Change of MAH and Local Representative

Is transfer a variation or a notification?

It is a notification.

How do we make a notification for transfer?

Application form available on our website as well as the following documentation:

  • Wholesale licence for new marketing authorisation holder
  • Proof of establishment for new marketing authorisation holder
  • SmPC, PIL and labeling text with tracked changes (if applicable)
  • Latest approved version of the mockups and the new final version (if applicable)

 

 Forms

What does it cost to make a transfer? 

It is part of the annual fee.

How long is the time for assessment? 

Our time for assessment is three months.

What changes can be made on the labeling mock-up during a transfer?

You may only modify MAH name and logotype.

How do we change our local representative?

Application form available on our website as well as the following documentation:

  • Wholesale licence for new marketing authorisation holder
  • Proof of establishment for new marketing authorisation holder
  • SmPC, PIL and labeling text with tracked changes (if applicable)
  • Latest approved version of the mockups and the new final version (if applicable)

 

 Forms

How long is the time for assessment?

Our time for assessment is three months.

What does it cost to change the local representatives?

To change the local representative does not cost anything.

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 LiiV 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 about 3 months. In the notification it should be stated that it concerns a product approved in the centralised procedure and that the PIL is not affected.

Parallel sales of packs of old and new label

Regarding new packaging the following applies to change of address of MAH, change of name of MAH and transfer of MAH: A new MAH is to commence production of the new labeling within six months from the date of labeling approval. As soon as the new labeling has begun to sell new MAH are advised to submit a letter to the Medical Products Agency (mah.ombud@mpa.se) containing information about the start of sales date. The Medical Products Agency allows six months of coexisting sales of products with the old and new label.

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 LiiV system the following night. 

Thus, it may take a few days until the product is available in the LiiV system.  Please note that you can only see your product in LiiV if you are the MAH or the local representative.

 For more information regarding LiiV (eHälsomyndigheten)

For additional questions regarding LiiV, please address them to servicedesk@ehalsomyndigheten.se

 
 

Contact us

Registrator
registrator@mpa.se

 

   
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information