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Concerns about the supply of pharmaceuticals to Northern Ireland

29 October 2020

The EU Environment Sub-Committee writes to Edward Agar MP, Minister at the Department for Health and Social Care with their concerns for the supply of pharmaceuticals to Northern Ireland from 1 January 2020.

Background

Approximately 98% of the medicines used in Northern Ireland are imported either from or via Great Britain, often originating in the EU. As of 1 January 2021 one of the EU laws regarding medicinal products, the Falsified Medicines Directive (FMD), which aims to prevent counterfeit medicines entering the supply chain and applies to the majority of prescription-only medicines, will apply in Northern Ireland but not in Great Britain. This creates uncertainty and worry for pharmaceutical companies about what rules will apply to medicines imported via Great Britain.
The Committee have serious concerns about the risk to the supply of prescription medicines in Northern Ireland from 1 January next year and have written asking for an urgent response on the following:

  • Whether medicines stockpiled now be sold legally in NI from 1 January with no changes to their package, label or inserts.
  • What assessment the Government made of the warehouse capacity for medicine stockpiles in NI ahead of 1 January.
  • Whether medicines placed on the market from 1 January have to be re-labelled or retested if they originate in the EU but pass through GB on their way to NI.
  • Given the time it will take pharmaceutical companies to adjust their packaging and / or supply routes as required, whether the Government has had discussions with the EU about a potential derogation period from the FMD to ensure there is no interruption to the supply of medicines to NI.
  • Whether the Government made progress on seeking a mutual recognition agreement with the EU to cover the inspection and batch testing of medicines.
  • If the Government is taking any other steps to ensure the consistent, affordable supply of a full range of prescription medicines in NI from 1 January 2021.

Further information