The below information outlines the process for the simultaneous review of veterinary medicine submissions to the Australian Pesticides and Veterinary Medicines Authority (APVMA) and the UK's Veterinary Medicines Directorate (VMD).
On this page
Purpose
The purpose of this guidance is to outline the process for the simultaneous review of veterinary medicine submissions to the APVMA and the UK VMD.
This information is for guidance only.
Simultaneous reviews offer the following benefits without compromising domestic standards and scientific rigour:
- Simultaneous access to 2 major markets for veterinary medicine stakeholders.
- Allows for the co-launch of products across both regions.
- Enables applicant teams to work simultaneously across regulatory jurisdictions with clear and collaborative key milestones.
- More choices for animal owners and food producers by supporting faster market access and expanding the number of treatment options available.
- A stronger global review community that allows regulators to work across jurisdictions to share knowledge and expertise.
- Independent, sovereign decision-making by each regulator while striving for harmonisation.
What is a simultaneous review?
Simultaneous reviews allow veterinary medicine applicants to submit a dossier to both the Australian and UK regulators at the same time. The evaluation is conducted independently by each country but in parallel, with the objective of issuing regulatory decisions at the same time.
Submissions must meet all application requirements for each nation.
Eligible products
Submissions may be for new veterinary chemical products, or for new uses of existing products that are already registered in both countries provided they have not been subject to relevant or significant safety-related regulatory action in either country.
The product must be identical in formulation and manufacturing including the source of the active ingredient. There may be differences in product labels. Currently, this opportunity is only open to applications which are based on a full dossier, that is containing all applicable technical information for safety, efficacy, and quality.
Submissions for veterinary medicines for minor uses are especially encouraged.
Generics are not currently eligible for review under this pathway. Veterinary medicines and products exempted from approval in the UK or Australia are also not eligible.
Biologicals will be considered on case-by-case basis. Import permits are required for Australia for biologicals that will be brought into the country.
Phases of a simultaneous review
Pre-submission phase
Expression of interest
Early interactions by industry with the regulators are important. Applicants are encouraged to contact the APVMA and VMD to learn more about this process and initiate dialogue with the regulators. Applicants may signal their interest by sending an expression of interest to both regulators at the earliest opportunity.
The expression of interest should also include a request for a pre-submission discussion. The request should as a minimum provide basic information on the proposed product and indicate the scientific disciplines that the applicant wishes to discuss as well as any specific issues/questions to be addressed by the regulators, although questions concerning scientific advice would be considered outside of this process. The regulators will then jointly work with the applicant to schedule these discussions.
The expression of interest should also include consent from the applicant to the regulators to authorise the exchange of relevant confidential information.
Pre-submission discussions
Pre-submission discussions are required to inform a decision on admissibility. This meeting is of a scoping/exploratory nature. The purpose of a pre-submission discussion where presentations are made by the applicant to the regulators is to introduce their new veterinary chemical product and to discuss whether it is a good candidate for this process.
Joint pre-submission discussions are required. These meetings should involve the applicant, including its representatives in both countries, and both regulators at the same time. If not possible, applicants may also have pre-submission meetings with each country individually.
The applicant is responsible for proposing an agenda in advance of the meeting, recording the meeting notes, and seeking any comments, clarifications, or corrections from meeting participants in a timely manner. Revised and finalised meeting notes should be shared with the regulators for approval and future reference.
If applicants would like to confirm and clarify data requirements, receive feedback on study protocols, clarify Australian specific requirements e.g. trade criteria, a Pre-Application Assistance (PAA) application must be submitted. One PAA can be submitted to address data requirements and establish a Project Plan (see below).
Decision on admissibility
If a submission is deemed to be an appropriate candidate, the regulators will request a formal letter from the applicant seeking a collaborative review.
For the APVMA, you should also submit a tier-3 PAA request at least 90 days before submission. The PAA will be used to establish a project plan.
Based on the information gathered through the pre-submission discussions and the formal request from the applicant, the regulators will consider a variety of factors before deciding to proceed. The regulators will communicate the decision on admissibility to the applicant via formal letters.
Timelines for review
Both regulators will aim to reach a final decision to approve or refuse within 210 calendar days after passing preliminary assessment (APVMA)/validation (UK).
The 210 days do not include the clock stop period (UK) or extended timeframe (APVMA). If the APVMA requires additional information the project plan will be amended to reflect the extended timeframe.
