Veterinary Medicines Regulatory Newsletter, April 2021

15 April 2021

Edition VMT004

Directors update: Dr Martin Ilott and Dr Donald Sibanda

Welcome to the fourth 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 Notifiable Variations and Item 10A application updates, as well as the Veterinary Labelling Code review and publication of new guidance for autogenous vaccines.

The Veterinary Medicines Team is focusing its activities on meeting the application target for the 2020–21 financial year that is set at 90%. At the end of the third quarter of the financial year we are pleased to report the team is currently exceeding this target.

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 applicants and 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.

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Performance report

The Veterinary Medicines Team delivered another strong quarter of timeframe performance at the end of the December quarter 2020.

We completed:

  • 99% of veterinary medicines product applications within timeframe, up from 98% in September quarter 2020
  • 93% of applications requiring major assessment for veterinary medicines within timeframe, increasing from 90% in September quarter 2020.

221 veterinary medicine product applications remained in progress at the end of December quarter 2020, down from 244 in September quarter 2020.

The full performance report for the December quarter 2020 is available on our website.

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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

Summary of use

Date of registration

Product registration no.

122696

Websters 6 in 1 B12 & Se Vaccine

5.0 IU/mL Clostridium

perfringens type D, 1.0 U/mL Corynebacterium pseudotuberculosis (ovis), 3.5 IU/mL Cl. novyi

type B, 2.5 IU/mL Cl. tetani, 2.5 IU/mL Cl. septicum, ≥ 0.3% PCV/ mL Cl. chauvoei, 2 mg/mL

vitamin B12 (hydroxocobalamin acetate) and 1 mg/mL selenium as sodium selenate

Virbac (Australia) Pty Ltd

For the prevention of cheesy gland (C. pseudotuberculosis), pulpy kidney (Cl. perfringens type

D), black disease (Cl. novyi type B), malignant oedema (Cl. septicum), tetanus (Cl. tetani) and

blackleg (Cl. chauvoei) in sheep and lambs and the prevention of selenium responsive conditions

and for the treatment and prevention of vitamin B12 deficiency in sheep.

24 November 2020

 88862

122698

Websters 6 in 1 B12 Vaccine

5.0 IU/mL Clostridium

perfringens type D, 3.5 IU/mL Cl. novyi type B, 2.5 IU/mL Cl. tetani, 2.5 IU/mL Cl. septicum,

1.0 U/mL Corynebacterium pseudotuberculosis (ovis), ≥ 0.3% PCV/mL Cl. chauvoei and 2 mg/mL

vitamin B12 (hydroxocobalamin acetate)

Virbac (Australia) Pty Ltd

For the prevention of cheesy gland (C. pseudotuberculosis), pulpy kidney (Cl. perfringens type

D), black disease (Cl. novyi type B), malignant oedema (Cl. septicum), tetanus (Cl. tetani) and

blackleg (Cl. chauvoei) in sheep and lambs and for treatment and prevention of vitamin B12

deficiency in sheep

24 November 2020

88864

120624

Vanguard B-Oral Live Vaccine For Dogs

Live attenuated Bordetella bronchiseptica ≥ 1.4 x 10^8 CFU per dose

Zoetis Australia Pty Ltd

For the active immunisation of healthy dogs and puppies from eight weeks of age to reduce

clinical signs and nasal shedding caused by Bordetella bronchiseptica

24 November 2020

88237

107550

Vanguard Intranasal Resp 3 Live Vaccine For Dogs

Each dose contains live attenuated: Canine Adenovirus Type 2 (≥10^3.1 TCID50), Canine

Parainfluenza Virus (≥10^5.0 TCID50), Bordetella bronchiseptica (≥1.3 x 10^6 CFU)

Zoetis Australia Pty Ltd

For the active immunisation of healthy dogs and puppies from 8 weeks of age to reduce

clinical signs associated with respiratory tract disease and shedding induced by Bordetella

bronchiseptica, Canine Parainfluenza Virus (CPI) and Canine Adenovirus Type 2 (CAV-2)

13 November 2020

83109

121504

Penethaject RTU Antibiotic Injection

333.3 mg/mL penethamate hydriodide

Bayer Australia Ltd (Animal Health)

For the treatment of mastitis caused by susceptible gram-positive pathogens in lactating cows

20 January 2021

88498

113108

Cipiosyn

0.5 mg/mL oestradiol cypionate

Syntex SA

To induce oestrus and ovulation in cattle after progesterone priming with an intravaginal insert containing progesterone, as part of a reproductive management programme

 

24 February 2021

85382

123515

GlanEry 7 In 1 B12 Vaccine For Sheep

Corynebacterium pseudotuberculosis (ovis) ≥ 6 CPU/mL, Clostridium perfringens type D ≥

