List of approved countries for authorised human medicines

AI Summary

This guidance document from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the regulatory framework regarding approved countries for medicinal products under the Human Medicines Regulations 2012. Since January 1, 2021, these lists have been essential for UK importers and wholesalers to maintain compliance while recognizing international regulatory standards. Specifically, the lists identify approved countries for the importation of medicines under a wholesale dealer’s license, the batch testing of medicinal products, and the manufacturing of active substances with standards equivalent to those in the UK. A key focus of this guidance is the continuity of recognition for Qualified Person (QP) certification and active substance manufacturing standards from specified nations. While the UK currently accepts batch testing performed in European Economic Area (EEA) countries, this arrangement was scheduled for review before December 31, 2022. The MHRA has committed to providing a two-year notice period before implementing any changes resulting from this review. As this is a general regulatory guidance rather than an enforcement report, no specific company name, inspection dates, or violations are cited. Instead, the document serves as a compliance roadmap for all UK pharmaceutical entities. Required actions for stakeholders include regular monitoring of the approved country lists to ensure that their supply chains and testing protocols remain aligned with UK law. For further assistance, the MHRA provides contact details for its Customer Services Centre and various industry trade associations, such as the Association of the British Pharmaceutical Industry and the British Generic Manufacturers Association.