Reply To: MHRA ICSRs monitoring

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Anne Lloyd

Dear Member

Please note that the response to your query represents the views and suggestions of the PIPA Committee Members and are intended as guidance. Please also refer to guidelines and your own company procedures.

What is the standard timelines for sending of acknowledgement for cases received from MHRA?

The Acks cannot be sent until the Report Type column in the Report Management table is populated, which may take a few days. However, the MHRA have not issued guidance on how soon the Ack needs to be sent, presumably because companies will be following different timelines for how often they download the ASPRs.

Another question – how to convert .xml files of ICSR cases to .rtf or any other MS Word format?

The MHRA don’t provide the software to do this and if you don’t have suitable software in-house you can do it in EVWEB if you have access to that.

Kind regards