COMMISSION DELEGATED REGULATION (EU) …/... of 13.1.2021 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

Directive 2011/62/EU (the Falsified Medicines Directive) sets out the Union’s legal framework for preventing falsified medicines from entering the legal supply chain and reaching patients. Under Article 54a(2) of Directive 2001/83/EC (as amended by Directive 2011/62/EU), Delegated Regulation (EU) 2016/161 supplements the rules in Directive 2001/83/EC by setting out detailed rules for the safety features appearing on the packaging of medicinal products for human use. These safety features include the affixing of a UI which allows medicinal products to be verified throughout the supply chain, and the addition of a tamper-evident device on each pack of medicines that can be prescribed. When a product is being exported to any third country, Article 22 of Delegated Regulation (EU) 2016/161 provides that wholesalers must verify and decommission any UI previously affixed to a pack before it is exported.
EU Commission Delegated Regulation of 13 January 2021 amends Article 22 of Delegated Regulation (EU) 2016/161, waiving the requirement for wholesalers to decommission the unique identifier (UI) on packs of medicinal products entering the UK from the EU market, for a period of 12 months from 1 January 2021 to 31 December 2022. This Delegated Regulation sets out one element of what was previously agreed by the UK and EU at the Withdrawal Agreement Joint Committee (WAJC) for the smooth implementation of the Northern Ireland Protocol.
Given that the UK is now a third country, the Falsified Medicines Directive (FMD) no longer applies. However, under the terms of the Northern Ireland Protocol (NIP), the Directive continues to apply in the UK in respect of Northern Ireland (NI). This means that medicines with a marketing authorisation valid in Northern Ireland will require a unique identifier and a tamper evident device on each pack.

Topic  Health 
Department  Health 
Council Reference  5371/21 
COM Reference   
SEC Reference   
PE Cons   
C Reference  C(21)251 

Associated file(s)

  1. 5371/21 - 406 KB - pdf
  2. EM C(21)251 - 117 KB - pdf

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