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This publication is available at https://www.gov.uk/government/publications/appointing-nominated-persons-to-your-business-if-theres-no-brexit-deal/appointing-nominated-persons-to-your-business-if-theres-no-brexit-deal
Delivering the deal negotiated with the EU remains the government’s top priority. This has not changed.
However, the government must prepare for every eventuality, including a no deal scenario. For 2 years, the government has been implementing a significant programme of work to ensure that the UK is prepared to leave the EU on 29 March 2019.
It has always been the case that as we get nearer to that date, preparations for a no deal scenario would have to be accelerated. We must ensure plans are in place should they need to be relied upon.
In the summer, the government published a series of 106 technical notices setting out information to allow businesses and citizens to understand what they would need to do in a no deal scenario so they can make informed plans and preparations.
This technical notice offers guidance for continued planning in the event of no deal.
Also included is an overarching framing notice explaining the government’s approach to preparing the UK for this outcome in order to minimise disruption and ensure a smooth and orderly exit.
We are working with the devolved administrations on technical notices and we will continue to do so as plans develop.
If the UK leaves the EU without a deal on 29 March 2019, the requirements for placing certain products on the UK and EU markets, including the arrangements for nominated persons, will change.
The purpose of this notice is to explain future arrangements for nominated persons (‘authorised representatives’ and ‘responsible persons’) in relation to manufactured goods in a ‘no deal’ scenario.
This notice does not cover the following areas:
- The role of Qualified Persons and Qualified Persons Responsible for Pharmacovigilance (QPs and QPPVs) for pharmaceuticals. Guidance available here: Batch testing medicines if there’s no Brexit deal and Medicines, Medical Devices and Clinical Trials and further guidance on the regulation of medicines, medical devices and clinical trials
- The role of the Only Representative for chemicals
- Authorised Representatives for medical devices
For the purposes of this notice, references to EU countries should be read as references to EEA states (Iceland, Liechtenstein and Norway).
Before 29 March 2019
Businesses can appoint nominated persons to carry out certain tasks on their behalf. The tasks a nominated person can carry out are defined in different pieces of EU product legislation. Persons who can carry out the role of nominated person may also be known as authorised representatives and responsible persons, depending on the relevant legislation.
For example, where a manufacturer appoints an authorised representative, that representative must hold technical documentation and declaration of conformity about a product and provide this to market surveillance authorities in EU countries upon request.
Generally, for most product areas the appointment of an authorised representative is optional. It is mandatory in the following circumstances:
- for some products (such as medical devices and marine equipment) where the manufacturer is not based in an EU country
- for cosmetics: a responsible person carries out specific duties, including ensuring that the product is safe for human health, and is mandatory for non-EU manufacturers
After March 2019 if there’s no deal
Any UK-based nominated person will no longer be recognised under EU law. This means they will not be recognised as able to carry out tasks on the manufacturer’s behalf.
To minimise disruption immediately after exit, existing authorised representatives based in an EU country will continue to be recognised in the UK. However, new authorised representatives will need to be based in the UK to be recognised under UK law. Examples of EU production regulations that include the role of authorised representatives can be found at Annex A of the technical notice on ‘New Approach’ product regulation
For cosmetics, responsible persons based in an EU country will no longer be recognised by the UK after March 2019 (Regulation (EC) N° 1223/2009 is the main EU legislation covering cosmetics and covers the role of the responsible person). Businesses wishing to place cosmetics on the UK market will need to appoint a UK-based responsible person. This is due to specific legal duties assigned to the responsible person and their importance on ensuring the safety of products placed on the market.
The implications outlined below relate to UK, EU and third country businesses.
This notice does not apply to medical devices. A separate notice has been published for medical devices.
Businesses with an existing authorised representative based in an EU country will not be impacted in the short term and can continue to use the same authorized representative in respect of both the EU and UK markets in the same way.
Businesses with an authorised representative based in the UK will no longer be able to rely on that representative to carry out all the required tasks for products placed on the EU market.
Businesses wishing to appoint a new authorised representative to carry out tasks on their behalf in the UK should be aware that the authorised representative must be located in the UK but will be unable to carry out tasks relating to products being placed on the EU market.
Businesses placing cosmetic products on the EU market will not be able to use a responsible person located in the UK.
Businesses placing cosmetic products on the UK market will not be able to use a responsible person located in an EU country.
Actions for businesses and other stakeholders
The actions outlined below relate to UK, EU and third country businesses. These businesses may want to discuss their requirements and necessary actions with their counterparts in the country they wish to establish representation.
Businesses with an authorised representative based in the UK will need to establish a new authorised representative in an EU country if they want an authorised representative to carry out tasks on their behalf within the EU.
Businesses wishing post exit to appoint a new authorised representative to carry out tasks on their behalf in the UK will need to appoint a representative located in the UK.
Businesses placing cosmetic products on the EU market will need a responsible person located in an EU country.
Businesses placing cosmetic products on the UK market will need a responsible person located in the UK.
This notice is meant for guidance only. You should consider whether you need separate professional advice before making specific preparations.
It is part of the government’s ongoing programme of planning for all possible outcomes. We expect to negotiate a successful deal with the EU.
The UK government is clear that in this scenario we must respect our unique relationship with Ireland, with whom we share a land border and who are co-signatories of the Belfast Agreement. The UK government has consistently placed upholding the Agreement and its successors at the heart of our approach. It enshrines the consent principle on which Northern Ireland’s constitutional status rests. We recognise the basis it has provided for the deep economic and social cooperation on the island of Ireland. This includes North-South cooperation between Northern Ireland and Ireland, which we’re committed to protecting in line with the letter and spirit of Strand two of the Agreement.
The Irish government have indicated they would need to discuss arrangements in the event of no deal with the European Commission and EU countries. The UK would stand ready in this scenario to engage constructively to meet our commitments and act in the best interests of the people of Northern Ireland, recognising the very significant challenges that the lack of a UK-EU legal agreement would pose in this unique and highly sensitive context.
It remains, though, the responsibility of the UK government, as the sovereign government in Northern Ireland, to continue preparations for the full range of potential outcomes, including no deal. As we do, and as decisions are made, we’ll take full account of the unique circumstances of Northern Ireland.
Norway, Iceland and Liechtenstein are party to the Agreement on the European Economic Area and participate in other EU arrangements. As such, in many areas, these countries adopt EU rules. Where this is the case, these technical notices may also apply to them, and EEA businesses and citizens should consider whether they need to take any steps to prepare for a ‘no deal’ scenario.