Medicines: apply for a parallel import licence

AI Summary

This MHRA guidance outlines the regulatory requirements for the UK parallel import licensing (PLPI) scheme, applicable to companies importing medicines from the European Economic Area. Under the framework, imported products must have no therapeutic difference from UK-authorized versions and must adhere to Good Manufacturing Practice (GMP) standards. A significant update involves the Windsor Framework, effective January 1, 2025, which transitions medicines to a UK-wide licensing model and removes EU Falsified Medicines Directive safety feature requirements in Northern Ireland. To comply, companies must hold a Wholesale Dealer’s License (WDA(H)) and a Manufacturer’s License (MIA) for assembly or repackaging. Key issues identified for regulatory scrutiny include the failure to update patient information leaflets (PILs) in line with UK safety changes, inadequate user testing of leaflets, and missing excipient declarations on labels. The MHRA employs a 'One RFI' rule, where applications are refused if deficiencies are not corrected within 30 days of a single request. Required actions for license holders include submitting all applications via the MHRA portal, ensuring all site functions are correctly licensed, and maintaining records for potential recalls. Companies may utilize the 'Tell and Do' procedure for low-risk variations to continue distribution during assessment. Licenses are valid for five years, and compliance—including Braille accuracy and safety updates—is verified through routine GMP inspections.