manufacture
- Veterinary Labelling Code update
- Veterinary Immunobiologicals Working Group
- Useful information for industry
- Guidance material for applicants
- Compliance and Monitoring
Directors update: Dr Martin Ilott and Dr Donald Sibanda
Welcome to the second edition of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) quarterly Veterinary Medicines Regulatory Newsletter.
In this edition, we have included updates on the Veterinary Labelling Code project and the revised process for varying sites of manufacture, plus a 'useful information for industry’ section which provides tips on how to resolve data list issues and common errors in application forms.
We continue to encourage applicants to participate in APVMA stakeholder meetings which are currently being held remotely. These meetings are a valuable forum for both industry and the APVMA Veterinary Medicines Team to discuss current and future applications, priorities, and work through any concerns. These meetings can be organised through your Case Manager by emailing casemanagement@apvma.gov.au.
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.
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
The APVMA’s revised cost recovery arrangements took effect on 1 July 2020. Due to the large number of applications received in the week prior to 1 July, clients may have experienced a delay of up to three weeks before applications appeared in their account. The APVMA has cleared this backlog and overall timeframes will not be affected.
In August we published an updated guidance document on veterinary drug joint reviews. ‘Joint review’ is the evaluation of a veterinary drug submission shared by two or more countries. Each regulator is assigned a technical section of the submission, and each review report is peer-reviewed by the other countries’ regulators. The aggregation of the review reports constitutes the basis for the regulatory decision of all regulators in their respective countries, and provides more timely access to market for applicants and end users.
Performance report
The Veterinary Medicines Team delivered another strong quarter of timeframe performance at the end of June quarter 2020.
We completed:
- 95 per cent of veterinary medicines product applications within timeframe, up from 87 per cent in March quarter 2020
- 89 per cent of applications requiring major assessment for veterinary medicines within timeframe, increasing from 79 per cent in March quarter 2020.
268 veterinary medicine product applications remain in progress at the end of June quarter 2020, down from 320 in March quarter 2020.
The full performance report for the June quarter 2020 is available on our website, including statistics for the 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 combinations of active constituents or new active constituents published in the Gazette during the last quarter.
|
Application no. |
Product name |
Active constituent/s |
Applicant name |
Summary of use |
Date of registration |
Product registration no. |
|---|---|---|---|---|---|---|
|
100621 |
FelineGuard FeLV |
Inactivated feline leukaemia virus (FeLV) subtypes A, B and C (Kawakami-Theilen strain) including gp70 sub-unit antigen |
Zoetis Australia Pty Ltd |
Registration of a 218.4 ug/m L inactivated feline leukaemia virus subtypes A, B and C (Kawakami-Theilen strain) and gp70 sub-unit antigen product to protect susceptible cats against persistent feline leukaemia virus (FeLV) infection and associated clinical disease. |
12 May 2020 |
80322 |
|
120210 |
Cydectin Platinum Dual Active LV Pour-On For Cattle |
200 g/L levamisole (as base), 10 g/L moxidectin |
Virbac (Australia) Pty Ltd |
For treatment and control of gastrointestinal nematodes in cattle. |
27 May 2020 |
88072 |
|
121396 |
Draxxin KP Plus Ketoprofen Injectable Solution For Cattle |
120 mg/mL ketoprofen, 100 mg/mL tulathromycin |
Zoetis Australia Pty Ltd |
For the treatment of bovine respiratory disease and associated pyrexia in cattle. |
24 July 2020 |
88472 |
|
122199 |
Amproline 400 mg/ml Solution for use in drinking water |
400 mg/mL amprolium hydrochloride |
Huvepharma EOOD |
For treatment and prevention of economically important strains of coccidiosis including Eimeria tenella, E. necatrix and most strains of E. acervulina in broilers, breeders, replacement pullets, turkeys, ducks and pigeons. |
12 August 2020 |
88760 |
|
119821 |
Fostera Gold PCV MH |
Mycoplasma Hyopneumoniae—Inactivated Antigen—Inactivated Mycoplasma Hyopneumoniae Antigen
Porcine Circovirus Type 1-Type 2a Chimera Inactivated
Porcine Circovirus Type 1-Type 2b Chimera Inactivated |
Zoetis Australia Pty Ltd |
For active immunisation of pigs to reduce viraemia, virus load in lymphoid tissues, the incidence of lesions in lymphoid tissues associated with PCV2 infection and reduction in faecal virus shedding. For active immunisation of pigs to reduce the severity of lung lesions caused by Mycoplasma hyopneumoniae.
