WITHDRAWN: Post-Brexit implications: Review of marketing authorisations in Malta

Abstract

Geopolitical incidences such as Brexit can have a significant impact on the stability of the pharmaceutical supply chain and availability of medicines in a small island state like Malta. During Brexit amendments in existing policies in the medicine supply chain were required in Malta and requests for exemptions from the requirement of a marketing authorization (MA) through application of Article 20 of the Maltese Medicines Act could be made. The study aimed to understand whether Brexit affected medicine availability in Malta by identifying which medicines are not available post-Brexit. Review of the (i) Maltese Government Formulary List (GFL) and (ii) Malta Medicines Authority (MMA) database was undertaken and statuses of MA of medicines were identified. Availability of medicines with Withdrawn or Invalidated MA from the UK via alternative routes was checked. For medicinal products in the GFL, 11 had MAs previously held in the UK and for 4 of them, there were no requests for use of Article 20. Review of the MMA database identified 542 MAs with MA holders based in the UK that were withdrawn by companies and 544 MAs that were Invalidated MAs from the UK because they no longer met requirements in the EU legislation. The study sheds light on the impact of Brexit on availability of medicines which have a MA in Malta.