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News from EMA – Regulatory Contact Point.

created on 13 June 2016

News from EMA – Regulatory Contact Point.

Today, 13. June, the EMA published a new requirement on their website (http://eudravigilance.ema.europa.eu/). This requirement requires pharmaceutical companies that are registered with the EMA to register a ‘Regulatory Contact Point’. This Contact Point could be an individual or department that may be contacted by the EMA. This contact should not be a local contact but from Headquarters and must be different from the QPPV.

pharmasol recommends that the QPPV informs the Regulatory Affairs department about this new requirement and in alignment with Regulatory Affairs provides the contact details (telephone number and (generic) email) of the Regulatory Affairs department, not an individual. If you register an individual, you would need to track regularly that this individual is still with your company.

 

Marc Zittartz (Chief Quality Officer) and Cheryl James (Principal PV Analsyt)

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