Are you preparing for Marketing Authorization Transfer? You should check your process again for important little details
Marketing Authorization Transfer (MAT) can cause seriuos extra workload on every related departments. As a consequence sometimes there is not enough time to ensure tha cross-departmental communication flows efficiently and important details can be missed out. Most of the administrative work is done by the Legal and Regulatory Departments but clear communication among Pharmacovigilance and IT is also essential.
If you have only a few affected products, it is usually not a big deal to handle the process. However, when a bigger portfolio moves even experienced Regulatory professionals can forget about the importance of pre-defined rules between companies.
Just consider the following few points and you will see what is the issue:
• The approval process of bigger transfered portfolio can last longer than expected. Are you prepared for handling some products even long after the official deadline determined in the MAT contract?
• You need to be really lucky to transfer only products where no other assessment is ongoing. You need to agree with your MAT partner how to handle the transition in these cases.
• Companies track regulatory submissions really differently. Consult with you IT department and check the partner’s system. Maybe they don’t track the workflows or have different steps/deadlines which needs to be syncronized.
• Your compliance measurement points might track different actions compared to the partner. Who will be on charge when an issue pops up?
• You have 30 days reporting deadline for XEVMPD (EU countries) after MAT. Will you receive every necessary documents in time?
And these are just a few points on my list what I check while preparing for a MAT.
Sometimes it is worthy to consider the involvment a third party consultant in order to mediate the MAT. Providing access to the consultant for the Transferor’s and Transferee’s system can be really helpful as she/he will have a comprehensive overview on the overall tasks.
Now you should check your MAT process again and determine what kind of tasks are really essential to the successfull transfer.