The assessment procedure will progress in accordance with the following table:
| Phase | Timetable |
|---|---|
| Preliminary assessment | 1 month Clock starts once application has passed preliminary assessment. |
| Initial assessment | Assessment day 0–120 Assessment of application data begins. |
| Co response 1: Request for additional information | In Australia, the project plan will be adjusted to reflect the duration of the UK stop-clock period (i.e. 90–180 days) In the UK, the assessment clock will stop for 90 days (may be increased to 180 days upon request). The applicant is issued a request for additional information to support the progression of the application. |
| Second assessment | Assessment day 121–150 The APVMA and VMD assess any additional data or responses and progress application. Alternatively, the APVMA and VMD may issue a second request for information. |
| Co response 2: Request for additional information | 60 days In Australia, the project plan will be adjusted to reflect the duration of the UK stop-clock period (i.e. 60 days). In the UK, the clock will stop for 60 days. |
| Third assessment round | Assessment day 151–180 The APVMA and VMD assess any additional data submitted by the applicant. |
| Sign-off | Assessment day 210 If required, the APVMA will initiate public consultation on proposed decision. The APVMA and VMD will make national sovereign decision to approve or refuse the application. |
Your application will progress into a national phase, where the APVMA and VMD undertake independent activities to issue product registration (AU)/authorisation (UK).
Submission filing phase
Coordinated filing
Applicants must file separate submissions to both regulators independently and simultaneously. Applicants are to file their submission to each country:
- Australia via the APVMA Online Services Portal
- UK via the VMD Digital Service.
All submissions must meet all applicable national regulatory and administrative requirements.
The content of the submissions should be the same, including nation-specific technical requirements. There may also be national-specific administrative documentation or fees payable, as per national regulatory requirements, policies, or processes. Applicants are encouraged to confirm applicable fees with both regulators prior to submission. APVMA-specific requirements should be requested in writing during pre-application assistance.
Applicants are to submit in the Notice to Applicant (NtA) format to both countries, as set out in Volume 6b of the European Notice to Applicants.
Applicants should contact the APVMA for additional guidance if NtA format is to be submitted. Additional guidance will also be included in the PAA.
To enable the review process, data and other information (including confidential business information) provided by the applicant will be discussed by the regulators. Applicants are asked to provide a letter of consent authorising this exchange of information with their application submission.
Submission completeness check (preliminary assessment/validation
Each regulator will perform an initial check of the submission to ensure that the submission can be accepted for review.
If the regulators have questions about the content of the submission at this stage, they will send it to the applicant with a copy to the other regulator.
It is the applicant’s responsibility to ensure that both regulators have an updated consolidated dossier at the end of validation so both countries are working on identical dossiers and no data are missing.
At the end of validation, each regulator will send a communication to the applicant informing them the submission has passed validation and will progress to review.
Submission review/assessment phase
Regulators will meet to discuss the submission and identify any data gaps or areas that require clarification.
Requests for additional information will be agreed upon by both regulators but the applicants will receive separate notices from the APVMA and VMD. Applicants will be provided with an established amount of time in which to submit completed responses. Applicants are required to share their responses to all questions with both regulators.
Opportunities to harmonise and align labelling will be considered. Ultimately however, the label must comply with the relevant national legislative requirements for labelling veterinary medicines.
If the applicant is seeking to meet with one regulator at any point during the submission review process, it is incumbent upon them to inform and invite the other regulator to participate.
Sovereign decision
Each regulator makes its own sovereign decision in accordance with relevant national legislation.
Each regulator will undertake the necessary national administrative and/or legal steps and regulators will, if possible, synchronise the timing and communication related the issuance of decisions.
In the event of a negative decision by one or both regulators the applicant is encouraged to discuss available options and the administrative process to address deficiencies with the regulator(s) based on their regulatory frameworks. Note that relevant national reconsideration/procedural fairness and appeals processes apply.
Additional considerations
Should an applicant wish to withdraw a submission from the simultaneous review, they are encouraged to contact both regulators at the earliest opportunity prior to cancellation to discuss any concerns and regulatory considerations.
Once a product has been registered, it is the responsibility of the applicant to adhere to all applicable national post-market regulatory requirements. Regulators will continue to collaborate and exchange information to support post-market monitoring, risk assessment and risk management activities, as appropriate.
Contact information
For more information contact:
Australia
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
Australia
Email: InternationalCoordinator@apvma.gov.au
United Kingdom
Head of Regulatory Affairs
Veterinary Medicines Directorate
Email: postmaster@vmd.gov.uk