Anonymised Single Patient Reports

Anonymised Single Patient Reports 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 (ADROIT Electronically Generated Information Service), Anonymised Single Patient Reports 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 MHRA is also pleased to announce that from 2 August 2010 all ASPRs will be sent out to marketing authorisation holders (MAHs) electronically via E2B or as PDF documents.

MHRA Portal: ASPRs as PDF documents
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.

For registered users
Many companies already are registered users of the Portal and for these companies the MHRA will provide two additional free portal user accounts. If you have not done so already please contact our team at pharmacovigilanceservice@mhra.gsi.gov.uk to activate your account for the receipt of ASPRs via this method.

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

Email: ASPRs as PDF documents
MAHs that cannot currently receive E2B ICSRs or do not have access to the MHRA portal, an interim arrangement will be implemented. ASPRs will be emailed as PDF documents to the European Qualified Person in Pharmacovigilance (EUQPPV). They can also be emailed to an additional designated email address if required.

Please provide additional designated email addresses to the Pharmacovigilance Service Desk at pharmacovigilanceservice@mhra.gsi.gov.uk.

E2B: ASPRs as ICSRs
MAHs ready to start testing the receipt of ASPRs as E2B ICSRs should contact the testing team at ICSRtesting@mhra.gsi.gov.uk. Please note that MAHs who have completed inbound testing with the MHRA will be given highest priority for testing receipt of MHRA ICSRs.

On what basis are ASPRs sent out?
As part of the Better Regulation of Medicine Initiative (BROMI) the MHRA have implemented a series of changes to the logic which defines which MAHs receive ASPRs/ICSRs. It is expected that these changes will result in a reduction in the number of ASPRs/ICSRs that MAHs receive.

• When the suspect drug is reported as a brand name only the MAH that holds that licence(s) for that brand will receive an ASPR/ICSR
• When the suspect drug is a multiconstituent product (e.g. co-codamol) only MAHs that hold a licence for the same combination of actives will receive an ASPR/ICSR
• When the suspect drug is reported as a single active substance, all MAHs that hold a licence for a product only containing the single active substance will receive an ASPR/ICSR
• When the suspect drug is reported at the active substance level, every company holding a current marketing authorisation for a suspected active substance will receive an ASPR

ASPRs will be sent using 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 for receipt of ASPRs via the MHRA Portal or receipt via E2B.

Once registered, companies will receive ASPRs based on the company numbers registered in these accounts.

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.

Who are the key contacts in the MHRA for E2B reporting?
For technical assistance please contact:

Sarah Cumber 020 3080 6636 sarah.cumber@mhra.gsi.gov.uk
Rebecca Webb 020 3080 6275 rebecca.webb@mhra.gsi.gov.uk
Patrick Batty 020 3080 6504 patrick.batty@mhra.gsi.gov.uk

Or email:
ISCRtesting@mhra.gsi.gov.uk to register for E2B testing with the MHRA

Please email ASPR Portal enquiries to pharmacovigilanceservice@mhra.gsi.gov.uk