In this section...
ADR reports are sent out to marketing authorisation holders (MAHs) electronically. For companies that have completed E2B 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 send 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
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.
Please note 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 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 email@example.com 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). 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.
ASPRs for the above active substances will be uploaded into 3 folders in the Portal.
Paracetamol ASPRs in 00001
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
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 firstname.lastname@example.org.
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.
Who are the key contacts in the MHRA for E2B reporting?
For technical assistance please contact:
E2B.Support@mhra.gsi.gov.uk for enquires regarding submission of submission of production cases and receipt of automated acknowledgements.
email@example.com for enquiries specifically regarding ASPRs.
Portal helpdesk for general queries regarding the portal, such as workspaces and user login or permission problems 020 3080 7100, firstname.lastname@example.org.
For further information regarding E2B reporting please see our frequently asked questions.
|Page last modified: 01 February 2013|