How will the Northern Ireland Protocol impact companies in the pharmaceutical sector? That is a question that we have been asked many times in recent months. The issue of the Northern Ireland Protocol has continued to be a source of disquiet and uncertainty for life science companies. With that in mind, we have created a brief guide on the protocol. The guide answers some of the most commonly asked questions that we have received by email in recent weeks. If you have any questions about the Northern Ireland Protocol and its impact on medicinal products, or another Brexit-related question, you can submit it in the form on our Contact Us page.
This article answers:
- What Is The Northern Ireland Protocol?
- Why Is It Being Introduced?
- What Impact Will the Northern Ireland Protocol Have On the Pharmaceutical Industry?
- What Is An Impacted Medicinal Product?
and finally, we offer our advice on how you and your company can best manage the situation.
What Is The Northern Ireland Protocol?
“The Northern Ireland Protocol necessitates checks and customs controls on goods entering Northern Ireland from Great Britain. To a lesser extent, it necessitates some controls on goods leaving Northern Ireland and going to Great Britain. The exact extent of both such checks and controls are to be agreed in an EU UK joint committee in the course of 2020”. (Source: BrexitLegal.ie)
Under the terms of the Protocol, Northern Ireland remains bound by EU single market rules for:
- Product requirements and safety, including chemical and medicinal safety
- Animal and plant health welfare
- Food safety and standards for animal products
- Farming standards
Why Is It Being Introduced?
Brexit has brought significant changes to the UK and EU trade agreements. These changes increased the risk of the reintroduction of a ‘Hard Border’ between the Republic of Ireland and Northern Ireland. It must be noted that the reintroduction of a hard border is regarded as an issue that could potentially lead to political instability.
In December 2017, the UK and EU committed to ensuring that there would be no physical checks or infrastructure on the island of Ireland. However, this proved difficult to do while maintaining the integrity of the EU single market and allowing the UK the freedom to have a clean break from the EU. The EU proposed a Northern Ireland-only backstop where Northern Ireland would remain in the EU’s customs territory and align with EU single market rules, but this was rejected by the then Prime Minister.
The protocol was re-negotiated by the United Kingdom’s Prime Minister, Boris Johnson in October 2019 and was made part of the withdrawal agreement for the UK leaving the EU on 31st of January 2020. The ‘Protocol on Ireland/Northern Ireland’ requires custom and regulatory alignment between the EU and Northern Ireland only.
The protocol means that goods will not need to be checked along the Irish border, between Northern and Southern Ireland, when the new UK-EU relationship begins, on 1 January. Northern Ireland will remain part of the UK customs territory but must align with the EU customs regulations. However, to comply with EU requirements, checks will be required on certain goods entering Northern Ireland from Great Britain (England, Scotland, and Wales), thus creating a regulatory and customs border in the Irish Sea.
Currently, as part of UK-EU trade talks, tariffs (taxes on imports) may be charged on goods “at risk” of moving from Northern Ireland into the Republic of Ireland as Ireland remains in the EU. A joint committee of UK and EU government officials will determine if goods are at risk of onward movement to the EU.
What Impact Will the Northern Ireland Protocol Have On the Pharmaceutical Industry?
From next year, Northern Ireland will continue to uphold the EU’s falsified medicines directive (FMD), however, the UK will not. This directive prevents falsified or fraudulent medicines from entering the EU market. The manufacturers must continue to place a barcode on each of the product packs and log crucial product information on the relevant EU database.
The Association of the British Pharmaceutical Industry (ABPI) has requested the British government to negotiate a 1-year ‘Phase In’ phase to help prevent any expected disruptions to the supply of medicines.
Continuation of regulatory alignment between NI and the EU will ensure minimum disruption due to Brexit. The regulatory alignment will also ensure a company’s manufacturing and associated qualified person (QP) certification, performed at the NI site, will be recognized in both the UK and EU.
