Anonymised Single Patient Reports

Anonymised Single Patient Reports (ASPRs) are to be provided to the Pharmaceutical industry via the MHRA portal.

Changes to how companies will receive Anonymised Single Patient Reports from the MHRA
Since the decommissioning of ADROIT and AEGIS, Anonymised Single Patient Reports (ASPRs) have been provided in hardcopy to the relevant Company EU Qualified Person for Pharmacovigilance.

The provision of paper versions of the ASPR was intended as a short term solution pending the introduction of electronic reporting. The introduction of electronic reporting between Industry and the MHRA has not progressed as rapidly as hoped. It is clear also that some companies find it more complex to receive than to send electronic reports which inevitably will add to the delay.

In order to reduce the burden of hardcopy ASPRs the MHRA have decided to use the MHRA Portal to provide ASPRs electronically to Industry. Once implemented, companies will receive ASPRs via the Portal until such time as the company has successfully implemented two way electronic transmission of Individual Case Safety Reports (ICSRs) i.e. for inbound to the MHRA and outbound from the MHRA, fully compliant with regard to E2B(M) and using appropriate MedDRA codes/ terms.

MHRA Portal: ASPR interim solution
The MHRA portal is a secure web based method for transmission of documents between Industry and the MHRA. ASPRs as pdf files will be uploaded on a daily basis into a new area in the portal. ASPRs will remain on the portal for 14 days after which time they will be deleted.

Registered users
Many companies already are registered users of the Portal and for these companies the MHRA will provide 2 additional free portal user accounts. These companies will receive an e-mail from the MHRA confirming the implementation date for their company so their administrators can set up access.

New users: Registering for the Portal
For those companies who do not currently have access to the portal and are not currently receiving their ASPRs electronically, please register for the portal by going to https://portal.mhra.gov.uk and complete the registration form. The hardware and software requirements are a PC with Windows, Internet Explorer, Adobe Acrobat Reader 7.0.5 or higher and broadband internet access.

On what basis are ASPRs sent out?
ASPRs are sent out based on the suspected active substances listed in each ADR report. Every company holding a current marketing authorisation for a suspected active substance will receive an ASPR, irrespective of whether or not the brand name for the drug was reported.

ASPRs will be loaded into the portal using the list of active substances taken from current marketing authorisations for each company number. (The company number is 12345 for PL 12345/0001). Companies with multiple company numbers should register all of these.

Once registered, companies will receive ASPRs based on the company numbers registered in the portal account. Please see the following example:

MAH X has a portal account and has the following company numbers registered - 00001, 00002 and 00003.

Actives from the current granted licences for each company number are as follows:
00001 - paracetamol
00002 - simvastatin
00003 - ramipril

ASPRs for the above active substances will be uploaded into 3 folders in the portal. 
Paracetamol ASPRs in 00001
Simvastatin ASPRs in 00002
Ramipril ASPRs in 00003

If a company has a number registered in multiple portal accounts, the ASPRs for that company number will appear in both portal accounts.

What if a company is already receiving E2B ICSRs from the MHRA?
The company does not require the Portal interim solution as the ultimate aim is for all companies to receive Individual Case Safety Reports (ICSRs) electronically.

Who are the key contacts in the MHRA for E2B reporting?

For technical assistance please contact
Phil Tregunno     020 7084 2696  phil.tregunno@mhra.gsi.gov.uk
Mitul Jadeja        020 7084 3537  mitul.jadeja@mhra.gsi.gov.uk
Sarah Cumber   020 7084 2636  sarah.cumber@mhra.gsi.gov.uk
Rebecca Webb 020 7084 2275   rebecca.webb@mhra.gsi.gov.ukk

Or e-mail
ISCRtesting@mhra.gsi.gov.uk  to register for E2B testing with the MHRA
ICSRInformation@mhra.gsi.gov.uk for enquiries regarding electronic reporting

Please e-mail ASPR Portal enquiries to ASPRenquiry@mhra.gsi.gov.uk

What if a company is using EVWEB webtrader to send and receive ICSRs?
If a company is using EVWEB in production and would wish to receive ICSRs from the MHRA using EVWEB then please contact: shelley.gandhi@mhra.gsi.gov.uk