Onset of immunity: For PCV2 and Mycoplasma hyopneumoniae, 3 weeks after a single (2 mL) vaccination or on the completion of the two-dose (2 x 1mL) vaccination schedule.
Duration of immunity: For PCV2 and Mycoplasma hyopneumoniae, 23 weeks after a single vaccination or a two-dose regime. |
3 August 2020 |
87927 |
|
121826 |
Fostera Gold PCV Metastim |
Porcine Circovirus Type 1-Type 2a Chimera Inactivated
Porcine Circovirus Type 1-Type 2b Chimera Inactivated |
Zoetis Australia Pty Ltd |
For active immunisation of pigs to reduce viraemia, virus load in lymphoid tissues, the incidence of lesions in lymphoid tissues associated with PCV2 infection and reduction in faecal virus shedding.
Onset of immunity: For PCV2, 3 weeks after a single (2 mL) vaccination or on the completion of the two-dose (2 x 1mL) vaccination schedule.
Duration of immunity: For PCV2, 23 weeks after a single vaccination or a two-dose regime. |
3 August 2020 |
88614 |
|
121398
|
24·7 Smartrace Adult Cattle Oral Boluses |
4139mg calcium iodate, 485mg basic cobalt (II) carbonate and 220mg sodium selenate |
Agrimin Ltd |
For supplementation of the trace elements iodine, cobalt and selenium in adult cattle over 400 kg live weight. |
24 August 2020 |
88474 |
|
121399 |
24·7 Smartrace Growing Cattle Oral Boluses |
3363 mg calcium iodate, 394 mg basic cobalt (II) carbonate and 179 mg sodium selenate |
Agrimin Ltd |
For supplementation of the trace elements iodine, cobalt and selenium in growing cattle between 200–400 kg live weight. |
3 September 2020 |
88475 |
|
117504 |
Nobivac Canine Oral Bb Live Vaccine |
Live attenuated Bordetella bronchiseptica, strain B-C2 (≥1 × 10^9 CFU per dose) |
Intervet Australia Pty Limited |
For the active immunisation of healthy dogs and puppies from 7 weeks of age to reduce coughing and shedding caused by Bordetella bronchiseptica infection. |
24 August 2020 |
87083 |
Making changes to veterinary sites of manufacture
We’ve updated the application requirements for making changes to veterinary sites of manufacture.
Prescribed variations (Item 13A)
The Agricultural and Veterinary Chemicals Code (Prescribed Variations) Instrument 2019 has been updated to allow two new types of variation application to be made as prescribed variations (Item 13A applications).
Holders will now be able to add an overseas site of manufacture that performs secondary steps of manufacture through an Item 13A application. Secondary steps are defined as those manufacturing steps which have no direct contact with the veterinary chemical itself, for example, secondary packaging, labelling, storage and quality control testing (excluding biological assays for immunobiological products).
In some circumstances, holders will also be able to add an overseas site of manufacture which performs primary steps of manufacture, where the site has already been approved for those steps of manufacture for another veterinary product for which they are the holder.
Changes to Item 12 (non-technical assessment)
Holders of veterinary products (excluding immunobiological products) are now able to vary an overseas site of manufacture that performs primary steps of manufacture via an Item 12 application, when the new site has not already been assessed for another product with the same holder.
Previously, this type of variation would require an Item 14 application. However, the APVMA now considers a chemistry assessment is no longer required as, like an Australian manufacturing site change, we would be satisfied the product is manufactured to an equivalent standard required by the APVMA for Australian sites, through Good Manufacturing Practice (GMP) certification.
