Change of marketing authorisation holder and local representative

Notification of transfer of the holders of marketing authorisations

The notification submitted to the Swedish MPA should contain:

• The Wholesale Dealer Authorisation for new marketing authorisation holder.
• Proof of establishment for new marketing authorisation holder.
• SmPC, PL and labelling text with tracked changes.
• Latest approved version of the mock‍-‍ups and the new final version, if affected.

Notification of new/removal of/change of local representative

The notification submitted to the Swedish MPA should contain:

• The Wholesale Dealer Authorisation for new local representative or marketing authorisation holder if the local representative is removed.
• Proof of establishment for new local representative.
• PL with tracked changes if the texts is affected.
• Latest approved version of the mock‍-‍ups and the new final version, if affected.

Notification of name/address change of the local representative

The notification submitted to the Swedish MPA should contain:

• The Wholesale Dealer Authorisation for the local representative.
• Proof of establishment for the local representative.
• PL with tracked changes if the text is affected.
• Latest approved version of the mock‍-‍ups and the new final version, if affected.

A notification of change of name or address for the marketing authorization holder should be submitted as a variation application. For human medicinal products, a variation type IA under the category A.1 should be submitted. For veterinary medicinal products, the MAH should record the change in the union product database (UPD).

Products approved though the central procedure

For products approved through the central procedure all notifications regarding the marketing authorisation holder should be submitted to EMA.

For more information on how you submit these notifications, visit EMA's website.

If the local representative is stated in the package leaflet the notification should be submitted to EMA. The processing time for notification submitted to EMA is approximately three months. If the local representative is not mentioned in the package leaflet the notification should be submitted to the Swedish MPA. The Swedish MPA will assess the notification within three months. It should be stated in the notification submitted to the Swedish MPA that the product is centrally authorised and that the package leaflet is not affected by the change.

The form “notification of new/removal/change of local representative” or “notification of name/address change of the local representative” should be used for notification that to the Swedish MPA.

Fee

The cost for a notification regarding transfer of the marketing authorisation holder or changes of local representative is part of the annual fee.

Time for assessment

The evaluation time is maximum three months.

In case a change regarding the local representative is associated with a transfer of marketing authorisation, both these notifications could be submitted in parallel. If the transfer leads to a change in product name, the variation for changing the product name could be submitted at the same time.

If a fixed implementation date is requested, the notification should be submitted to the Swedish MPA three months before the requested date. The decision and Product Information will be sent on the requested date.

Changes in the product information

Labelling

Only changes regarding name and address for the marketing authorisation holder and local representative as well as the logotype can be made in these notifications.

Other changes in the layout for mock-ups must be submitted separately. Separate layout changes could be submitted in parallel.

Summary of Product Characteristics and Package Leaflet

Only changes regarding name and address for the marketing authorisation holder and local representative can be made in these notifications.

Other changes in the Summary of Product Characteristics and Package Leaflet must be submitted separately.

Products in LiiV

For notifications handled by EMA, the Swedish MPA receives the final decision from the European Commission. Our systems are updated manually after receiving the decision and the information is transferred to LiiV the following night. Therefore, it can take a couple of days from the day of decision until the product is visible in LiiV.

For notifications handled by the Swedish MPA the information is transferred to LiiV the following night after the implementation date.

Please note that you can only see the product in LiiV if you are the marketing authorisation holder or the local representative.

Old product information

From the date of implementation, no product information containing information regarding the previous MAH can be released. Only product information with information related to the new MAH can be released.

Parallel sales of packs of old and new label

In case of transfer of the marketing authorisation, the following applies:

• The implementation date is the day the new MAH will be visible in the systems. The implementation date of the new MAH can ben be adjusted according to the company’s wishes.
• No packages with previous MAH can be released from the implementation date. Already released stock may be sold in parallel for six months if the previous MAH has given permission to the new MAH.
• In case of a MA-transfer with following change of trade name, old and new package can be sold in parallel for one month.
• The vendor’s stock can be sold to completion and no active withdrawal is required.

In case of changes to the information regarding the local representative:

• The Swedish Medical Product Agency has decided that packaging with the previously approved labelling or package leaflet may be released onto the market is extended to 12 months.

As soon as the new labelling has been put on the market, the new MAH is advised to submit at letter to the Swedish MPA containing information about the start of sales date for new packaging.

The letter should be sent to mah.ombud@lakemedelsverket.se

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