Medicines without marketing authorisation (MA) and batch certificates

It shall not be registered batch certificates for medicines without MA.

According to the wholesalers, it is only requirement for CoC for batches that have been released for the Norwegian market. If the batch is purchased as medicine without MA, the batch is not released for the Norwegian market. Accordingly, there is no requirement that wholesalers must check the CoC for the batch before the product can be added to salable stock. It is therefore only possible to upload batch certificates for medicines with MA in VareWeb.


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