To the attention of interested persons
As announced in the Commission BREXIT Notice on medicines in January this year, the Commission had adopted and published the Delegated Regulation to amend the Falsified Medicines Directive in view of addressing the BREXIT outstanding issues on medicines.
In order to ensure that medicinal products are marketed with a unique identifier in the small markets currently dependent on the United Kingdom for their supplies of medicinal products, it is granted a temporary derogation until 31 December 2021 from the obligation of wholesalers to decommission the unique identifier of the products which they intend to distribute in the United Kingdom as those products may be re-exported to the Union.
This derogation should not affect the application of Union law to and in the United Kingdom in respect of Northern Ireland in accordance with Article 5(4) of the Protocol on Ireland/Northern Ireland to the Withdrawal Agreement in conjunction with Annex 2 to that Protocol.
Please find the link of that act:
This has also been added to the DG SANTE BREXIT webpage: