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"I"

immediate container
Guideline or reference source
ISO11239 IDMP Data elements and structures for the unique identificaiton and exchange of regulated information on pharmaceutical dose forms , units of presentation, routes of administration and packaging
Definition
packaging in which a manufactured item or pharmaceutical product is contained and with which it is in direct contact   EXAMPLES Ampoule, vial, prefilled syringe, bottle, blister.   NOTE 1 An immediate container can be fitted with or have integrated into it an administration device and/or closure.   NOTE 2 A pharmaceutical dose form can fulfil the role of an immediate container, e.g. a capsule containing a powderfor inhalation; the capsule in this case is not a container.   NOTE 3 An alternative, compatible definition of immediate container (“immediate packaging”) is given in Directive 92/27/EEC.   NOTE 4 Adapted from ENV 12610:1997.
Used For
immediate pack
immediate packaging
primary pack
Broader Term
container closure system
Related Term
intermediate packaging
investigational medicinal product batch identifier baid_2
labelling
outer packaging
packaging and labelling
shelf life after first opening the immediate packaging
 

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