Brexit - Medicinal Products - Commission Temporarily Redesigns Supply Chains to Cyprus, Ireland, Malta and Northern Ireland
On 17 March 2021, the Official Journal of the European Union published 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” (see, attached copy; the Delegated Regulation).
The Delegated Regulation gives effect to a Commission Notice of 23 December 2020 in which the European Commission addressed the issues faced by market operators in Cyprus, Ireland, Malta and Northern Ireland, which are historically dependent on the United Kingdom for their medicine supplies, in complying with the EU’s pharmaceutical acquis following Brexit (see, Van Bael & Bellis Life Sciences News Alert of 23 December 2020). One of the issues identified was that there are currently no importers holding a manufacturing authorisation in Cyprus, Ireland, Malta and Northern Ireland. However, a manufacturing authorisation is required to affix a unique identifier on medicinal products which are imported from outside the EU and placed on the market in the EU.
As there are currently no wholesalers in Cyprus, Ireland, Malta and Northern Ireland which can affix a unique identifier on medicinal products that are imported from the United Kingdom, the Delegated Regulation makes it possible for medicinal products which are exported from the EU to the United Kingdom to maintain their initial unique identifier. More precisely, the Delegated Regulation introduces a temporary derogation from the obligation of EU wholesalers to decommission the unique identifier of any medicinal products which they distribute in the United Kingdom. This will facilitate onward distribution of the medicines from the United Kingdom to the cited EU Member States and Northern Ireland. The exemption applies retroactively from 1 January 2021 and will apply until 31 December 2021.
The unique identifier was introduced by the Falsified Medicines Directive (Directive 2011/62/EU) with a view to allowing wholesalers and healthcare professionals to verify the authenticity of medicinal products and to identify individual packs.