Regulatory Open Forum

Dear Colleagues,
If Company X has approval for a product in Russia, and Company Y buys the Company X, what is required to show the transfer of ownership of the registration to company Y?  How long would that take?
Many thanks,
Jo

Dear Jo,

For pharmaceutical product if no other parts of the dossier apart from the MAH name is changing then this is considered as administrative variation which takes 30 days for approval by RU MOH (respective PoA from the manufacturer to the new MOH is required in this case). You will also need to define which company will be responsible for the vigilance reporting and complaints handling after the product is acquired as these contact details are mandatory to appear in the product leaflet. To submit this variation a respective QTA reflecting responsibility matrix between manufacturer and local representative to be presented to the authority and this is also considered as administrative change. 
For medical devices only importer contact information on the package and/or leaflet should be changed if necessary by submitting the relevant PoA and this takes 15 days for approval.

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Julia Ershova
Moscow
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Original Message:
Sent: 09-Apr-2019 15:03
From: Jo Huang
Subject: Question on Russia

Dear Colleagues,
If Company X has approval for a product in Russia, and Company Y buys the Company X, what is required to show the transfer of ownership of the registration to company Y?  How long would that take?
Many thanks,
Jo

Julia,

I deeply appreciate your valuable input. 

Kind regards,
Jo
Original Message:
Sent: 10-Apr-2019 03:57
From: Julia Ershova
Subject: Question on Russia

Dear Jo,

For pharmaceutical product if no other parts of the dossier apart from the MAH name is changing then this is considered as administrative variation which takes 30 days for approval by RU MOH (respective PoA from the manufacturer to the new MOH is required in this case). You will also need to define which company will be responsible for the vigilance reporting and complaints handling after the product is acquired as these contact details are mandatory to appear in the product leaflet. To submit this variation a respective QTA reflecting responsibility matrix between manufacturer and local representative to be presented to the authority and this is also considered as administrative change.
For medical devices only importer contact information on the package and/or leaflet should be changed if necessary by submitting the relevant PoA and this takes 15 days for approval.

------------------------------
Julia Ershova
Moscow

Original Message:
Sent: 09-Apr-2019 15:03
From: Jo Huang
Subject: Question on Russia

Dear Colleagues,
If Company X has approval for a product in Russia, and Company Y buys the Company X, what is required to show the transfer of ownership of the registration to company Y?  How long would that take?
Many thanks,
Jo