The European Pharmacopeia (Ph. Eur.) includes a Section 3. on materials for containers (Subsection 3.1) and containers (Subsection 3.2). For historical reasons, the general chapters of this 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 at its 162nd session to modify the structure of Section 3. of the Ph. Eur.