14 February 2012

EVMPD: SSI to be optional

EMA staff met with industry representatives yesterday (30 January) and announced a significantly reduced subset of information to be required for the xEVMPD by 2nd July 2012.

The Agency will not ask for the following mandatory data elements for medicinal products by July 2012:

    Additional Monitoring
    Location of the Pharmacovigilance System Master File
    Description of packaging information
    Regulated documents (Condition of marketing authorisation, Labelling and Package Leaflet).

In addition the highly controversial Structured Substance Information (SSI) is now optional. In terms of documents, only the SmPC will be required.

Source: http://www.pharmaereport.com/content/blog.php?h=SSI-to-be-optional

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