I am writing to give you an important update on our work together to ensure continuity in the supply of medicines and medical devices to the UK. This follows the negotiated withdrawal agreement between the government and the EU and the UK-EU Trade and Cooperation Agreement (TCA), which came into force at the end of the transition period (EoTP).
Maintaining our working relationship
First of all, I would like to thank you for the continued critical role you play in ensuring continuity of care in the health and care sectors. The past year has been a tremendous challenge due to the global impact of COVID-19, and we know that many of your supply chains have been and remain under heavy strain.
The ongoing pandemic and the return of planned and elective care in the NHS mean we must prepare thoroughly for the next phase of this process. The risks remain for the next year, and we need to make sure our supply chains are able to withstand these short-term challenges and work together to develop long-term strategies to improve resilience of care for the benefit of patients. Over the past 18 months, we’ve learned the importance of working together to make supply chains more resilient, and we will continue to do so.
Maintaining current readiness
While there have been isolated, often complex, disruptions since January 1, we did not determine the extent of supply disruption to support our planning assumptions. Given that this is good news, the Department of Health and Social Affairs (the Department) believes that we have a few more months on standby as part of our shared goal of ensuring patient safety through resilient supply chains have to stay.
There are challenges that need to be recognized, not least the ongoing response to the coronavirus pandemic (COVID-19), the growing third wave in Europe and the likely impact here in the UK. There is still a risk of COVID-19 affecting global borders and, as we’ve seen over the past 12 months, the effects are difficult to anticipate and mitigate, although we do whenever possible. For these reasons, the NHS Supply Chain department has asked to keep an emergency medical device and clinical supplies inventory on the Centralized Stock Build (CSB) for the foreseeable future and we strongly encourage you to keep your UK inventory where it is available were built and will remain.
The department is required to review these contingency measures and report back to the industry with recommendations after this review and in the summer. This review includes a look at the COD and our recommendations to the industry, taking into account the latest findings as well as the situation and outlook for COVID-19.
Some of you have decided to create your own diversion plans before the EoTP. To ensure your supply chains are stable, you may want to continue to incorporate alternative logistics routes into your plans to support uninterrupted replenishment in the UK. The government will maintain the availability of state-secured freight capacities (GSFC) until the end of June. See the list of critical goods that can be transported with GSFC.
The National Supply Disruption Response (NSDR) remains operational and is available to support supply disruptions. Information on how to contact the NSDR can be found here.
Import controls come into force on October 1, 2021 and January 1, 2022
The gradual border controls originally planned for April 1 and July 1, 2021 have now been postponed to October 1, 2021 and January 1, 2022, respectively. As the government has revised the schedule for the introduction of import controls from the EU to the United Kingdom (UK), it is important that you use this time to continue the preparations for the introduction of these controls.
The import controls represent a general update of the import requirements for hygiene and plant protection (SPS). SPS measures include the requirement of prior notification to the national authorities before goods are imported, health certification and the import of goods via a border control post Post, BCP), which is equipped to handle the imported goods. These changes are carried out in 2 phases:
As of October 1, 2021, imports of all products of animal origin (POAO), certain animal by-products (ABP), regulated plants and plant products must be subject to prior notification to the UK authorities on the import of products, animals, food and feed (IPAFFS) and must be accompanied by correct health documentation. However, if your product has a license under the Medicines Legislation issued by the Medicines and Health Products Regulatory Authority (MHRA) or the Veterinary Medicines Directorate (VMD), or has a CE mark, the product is from Hygiene Controls and plant protection (SPS) excluded. This applies to products that are not finished drugs, as finished drugs are not subject to SPS controls.
The UK’s full import controls will come into effect on January 1, 2022. Products subject to SPS controls must go through a specific BCP equipped to handle the goods in question and must undergo controls with a list of approved BCPs available. Goods are subjected to an increased number of physical controls. This refers to applicable drugs, medical devices, and any other category of health care.
More information on the gradual border controls in October this year and January 2022. More information on the continuation of the Approved Removals System to Northern Ireland (STAMNI), which will now be extended until at least October 1, 2021
Regulation of medical devices
Medical device suppliers in Northern Ireland (and the EU) must comply with the Medical Device Regulation (MDR) on May 26, 2021.
MDR is not implemented in the UK, but in accordance with the Northern Ireland Protocol in Northern Ireland (NI). Further information on device control can be found here.
Batch testing of drugs
We have listened to industry concerns about the need for adequate lead time to implement our future drug batch testing strategy. The TCA contains important facilitations related to pharmaceuticals, including an agreement to recognize GMP (Good Manufacturing Practice) inspections and a working group for medical devices. The UK previously agreed on two-year unilateral recognition of EU batch tests for a limited period starting January 1, 2021.
We have since put in place a two-year notice period for any change in the current position of unilateral batch test recognition in the EU / European Economic Area (EEA) and will be conducting a full review of the future batch test strategy for the UK in collaboration with industry and other stakeholders throughout. The two-year notice period will be triggered as soon as this review has been completed, at the latest by the end of December 2022.
This means that the continued recognition of EU / EEA batch tests does not end on January 1, 2023.
While the notice period allows the sector to continue to focus on the pandemic and protect the supply of medicines to UK patients, the standstill policy has not changed in other areas. We continue to encourage and support industrial partners to prepare for the end of the deadlock in all other areas later this year.
The MHRA has updated its batch testing guidelines to reflect the addition of the two-year notice period.
Ships to NI starting January 1, 2022
The department is aware of the challenges to be delivered to NI from January 1, 2022. We are currently working with all partners to address this issue.
Report changes to offers
Please stay in close contact with the teams in the department and address any supply problems, bottlenecks or interruptions.
For pharmaceuticals, this is done via the DASH portal (Discontinuations and Shortages). It is a legal requirement to notify the department through the DASH portal of any perceived supply disruptions or bottlenecks in all UK countries (English, Scottish, Welsh and Northern Irish markets), although there is still a separate PO Box for EoTP-related returns or inquiries.
For pharmaceuticals, medical devices, substances of human origin, non-clinical goods, and services and supplies for clinical trials, please notify the appropriate teams in the department using the mailboxes below.
In addition to this letter and the continued commitment of the DHSC teams, we will continue to host webinars to which you will be invited. We continue to encourage you to join our online DHSC eXchange platform, which now offers a wide range of relevant government content for suppliers. If you are not already a member, you can request an invite by emailing your usual contact or one of the teams to the email addresses provided above.
We continue to work hand in hand with the NHS, industry associations, decentralized administrations, MHRA and other government departments to strengthen supply chains.
More information on border and customs processes can be found at www.gov.uk/transition. All guides and advice on COVID-19 can be found at www.gov.uk/coronavirus. For GSFC-specific questions, please contact firstname.lastname@example.org. You can follow these Twitter accounts to stay up to date:
Chief Commercial Officer
Ministry of Health and Social Affairs