Correspondence

ASRU operational newsletter, February 2024

Published 15 February 2024

Introduction

I am pleased to present the February 2024 ASRU operational newsletter. This newsletter provides the latest updates on ASRU’s regulatory reform programme, the licensing and compliance assurance functions, and demonstrates our commitment to maintain open and transparent communication regarding ASRU’s regulatory delivery.

As we look ahead to the new year, I’m excited by what is to come. As you know, we restarted the ASRU reform programme in May 2023, and this year we will be implementing improvements as part of reform. These operational newsletters will keep you updated if and when there are operational changes to the way ASRU operates. I would like to reassure you that throughout reform, ASRU is committed to maintaining a quality service through our licensing and compliance assurance functions.

At present, you should not expect any significant changes to ASRU’s operations. This newsletter provides a short update on current workstreams within the licensing function. I hope you find it helpful and informative.

Kate Chandler

Head of Unit, ASRU

Licensing

Updated guidance notes for project licence applications

ASRU would like to take this opportunity to thank the regulated community for the feedback we received on the guidance notes for project licence applications.

The guidance notes are intended to assist project licence applicants, Named People and AWERB members on the process of preparing an application for a new project licence or amendment.

The updated guidance note can be found on GOV.UK.

Please send any feedback relating to this guidance to ASRUOperationalRelationshipManagement@homeoffice.gov.uk.

Prospective authority licensing requests

Where studies are requested to meet regulatory requirements, they will be performed in compliance with relevant UK and 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 authorisation form and submitting this to ASRU licensing. Any valid scientific justification will be included within the records of the project licence.

Intention to refuse process for a new project application or amendment

Where an applicant applies for a new project licence or amendment and the ASRU staff member assessing the application determines that it should be refused, there is now a defined ASPeL process. We will indicate our intention to refuse where the application does not meet the requirements of ASPA Sections 5A and B, and/or the harm benefit analysis is negative, and ASRU determines that these deficiencies cannot be resolved by revision.

The ASRU staff member will complete a ‘Notice of Intention to Refuse a Licence Application’ in ASPeL that will be sent by email to the applicant and Establishment administrators. The application will be returned on ASPeL as the 40-day assessment period will end. The purpose of the notice is to inform the applicant that the Secretary of State proposes to refuse the licence under the Act and provide the reasons for recommending refusal of the licence application. The applicant is provided with the opportunity to make written or oral representations to a person appointed by the Secretary of State. If the applicant wishes to make representations, they must notify ASRU by email within 28 days from the date of service. The application will remain with the applicant pending the outcome of the Refusal and Section 12 (representation) process.

What do you need to do?

When an applicant receives a ‘Notice of Intention to Refuse a Licence Application’ they should inform ASRU whether they intend to make representations or not as soon as possible by email (asrulicensing@homeoffice.gov.uk). If an applicant does not inform ASRU of their intention to make representations within 28 days of receiving a Notice of Intent to Refuse, the application will be refused. If the applicant makes representations, depending on the outcome the application may either be resubmitted with or without changes, or refused.

Overdue submission of retrospective assessments

ASRU have received a number of late submissions of retrospective assessments, and we would like to remind establishments that where these are required, they must have been reviewed by your AWERB and be submitted on ASPeL within 6 months of the expiry of the project licence. We will shortly be publishing all retrospective assessments, aligned to our publication of non-technical summaries.

ASPeL updates

Corporate establishments - April 2023

What did we change?

Every Establishment Licence is now either categorised as ‘Corporate PEL’ or ‘Individual PEL’.

Corporate PELs have a Named Person Responsible for Compliance but will also now be required to provide contact details for an individual legally responsible for the company or organisation (such as a company secretary).

Individual PEL Establishment Licences have a PEL Holder, who is the legally responsible person.

Check the Establishment Details section in ASPeL to see if your establishment has been categorised as ‘Corporate’ and make sure the contact details for a legally responsible person have been added.

Why did we make this change?

ASPA Section 18 states that when an Establishment Licence Holder is a corporate entity, a Named Person Responsible for Compliance has responsibility delegated to them but the ultimate legal responsibility nevertheless lies with the corporate entity. ASRU therefore need to be able to contact an individual who has ‘ultimate legal responsibility,’ because this is not necessarily the Named Person Responsible for Compliance even if responsibility has been delegated to them.

ASRU guidance requires any change to an Establishment Licence Holder to be notified to them within 24 hours. This feature allows HOLCs to ensure their Establishment remains compliant, by keeping appropriate contact details up to date within ASPeL.

Replaced the cosmetics condition - August 2023

What did we change?

We changed the ‘cosmetic use’ condition in PPL applications in line with the recently changed policy.

Why did we make this change?

We did this to align to the policy change prohibiting the use of animal testing exclusively for cosmetics.

Post launch amendments to the HBA document upload - September 2023

What did we change?

We added the functionality in ASPeL for PPL applications and new PPL amendments, to upload the harm benefit assessment, streamlining internal processes and providing an efficient and effective information management system within ASPeL.

Why did we make this change?

