MHRA: Parallel Import Licence Windsor Framework: Key Details

• The MHRA operates a UK parallel import licensing scheme for EEA-authorised medicines, requiring therapeutic equivalence to UK products.
• Applications for parallel import licences are categorised based on common origin and complexity, with specific submission requirements via the MHRA portal.
• From January 1, 2025, the Windsor Framework will empower the MHRA to license all medicines across the entire UK, including Northern Ireland.
• The Windsor Framework will invalidate Parallel Distribution Notices in Northern Ireland and disapply EU Falsified Medicines Directive requirements for medicines supplied there.
• Despite changes to EU FMD safety features for parallel imports from 2025, licence holders must still ensure proper decommissioning of medicine packs.

From this date, the MHRA will assume responsibility for licensing all medicines across the entirety of the United Kingdom, including Northern Ireland.

The Medicines and Healthcare products Regulatory Agency (MHRA) oversees a crucial UK parallel import licensing scheme, enabling medicines initially authorised in a European Economic Area (EEA) Member State to be marketed across the United Kingdom. This is permissible provided the imported product demonstrates no therapeutic difference from its cross-referenced UK counterpart. Companies seeking to engage in this practice must ensure they meet specific regulatory criteria, including holding a manufacturer’s licence if product assembly or repackaging is required.

Further stipulations apply to certain categories of medicines. For instance, products controlled by the Misuse of Drugs Act necessitate an additional import licence from the Home Office. While the MHRA grants parallel import (PLPI) licences, it does not assess potential trademark infringements; applicants remain responsible for ensuring they are entitled to use the product name and that it does not infringe upon third-party trademarks. Licence holders are also obligated to comply with all other statutory provisions and respect any private civil rights of third parties.

The MHRA PLPI application process is structured into three distinct categories. A 'simple' parallel import licence is granted when the imported and UK products share a common origin, which is the traditional criterion for such licences. The second category applies when the products do not share a common origin, as defined, and the application is considered complex, requiring additional scrutiny. The third category also involves products without a common origin, but the application is not deemed complex, simplifying the assessment process.

All applications must be submitted through the dedicated MHRA portal, where the electronic application form is available. It is imperative that all sections of this form are completed accurately, including details of the appropriate UK cross-reference product. Submissions that fail to meet the specified requirements will be invalidated and rejected, with reasons communicated via email. Should an application be rejected as invalid, the entire submission process must be restarted and resubmitted. Applicants are recommended to provide a separate company functions list, which, if supplied, negates the need to complete sections 12, 13, 14, and 15 of the application form. Additionally, a minimum set of documentation must accompany the completed form, with each document submitted as a separate PDF file.

A significant shift in the regulatory landscape for medicines parallel import in Northern Ireland is set to occur with the full implementation of the Windsor Framework on January 1, 2025. From this date, the MHRA will assume responsibility for licensing all medicines across the entirety of the United Kingdom, including Northern Ireland. A direct consequence of this framework is that Parallel Distribution Notices (PDNs) will no longer be valid for medicines supplied in Northern Ireland.

The Windsor Framework establishes the long-term arrangements for the supply of medicines into Northern Ireland, ensuring a unified UK-wide approval and licensing system by the MHRA. Crucially, it provides for the disapplication of European Union (EU) Falsified Medicines Directive (FMD) requirements for medicines marketed and supplied within Northern Ireland. This means that from January 1, 2025, EU FMD safety features will no longer apply to parallel import licences. However, PLPI licence holders will still be required to ensure that packs are correctly decommissioned and cannot re-enter the supply chain, maintaining a critical aspect of supply chain integrity.

Lawyers and compliance officers advising pharmaceutical clients must review the updated MHRA guidance on parallel import licences, particularly the impact of the Windsor Framework from 1 January 2025 on Northern Ireland supply and EU FMD requirements. This necessitates an assessment of current licensing strategies and application processes to ensure ongoing compliance and avoid supply chain disruptions.

Source: Original reporting via GOV.UK