6/7 June 2023
Due to the Brexit, the question arises whether medicinal products have to be decommissioned in advance when distributed to the UK.
As the UK has been a third country since 1 January 2021, under Delegated Regulation 2016/161, the unique identifier (UI) for packs of medicines exported to the UK would need to be verified and decommissioned prior to the export. This would be accompanied by the obligation for importers to affix new UIs on products if they are then shipped further, e.g. to Cyprus, Ireland, Malta or Northern Ireland.
However, according to the EU Commission, there are currently no importers based in Cyprus, Ireland, Malta or Northern Ireland who hold a marketing authorization for medicinal products and who are able to comply with the obligation to affix a new UI. Therefore, the Commission has decided to waive the obligation to decommission the UI from 1 January 2021 to 31 December 2021. With a corresponding amendment to the Delegated Regulation 2016/161, the obligation to decommission for medicinal product packs intended for distribution in the UK will be waived for this period.
For more information, please consult the Delegated Regulation on the derogation from the obligation of wholesalers to decommission the unique identifier of products exported to the United Kingdom.