New Organization First User QPPV/RP or Change of EU QPPV/RP

On 13 November 2019 the EMA published the updated First User or Change of EU QPPV/RP for new organization

If a change of qualified person for pharmacovigilance/responsible person for EudraVigilance (QPPV/RP), named person or legal representative within the organisation occurs, you need to notify EMA.

There are 2 possible scenarios, please choose the one relevant to your case.

A) There is still a QPPV/RP in your organisation – change of QPPV/RP

B) There is no QPPV/RP in your organisation – first user QPPV/RP of a new organisation

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