428 - If I have an APS which is left behind, however only contains the name of the product with no other information (i.e., company name, price, quantity, indication etc.), do I need PAAB’s approval?

  • If the piece has nothing on it other than the drug name and it is linked to no other materials (e.g. it distributed alone rather than with other pieces), it is exempt from preclearance. Refer to PAAB code 1.5