Current Issues

In the run up to the end of the Transition Period on 31^st December 2020, the HDA worked closely with the Department for Health and Social Care and other medicines supply chain representatives on assessing levels of preparedness to ensure the continued supply of medicines across the four countries of the United Kingdom.

With the Transition Period having come to an end, the UK is now a third country in relation to the EU. The HDA welcomed the Brexit deal agreed to in December 2020, stressing that this was the best possible outcome to prevent disruptions to the supply of medicines to patients. Despite a deal being reached, much remains to be done to ensure a safe and resilient supply chain post-Brexit, and we continue to work with partners up and down the supply chain on a number of areas key to the HDA, including:

• Mutual recognition procedures. The MHRA has published guidance on the approach it intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP) with the UK as a Concerned Member State (CMS) and not completed by 31^st December 2020. More information can be found here. The HDA is working with its members and industry partners to ensure a smooth implementation of the new guidance.
• Guidelines on Good Distribution Practice (GDP). EU GDP guidelines have been transferred directly into UK law, and the UK has committed to following these for the next two years. The MHRA would still be able to implement any changes to the guidelines independently of the EMA if it wished to do so, but the sector welcomed this decision which will provide the time to design future regulations that are tailored to the UK medicines supply chain.
• Northern Ireland. The UK and the EU have agreed a phased process for implementing medicines regulation in Northern Ireland up to 31^st December 2021, providing healthcare distributors with welcome preparation time to ensure a smooth transition and maintain continuity of medicines supply. Until the end of this year, medicines can be supplied from Great Britain to Northern Ireland without requiring additional regulatory importation controls. But from 1^st January 2022, medicines supplied from GB to NI will require further controls (manufacture and import authorisation, batch testing, and qualified person (QP) certification done in Northern Ireland or an EEA state) – changes that the sector is already planning ahead for.
• Falsified Medicines Directive. With the Transition Period having come to an end, UK legislation relating to the Falsified Medicines Directive (FMD) and associated Delegated Regulation of the Directive (DR) has been revoked as of 1^st January 2021 for GB nations, with end users now disconnected from the UK Medicines Verification System. Under the terms of the Northern Ireland Protocol, FMD will still apply in Northern Ireland for at least four years, at which point Northern Ireland will decide through democratic consent whether or not these provisions remain in place. Under the Medicines and Medical Devices Bill (currently progressing through Parliament), the UK Government would be able to make its own regulations aimed at preventing falsified medicines from entering the medicine supply chain. Industry stakeholders will be consulted as part of these new regulations, and the HDA plans to fully engage in the process where and when appropriate to do so.
• Medical devices. The Brexit deal contains several provisions to ensure that both parties are able to work together to remove unsafe devices from their markets, that medical devices are effectively labelled, and that there is ongoing opportunity for further collaboration. This will be further supported by the UK’s Medicines and Medical Devices Bill 2019-21, which is currently progressing through Parliament. The Bill addresses safety and regulation of medical devices and medicines, and aims to provide a framework for innovation in post-Brexit UK.

We will continue to work closely with stakeholders up and down the supply chain and beyond to maintain the flow of medicines throughout this transition phase, and successfully plan for the months and years ahead.