Further information
To make an application to vary a veterinary site of manufacture, please use the tailored guidance for applicants as the decision tree has not yet been updated to allow these application types.
It is a condition of registration that registered veterinary products are manufactured at sites that hold appropriate GMP certification, or the overseas equivalent recognised by the APVMA. This requirement is not changing.
Veterinary Labelling Code update
Following feedback from industry, we are reviewing and updating the labelling requirements for veterinary products as set out in the Veterinary Labelling Code. Industry stakeholders expressed the need for more clarity around several general and specific labelling requirements and/or guidance, to support e-label submissions and presentation of marketed labels.
In consultation with Animal Medicines Australia (AMA) and the Veterinary Manufacturers and Distributors Association (VMDA), we have commenced our review of the general and 18 specific labelling requirements (total of 47 sections) which will be submitted in parts to industry for consideration and comment. We are also revising the presentation of this content on our website by integrating the 18 specific labelling requirements into the general label content section and using buttons/drop down menus to improve readability.
The first two batches of Veterinary Labelling Code sections (21 in total) have been circulated to industry bodies and we are currently reviewing the feedback received. We intend to meet with each industry body to discuss specific label sections that require further industry discussion and to have all 47 sections reviewed by the end of 2020. In early 2021 we plan to collate the online content for final review and anticipate to have the updated Veterinary Labelling Code launched by next financial year.
Veterinary Immunobiologicals Working Group
The 20th meeting of the Veterinary Immunobiologicals Working Group (VIWG) was held remotely for the first time on 2 September 2020, with a focus on autogenous vaccines.
Autogenous vaccines are a useful addition to registered vaccines in animal disease control and in maintaining animal health and welfare. The use of veterinary vaccines, including inactivated autogenous vaccines, can also be an additional prophylactic tool to avoid occurrence of diseases, which require antibiotic treatment.
The growing interest in the use of autogenous vaccines has led to a joint APVMA-industry review of the current guidance for the technical requirements for autogenous vaccine (sometimes referred to as custom vaccines) for granting permit applications. Following our recent public consultation which closed 4 June 2020, the VIWG reviewed the updated technical guidance with a view to adopting the guidance by December 2020. It is hoped the new guidance will facilitate the approval process to ensure autogenous vaccine permits are granted in a timely manner, providing products of satisfactory quality and safety.
Useful information for industry
We’ve compiled some tips for industry to assist with data list rejections and common application form errors.
Data list rejections, causes and tips
In recent months, the APVMA has received a number of applications with large data lists and a large amount of supporting data. In order to pass Preliminary Assessment, an APVMA Case Manager must match each file against the data list items. It can take time to match the data item against the received file, particularly if data item descriptions and file names do not match. Furthermore, data lists will not upload if data is not provided for mandatory fields (for example, date, title, and author).
To facilitate a streamlined data list upload and review process, please refer to our tips below:
- Please use a unique reference number, preferably under 25 characters, for each data item. Larger reference numbers may not import into APVMA systems.
- If possible, incorporate part or all of the reference number into the data item file name, as this will allow the APVMA to quickly match the data item against received files. If the APVMA asks you to resend a ‘missing’ data item, please consider incorporating the reference number or data item number into the file name.
- The date field on each data item must have a numeric entry. Acceptable date formats for data items are: YYYY; month YYYY; DD month YYYY; or DD.MM.YYYY. Please do not use variations such as DDth or DD mon YYYY as these will not import correctly into APVMA systems.
- Please avoid diacritics on author names as the diacritics will import as special characters which are not accepted.
- If data items are to be shared amongst modules, please consider providing a separate reference table entitled ‘instructions for data list’ with an outline of which data items are to be shared. Alternatively, for a small number of items please add an explanation into the Executive Summary of the application. This will prevent duplicate files being imported as separate data items.
Additional information about this process is available on our website. Please contact casemanagement@apvma.gov.au or datalist@apvma.gov.au if you require assistance.
Common application form errors
To ensure a smooth application assessment process, we encourage applicants to read the following list of common application form errors, which can create challenges during the application process.
