Northern Ireland Supply Flashcards
What is the NI Protocol
- The NI Protocol means NI effectively remains in the EU so most Brexit‐driven changes only apply to Great Britain (GB)
○ CAP MAs will remain valid in NI
○ NI remains in the EMVO
○ Exports from GB to NI to need re‐testing and QP certification in NI or EU
○ Initial ‘Grace Period’ until 1/1/2022
European Commission, 17 December 2021; human medicines made in GB can be exported to NI on basis of GB testing and QP certification, provided that
○ NI MAs will have to apply the full range of EU medicines law
○ NI MAs will have to contain a “legal prohibition of sale (resale) outside its geographical scope”; i.e. NI medicines cannot be legally sold elsewhere in the EU
○ The EU FMD safety features provisions would have to be applied such that an NI pack scanned elsewhere in the EU would not be accepted
* EU Directive 2022/642 implemented these changes from 20 April 2022
Northern Ireland supply
- Medicines that have been tested and QP certified in GB will not need to be re‐tested and re‐certified in NI, so medicines can be exported from GB directly to wholesalers, hospitals, etc.
- IMPs can continue to be supplied from GB to NI, providing they have been QP certified in either GB or the EU
- Changes only apply to human medicines, not to veterinary medicines
- Packs that have UK MAs still need to comply with EU FMD provisions so that they can be supplied to NI
- PLGB packs are “encouraged” to at least comply with the tamper evidence part of the FMD requirements.
- The derogation that packs supplied from EU to GB do not need to be decommissioned on export from EU has been extended for another 3 years until end of 2024.
The UK will be bringing forward proposals for a UK system for serialisation etc. later this year.
NI protocol impact to licensing
- Many changes impacting licencing, so Reg. Affairs departments need to be aware. New guidance is going to be issued by MHRA very soon.
○ It is going to be easier to have UK‐wide PLs unless the product is centrally authorised (a CAP) in the EU.
○ EU CAPs will only be able to have GB PLs as not possible in EU to have a national MA for a CAP and the CAP will apply in NI.
○ New Northern Ireland MHRA Authorisation Route (NIMAR) being introduced by UK to allow supply of PLGB products to NI where there is a medical need for the product that cannot be supplied from the EU.
○ You cannot apply for a NIMAR, it is just agreed by the DHSC with the NIE and issued by the MHRA to meet medical needs
○ List of NIMAR products will be on the MHRA’s .gov.uk website.
NIMAR Route
NIMAR Route applicable from 1 January 2022
* Guidance published 24 May 2022, which covers:
○ Medicines eligible for supply via NIMAR
○ Distinguishing between supply under NIMAR and Regulation 167 (specials route)
○ Distribution of NIMAR medicines to NI
○ Prescribing medicines on the NIMAR list
Dispensing medicines on the NIMAR list
Windsor Agreement
Agreed on 27 February 2023
* When implemented, changes will be:
○ UK legislation will apply to Northern Ireland rather than EU legislation
○ MHRA will approve medicines for the whole UK market. Pharmaceutical companies will be able to produce a single pack valid across whole of the UK
○ The Falsified Medicines Directive provisions for medicines in NI to have safety features will NOT apply. Packs exported to NI from GB will need to be labelled for “UK only”
○ New innovative medicines, which in the EU would have to be assessed under the centralised procedures, will be approved under the UK regulatory system rather than managed by the EMA
Framework needs to be translated into both EU and UK law before it is implemented
* Delegated EU Regulation
* SI under the Medicines and Medical Devices Act 2021 in UK
○ EMA and MHRA will need to issue guidance once legislation is effective
○ UK will have to guarantee “effective monitoring, enforcement and controls” of the new rules
○ UK DHSC target date for implementation is January 2025
* So what rules will apply during 2024?
Windsor regulations
New EU Regulation 2023/1182 for human medicines
* Amends Directive 2001/83
* Published on 14 June 2023
○ To be implemented on 1 January 2025, providing UK has provided the required guarantees
* If guarantees are given before or after 1 January 2025, the regulation will apply from the first day of the month following the month during which the UK provided the guarantees
Windsor implementation
MHRA confirm 1 January 2025 as start date and issued transitional guidance on 9 June 2023
* Transitional guidance:
○ ‘UK only’ labels may be placed anywhere on a medicine pack
○ MHRA will continue to allow manufacturers to supply medicines in legacy EU packaging until 31 December 2024, extending the previous 31 December 2023 deadline
○ Packs in existing packaging already on the UK market, and within the supply chain, may remain until the date of their expiry
○ MHRA will expect anti‐tamper devices to remain on all medicine packaging
○ UK‐based suppliers or distributors of medicines should prepare for different packaging for medicines to be supplied to UK and EU markets from 1 January 2025 ○ Comprehensive guidance on the requirements for medicines to be placed on the market in NI will be provided in due course ○ In advance of these new arrangements taking effect, the Northern Ireland MHRA Authorised Route (NIMAR) will continue to function ○ The introduction of a ‘bridging mechanism’ to allow companies to supply NI with EU Centrally Authorised medicines for up to 6 months when the MHRA licenses a product before the EMA ○ This mechanism is permitted by EU Directive 2022/642
28 July 2023: guidance on “Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework”
- For ‘UK Only’ label:
○ ‘UK Only’ may be presented anywhere on the outer packaging of the medicine
○ The text must be conspicuous and clearly legible, at least 7‐point font and in line with Article 5 of EU Regulation 2023/1182, current MHRA expectations and best practice guidance
○ There are no other font or style requirements
MHRA will continue to allow manufacturers to supply medicines in legacy EU packaging until 31 December 2024
* The ‘UK Only’ statement can be applied via a sticker for a limited time period of 6 months, to 30 June 2025
○ After this date, ‘UK Only’ must be printed directly onto the packaging
* From 1 January 2025 EU FMD ‘safety features’ are not required
○ MHRA ‘encourage’ the continuation of tamper evident features
○ 2D bar code and serialisation can continue to be applied if a company wishes
MHRA must be informed before implementing any new artwork changes
* Companies have until 31 December 2024 to do so
* The guidance specifies two ways in which companies can notify the MHRA of artwork changes
* From 1 January 2025, joint EU/UK packs can no longer enter the supply chain
○ Packs released prior this date can remain on the market until expiry
