Cialis Professional (Tadalafil)

Pharmacovigilance system The Marketing Authorisation Holder must ensure that the systempharmacovigilance presented in Module 1. 8.1. Authorisation Holder isin place and functioning before and whilst the product you are marketing.

Risk Management Plan The Marketing Authorisation Holder commits to performing the studies andpharmacovigilance activities detailed in the Pharmacovigilance Plan, asagreed in version 1 of the Management Plan (RMP) presented in Module 1. 8.2. of Marketing authorization, as well as all subsequent updates of the RMPagreed by the CHMP.

According to the CHMP Guideline on Risk Management Systems formedicines for human use, the updated RMP should be submitted at the same timethe Periodic Safety Update Report (PSUR).

It should also be submitted an updated RMP When new information is received that may impact on the current specifications Security in the Pharmacovigilance Plan or risk minimization activities Within 60 days after being hit an important (pharmacovigilance orminimization of risk) At the request of the European Medicines Agency.