Gaining competent authority validation for design certificate: can both working arrangements and processes be improved to reduce regulatory burden and facilitate ongoing transports?

Abstract

AbstractCompetent authorities worldwide have the power to issue an extension to an existing package design certificate with the process appropriately termed timely renewal in the USA. An extension or timely renewal allows competent authorities sufficient time to challenge and review the safety of the package design, applicants to respond to questions raised and user’s to continue to use the package. However, when requests are made to validate a design certificate of foreign origin, no similar processes or conventions exist, giving little flexibility to competent authorities. Several issues arose during recent European validation applications that had the potential to delay validation issue. If any significant delay had occurred, it had the potential to adversely impact transports. The present paper aims to encourage discussion surrounding the certificate validation process legal framework and promote the development of working practices and processes that readily support the safe, efficient and effective ...