In this section...
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.
E2B: ASPRs as ICSRs
The MHRA is now encouraging MAHs to move to the receipt of ASPRs as E2B ICSRs.
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 firstname.lastname@example.org 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:
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.
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.
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:
For further information regarding E2B reporting please see our frequently asked questions.
|Page last modified: 09 January 2014|