Commission Delegated Regulation (EU) 2022/315 of 17 December 2021 amending Delegated Regulation (EU) 2016/161 as regards the derogation from the obligation of wholesalers to decommission the unique identifier of medicinal products exported to the United Kingdom (Text with EEA relevance)

A wholesaler shall verify the authenticity of the unique identifier of at least the following medicinal products in his physical possession: (a) medicinal products returned to him by persons authorised or entitled to supply medicinal products to the public or by another wholesaler; (b) medicinal products he receives from a wholesaler who is neither the manufacturer nor the wholesaler holding the marketing authorisation nor a wholesaler who is designated by the marketing authorisation holder, by means of a written contract, to store and distribute the products covered by his marketing authorisation on his behalf. A wholesaler established in Northern Ireland, Cyprus, Ireland or Malta shall perform adequate verifications to ensure that shipments of medicinal products manufactured and labelled for the United Kingdom market comply with the requirement to bear safety features under Article 54a(1) of Directive 2001/83/EC when received from the manufacturer, the marketing authorisation holder or a wholesaler who is designated by the marketing authorisation holder, by means of a written contract, to store and distribute the products covered by his marketing authorisation on his behalf.’

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2022.