Export drugs and medicines: special rules

AI Summary

This regulatory guidance outlines the mandatory requirements for exporting controlled drugs, human medicines, and veterinary medicines from the UK. The framework is governed by the Medicines and Healthcare products Regulatory Agency (MHRA), the Veterinary Medicines Directorate (VMD), and the Home Office. While the document does not reference a specific company inspection, it establishes the compliance standards all exporters must meet regarding Good Manufacturing Practice (GMP) and legal authorizations. Key requirements include securing specific licenses based on the substance type. Controlled drugs, such as opioids and stimulants, require a Home Office controlled drug licence. Products potentially used for lethal injections must be supported by an Export Control Joint Unit licence. For general human and veterinary medicines, companies must possess valid manufacturer, wholesale dealer, and marketing authorizations. To facilitate international trade, exporters must apply for specific export certificates. The MHRA manages five certificate types for human medicines, including Certificates of Pharmaceutical Products and Manufacturing Status. The VMD oversees the 'Defra' certificate series for animal medicines, verifying that products are UK-authorized and manufactured at sites meeting GMP standards. Required actions for companies include identifying the necessary certificate via importer consultation, submitting applications through the MHRA portal or VMD email, providing supporting evidence from marketing authorization holders, and paying the prescribed fees. Failure to adhere to these certification and licensing protocols may result in the prohibition of exports.