Therefore, they will have to have a marketing authorisation granted under EU law. It provides that whilst NI remains part of the UK VAT area and Customs territory, it also has access to the EU’s Single Market. Checks might involve physical inspections on certain goods coming from England, Wales or Scotland, and/or additional paperwork for businesses. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. The government said the protocol … This means that Northern Ireland will follow whatever opportunities and obligations result from UK trade policy, including rules attached to future trade agreements between the UK and other countries. Now that it has left the EU, the UK is seeking to negotiate new trade deals. From next year, Northern Ireland will continue to uphold the EU’s falsified medicines directive (FMD), however, the UK will not. The Northern Ireland protocol is supposed to be operational by January and has to be applied even if the UK and EU do not reach a trade deal. This website uses cookies to improve your experience. A medicinal product/active pharmaceutical ingredient shipped from Great Britain to Northern Ireland is an imported medicinal product. This forms part of the overall Withdrawal Agreement and will apply unless and until it is superseded, in whole or in part, by any subsequent agreement. This forms part of the overall Withdrawal Agreement and will apply unless and until it is superseded, in … This paper by Blair Horan examines the implementation of the Protocol, and the prospects for a successful outcome to the EU-UK negotiations Author: Blair Horan. During Brexit negotiations, all sides agreed that protecting the Northern Ireland peace deal (the Good Friday agreement) was an absolute priority. The Northern Ireland Protocol. These changes increased the risk of the reintroduction of a ‘Hard Border’ between the Republic of Ireland and Northern Ireland. The UK and Ireland’s shared membership of the European Union supported the free movement of trade across the Irish border. The Protocol excludes the possibility for the United Kingdom in respect of Northern Ireland to: You should also note that the United Kingdom, in respect of Northern Ireland, may not act as reference Member State or trigger referrals. A medicinal product placed on the market in Northern Ireland has to comply with the, 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. IIEA 9th October 2020 1 min. Politics Boris Johnson Brexit Ireland Irish border Northern Ireland Withdrawal Agreement Why this Irish border protocol could see the UK face infringement proceedings The arrangement is designed to keep the Irish land border open—but details of how it will work remain up in the air 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. 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. Northern Ireland will continue to follow several of the EU's rules, and lorries will continue to … To a lesser extent, it necessitates some controls on goods leaving Northern Ireland and going to Great Britain. This means that Northern Ireland will follow whatever opportunities and obligations result from UK trade policy, including rules attached to future trade agreements between the UK and other countries. CMC & Pharmaceutical Regulatory Affairs Services, MIA Services (Manufacturer’s & Importer’s Authorisation Licence). The task of determining which goods will end up in the EU is being undertaken by a Joint Committee set up by the EU and the UK to oversee the implementation of the protocol. You can access all of our Brexit articles, e-books, and guides by clicking here. These cookies will be stored in your browser only with your consent. The Centre on Constitutional Change applies the best of social scientific scholarship to the questions raised by the UK’s evolving territorial relationships. How will the Northern Ireland Protocol impact companies in the pharmaceutical sector? Regarding medicinal products the guidance stresses that: The protocol applies from the end of the transition period, currently, 01st January 2021. 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. That is a question that we have been asked many times in recent months. Gurtnafleur Business Park, Checks might involve physical inspections on certain goods coming from, Freedom of information publication scheme. It is a crucial part of the draft Withdrawal Agreement . The ‘Protocol on Ireland/Northern Ireland’ requires custom and regulatory alignment between the EU and Northern Ireland only. These checks are designed to ensure that only goods that are in line with EU rules and meet EU standards can freely enter the Republic of Ireland (and, therefore, the European Union) via Northern Ireland. It is designed to avoid customs tariffs, customs declarations and customs controls in trade between Northern Ireland and the European Union, in particular the Republic of Ireland. Clonmel, Co. Tipperary, Call us at 00353 52 61 76706, email us at info@acornregulatory.com or complete the form below if you would like us to help. Suite 6, Powerstown House, That is a question that we have been asked many times in recent months. The ‘Protocol on Ireland/Northern Ireland’ requires custom and regulatory alignment between the EU and Northern Ireland only. Given Northern Ireland’s history of conflict, this was economically and politically important because it helped to make the border a less divisive issue. The Withdrawal Agreement concluded by the UK government and the EU contains special arrangements for Northern Ireland. We are assisting many of our clients with issues relating to this. The manufacturers must continue to place a barcode on each