5.1 Is transfer a variation or a notification?
It is a notification.
5.2 How do we make a notification for transfer?
A cover letter on your letterhead and completed application form available on our website and documents, according to the form should be sent to the Medical Products Agency. See the link
Forms
5.3 What does it cost to make a transfer?
It is part of the annual fee.
5.4 How long is the time for assessment?
Our time for assessment is three months.
5.5 What changes can be made on the labeling mock-up during a transfer?
You may only modify MAH name and logotype.
5.6 How do we change our local representative?
A cover letter on your letterhead and completed application form available on our website and documents, according to the form should be sent to the Medical Products Agency. See the link
Forms
5.7 How long is the time for assessment?
Our time for assessment is three months.
5.8 What does it cost to change the local representatives?
To change the local representative does not cost anything.
5.9 When should the change of local representative for a product approved in the centralised procedure be announced to EMA / to MPA?
If the local representative is mentioned in the PIL (which is a choice of the MAH to include or not) the change is to be sent to the EMA and the total office turnaround time is about 3 months (until the national database NPL is updated).
If the local representative is not mentioned in the PIL a notification only needs to be sent to the MPA and the total office turnaround is many times less than one month. In the notification it should be stated that it concerns a product approved in the centralised procedure and that the PIL is not affected.
5.10 Why can we not find our centrally authorised product in NPL, in spite of that we can see that the product has been approved by the commission?
When the MPA receives the final decision from the European Commission, our computer systems will be updated manually. The information is then transferred to the NPL system the following night.
Thus, it may take a few days until the product is available in the NPL system. Please note that you can only see your product in NPL if you are the MAH or the local representative. For additional questions regarding the NPL, please address them to nplcentral@mpa.se.