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Resulting from EU regulation, a completely new medicine verification program was released in 2019 and that is accustomed to establish, validate and register the distribution of Spanish pharmacy solutions in Spain. More info can be found for the website link down below from your CAB (
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To overview: Performance scientific tests of in vitro diagnostic health-related devices Halt, Termination or Conclusion of a For everyformance Review Request for waiving the authorisation Authorisation Notification of the Submit-Market Performance Research Substantial modifications Notifications of performance studies with CDx still left-over samples Application for decision on requirement to approve MD / IVD Hazard assessment
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