print_label | resize_label
Key requirements

Definitions

Life of Product- The time from discovery of the Product until (i) the clinical development of an investigational Product is discontinued; (ii) it has become a Discontinued Product; or (iii) it has become a Divested Product.

A product is considered active: 1) until formal discontinuation of clinical development or an investigational product, or 2) as long as the Company or a licensee continues to manufacture or sell the product anywhere in the world.

Active Life-While active- review annually. Records require action when no longer active, current, useful, or superseded or the record closed.

Applicability of Legal Hold: If it should be identified that retained information has become relevant to an ongoing or potential legal matter, information may be preserved, under the authority of the Company Legal counsel, until the matter is resolved and the hold is officially released.  Legal Hold supersedes/overrides the planned disposal schedule.