Commission Delegated Regulation (EU) 2021/457 of 13 January 2021 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 (Text with EEA relevance)

• Date of Signature: 13 January 2021
• Published date: 17 March 2021
• Official Gazette Publication: Official Journal of the European Union, L 091, 17 March 2021

17.3.2021 EN Official Journal of the European Union L 91/1

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COMMISSION DELEGATED REGULATION (EU) 2021/457

of 13 January 2021

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

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (1), and in particular Article 54a(2)(d) thereof,

Whereas:

(1) Article 54a(1) of Directive 2001/83/EC provides that medical products subject to prescription shall bear safety features.

(2) Pursuant to Article 22(a) of Commission Delegated Regulation (EU) 2016/161 (2), a wholesaler is to decommission the unique identifier of medicinal products which he intends to distribute outside of the Union.

(3) On 1 February 2020, the United Kingdom withdrew from the European Union and from the European Atomic Energy Community. Pursuant to Articles 126 and 127 of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (the ‘Withdrawal Agreement’), Union law is applicable to and in the United Kingdom during a transition period that is to end on 31 December 2020 (‘transition period’).

(4) In accordance with Article 185 of the Withdrawal Agreement and Article 5(4) of the Protocol on Ireland/Northern Ireland, Union legislation on medicinal products apply in Northern Ireland after the end of the transition period.

(5) The withdrawal of the United Kingdom from the Union would, in the absence of a derogation from the applicable rules, thus have the effect that the unique identifiers must be decommissioned for medicinal products intended to be distributed in the United Kingdom.

(6) A number of medicinal products are supplied to Cyprus, Ireland, Malta or Northern Ireland through Great Britain. After the end of the transition period, in accordance with Article 54a(1) of Directive 2001/83/EC, it would be for importers holding a manufacturing authorisation in those areas to affix a new unique identifier on the medicinal products when they

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