New EMEA Guideline on Plastic Packaging Materials

New EMEA Guideline on Plastic Packaging Materials

This guideline describes which data regarding plastic immediate packaging materials have to be handed in together with the dossier for the marketing approval of an API or medicinal product. The term "immediate" refers to those materials that are in direct contact with the API or medicinal product.

This guideline does not refer retrospectively to products that are already on the market. However, the requirements laid down in this guideline have to be observed in case of a variation (i.e. a change) in the packaging material and the notification of change involved.

The scope of data on a packaging material necessary to obtain a marketing authorisation for a medicinal product follows from a decision tree in Appendix II. This tree shows that only few data are required for plastic packaging materials for solid dosage forms (general information, specification). In contrast to this, additional data (going as far as extraction studies, interaction studies and toxicological information) are needed for plastic packaging materials for inhalants, parenterals and ophthalmics.
   

FDA-/GMP-Compliant Exctractables and Leachables Testing
29-30 September 2005, Vienna Austria

Elastomeric Closures for Injections
(including a visit of a rubber stopper manufacturer)
22./23. November 2005, Brussels

Author:
Dr Günter Brendelberger
on behalf of ECA