Getting set-up on iRIS
How to get iRIS
Application process and iRIS
Making payments using iRIS
iRIS features and functionality
iRIS support and help
1. What is iRIS?
iRIS is the MHRA’s new, online account management facility for our customers which will allow users - once they have registered - to view their current and historical account details online.
It has been introduced by the MHRA to offer customers greater visibility over their MHRA account information and give them more control over the management of their customer accounts. It will also provide greater transparency over the allocation process between customers’ payments and MHRA invoices but only invoices in respect of licence applications. Additionally, iRIS will automate this allocation process.
2. Is iRIS secure?
Yes. iRIS is hosted on a secure web server that is SSL encrypted.
3. Will iRIS impact the current service fees I pay?
No. iRIS will be funded by monies designated for MHRA IT systems’ development. There will not be a cost to our customers for registering and/or using iRIS.
4. Which applications can I submit a payment for?
You will not use iRIS in place of your existing banking arrangements to make payments to the MHRA. Instead, iRIS will enable you to create a ‘commitment’ to make a payment to the MHRA (see section ‘Making payments using iRIS).
You can use iRIS to create commitments to pay the following application types: Product License/Parallel Import License fees, Process License fees (Wholesale Dealer applications) and Clinical Trial fees. Additionally, you can elect to create a commitment (see section ‘Making payments using iRIS) to send a payment in respect of all types of application you may need to submit.
iRIS does not cover Annual Periodic fees or Inspection fees. However, if you wish to create a commitment (see section ‘Making payments using iRIS) to make a payment specifically to pay for these types of fees, a manual allocation by the MHRA will be possible. Please contact our Accounts Receivable team on 0203 080 6533 between 9am and 5pm Monday to Friday for further guidance if required.
5. Do I have to use iRIS to pay for these applications
iRIS is not mandatory and you can continue to make payments to the MHRA the way in which you currently do. However, these payments will be subject to manual processing and may therefore take longer to process and subsequently allocate to invoices.
6. Does iRIS apply to the Variation Deposit Scheme (VDS)?
No. iRIS will replace the VDS scheme which will cease to operate once iRIS launches. If your company is part of the VDS you will have received a notification by letter of this change and the options available to you for any monies still held on deposit against your account. Please contact our Accounts Receivable team for more information on this on 0203 080 6533 between 9:00 and 17:00 Monday to Friday.
7. When can I begin using iRIS?
iRIS will be launched to customers from 26 September 2011. To get set-up on iRIS, you must register first. You can register on MHRA website on the iRIS information pages, and in particular the Register for iRIS section.
Getting set-up on iRIS
How to get iRIS
8. Is my company automatically signed up for iRIS?
No. If your company would like to be set-up for iRIS please complete the registration form available on the MHRA website on the iRIS information pages, and in particular the Register for iRIS section. Once you complete this form we will set-up an account for your company.
9. What happens after registration?
You will receive an acknowledgement email to confirm that your registration form has been received within 48 hours. We will use the information you have provided to set-up an iRIS account for your company. Once this has been done a password notification email will be sent to the contact email address provided in the registration form. This email will have log-in details, and information on how to access iRIS and get started.
10. Who will receive the password notification email?
The password notification email will be sent to the contact details provided in the registration form.
11. Where can we access iRIS?
A link to iRIS can be accessed from the MHRA website in on the iRIS information pages, and in particular the Access iRIS section.
12. Can we set-up more than one iRIS account?
No – you will have one iRIS account that is linked to your existing MHRA customer account number. You can however have more than one registered user, if required.
13. If our company has more than one entity can we register as a single user?
No. If the companies are separate legal entities with licences attached to them and have separate MHRA customer account numbers, each company must register for a separate iRIS account.
14. Where and when do we get log-in details?
A password notification email will be sent to you after submission of the registration form. Username and password details will be sent in this email.
15. How many usernames and passwords can we have for our company?
You can have more than one registered user if required. If you think you will require more than three users, please contact our Accounts Receivable team on 020 3080 6533 between 9:00and 17:00 Monday to Friday to discuss your requirements. Requests for more than three users will be considered by MHRA on a case-by-case basis.