of the product packs and log crucial product information on the relevant EU database. Mr Cairns explained how "Brexit hasn’t really turned out very well for the people of Northern Ireland" adding how the Northern Ireland Protocol "hangs around Arlene Foster and the DUP’s neck." , this was economically and politically important because it helped to make the border a less divisive issue. Brexit Northern Ireland Question Explained - What is Northern Ireland Protocol? The Irish backstop (formally the Northern Ireland Protocol) is a defunct appendix to a draft Brexit withdrawal agreement developed by the May government and the European Commission in December 2017 and finalised in November 2018, that aimed to prevent an evident border (one with customs controls) between the Republic of Ireland and Northern Ireland after Brexit. Earlier this month it … This category only includes cookies that ensures basic functionalities and security features of the website. As the NI Protocol only covers goods but not services, this means that EU VAT rules will apply to goods but UK VAT rules will apply to services in respect of Northern Ireland. Informally it is called the Northern Irish 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. This article is part of our extensive Brexit coverage. What is the Northern Ireland consent mechanism in the Withdrawal Agreement? As EU chief negotiator Michel Barnier explained: “The difficulties on the island of Ireland are caused by Brexit, not by the protocol. Politics Explained. Northern Ireland will continue to follow several of the EU's rules, and lorries will continue to … participate in the decision-making and decision-shaping of the Union. 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. The result is the Northern Ireland Protocol, which forms part of the Withdrawal Agreement and takes into account the special circumstances of the region. Northern Ireland Protocol explained (Image: EXPRESS) Ministers have used post-Brexit freedoms to help struggling businesses through the pandemic. The Protocol which was agreed as part of the Withdrawal Agreement seeks to avoid a hard border in Ireland, protect the EU Single Market and maintain NI’s place in the UK internal market. This means that, when it comes to producing goods, for example, in agricultural and food products, or manufactured goods, the rules followed in Northern Ireland have to remain in line with EU rules, even if the rules in the rest of the UK change. ... the Northern Ireland protocol, or a global pandemic present. The operation of the Northern Ireland Protocol in the UK-EU Withdrawal Agreement has meant that many in Northern Ireland feel … (Source: BrexitLegal.ie). The exact extent of both such checks and controls are to be agreed in an EU UK joint committee in the course of 2020”. Northern Ireland will also continue to align with all relevant EU rules relating to the placing on the market of manufactured goods. But opting out of some of these cookies may affect your browsing experience. How will the Northern Ireland Protocol impact companies in the medical devices sector? What Impact Will the Northern Ireland Protocol Have On the Pharmaceutical Industry? He explained that while the Good Friday Agreement brought the armed conflict to an end, it didn't change how people there coexist. Now that it has left the EU, the UK is seeking to negotiate new trade deals. Product requirements and safety, including chemical and medicinal safety, Food safety and standards for animal products, A written statement from the manufacturer or a wholesaler who has sold or supplied the batch, Reference to company internal systems (e.g. The protocol is a creative and complex solution designed to avoid the reintroduction of a hard border between Northern Ireland and the Republic of Ireland. It is a legal document that acknowledges the unique situation of Ireland and Northern Ireland and the specific impact Brexit will have on the land border between them. We'll assume you're ok with this, but you can opt-out if you wish. This requires some checks and controls on certain goods entering Northern Ireland from the rest of the UK, if those goods are at risk of crossing the Irish border into the EU market. It is mandatory to procure user consent prior to running these cookies on your website. The Northern Ireland/Ireland Protocol is an annex to the Withdrawal Agreement agreed between the United Kingdom and the European Union in October 2019. Northern Ireland will remain aligned to EU regulations in areas needed to avoid a hard border, such as ‘industrial goods’ and agri-food. in respect of Northern Ireland shall be indicated as "UK(NI)" or "United Kingdom (Northern Ireland)". The Northern Ireland/Ireland Protocol is an annex to the Withdrawal Agreement agreed between the United Kingdom and the European Union in October 2019. We also use third-party cookies that help us analyze and understand how you use this website. The Protocol which was agreed as part of the Withdrawal Agreement seeks to avoid a hard border in Ireland, protect the EU Single Market and maintain NI’s place in the UK internal market. 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. Northern Ireland will remain aligned to EU regulations in areas needed to avoid a hard border, such 15 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 at the end of this page. EU customs duties (tariffs) will also apply to goods entering Northern Ireland from the rest of the UK unless it is clear that these goods are not at risk of crossing the Irish border and thereby entering the European Union. 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