US: Richtsnoer verpakking en etiket injecteerbare medicijnen

The US FDA published a draft guidance for industry on the “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use”.
When finalized, this guidance provides industry with the FDA’s recommendations on the selection of appropriate package type terms and selection of appropriate discard statements for injectable medical products for human use. Specifically, it provides FDA’s revised definitions for single-dose and multiple-dose containers, and introduces the definition of a new package type term, “single-patient-use” container (FDA, 21 oktober 2015).
Klik hier om het concept richtsnoer te downloaden (116 kB).
Klik hier voor meer informatie over de NVC E-Course Pharmaceutical Packaging.

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