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EMA Updated Guidance: Periodic Safety Update …
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Jun 01, · EMA post-authorisation procedural advice (Rev.70, April 2017) This Q&A has been updated with substantial new information relating to PV procedures. NEW Q&A Periodic Safety Update Reports: Do I have to submit a PSUR if the marketing authorization for my product has been granted on or after the data lock point (DLP) in the EURD list?
April/May Latest Headlines — ESPL Regulatory Consultingwww.espl-regulatory.com › news
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EU PROCEDURES. Update – EMA post-authorisation procedural advice for users of the centralised procedure
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