# List of approved countries for authorised human medicines Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/f0b1d8e9-672d-4a0f-8f7b-806776f04f74 Type: Guidance Published: December 31, 2020 Updated: December 22, 2021 > 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. --- ## Content The Human Medicines Regulations 2012 refers to lists of approved countries for: Importation of medicines under a wholesale dealer’s licence Batch testing of medicines Manufacturing of active substances with regulatory standards equivalent to the UK The list of approved countries will enable UK importers and wholesalers to continue to recognise QP certification and regulatory standards for active substance manufacture performed in certain countries in the same way as before 1 January 2021. The UK’s acceptance of batch testing done in EEA countries will be reviewed before 31 December 2022. A two-year notice period will be given in the case of changes. This guidance provides the lists of countries and a summary of the circumstances under which the lists can be used. Contact For further information, please email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. Alternatively, contact your Trade Association by emailing: Association of the British Pharmaceutical Industry (ABPI): regulatory@abpi.org.uk British Generic Manufacturers Association (BGMA): info@britishgenerics.co.uk BioIndustry Association (BIA): regulatory@bioindustry.org Clinical & Contract Research Association (CCRA): mail@ccra.org.uk Ethical Medicines Industry Group (EMIG): info@emig.org.uk Health Food Manufacturers’ Association (HFMA): pennyviner@btconnect.com The National Pharmacy Association (NPA): independentsvoice@npa.co.uk Proprietary Association of Great Britain (PAGB): regulatory@pagb.co.uk ## Attachments - [List of approved countries](/government/publications/list-of-approved-countries-for-authorised-human-medicines/list-of-approved-countries)