16. How do we request additional usernames and passwords?
Email us at email@example.com with your request or call us on 020 3080 6533 between 9:00and 17:00m Monday to Friday.
17. What do we do if we need a password reset?
Email firstname.lastname@example.org with your request or call 020 3080 6533 between 9:00 to 17:00 Monday to Friday.
Please note - when requesting a new password, you will need to provide the contact details of the person the password details need to be sent to if it is a different individual from the contact details provided on the registration form. If this is not communicated, the new password details will be sent to the contact details on the registration form.
Application process and iRIS
18. Will iRIS increase the speed at which our licence applications are processed?
No. iRIS is a ‘finance based’ online account management facility for our customers which will improve and automate processes within the MHRA’s finance department.
It will however enable us to update information relating to whether fees have or have not been paid much faster and will give MHRA assessors access to this information in real time. This will enable them to make more informed decisions, quicker, about the paid status of your license application(s).
19. Will we still need to submit a Proof of Payment as part of our application?
Yes. The submission process for applications will not change as a result of iRIS. A copy of the automated email you receive from us on receipt of your payment would be the preferred document. Alternatively you can provide a copy of the BACS or CHAPS electronic confirmation form. This document should be named 'proof of payment' in PDF format and stored in the location as specified in the NeeS and eCTD published guidance.
20. What happens to licence applications that have been submitted pre-iRIS and are either still waiting to be invoiced or will be invoiced after iRIS is deployed?
These will be processed in the normal way. At the stage where the licence application(s) is about to be 'validated', i.e. the stage where the invoice for the application is to be generated, your MHRA customer account is searched for a payment(s) containing a Deposit Invoice reference number (see Q22). If sufficient funds exist to pay the licence application(s), the application is processed and funds will be 'reserved' from your payment in order to pay your invoice automatically. If insufficient funds exist, your application might not be progressed further (see Q31).
Any existing unallocated payments on your customer account which have previously been submitted to the MHRA cannot be used to automatically pay any uninvoiced licence applications. These payments can either be offset to other unpaid invoices (if applicable) or returned to you (see Q27). Additionally, unpaid invoices in respect of licence applications that were submitted before 15 August 2011 will not be automatically allocated by any payments that are submitted as part of the iRIS process.
21. Will the MHRA allocate any payments that our company creates for future licence applications against other unpaid invoices?
In some circumstances, invoices generated in respect of licence applications after 15 August 2011, and which remain unpaid, might be cleared automatically by payments that are created under the iRIS solution. However (see Q20) it is unlikely that invoices will be generated where no iRIS payment is available to fund it. For further information, you can email us at email@example.com or call us on 020 3080 6533 between 9:00 and 17:00 Monday to Friday.
Making payments using iRIS
22. How do we create a payment on iRIS?
iRIS allows you to create a ‘commitment’ to make a payment to the MHRA; you do this by creating a Deposit Invoice. Refer to the iRIS Reference Guide available on MHRA website on the iRIS information pages, and in particular the Access iRIS section for guidance on how to create a Deposit Invoice.
You will still need to instruct your bank to remit the actual payment to us by electronic BACS method in the same way that you currently do.
23. How do we cancel a Deposit Invoice that has been created in error or a Deposit Invoice that is not used?
If you have created a Deposit Invoice in error or have an invoice that is not used, please contact our Accounts Receivable team on 020 3080 6533 between 9:00 and 17:00 Monday to Friday who can cancel the record.
24. How much money do we have to deposit?
You determine the amount that you wish to deposit. You can create a commitment to deposit either a lump sum based on your anticipated licence application spend (recommended) or you can create a commitment for a specific application fee in respect of single licence application fees (or fees in the case of more than one licence application). Automated payment to invoice allocations will be carried out in chronological order of when the invoice is created. Therefore, if you submit several licence applications and create several corresponding deposit invoices, it is possible that multiple payments will be drawn down to fund a single application (for example in instances where there are insufficient funds on one Deposit Invoice to fund an application).
25. Where will the money we deposit be lodged?
The money you deposit will be credited to the MHRA bank account as is the case at present. A corresponding payment transaction will then be posted onto your MHRA customer account and this payment will be used to pay invoices as and when they are generated until the payment runs out.
