Verification of the authenticity of the unique identifier by wholesalers
Article 1
Open ↗Delegated Regulation (EU) 2016/161 is amended as follows: (1) in Article 3(2), point (d) is replaced by the following: ‘(d) ‘active unique identifier’ means a unique identifier which has not been decommissioned or which is no longer decommissioned, and which has not been identified as a ‘non-Union pack’ as referred to in Article 36, point (p);’ (2) Article 20 is replaced by the following: ‘Article 20 Verification of the authenticity of the unique identifier by wholesalers 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.’ (3) in Article 22, the final paragraph is replaced by the following: ‘By way of derogation from point (a), until 31 December 2024, the obligation to decommission the unique identifier of medicinal products which the wholesaler intends to distribute outside of the Union shall not apply to medicinal products manufactured and labelled for the United Kingdom market or for the United Kingdom market and the markets of Cyprus, Ireland or Malta, which he intends to distribute in the United Kingdom.’ (4) in Article 26, the following paragraph 4 is added: ‘4. Until 31 December 2024, the authorities of the United Kingdom in respect of Northern Ireland may waive the obligation to verify the safety features and decommission the unique identifier of a medicinal product supplied to the persons or institutions listed in Article 23 for products for the market of the United Kingdom in respect of Northern Ireland supplied from wholesalers located in other parts of the United Kingdom.’ (5) in Article 32(1), point (b), a final sentence is added: ‘Repositories which serve territories outside of the Union shall not be connected to the hub.’ (6) in Article 36, the following point (p) is added: ‘(p) the triggering of an alert identified as a ‘non-Union pack’ in the repositories system and in the terminal where the verification of the authenticity of a unique identifier in accordance with Article 11 takes place when both of the following conditions are met: (i) the verification finds that the medicinal product bearing the unique identifier is manufactured and labelled for the United Kingdom market or for the United Kingdom market and the markets of Cyprus, Ireland or Malta; (ii) the verification does not take place in Northern Ireland, Cyprus, Ireland or Malta.’