Bundle allows multiple MedicinalProductDefinitions

[rlindstrm]

Disclaimer: I have not read all the narrative documentation, so I might be completely wrong.

According to my undestanding ePI Bundle should be a definitional description of one product.
Bundle, however, allows multiple MedicinalProductDefinitions. Composition allows multiple subjects.

PackagedProductDefinition and AdministrableProductDefinition do not have a mandatory reference to the MedicinalProductDefinition, which makes it very difficult to assemble the correct product information if these references are missing and multiple MedicinalProductDefinitions occur in the Bundle.

Either only one MedicinalProductDefinition and Composition.subject is allowed, or the references from other resources need to be forced as mandatory.

[cander2]

The Bundle is a FHIR document about multiple products because ePIs are almost always about multiple products.

Here are instructions on assembly: http://build.fhir.org/ig/HL7/emedicinal-product-info/steps-to-create-epi3.html
Extensive discussion here about how to handle FHIR document Bundles: https://chat.fhir.org/#narrow/stream/179252-IG-creation/topic/Entry.20isn't.20reachable.20by.20traversing.20from.20first.20Bundle.20entry

Can consider making the references mandatory for Type 2 and Type 3 ePIs. Need to think on this a little further to determine whether it negatively impacts implementation in Jordan, Brazil and APAC.