Medicines that have been certified by a Qualified Person and released for sale or supply before 11 pm on 31 December 2020 will be considered to have been ‘placed on the market’. The protocol enables these batches to remain available for sale or supply between Great Britain, Northern Ireland, and the EU after 1 January 2021 without additional regulatory checks. They may be supplied to a wholesale dealer or other authorised person, such as a pharmacy or hospital, in Northern Ireland by a manufacturer or wholesaler in Great Britain. A batch may be confirmed as being placed on the market before 11 pm on 31 December 2020 using evidence such as:
- A written statement from the manufacturer or a wholesaler who has sold or supplied the batch
- Reference to company internal systems (e.g. global Enterprise Resource Planning system) that show batch certification
To enable this supply chain verification, manufacturers should ensure that the date of placing on the market is visible to the supply chain.
Medicines brought from Great Britain into Northern Ireland will be considered ‘imported medicines’ under the relevant EU legislation. Therefore, they will have to have a marketing authorisation granted under EU law. Medicines sold in Northern Ireland will have to be labelled with the details of the holder of the marketing authorisation or their local representative. Both must be located either in Northern Ireland or in an EU member state – not in Great Britain.
From 1 January 2021, the importation of active substances into Great Britain (England, Wales, and Scotland) will continue to be accepted without Written Confirmation from European Economic Area (EEA) countries, the USA, Japan, the Republic of Korea, Brazil, Australia, Israel, and Switzerland, as well as from Northern Ireland. Northern Ireland will also continue to align with all relevant EU rules relating to the placing on the market of manufactured goods.
What Is An Imported Medicinal Product?
- A medicinal product/active pharmaceutical ingredient shipped from Northern Ireland to the EU is not an imported medicinal product.
- A medicinal product/active pharmaceutical ingredient shipped from Great Britain to Northern Ireland is an imported medicinal product.
Our Advice
- A medicinal product placed on the market in Northern Ireland has to comply with the EU acquis for medicinal products, i.e. the product has to be covered by a marketing authorisation issued by the Commission or the United Kingdom in applying the EU acquis for medicinal products;
- Marketing authorisation applicants who wish to obtain a marketing authorisation for the United Kingdom in respect of Northern Ireland must include Northern Ireland in the scope of their marketing authorisation application in the decentralised procedure (DCP) or the mutual recognition procedure (MRP);
- Do not forget that UK products will continue to be part of Union referral procedures in respect of Northern Ireland; the scientific opinion and Commission Decisions will include UK products in respect of Northern Ireland.
- Non-serious adverse events occurring in Northern Ireland must be reported as if they have occurred in the EU.
- The territory of Northern Ireland is included in the assessment of prevalence, ‘well-established use’, as well as the ‘sunset clause’.
The Protocol excludes the possibility for the United Kingdom in respect of Northern Ireland to:
- participate in the decision-making and decision-making of the Union.
- initiate objections, safeguard, or arbitration procedures to the extent that they concern regulations, standards, assessments, registrations, certificates, approvals and authorisations issued or carried out by EU Member States.
- act as the leading authority for assessments, examinations, and authorisations;
- invoke the country of origin principle of mutual recognition for products placed legally on the market in Northern Ireland.
You should also note that the United Kingdom, with respect to Northern Ireland, may not act as a reference Member State or trigger referrals. Also, an official batch release by the United Kingdom in respect of Northern Ireland is not recognised in the EU.
Regarding medicinal products, the guidance stresses that:
- a medicinal product authorised in the United Kingdom in respect of Northern Ireland is not to be considered as a reference medicinal product in the Union.
- the marketing authorisation holder of a medicinal product, the registration holder for a traditional herbal medicinal product, and the QPPV may not be established in Northern Ireland, except for authorisations by the United Kingdom in respect of Northern Ireland.
- The principle of exhaustion of intellectual property rights does not apply to the territory of Northern Ireland.
The protocol applies from the end of the transition period, currently, 01st January 2021.
We Can Help
As we mentioned at the beginning of this article, the NI Protocol has been a topic of interest for client companies. We are assisting many of our clients with issues relating to this. Get in touch with us if you would like our advice or assistance on the issue. Also, if you have a question for us, you can submit it to us by entering it into the ‘How Can We Help You?’ box in the form below.
Call us at 00353 52 61 76706, email us at info@acornregulatory.com.