This streamlines internal processes and makes it easier to refer to previous decisions when considering new amendments.

PIL E Filters - December 2023

What did we change?

Category E personal licences (PIL-E) have now been separated from standard personal licences (PIL) in list filters.

Why did we make this change?

This makes it easier for HOLCs and Inspectors to filter by specific licence types at their establishment to review and manage training and education licences.

Training and education permissible purpose in ROPs – December 2023

What did we change?

There has been a small change to the permissible purpose options available when completing a return of procedure.

Until now, two of the options available to you when choosing a permissible purpose for your ROP were:

• higher education
• training for the acquisition, maintenance or improvement of vocational skills

Those two options have now been combined into one:

• higher education or training courses

This option should be selected when completing a ROP for any project licence that includes educational courses delivered by universities and colleges, or vocational training in surgical procedures and other skills.

You will still have all the other permissible purposes available to you when completing a ROP so remember to select all that apply.

Why did we make this change?

We have changed this to bring it in line with the wording used in legislation, ASRU guidance and in the project licence application.

This will simplify the ROPs setup process and make the permissible purposes consistent with the choices available when applying for a licence.

Licence fees

Establishments will be granted a window from 25 March to 5 April 2024 to complete PIL transfers without incurring additional charges. Please provide a list of all PIL transfers during this window to ASRUBusiness@homeoffice.gov.uk.

As we approach the end of the financial year, please review the ‘Licence Fees’ Section on ASPeL to ensure you are being charged correctly for PILs between 6 April 2023 – 5 April 2024.

We have made several changes to the ‘Contact Information for Billing’ section on ASPeL, including the addition of required fields for billing purposes and for establishments to confirm the information provided is correct.

Therefore, we kindly ask establishments to complete the ‘Contact Information for Billing’ section on ASPeL, including the correct billing address and Purchase Order Number. If you do not wish to pay by Purchase Order, you can enter an alternate payment method.

Priority for invoicing will be given to establishments who have provided a purchase order number or alternate payment method. The reason for this is the majority of establishments operate a ‘no PO, no pay’ policy when submitting invoices for payment. When raising purchase orders, please use the ASRUBusiness@homeoffice.gov.uk email address for notification to be sent.

If you have any queries relating to the 2023 to 2024 fee period, please contact ASRUBusiness@homeoffice.gov.uk.

Return of Procedures

Thank you to those who have submitted your end of year returns.

Please could HOLC’s check ASPeL to ensure all returns have been submitted as the deadline of 31 January 2024 has now passed.

Due to the influx of returns, some PPL holders may have noticed a delay in receiving an automated confirmation from ASPeL. We would like to confirm we are aware of this issue and are looking into this.

If you have any queries in relation to returns, please contact us at ROPReturns@homeoffice.gov.uk.

Relationship management

Complaints process

ASRU has now launched the new process for reviewing and responding to complaints. This procedure will ensure that complaints are received and responded to in a consistent way. The complaints process will provide a formal route for the regulated community to bring a complaint to the attention of ASRU.

The new complaints process and accompanying form can be found on GOV.UK.

Stakeholder meetings

The HOLTIF meeting took place on MS Teams on Thursday, 25 January. Emma Bayliss Head of Licencing and Grace Shaba from ASPeL enablers team presented at this meeting. The agenda included an operational update by ASRU and an ASPeL update from enablers team, followed by a question-and-answer session.

Contacting ASRU

Compliance assurance

Audit:

• audit related queries

ASRUAudit@homeoffice.gov.uk

Standard Condition 18

• requests to keep animals alive
• Standard Condition 18 reports

ASRUStandardCondition18@homeoffice.gov.uk

POLE notification:

• notifying ASRU of upcoming work at a POLE - please ensure the email subject line includes the PPL number, PPL holder’s surname and the name of the establishment

ASRUPOLEnotification@homeoffice.gov.uk

Enforcement:

• reports of potential non-compliance
• reports required by a licence condition or as a result of enforcement action
• advice on whether a non-compliance may have occurred
• contact during a non-compliance investigation

ASRUEnforcement@homeoffice.gov.uk

Licensing:

• specific queries relating to an individual licence application
• evidence to support an exemption from mandatory training
• requests to re-home animals where not already authorised
• advice on interpretation of licence authorities
• guidance on becoming an establishment
• advice on whether work needs to be regulated
• advice on applying for licences
• guidance on how we will assess applications
• information to support a PEL application or amendment notification of AWERB dates
• AWERB terms of reference

ASRULicensing@homeoffice.gov.uk

ASPeL technical queries:

• technical advice on the use of ASPeL

ASPELTechnicalQueries@homeoffice.gov.uk

Home Office liaison contacts (HOLCs) and complaints inbox:

• raising concerns about the timeliness or completeness of response from any of our teams or any other concerns about any individual request or interaction
• raising concerns about the timeliness or completeness of response from any of our teams or any other concerns about any individual request or interaction from the regulated community

ASRUOperationalRelationshipManagement@Homeoffice.gov.uk

Fees or business enquiries

ASRUBusiness@homeoffice.gov.uk