Description
In response to a safety signal, a regulatory action, called the Urgent Safety Restriction (USR), is taken. This action is intended to push an interim change to the marketing authorization’s terms for a medicinal product in Europe. Described within this class are the procedures and principles for Urgent Safety Restrictions (USRs).
Objectives contained within this course are as follows: To train on what to do following a Urgent Safety Restriction, a specification for the requirements for a variation application is necessary; review an outline of the 24-hour procedure for a USR’s execution; offer a description of general regulatory requirements for initiation and preparation of a USR; provide a description of the triggering of a USR; and to offer an explanation of the purpose of Europe’s Urgent Safety Restrictions.
