Pharmacovigilance Compliance Reporting no longer required by MHRA

Drug manufacturers are no longer required to submit pharmacovigilance compliance reports, unless specifically requested by the MHRA.

Such reports were used by the MHRA as a factor to assess the risk of medicines and while compliance reports were no mandatory, companies who did not submit them would be classed as high-risk products.

The MHRA now says it will contact companies directly if it requires information about their authorised products and pharmacovigilance systems.

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Published 29. July 2016 in News UK