• Образователен план за пациентите, който цели намаляване на риска и подпомагане на безопасната и ефикасна употреба на продукта.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.1 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.