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As we approach the next instalment of Pharmapack Europe, a potentially perilous situation in relation to drug packaging has emerged for pharmaceutical companies should Brexit result in a ‘no deal’ scenario.
As we approach the next instalment of Pharmapack Europe, a potentially perilous situation in relation to drug packaging has emerged for pharmaceutical companies should Brexit result in a ‘noâdeal’ scenario.
Should the United Kingdom leave the European Union without a deal in place on 29 March 2019, then many companies in both Europe and the United States could end up missing an EU export administration deadline, which was highlighted in a press release from GlobalData (1).
Under the current system, which is a mutual recognition procedure (MRP), a single European country can assess a product and award it with a marketing authorization. This authorization is then accepted across the whole of Europe.
However, if the UK leaves the EU without a deal, it will become a third country and as such any marketing authorization number for products approved in the UK after 29 March 2019 will not be recognized within Europe and vice-versa. Therefore, companies will be required to gain an extra marketing authorization number that must be placed on the exterior drug packaging.
As revealed by Lynne Byers, executive director of NSF International’s pharma biotech services, during an event at CPhI Worldwide in Madrid, the change to marketing authorization would be a huge undertaking for companies, particularly those with large product portfolios (2).
“If you change a batch release site, your QP, and your marketing authorization number, the packaging will be affected,” Byers confirmed. “All the artwork will need to change and everything will need to be repackaged, which is a substantial issue.”
1. GlobalData, “Pharma Companies May Miss Crucial EU Drug Packaging Deadline in Event of a ‘No-Deal’ Brexit, Observes GlobalData,” Press Release, 4 December 2018.
2. PharmTech, “Prioritizing Pragmatism in Face of a ‘No-Deal’ Brexit,” 20 November 2018, PharmTech.com.
Pharmaceutical Technology Europe
Vol. 31, No. 1
When referring to this article, please cite it as F. Thomas, “Packaging Peril: ‘No-Deal’ Brexit May Lead to Missed Deadline," Pharmaceutical Technology Europe 31 (1) 2019.