The centralised procedure - questions and answers

Change in the local representative for centralised approved products

Local representative printed in the package leaflet (PIL):

The Marketing Authorisation Holder (MAH) should apply via a 61(3) notification through the European Agency (EMA).

After approval, the MAH should upload the new PIL on www.indlaegsseddel.dk

For products not marketed in Denmark our internal system will be updated automatically after approval of the 61(3) notification.

For already marketed products the responsible entity with access to DKMAnet (MAH or local representative) should make the change directly via DKMAnet.

Local representative not printed in the package leaflet (PIL):

The Marketing Authorisation Holder (MAH) should submit a power of attorney (PoA) allowing the new local representative to act on behalf of the MAH at the national level.

This PoA should be submitted to: Send an email

For products not marketed in Denmark our internal system will be updated automatically after the PoA is validated and approved.

For already marketed products the responsible entity with access to DKMAnet (MAH or local representative) should make the change directly via DKMAnet.