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  • 1.  PMCF equivalence in Pharma

    This message was posted by a user wishing to remain anonymous
    Posted 16-Jun-2022 10:15
    This message was posted by a user wishing to remain anonymous

    HI all,

    I am unfamiliar with the pharmaceuticals sector but is there similar requirements to a PMCF, SSED or SSCP in the pharmaceutical regulation? Happy for any guidance. Thank you!


  • 2.  RE: PMCF equivalence in Pharma

    Posted 24-Jun-2022 20:35
    Hi Anon

    There are a variety of investigation and  reporting requirements applicable to drug manufacturers. For an overview, try this EMA page:

    https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance-post-authorisation


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    Anne LeBlanc
    United States
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    Original Message


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