Appendix XX Materials Used for the Manufacture of Containers

(Ph. Eur. method 3.1)

The materials described in this chapter are used for the manufacture of containers for pharmaceutical use. Their use may also be considered for the manufacture of part or all of objects used for medico-surgical purposes.

Materials and polymers other than those described in the Pharmacopoeia may be used subject to approval in each case by the competent authority responsible for the licensing for sale of the preparation in the container.

Transmissible spongiform encephalopathies (5.2.8)

A risk assessment of the product with respect to transmissible spongiform encephalopathies is carried out, and suitable measures are taken to minimise any such risk.