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Progress urged so pharmaceutical grace period is not wasted

26 November 2020

The EU Environment Sub-Committee writes again to Edward Argar MP, Minister at the Department for Health and Social Care, regarding their concerns for the supply of pharmaceuticals to Northern Ireland from 1 January 2021.

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 received a letter from the Minister at the Department for Health and Social care, with the most significant update informing the Committee that the European Commission has agreed to a 12 month grace period before the regulations have to be complied with, providing businesses with more time to prepare.

The Committee has written again saying it welcomes the grace period, which relieves the immediate pressure and will allow businesses more time to prepare for any changes, regarding the supply of prescription medicines to NI consumers from 1 January. However, the same uncertainties now apply from 2022, so the Committee urges progress in the coming months so that the grace period is not wasted.

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