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New reporting obligation for supply shortages of prescription medicines


Since 1 April 2020, if prescription drugs are not available or only available in limited quantities, marketing authorisation holders have had to notify the BASG. Since the new regulation came into force, over 30 medicines have already been included in the BASG's register of marketing restrictions - most of them based on a notification by the marketing authorisation holder, but some also on the initiative of the BASG. These drugs are subject to a temporary export ban. Failure to comply with this ban may result in sanctions.

The complete article is available in German.

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