Press releases

Release issued 19th May 2005

PDS are delighted to announce that the range of regulatory services has recently expanded to include a new pharmacovigilance service. There has recently been a substantial change in the way in which the pharmacovigilance responsibilities of the Marketing Authorisation Holder (MAH) are regulated by the MHRA.

A responsible Qualified Person for pharmacovigilance must be named on the Marketing Authorisation (MA), and the MAH must have written procedures in place for the reception, tracking and reporting of adverse reactions onto a validated database. The MAH also has to perform a weekly search of the published literature to identify any adverse reaction reports that have appeared, and to report them to the MHRA. The MHRA is now actively inspecting MA holders for compliance with the new regulations, and have made it clear that they will take legal action for non-compliance. PDS has recruited the services of an experienced Qualified Person for pharmacovigilance, which will enable clients to be compliant with the requirements of the MHRA. The Director of Regulatory Affairs, Paul Sugden, welcomes informal enquiries relating to this new offering.

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