EU Exit
The UK has left the EU and the transition period is set to come to an end on 31 December 2020. Government continues to consider what the final EU Exit arrangements might be.
DHSC has written to suppliers of medicines (4 August 2020 and 14 August 2020) setting out the Government’s preparations alongside its expectations of the industry in the run up to 31st December 2020. The letters mention the Reasonable Worst Case Scenario (RWCS) that Government is using. This includes a risk of significant disruption across the short straits for 6 months following the end of the transition period, with a particular risk during the first 3 months.
To combat this, suppliers are encouraged to review their own logistics arrangements and consider the appropriateness of using existing supply chain routes during this period. From the Government side, a 4-year procurement framework for freight capacity for ‘Category 1’ goods, which includes all health supplies, was initiated in 2019 and remains in place. DHSC has also retained its express freight service arrangements to support the urgent movement of medicines and medical products if other measures experience difficulties Full text is available below.
The fourth meeting of the Ireland/Northern Ireland Specialised Committee was held on 5 Nov 2020 via video conference and co-chaired by officials from the UK Government and the European Commission.
The UK and the EU exchanged updates on the implementation of the Protocol. The Committee noted that an agreed approach had been reached on a phased process for implementing medicines regulation in Northern Ireland up to 31 December 2021, providing the additional time needed for businesses to prepare in relation to batch testing, importation and Falsified Medicines Directive requirements. Full press is available below.
Correspondence and Links
- 09 Jun 23 Windsor Framework Medicines Announcement – GOV.UK (www.gov.uk)
- 30 May 23 Press Release from Council of European Union Confirming that the EU is Continuing to Put in Place the Windsor Framework
- 26 May 23 MHRA Announces that MHRA Will Allow Medicines to be Placed on the Market If They Have Been Authorised by Regulators in Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States
- 28 Feb 23 CPNI CU#230228B RE: Windsor Framework
- 27 Feb 23 The Windsor Framework – Sector Explainer – GOV.UK (www.gov.uk)
- 22 Nov 22 Findings of the House of Lords Sub-Committee on the Protocol on Ireland/Northern Ireland’s Inquiry into the Northern Ireland Protocol Bill
- 11 Oct 22 Northern Ireland Protocol Bill 2nd Reading – Parliamentary Bills – UK Parliament
- 24 May 22 The Northern Ireland MHRA Authorised Route (NIMAR) – GOV.UK (www.gov.uk)
- The UK Transition
- 21 Jan 22 CPNI CU#220121A RE: Reminder to Report Medicines Shortages to CPNI
- 10 Mar 21 CPNI CU#210310A RE: Scheme for Temporary Agri-Food Movements to Northern Ireland (STAMNI)
- 03 Mar 21 CPNI CU#210303A RE: Reminder to Report Medicines Shortages and Supply Chain Issues to CPNI
- 03 Feb 21 CPNI CU#210203B RE: Daily Summary
- 11 Jan 21 CPNI CU#210111A RE: HSCB CORRESPONDENCE Import Declaration for Medicines and Medicines Supplies
- 31 Dec 20 Moving Goods Into, Out of, or Through NI from 1 January 2021
- 31 Dec 20 Supplying Authorised Medicines to NI from 1 January 2021
- 17 Dec 20 CPNI CU#201217B RE: Prescriptions Issued by EEA Health Professionals following the Transition Period
- 17 Dec 20 CPNI CU#201217A RE: Great Britain to Northern Ireland Trade Webinar
- 08 Dec 20 EU Transition Stakeholder Briefing
- 08 Dec 20 CPNI CU#201208A RE: Update on EU Transition – DoH Echo Session
- 30 Nov 20 CPNI CU#201130B RE: CPNI ZOOM LOGON DETAILS for CPNI Contractor Meeting — Thursday 3rd December 2020 @ 7:30pm —
- 27 Nov 20 CPNI CU#201127C RE: CPNI ZOOM Online Contractor Meeting — Thursday 3rd December 2020 @ 7:30pm —
- 25 Nov 20 DoH (NI) EU Exit Operational Readiness Guidance
- 05 Nov 20 Press Release Ireland/Northern Ireland Specialised Committee
- 03 Nov 20 CPNI CU#201103C RE: EU Exit
- 03 Aug 20 Letter to Medicine Suppliers
- 21 Nov 19 EU Exit Letter from Cathy Harrison (CPO) to HSC Organisations RE: Extension Period Next Steps
- 03 Jul 19 Letter from Cathy Harrison (CPO) RE: Continuity of Supply of Medicines and Medicinal Products into the UK
Medicines Shortages
Medicine shortages is a continuing issue with an increasing number of products being awarded a concessionary price. We appreciate the lengths contractors take to try to maintain medicine supply to patients but inevitably we know there are instances when not all medicines prescribed can be supplied at once.
CPNI has produced a standard patient leaflet to help contractors explain to patients the ongoing matter of medicine shortages.
Furthermore, CPNI has developed a Medicines Shortage Reporter to help contractors report problems experienced in obtaining medicines. This includes generic items and branded medicines.