Packaging directive: committee to rule on devices:
This article was originally published in Clinica
Executive Summary
The text of the revised directive on packaging and packaging waste, adopted on February 11, was published in the Official Journal of the European Union on February 18. It includes an amendment that leaves difficult decisions concerning the primary packaging and packaging waste of medical devices to a Commission committee, known as the Article 21 committee. The amendment reads: "The Commission-shall determine the technical measures necessary to deal with any difficulties encountered in applying the provisions of this Directive in particular...primary packaging for medical devices and pharmaceutical products."