Spring Intro 2023

Jenny Lamport

Names and addresses

 Applicant  Communication during assessment  Communication post approval  Manufacturer of the finished product  Manufacturer/importer responsible for batch release and actual site(s) of control/testing  Manufacturer of active substance  Contract companies for bioavailability/bioequivalence (BAV/BEQ) studies

The Organisation for Professionals in Regulatory Affairs

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Application form

Name of persons responsible for ● Pharmacovigilance QPPV

● Scientific services ● Defects and recalls

Attached documents eg - Manufacturers authorisation - Declaration signed by the Qualified Person that the active substance is manufactured in accordance with GMP

The Organisation for Professionals in Regulatory Affairs

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