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Supply chain

FMD and Brexit risks medicine shortage, European pharmacy body warns

The Falsified Medicines Directive (FMD) and Brexit could contribute to an increased risk of medicines shortages in Europe, a European pharmacy body has warned.

The European Industrial Pharmacists Group (EIPG), which represents professional organisations of pharmacists employed in the pharmaceutical or allied industries in Europe, reviewed the implications for Qualified Persons of both the FMD and the impact of Brexit on pharmacists in their roles to ensure availability of efficacious medicinal products for patients.

The group noted that all actors in the pharmaceutical supply chain must adapt their quality systems in considerably short time frames for both the FMD and Brexit, and that this relies heavily on key individuals — in particular Qualified Persons, who are responsible for certifying batches of medicines prior to release, and Responsible Persons, who are responsible for ensuring a quality system is implemented and maintained at wholesale distributors of medicines.

Claude Farrugia, president of the EIPG, said the FMD deadline “exacerbates the potential risk to the availability of medicines” because it coincides with Brexit. The UK is scheduled to leave the European Union (EU) on 29 March 2019, followed by the FMD launch on 9 February 2019.

On 29 January 2018, the Brexit Health Alliance, which aims to safeguard the interests of patients and the healthcare and research relied upon during Brexit negotiations, warned that medicines supplies could be disrupted when the UK leaves the EU, and called on negotiators to put patients first.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20204843

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