5 IU/mL, C. tetani ≥ 2.5 IU/mL C. novyi type B ≥ 3.5 IU/mL, C. septicum ≥ 2.5 IU/mL (as

ultrafiltered toxoids), C. chauvoei (meets Ph. Eur.), Erysipelothrix rhusiopathiae ≥ 40 IU/dose (as

formol cultures), 2 mg/mL hydroxocobalamin

Zoetis Australia Pty Ltd

For the active immunization of

sheep to prevent mortality or clinical signs associated with enterotoxaemia (pulpy kidney),

tetanus, black disease, swollen head in rams, malignant oedema and blackleg; to reduce the clinical signs and lesions associated with caseous lymphadenitis (CLA or cheesy gland); to

reduce clinical signs of erysipelas arthritis and for the treatment and prevention of Vitamin B12

deficiency in sheep, in areas of known or suspected cobalt deficiency

26 February 2021

89053

123649

GlanEry 4 In 1 B12 Vaccine For Sheep

Corynebacterium pseudotuberculosis (ovis) ≥ 6 CPU/mL, Clostridium perfringens type D ≥

5 IU/mL, C. tetani ≥ 2.5 IU/mL (as ultrafiltered toxoids), Erysipelothrix rhusiopathiae ≥ 40 IU/dose

(as formol culture), 2 mg/mL hydroxocobalamin

Zoetis Australia Pty Ltd

For the active immunization of sheep to prevent mortality or clinical signs

associated with enterotoxaemia (pulpy kidney) and tetanus; to reduce the clinical signs and

lesions associated with Caseous lymphadenitis (CLA or cheesy gland); to reduce the clinical

signs of erysipelas arthritis and for the treatment and prevention of Vitamin B12 deficiency in

sheep, in areas of known or suspected cobalt deficiency

26 February 2021

89115

124028

DICO Intravaginal Device

300 mg progesterone

Syntex S.A

For controlled breeding in sheep and goats

 

5 March 2021

89219

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Veterinary Labelling Code review

Following our previous Veterinary Labelling Code (VLC) update, all VLC sections have completed the internal APVMA review and been sent to Animal Medicines Australia (AMA) and the Veterinary Manufacturers and Distributors Association (VMDA). We are currently reviewing the feedback received from these industry bodies. The Veterinary Medicines Team continues to meet with industry to discuss specific label sections that may require further discussion.

The completed VLC sections from batches 1, 2 and 3 have been published to test pages on the APVMA website and we anticipate all VLC sections will be published to the test pages prior to June 2021. We are also working with the APVMA Communications Team to improve the presentation, accessibility and functionally of the VLC on the APVMA website and will make the test pages available to industry for final review before undertaking a public consultation.

The timeline for the VLC review has been extended to accommodate additional review and consultation and we now expect publication of the new VLC guidance to occur in September 2021.

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Autogenous vaccine guideline update

The new guidance on autogenous vaccines has been published on the APVMA website following a review of the technical and regulatory requirements for permit applications for autogenous vaccines that commenced in 2019. 

The new guidance introduces the concept of a ‘Master Permit’ to enable manufacturers to hold their portfolio of autogenous vaccines under one permit.

The growing interest in the use of autogenous vaccines led to a joint APVMA-industry review of the current guidance for autogenous vaccines (also referred to as ‘Custom vaccines’) for granting permit applications. A workshop on autogenous vaccines was attended by vaccine experts, autogenous vaccine manufacturers and APVMA regulators in January 2020 following a draft report on the current regulations for these products. The new guidance was subject to a public consultation that closed 4 June 2020, followed by further review by the Veterinary Immunobiological Working Group (VIWG) at its 2 September 2020 meeting. A post-meeting consultation with VIWG members ended 7 December 2020.

The new technical guidance is intended to facilitate the application and approval process and reduce regulatory burden for issuing autogenous vaccine permits. The technical guidance also provides clarity on the data requirements through their development with manufacturers and vaccine experts.

The Master Permit concept enables autogenous vaccine manufacturers to hold their portfolio of vaccines under one permit, thereby minimising the regulatory burden for applications and subsequent renewals. The microorganisms, vaccine formulations and target species can all be included under one permit issued by the APVMA. Manufacturers are encouraged to take advantage of this procedure where applicable.

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Useful information for industry

Tips for registrants: Information lists

The Agvet Code and Agvet Code Regulations require the APVMA to record and publish a short description of each item of information contained in, or accompanying, applications for approval, registration or variation of relevant particulars, or conditions of approvals and registration (known as an information list).

This includes, but is not limited to, the following items:

  • The title shown on the item of information.
  • The name and address of the authorising party for the information.
  • The name of the author, or each of the authors, of the information.

Registrants for veterinary products must abide by the legislative requirements when submitting information lists to the APVMA. Information lists that do not comply with the Agvet Code and Agvet Code Regulations will be returned to the registrant for amendment, which may result in delays during the evaluation period.

