Hello,
Any regulatory process in Japan is very lengthy. Since your company wants to change the distributor, you need to do y our homework well.
A no objection certificate will be required from your existing distributor who is also the MAH in Japan. Moreover, the process in online and your existing distributor will have to make an application to initiate the change in the distributor.
Hence, please negotiate with your current distributor/MAH in Japan to find best strategies to have efficient MAH transfer,
All the best !
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PURVI GORADIA
Manager Regulatory Affairs
Mumbai
India
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Original Message:
Sent: 09-Apr-2019 10:05
From: Anonymous Member
Subject: Changing MAH in Japan - How Difficult?
This message was posted by a user wishing to remain anonymous
May I ask who your MAH is? My company is looking for one. Any recommendations would be most helpful. We need one that covers med devices and quasi drugs.
Original Message:
Sent: 21-May-2018 15:26
From: Anonymous Member
Subject: Changing MAH in Japan - How Difficult?
This message was posted by a user wishing to remain anonymous
Hello,
We currently use a distributor in Japan to sell our products. The distributor holds the product licenses and serves as MAH. We are considering changing distributors and would like to understand how complex it is to transfer the product licenses from one distributor to another. I would like to ensure re-registration of products is not required and it is a fairly straight forward documentation exercise. I have found some information online but I am looking for advice from someone that has had this experience. Any ideas on how long the process can take and how much documentation is involved?
Thank you in advance for any advice and guidance!