Stream: implementers
Topic: Does Medication.manufacturer include the sponsor?
Richard Townley-O'Neill (Sep 11 2017 at 05:32):
In Australia, the authority that approves medications (the Therapeutic Goods Administration or TGA) records the sponsor, but not the manufacturer, of medications. The sponsor is the organisation that sponsors the medication through the approval process, they might not actually manufacture it.
Is sponsor within the scope of Medication.manufacturer ? I expect not.
Is this a widely used approach?
Jose Costa Teixeira (Sep 11 2017 at 10:51):
in Europe we have the Marketing Authorisation Holder. that is the entity that is responsible for the pre-market and post-market.
Jose Costa Teixeira (Sep 11 2017 at 10:53):
I expect that the medication.manufacturer would not be the same thing (unless the name would change to something less explicit).
And this should be covered by the medication reqork to align with IDMP . @Jean Duteau @Rik Smithies @Melva Peters @John Hatem
Jose Costa Teixeira (Sep 11 2017 at 10:54):
the Marketing Auth Holder (MAH) is much more relevant than the manufacturer. I would suggest a change of "manufacturer" to something else, but I expect the IDMP work should make that change redundant
Grahame Grieve (Sep 11 2017 at 14:54):
I think that the approval process for a medication is outside the scope of the medication resource
Jose Costa Teixeira (Sep 11 2017 at 14:57):
it should be indeed out of the clinical resource. the BRIDG folks are looking at IDMP which is the regulatory aspect.
I expect that in the rework of the medication resource, things that are not clinical should revert to the regulatory side (BRIDG).
Jose Costa Teixeira (Sep 11 2017 at 15:00):
I guess Manufacturer wants to convey the concept of "what is the brand of this product" as in Acme aspirin vs Bayer aspirin. if so, i'd argue that in Europe the MAH is the responsible, and more relevant than the actual manufacturer.
Last updated: Apr 12 2022 at 19:14 UTC
