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More than one Marketing Authorization Holder (MAH) in Japan

G

goodnature

#1
Is it possible to have more than one Marketing Authorization Holder (MAH) in Japan? We already have one distributor who acts as our MAH and we have recently had interest from another distributor who would like to order some of our products directly and not from our current MAH. Thanks!
 

maya_tanase

Starting to get Involved
#3
Could you Please indicate
Yes - we have had multiple MAHs.

This does bring some added burden as each MAH has to register the product and each MAH will inform the regulatory authorities of any vigilance actions.

But none of those are deal breakers.
Dear Adele, can you confirm me if the answer is still current? Can you tell me in which standards /law/ documents is indicated?
Many thanks
Maya
 
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