A PIF typically includes product description, CPSR, manufacturing method and GMP evidence, proof of claimed effects where relevant, animal testing information where required, label information and supporting documentation. The PIF must be kept available to competent authorities at the Responsible Person address.
Practical compliance point
Documentation and notification must be completed before placing the product on the relevant market. Requirements must be checked against the actual formulation, label, intended use and target jurisdiction.
How AsCo Europe can help
AsCo Europe can review the available data, identify gaps, prepare or coordinate the required documentation, and support the correct EU and/or UK market placement workflow.