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Post by 741084 on Aug 13, 2020 19:48:03 GMT 5.5
If EU authorized & Commercialized product is compassionately used in Australia, then it is Spontaneous
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Post by 190686 on Aug 13, 2020 19:48:23 GMT 5.5
Yes...
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Post by 741084 on Aug 13, 2020 19:48:44 GMT 5.5
If the product is undergoing clinical trials and not approved anywhere but still used compassionately then it cannot be Spontaneous
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Post by 190686 on Aug 13, 2020 19:49:04 GMT 5.5
Yes...
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Post by 190686 on Aug 13, 2020 19:49:44 GMT 5.5
Thanks for your inputs. For my client, there was no mandatory requirement from EMA for active monitoring as done in solicited programs, so considering it as PMS Here it seems like no active monitoring is required... So my interpretation is... It falls under the first explanation type... Therefore it should be spontaneous...
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Post by 741084 on Aug 13, 2020 19:50:42 GMT 5.5
Yes...
The problem now is with the country where the product has been supplied. It may be difficult to perform domestic reporting as there is no associated licence
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Post by 190686 on Aug 13, 2020 19:50:59 GMT 5.5
Yes...
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Post by 152336 on Aug 13, 2020 19:51:55 GMT 5.5
The problem now is with the country where the product has been supplied. It may be difficult to perform domestic reporting as there is no associated licence Can report: drug obtained country and Country of incidence (as per Module VI)
If it is under risk monitoring
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Post by 190686 on Aug 13, 2020 19:52:14 GMT 5.5
I think the question is... How do you report in a country to same country authorities when MAH does not exist in the country...
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Post by 152336 on Aug 13, 2020 19:52:29 GMT 5.5
Ooops!!
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