On 13 January 2021, the European Commission adopted a new Delegated Regulation, amending Delegated Regulation (EU) 2016/161 as regards a derogation from the obligation of wholesalers to decommission the unique identifier of products exported to the United Kingdom.
It clarifies the obligations of wholesalers in the medicines export process:
“The Commission has decided to waive the obligation to decommission the unique identifier when the products are distributed to the United Kingdom for a period of twelve months to ensure the presence of a unique identifier in the small markets dependent of the UK.
The presence of a unique identifier on the medicinal products imported into Northern Ireland, Ireland, Cyprus and Malta through Great Britain is an essential requirement as regards ensuring a high level of public health protection in those countries, and this presence can as yet only be achieved by means of wholesale distributors located in the Union not decommissioning the unique identifier of medicinal products.”
This Regulation shall apply from 1 January 2021.
On 1 February 2020, the United Kingdom withdrew from the European Union. Pursuant Withdrawal Agreement, EU law was applicable to and in the United Kingdom during a transition period that ended on 31 December 2020. In accordance with the Withdrawal Agreement and the Protocol on Ireland/ Northern Ireland, Union legislation on medicinal products apply in Northern Ireland also after the end of the transition period.