Re: Is the API rating really going to mean anything in the near future?
Excerpt from the article:<br /><br />To invoke Emergency Provisional Licensing (EPL), licensees are required to provide API with a detailed description of the event that created the need for the Emergency Provisional License; describe the steps that have been taken to find other sources of licensable material; and estimate the shortages expected duration. Also required: technical information showing that the use of the substitute component will not adversely affect the claimed performance of the licensed product.<br /> <br />Emergency licensing is meant to be as brief as possible, and under no circumstances will an EPL license be granted for longer than 90 days, API said. However, it may extend the initial license period beyond that time if the case warrants it.<br /> <br />API explicitly designed EPL to be a little-used procedure. Relief under this section will rarely be granted by API, it warned. The burden is on the licensee to clearly establish that there are exigent circumstances that justify the use of this type of remedy, and not, it added, simply because a licensee neglected to secure raw material supplies or failed to exercise good business practices.<br /> <br />EPL is intended to provide some flexibility in product licensing, Bachelder noted, provided there is an established need for a formulation change, and there exists enough data for a sound technical judgment regarding the finished products ability to meet claimed performance standards.