ARSAC

Newsletter 21.02.2019

Licencing Update

It has been just over 1 year since the implementation of licencing under IR(ME)R, and we have now approved over 580 licence applications for practitioner's and employers. Based on this experience we have the following advice for those who have still to complete an application.

Apply in good time

Please ensure that all applications are submitted at least 6 to 8 weeks prior to the date required in order to allow plenty of time for processing. Complex applications and those where queries have been raised may take longer. Recently the Support Unit has received a number of applications due to the imminent expiry of existing certificates on site which have resulted in sites and practitioners no longer being authorised for a period of time. 

Ensure you remain covered

Due to the change in regulations please note that as soon as the certificate expires you will not be authorised to administer the procedures specified even if an application for licences are currently being processed. Please ensure you review all outstanding certificates in place to ensure that both practitioner and employer licence applications can be submitted in good time.  

Amending an existing licence

Some practitioners and employers now need to amend their licences. The same https://www.gov.uk/government/publications/arsac-application-forms&source=gmail&ust=1550829624209000&usg=AFQjCNEodzoVfLAGLXFbz7HUYApu6V2Jpg">new licence application forms should continue to be used for amendment. Please ensure applications clearly state what additional procedure(s) has been applied for and that all information has been updated to include relevant training and experience and local governance requirements for the additional procedures.

Alternatives to 51Cr procedures

Following the cease in production of some 51Cr pharmaceuticals, employers, practitioners and researchers should check that they hold approvals for any alternative procedures that they wish to use. For research sponsors this may require a https://www.gov.uk/guidance/how-and-when-to-submit-research-applications-to-arsac%23amendments-to-research-studies&source=gmail&ust=1550829624209000&usg=AFQjCNHwzJ1yMez4fdOJNx0TOn-MLqILOQ">substantial amendment to the research study. For Employers and Practitioners a https://www.gov.uk/government/publications/arsac-application-forms&source=gmail&ust=1550829624209000&usg=AFQjCNHFUOOYpWmIxHrMmKFP8C_cSHHeiQ">new licence or amendment application may need to be submitted.

Submitting a notification to a licence or certificate

Information of what constitutes a notification is in the https://www.gov.uk/government/publications/arsac-notes-for-guidance&source=gmail&ust=1550829624209000&usg=AFQjCNEstXOavjE-vSIdxjycG_2mdbaZ4A">Notes for Guidance. If a notification against a licence or existing certificate needs to be made, details should be emailed to the ARSAC Support Unit. Please include and complete the relevant questions on the https://www.gov.uk/government/publications/arsac-application-forms&source=gmail&ust=1550829624209000&usg=AFQjCNFUF7k15k4KLWCudb0Zkh07RAX0MQ">application forms for the notification e.g. all details in Q18 for a new lead MPE.

Application forms

We have received lots of feedback from the community regarding the questions on the application forms. We hope to update the https://www.gov.uk/government/publications/arsac-application-forms&source=gmail&ust=1550829624210000&usg=AFQjCNHSLJUpJ4v3hEAUc05799b-z5aP0w">application forms and guidance shortly to make these sections clearer. Please ensure you are using the correct form when submitting an application. A further bulletin will be released when these forms go live. 

Committee Meetings

Minutes of the most recent committee meetings are now https://www.gov.uk/government/organisations/administration-of-radioactive-substances-advisory-committee/about%23meetings&source=gmail&ust=1550829624210000&usg=AFQjCNF8gL8AX_mnz1lKvqxksRIV6uyqTw">available on our website. 

For any further advise on applying for a licence please contact the Support Unit.