- For variation applications that include assessment modules, in section 1 ‘Product Details’ the application form requires all modules to be captured under the ‘Modules’ subheading. A common error includes the omission of the data protection module (number 12). All modules should be captured to avoid unnecessary delays during the recategorisation process.
- For variation applications, a common error includes listing the product to be varied under section 7 of the application form, ‘Access to information with a limitation of use period’. This section is specifically designed to include a reference product that may have a limitation of use period. Additionally, a check on what data items with ‘limitation of use’ placed on the reference product is necessary for registration applications that involve reference products with a limitation of use period.
- The following list of errors are specific to section 10 of the application form, ‘Formulation Details’:
- Not providing the CAS number or the constituent standard, for each of the constituents listed.
- No clarity in the grade of the water or diluent used. Specific examples include water for injections to the British Pharmacopoeia (BP)/European Pharmacopoeia (Ph.Eur) 0169, purified water BP/Ph.Eur 0008, and sterile diluent 9 CFR 113.54.
- Concentration of the constituents must be expressed in metric units.
- Formulation types are incorrectly provided.
- The following list of errors are specific to section 11 of the application form, ‘Manufacturers Details’:
- For variation applications that include any change to the manufacturing sites, incorporating details of all the sites of manufacture, including currently approved sites and proposed sites, are required.
- Stating ‘All steps’ under the subheading ‘Steps of manufacture’ is not acceptable. The individual steps of manufacture for the MQL section must be listed in order for the APVMA to verify these nominated steps against the Good Manufacturing Practice (GMP) license provided.
- Addresses of the manufacturing sites do not match with the provided GMP licenses.
- For applications to register a chemical product, section 12 of the Agvet (Application Requirements) Instrument 2014 requires the manufacturing site of the active be specified. The details provided under section 13 ‘Manufacturers of Active Constituents’ need to match a currently approved manufacturing site for an approved active, otherwise the application does not satisfy the application requirements.
- Additionally, special characters entered into section 13 of the application form, ‘Manufacturer of actives’, will cause an import failure on the application. For example, ‘-‘ or ‘/’ instead of the active number.
Guidance material for applicants
We’ve released a new tailored guidance pathway to assist applicants with formulation changes, and published updated manufacturer’s declaration templates.
New tailored guidance for formulation changes
Changes to the formulation of a veterinary chemical product may be required for a variety of reasons, including the availability of excipients or changes to the purity of the source of active used in the formulation. All variations to approved product formulation details require an application to be made. The level of information supporting the variation and the assessment required will vary according to the proposed change and significance it may have with respect to ensuring the continued safety and efficacy of the product.
New guidance material for amendment of formulations is available on our website.
Updated manufacturer’s declaration templates
We’ve updated our manufacturer’s declaration templates, to be provided in applications where the product being registered is the same as a reference product. The updated manufacturer’s declaration templates are available on our website.
Compliance and Monitoring
Hormonal Growth Promotants
The National Hormonal Growth Promotant (HGP) Control and Monitoring System provides continued assurance to the European Union (EU) and other trade partners that Australian beef and beef products imported have not been treated with HGP products.
The APVMA has an important role in the operation of this system by managing the authorisation of importers and resellers, and ensuring correct supply records are maintained. The APVMA continues to work closely with a range of participants in the scheme, and has recently updated templates and information about the program on the APVMA website, including a downloadable fact sheet.
All parties within the supply chain for HGPs (including importers, exporters, manufacturers and retailers) are regarded as suppliers. Australian retailers must be authorised to supply HGP products by completing the notice of intention to supply Hormonal Growth Promotants form.
It is the supplier’s responsibility to obtain a fully completed HGP purchaser declaration form every time HGPs are supplied, and suppliers are required to submit a HGP monthly return form to the APVMA which records HGP acquisitions, sales, exports, returns and disposals. An audit of each monthly return ensures batch numbers, property identification numbers and notification numbers are correct.
Ongoing audit, compliance, traceability and record keeping of HGP products is imperative in ensuring Australian producers have access to premium and emerging markets. There are currently more than 200 registered suppliers in the system, and a list of current HGP notification numbers is available on our website.