EU Commission amends Delegated Regulation on Safety Features again

In January 2021, the Delegated Regulation (EU) 2016/161 was amended to provide derogation from the requirement to decommission unique identifiers (UIs) of products exported to the UK until 31 December 2021. This derogation was intended to ensure the supply of medicinal products to small markets historically dependent on the UK, i.e. Northern Ireland, Cyprus, Ireland and Malta. In those markets, many medicinal products are purchased from the UK by wholesalers not holding a manufacturing and importation authorization (MIA). Thus, they are unable to meet the importation requirements regarding the safety features laid down in Delegated Regulation (EU) 2016/161.

In order to ensure that medicinal products continue to be marketed with safety features in Northern Ireland, Cyprus, Ireland and Malta, the European Commission decided to further extend the temporary derogation from the requirement to decommission UIs of products exported to the UK for another three years. According to the Commission, the period is needed to allow industry sufficient time to adapt the supply chains.

Amendments to Delegated Regulation (EU) 2016/161 and Definitions

• Repositories which serve territories outside of the Union shall not be connected to the hub.
• An "Active unique identifier" is an UI which has not been decommissioned or which is no longer decommissioned, and which has not been identified as a “non-Union pack” (i.e. triggering an alert when the verification of a medicinal product manufactured and labelled for the UK does not take place in Northern Ireland, Cyprus, Ireland or Malta).
• Verification of the authenticity of UIs by wholesalers
  A wholesaler shall verify the authenticity of the UI of at least the following medicinal products in his physical possession:
  - Medicinal products returned by persons authorized or entitled to supply medicinal products to the public or by another wholesaler
  - Medicinal products received from a wholesaler who is neither the manufacturer nor the wholesaler holding the marketing authorization (MA) nor a wholesaler who is designated by the MA holder (MAH) to store and distribute the products.
  A wholesaler in Northern Ireland, Cyprus, Ireland or Malta shall perform adequate verifications to ensure that shipments of medicinal products manufactured and labelled for the UK comply with the requirement to bear safety features.
• Until 31 December 2024, the obligation to decommission the UI of medicinal products which the wholesaler intends to distribute outside of the Union shall not apply to medicinal products manufactured and labelled for the UK.

The amendment shall enter into force on the day following that of its publication in the Official Journal of the European Union and applies from 1 January 2022. 

For more information please see Commission Delegated Regulation (EU) of 17.12.2021 amending Delegated Regulation (EU) 2016/161.