Brexit: Two-year implementation period for name and address changes
During an implementation period of maximum two years, it will be permitted to sell released packs on which a UK marketing authorisation holder or a representative is indicted as well as packs on which an EEA marketing authorisation holder or a representative is indicated for the concerned D.Sp.No. (Danish speciality number).
The following conditions must be met:
- A variation to change the name or address of the marketing authorisation holder or representative must be submitted and approved by the Danish Medicines Agency before 1 day after Brexit.
- The updated package leaflet with the new marketing authorisation holder or representative or address change must be uploaded to www.indlaegsseddel.dk no later than three months after approval of the variation.
- After Brexit, the Qualified Person (QP) is no longer permitted to release batches where a UK-based marketing authorisation holder or representative is indicated on the packaging material.
The two-year period will start from Brexit.
For every implementation of a new medicine pack, the marketing authorisation holder signals that only new packs related to the concerned medicine pack will be released from then on.
When new packs for all marketed medicine packs with the concerned D.Sp.No. (Danish speciality number) have been implemented, or at the latest when the implementation period has ended, only new packs with updated labelling, etc. can be released.
There is no requirement to withdraw packages with old labelling before the end of the period.
The period runs up to and including the date of Brexit in 2021.
Patient safety not at risk
The implementation period is not considered to put patient safety at risk because what is involved is just minor changes to the packaging material which are being implemented at a time delay.
Such delayed implementation is already permitted today without medicine packs being withdrawn from the market. This practice is also justified by the need to minimise environmental waste and to ensure the continued smooth supply of medicines to Danish consumers.