26. Will we receive interest on the money we deposit?
27. Can we get deposited payments back?
Yes, in exactly the same way as at present but any other monies due to the MHRA will be taken into consideration before any funds are returned. If there are other invoices outstanding, you can either settle these separately and receive a full refund or authorise the MHRA to ‘offset’ these against the value of the payment and receive the net amount.
28. Can a product licence designated payment be used for several variations to the same licence and how shall we know how it has been used?
Yes. All automated payment to invoice allocations will be carried out in chronological order of when the invoice is created. These allocations will be visible online and you will be able to drill down into these transactions to see further details. You will though continue to receive hard copy invoices, or electronically, if you have requested this.
29. Can we top up an existing payment?
No, a new Deposit Invoice commitment must be created and paid. Multiple payments can be drawn down to fund a single application (for example in instances where there are insufficient funds on one Deposit Invoice to fund an application).
If a payment(s) has insufficient funds to fully allocate an invoice, iRIS will not use the remaining payment amount to partially pay the invoice. In these instances, the application might not be progressed until further funds have been remitted.
30. Do we have to quote a product licence / wholesale dealers licence /clinical trials application number with our payment?
No, the allocation process is not driven by the reference number quoted when you create a Deposit Invoice, but by the type of Deposit Invoice created from the List of Values that will be available. For example, if you create a Deposit Invoice and select ‘Product Licence’ from the List of Values, that payment can only be allocated against invoices for Product Licence applications. You can however add a reference number when creating a Deposit Invoice for your own records.
31. How will we know if a fee has been ‘short paid’?
You can keep track of your payment records and the amounts you have available on your customer account on iRIS and you will be able to see upon reviewing this if your payment balance(s) is insufficient to pay the application fee. You may also be notified by phone or email by the MHRA’s Information Processing Unit (IPU) that your application has not been paid in full.
Your application will not be ‘validated’, ie invoiced, unless there are sufficient payment amounts on your account to meet the application fee being processed. If there are insufficient funds on your account, you will need to send a further payment. You can do this on iRIS by creating a new Deposit Invoice and making payment by BACS in the normal way.
32. Will invoices still be generated by the MHRA?
Yes. However, from September 2011, MHRA intends to transition to electronic mailing of invoices, credit notes and statements of account. For those customers where we have email addresses, these documents will be sent electronically. For those customers where no email address exists, hard copy documents will continue to be sent by post.
iRIS features and functionality
33. Does iRIS have any reporting/filter functionality (eg by licence number)?
You can filter transactions by type and status (eg open/closed) for Deposit Invoices, invoices, credit memos and payments and allows you to search individual transactions on your customer account.
34. Can iRIS export to Excel?
Yes. iRIS has the functionality to export information directly into Microsoft Excel.
35. What information will appear on a Deposit Invoice?
The information that you enter when creating a Deposit Invoice is for your own benefit and does not appear on the subsequent payment transaction. The Deposit Invoice number that is generated once it has been created appears on the payment transaction and it is this reference that is the key driver in the allocation process between payments and invoices.
36. Can we see details of invoice numbers in each payment record?
Yes. All invoices that have been allocated by the payment will be viewable, through a drill down function.
37. Can we see product licence numbers on iRIS?
Yes. These will be recorded on the invoices (as at present) and will be viewable on your iRIS screen.
38. Is there an option to see our transaction history?
Yes, there will be a drill down option which you can follow.
39. Can we see who has performed transactions as part of our transaction history?
No. Unfortunately this functionality is not available.
40. Is there an alert function to notify us when our funds are running low?
No. You can however check your status by logging into your iRIS account regularly.
iRIS support and help
41. Will there be personal (one-to-one) training?
No. We have developed a series of e-learning sessions, which you can go through individually online to familiarise yourself with iRIS. This is accessible via the MHRA website on the iRIS information pages, and in particular the Access iRIS section.
42. Will there be a help desk?
A help desk has not been set-up. However if you experience problems with iRIS or have questions you can email us at firstname.lastname@example.org or call us on 020 3080 6533 between 9:00 and 17:00 Monday to Friday.
43. Will the training module remain on site after rollout?
Yes, it will remain in perpetuity for the benefit of new users.