(1999; 168 pages) [Spanish]
7.3.6 Expiry/re-evaluation dating
Conducting a stability testing programme does not necessarily mean that expiry dates must be used. Where stability testing indicates a limited shelf-life, the label should declare an expiry date or indicate the need for re-evaluation testing at an appropriate interval to assure quality at time of use.
If the need for special storage conditions exists (e.g. protection from light, heat) such restrictions should be placed on the label.