The European Pharmacopoeia (Ph. Eur.) Commission announced to restructure Section 3 of the Ph. Eur. on materials and containers. A new Subsection 3.3. has been added to Section 3 to cover items that are classified as medical devices according to EU (European Union) legislation (i.e. containers for blood and blood components, sets for transfusion and syringes) and that are not used for primary packaging of pharmaceutical preparations.
Currently, the Ph. Eur. includes a Section 3 on materials for containers (3.1) and containers (3.2). For historical reasons, the general chapters of Section 3 include texts on primary packaging, as well as on medical devices. To clarify the interpretation of the legal status of these two types of containers, the Ph. Eur. Commission decided to modify the structure of Section 3. This change will involve the creation of a new Subsection: 3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes. According to the EDQM, this decision is based on results of an EDQM survey launched in 2017.
The creation of the new Subsection 3.3 will simplify the distinction between primary packaging and medical devices and consequently clarify the legal status of the texts in the different sections. Following the definition provided in Ph. Eur. General Notices, unlike monographs that are mandatory per se, general texts are provided for information and only become mandatory when applying the monograph in which they are cross-referenced. For example, the dosage form monographs refer to these general texts, therefore making them mandatory. However, the texts on medical devices, until now included in Subsections 3.1 and 3.2, are not systematically associated with monographs and, as a consequence, are not systematically mandatory.
Interested parties are invited to send their feedback to EDQM by 15 February 2019. The new structure of Section 3 (as shown below) will be published in the 10th Edition of the Ph. Eur. which will enter into force on 1 January 2020.
New structure of Ph. Eur. Section 3:
3. Materials and containers
3.1. Materials used for the manufacture of containers (e.g. Polyolefins, Silicone oil, Plastic additives)
3.2. Containers (e.g. Glass containers, Plastic containers, Rubber closures)
3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes (e.g. Sterile plastic containers for human blood and blood components, Sets for the transfusion of blood and blood components, Sterile single-use plastic syringes).
More information on the new structure of the section is available in the EDQM press release.