Registrations

A registration (license) is the agreement between a regulatory agency and a sponsor of a drug, drug product, or medical device for the purpose of marketing or free distribution of the product.

Registration is required after the drug or medical device has been evaluated for safety, efficacy and quality. A registration may also be referred to as a marketing authorization. Tracking registrations in Ennov InSight allows you to maintain information regarding a registration's status and any actions that need to be performed, such as renewals and periodic reporting.

You must have the following modules to perform registrations activities:

• Product Detail Management
• Registration Planning and Tracking

When you create a registration, you associate it with an application. You specify information such as the country for which the registration is being created, its license code, and the marketing authorization holder (MAH).