Europe – Ph. Eur. Section 3. Materials and containers: clarification of legal status

The European Pharmacopoeia (Ph. Eur.) Commission decided to restructure Section 3. of the Ph. Eur. on materials and containers. A new Subsection 3.3. has been added to Section 3. in order to cover specific medical devices: containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes.

The new structure of Section 3. will be published in the 10th Edition of the Ph. Eur. which will enter into force on 1 January 2020.

All concerned parties can submit their feedback on this decision by 15 February 2019. After registration on the Pharmeuropa section of the EDQM website, users will have access to the structure of Section 3. Materials and Containers