Anonymised Single Patient Reports

 

This section provides pharmaceutical industry pharmacovigilance departments with information on the changes to how Anonymised Single Patient Reports (ASPRs) will be received. Guidance documents
Guidance documents

ADR reports are sent to marketing authorisation holders (MAHs) electronically. For companies that have completed E2B outbound testing with the MHRA, E2B Individual Case Safety Reports (ICSRs) will be sent.  For companies with MHRA portal accounts, ADR reports will be received as pdf Anonymised Single Patient Reports (ASPRs).  For those companies without an MHRA portal account, pdf ASPRs will be sent via email to the European Qualified Person in Pharmacovigilance (EUQPPV). They can also be emailed to an additional designated email address if required.

Receipt of pdf ASPRs by email or the MHRA portal is intended to be an interim measure until E2B ICSRs can be received electronically.

E2B: ASPRs as ICSRs

The MHRA is now encouraging MAHs to move to the receipt of ASPRs as E2B ICSRs.

MAHs that are ready to start receiving ASPRs as E2B ICSRs should contact ICSRtesting@mhra.gsi.gov.uk. MAHs who are EVWEB users will be switched directly to receipt of E2B ICSRs. Gateway users will require a short test phase before this.

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 are already 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.

ASPRs will be sent using current marketing authorisations for each company number. (The company number is 12345 for PL 12345/0001).  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.

Email: ASPRs as PDF documents

For 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 Team at pharmacovigilanceservice@mhra.gsi.gov.uk.

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/ICSR

What is the process for contacting the MHRA concerning E2B reporting?

In the first instance all enquiries should be submitted via email to the following email addresses:
 

To escalate an E2B related issue, the following named individuals can also be contacted if you require to speak to a member of the E2B team in person:

Rebecca Owen, 020 3080 6022, rebecca.owen@mhra.gsi.gov.uk
Tahira Jan, 020 3080 619l, tahira.jan@mhra.gsi.gov.uk

For further information regarding E2B reporting please see our frequently asked questions.

The MHRA is currently updating its E2B MAH contact list. This list is used to contact MAHs in instances of technical problems with E2B submission of ICSRs. MAHs who wish to receive these updates from the MHRA please provide a relevant contact name and email address to E2B.Support@mhra.gsi.gov.uk

Page last modified: 09 January 2014