In case criteria for PCC are met, ensure that complete documentation as
requested in the global guidelines FT07 or FT08 is available.
In cases where the necessary documentation is not available from customers, the
Affiliate must attempt to contact customer at least three times within 5 business
days. These attempts must be documented in the case.
Note: Cases flagged as PCCs will be reviewed by global reporting teams (MDR
and EEA Vigilance) via IT system.