The PIF is central to the regulatory work field. A complete and up-to-date PIF will enable a short and efficient CPNP notification process from start to finish.
Delays are mostly caused by information/documents that need to be chased internally or at suppliers and/or when testing needs to be executed such as: accelerated stability tests (+/- 3-6 months); microbiological quality and stability including preservation efficacy (PET/challenge) tests (4-8 weeks); if needed patch/exposure tests (3-5 weeks); if needed claim support studies (duration dependent on claim and study approach); and/or when labelling including claims need to be adjusted.