Our guidance for preparing information lists provides additional detail about the specific types of information that may be consolidated into a single document or entry in an information list.

Questions about the legislative requirements for information lists may be directed to enquiries@apvma.gov.au.

Additional information on how to complete information lists was published in our September 2020 edition.

Use of the trademark symbol

The registered trademark symbol, ®, is reserved for trademarks registered with an appropriate government agency. The trademark symbol itself is not part of a product name and is therefore not considered to be a relevant particular in relation to the registration of a chemical product and label approval.

The APVMA will not include the trademark symbol in conjunction with a product name in any approval documentation we issue. A trademark can be included on the marketed label of a registered product without the need to notify the APVMA.

Questions about trademarks may be directed to enquiries@apvma.gov.au.

Agvet Code requests under section 8W and subsections 17(5) and 18(5)

The APVMA Veterinary Medicines Team has received an increased number of applications under section 8W and subsections 17(5) and 18(5) of the Agvet Code, which has resulted in delays of 6 to 12 weeks to process these requests. The turnaround time for these requests is dependent on the number of products, the amount/details of information requested, and if the application is for an older product registration.

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10A applications

For an Item 10A application to be successful, please ensure that the original (existing) approved label is compliant with the current Veterinary Labelling Code. Any requests made to update the approved label particulars under an Item 10A application will not be permitted and will result in the refusal of your application due to non-compliance with the Veterinary Labelling Code. 

To mitigate the risks of an application being refused, applicants are encouraged to submit an Item 12 variation application to update the original (existing) approved label prior to submitting the Item 10A application.

Please note: the Item 10A application label is identical to the original approved label except for the following exceptions:

  • The registered product name can be replaced with the additional marketing name wherever it occurs on the label.
  • It may contain a subset of the claims and instructions for use from the approved label, such as the animals treated on the existing product’s label.

More information about Item 10A applications is available on our website.

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Notifiable Variations

It is important applicants understand the changes permitted to active constituents, products and labels under the Agricultural and Veterinary Chemicals Code (Notifiable Variations) Instrument 2019 (NV Instrument).

For example, some applicants have applied to add pack sizes outside of the currently approved ‘range’ for a registered product. Under Item 13 of the NV Instrument, the proposed net contents must be within the range recorded in the Register for the product:

A variation of the net contents of a veterinary chemical product but only if:

(a) the variation will not result in the instructions for use, or disposal, of the product or containers for the product, being modified or affected; and

(b) the net contents is in the range recorded in the Register for the product.

This Item includes a variation of an approved label but only if a label for the chemical product as varied would not include any misleading or deceptive information about the use, safety, environmental impact or efficacy of the chemical product.

The APVMA appreciates applicants may not wish to apply for an Item 12 application when the addition of a pack size is a non-technical assessment. However, The Agvet legislation does not allow for an NV to be used in these situations.

Further information about minor variations and Notifiable Variations is available on our website.

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13A applications

The Agricultural and Veterinary Chemicals Code (Prescribed Variations) Instrument 2019 was updated in August 2020.

As a result of this update, applicants can now make the following variations under an Item 13A application:

a) A variation to an already approved Australian manufacturer (with a licence) name or address, or both.

b) A variation to add an Australian manufacturer for any approved steps of manufacture.

c) A variation of an already approved overseas manufacturer name, or an update/correction to the address where the physical address has not changed.

d) A variation to add an overseas site of manufacture for secondary steps only.

e) A variation to add an overseas site for primary steps of manufacture when the overseas site has already been recorded as a site of manufacture for the same primary steps for another registered veterinary product with the same holder.

f) A variation to remove a site of manufacture.

More information about the variations permitted under an Item 13A application is available on our website.

Changes have also been made to the declarations at section 4 of the Item 13A application form. It is important applicants ensure the appropriate declarations are selected when lodging an application.

  • For applicants to vary an overseas site of manufacture:

(a) Select primary or secondary steps of manufacture.

(b) Select declaration that requirements are met.

  • For all applicants (variation to Australian or overseas site) both check boxes must be ticked:

(a) Declaration that proposed variation is a relevant particular as per the prescribed variation instrument.

(b) Declaration that the information provided is complete and correct.

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MQL news

Following the World Health Organization’s 11 March 2020 declaration of the novel coronavirus (COVID-19) pandemic, the APVMA is providing support to holders and manufacturers of veterinary medicines.

The COVID pandemic has resulted in travel restrictions and guidelines for social distancing that have affected the ability to perform Good Manufacturing Practice (GMP) inspections in Australia and overseas.

The APVMA has published updated guidance to assist veterinary manufacturers audited by the APVMA to demonstrate compliance with GMP while travel restrictions and other measures are in place.

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Team news

Dr Donald Sibanda has been appointed as a Director for the Veterinary Medicines Team.

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