Correspondence

ASRU operational newsletter, 1 April 2022

Published 8 April 2022

Dear all,

Re: Delivery of appropriate, timely and consistent regulation

ASRU has received recent correspondence from members of the regulated community, in which concerns have been raised regarding clarity of recent communications, timeliness and consistency of service, and regulatory delivery. In addition, concerns have been raised regarding the regulatory burden placed on Establishments. In this communication I hope to provide assurance and clarity on these matters and provide clear expectations.

ASRU’s operating model delivers compliance assurance and licensing functions underpinned by the principles of good governance, in alignment with our purpose of ‘Protecting Animals in Science by maintaining compliance with ASPA.’ For licensing, this means ensuring appropriate processes are in place at establishments and are used to generate application information. For compliance assurance, this means evaluation of governance systems for establishments and projects.

I would like to assure you that ASRU aims to continue to provide service delivery (licensing) in accordance with our statutory obligations and compliance assurance (including audit, Standard Condition 18, and enforcement) in alignment with ASPA.

The principles underpinning timely and consistent regulation are:

• prioritisation of activities in accordance with the statutory requirements of ASPA, which includes timely assessment of all new licences and amendments
• maximisation of the continuous improvement of governance systems
• ensuring that the responsibilities of licence holders for compliance and quality are clear

The operating model we deliver should now be familiar to you. Regulatory delivery is provided through these specific work areas, each with a dedicated inbox:

1. Compliance assurance
2. Licensing

At the following link is an updated document to provide full details of our operating model. In summary:

1. Licensing

This team will deliver the processing of applications for licences and licence amendments which will continue to be managed through ASPeL. Should you need to contact this team you can do so at ASRULicensing@homeoffice.gov.uk

The licensing service continues to be delivered through a “taxi rank system” with applications being assessed in the order they are submitted through the ASPeL electronic licensing system. We will prioritise licence applications using typical timelines that are aligned within the statutory timelines defined in ASPA. The typical timelines for the handling of licensing tasks are shown below and are based on the statutory requirements defined in ASPA. Please note that our typical timelines can vary, based on the complexity of the application and level of incoming applications to the Regulator.

All days referenced are working days:

New project application review and any returned project application review: 40 days/55 days for complex applications

New PPL amendment review: 40 days

Second and subsequent PPL amendment review: 40 days

Urgent PPL amendment: contact ASRULicensing@homeoffice.gov.uk

It is recommended that applications are submitted to ASRU as early as possible to reduce the risk of delays in licensing decision and provision of licence authorities. Applications must be submitted at least four months before authority is required.

We continue to receive requests to expedite first review of applications which are submitted less than three months prior to their expiry date, and which require transfer of animals. We will not expedite any such requests unless there are exceptional circumstances. It is the responsibility of PPL holders to ensure new licences are received in a timely manner and to have contingency plans for animals in these cases.

Prospective authority licensing requests

Where studies are requested to meet regulatory requirements, they will be performed in compliance with relevant UK & EU legislative bodies including the European Medicines Agency (EMA), European Chemicals Agency (ECHA), the Medicines and Healthcare Products Regulatory Agency (MHRA), Health and Safety Executive (HSE) and the Veterinary medicines Directorate (VMD) in the UK. The guidance given in the various guidelines of the International Conference of Harmonisation (ICH) and The Organisation for Economic Co-operation and Development (OECD) are followed in the design of safety evaluation programmes and in the design of studies.

For studies requested for other worldwide authorities, for example the US Food and Drugs Administration (FDA), a scientific justification will be sought if the study requirements exceed the requirements of the UK or EU regulatory authorities for similar studies; for example, by their requiring a greater number of animals or a more severe test. Permission to perform such tests will be obtained prospectively from the Secretary of State by submitting a completed Prospective Authority Form and submitting this to ASRU licensing. Any valid scientific justification will be included within the records of the Project Licence.

Please submit to: ASRULicensing@homeoffice.gov.uk

2. Compliance assurance

This team will deliver all activities which provide oversight and assurance to the public of licence holders compliance with ASPA and their licence conditions including:

• provision of facility, systems, and thematic audits
• monitoring of action plans for those establishments which are assessed as being of high risk of non-compliance (in special measures)
• enforcement activities through investigation and management of potential cases of non-compliance
• reviewing reports submitted which are part of compliance assurance (e.g., SC 18 reports, retrospective assessments, other reports required by a specific licence)

Audit

Throughout 2022, the audit programme will continue in accordance with the inspection requirements defined by ASPA.

Audit activity in 2022 will include:

• full systems audit. You will be notified in advance if your establishment has been selected for full systems audit and advised what you need to submit to us in advance
• facilities audits
• enforcement investigations
• facility assessment for licence amendment
• for-cause audits for other regulatory purposes such as investigation following a whistle-blowing report received by the Regulator

Audit system: summary

Audit type	Purpose	Location
Full systems	Evaluation of all systems against licence standard conditions and associated Standards required under ASPA	On-site with some virtual activity
Facilities	Evaluation of facility against Code of Practice requirements, ASPA requirements and associated systems	On-site
Enforcement investigation	Investigation of alleged non-compliance	# On-site or virtual
For-cause	Various e.g., result of whistle-blowing communication	# On-site or virtual

New requirement: AWERB report submitted with all project licence applications

Purpose

This requirement enables us to assess your compliance with ASPA Establishment Licence Standard Condition 6 (3,4)

AWERBs have a responsibility to advise the establishment licence holder whether to support project proposals, primarily considering such proposals from a local perspective and bringing local knowledge and local expertise to bear.

What do you need to do?

From 28th March, we will pilot this process with a small group of establishments. We have reached out to the establishments involved in the pilot separately to discuss.

Once we have reviewed the pilot cases and evaluated the findings, we will update all establishments with next steps.

3. Regulatory queries: updates to inboxes

We continue to provide a formal, centralised service to answer regulatory queries. Aligned to our operating model, we have made some changes to the inboxes to maximise efficiency, consistency and quality and ensure your query goes to the correct business area.

ASPA London, and Regulatory Advice inboxes are now closed, please use the following inboxes to submit your query:

Compliance assurance

Enforcement - ASRUEnforcement@homeoffice.gov.uk

Standard Condition 18 - ASRUStandardCondition18@homeoffice.gov.uk

Audit - asruaudit@homeoffice.gov.uk

Licensing

ASRULicensing@homeoffice.gov.uk

Home Office liaison (HOLTIF) and complaints inbox

ASRUOperationalRelationshipManagement@Homeoffice.gov.uk

ASPeL technical queries

ASPELTechnicalQueries@homeoffice.gov.uk

4. Licensing fees

Essential information to note in relation to the upcoming fee period

As with previous billing years, establishments will be granted a window of 14 days from 21st March to 3rd April 2022 to complete PIL transfers without incurring additional charges. Please provide a list of all PIL transfers during this period to ASRUBusiness@homeoffice.gov.uk.

We ask all establishments to check the ‘Licence Fees’ Section on ASPeL ahead of 5th April 2022 to ensure the listed PIL’s you are being charged is correct.

Establishments are kindly asked to complete the ‘Contact Information for Billing’ section on ASPeL to include the correct billing address and PO Number. If a PO Number is not required, please add a note to confirm to prevent a delay in your invoice being raised. If you have any queries relating to the fee period 2021-2022, please contact ASRUBusiness@homeoffice.gov.uk

Regards,

Dr Kate Chandler

Head of ASRU