Importing Medicines to NI to end 2021

Guidance Importing medicines into Northern Ireland before 31 December 2021 Industry must notify the MHRA if they will not be using these flexibilities From: Medicines and Healthcare products Regulatory Agency Published 9 March 2021 Contents Products approved in the UK before 31 January 2021 Products approved in the UK after 31 January 2021 and before […]

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EU Single Market Goods Rules in NI

Article 6 Protection of the UK internal market Nothing in this Protocol shall prevent the United Kingdom from ensuring unfettered market access for goods moving from Northern Ireland to other parts of the United Kingdom’s internal market. Provisions of Union law made applicable by this Protocol which prohibit or restrict the exportation of goods shall […]

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EU Food & Agricultural Rules in NI

29. Food – general – Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety156 The reference to Member State in the second subparagraph […]

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Medical Devices NI UK Post-Deal Guidance

Guidance Guidance for retailers: supplying medical devices to Northern Ireland How the supply of medical devices from Great Britain into Northern Ireland works. From: Medicines and Healthcare products Regulatory Agency Published: 5 January 2021 Last updated: 5 March 2021, see all updates Contents Overview Conformity marking Additional importer requirements Customs requirements Further information Print this page […]

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OTC Medicines NI UK Post-Deal Guidance

Guidance Guidance for retailers: supplying over-the-counter medicines to Northern Ireland How the supply of medicines into Northern Ireland works. Published 5 January 2021 From: Medicines and Healthcare products Regulatory Agency Contents What you need to do to supply authorised medicines from Great Britain to Northern Ireland Alternative supply chain options Glossary of terms Further information […]

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Access for NI Medicines UK Post-Deal Guidance

Guidance Unfettered Access Procedure for marketing authorisations approved in Northern Ireland How to apply for the Unfettered Access Procedure (UAP). Published 4 January 2021 From: Medicines and Healthcare products Regulatory Agency Contents How to apply Fees Assessment procedure If Major Objections are raised Print this page Marketing Authorisation Holders (MAHs) may seek recognition in Great […]

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Investigational Medicines NI UK Post-Deal Guidance

Guidance Supplying investigational medicinal products to Northern Ireland What you need to do to supply investigational medicinal products (IMPs) from Great Britain to Northern Ireland. Published 31 December 2020 From: Medicines and Healthcare products Regulatory Agency Contents Supply of investigational medicinal products until 31 December 2021 Supply of investigational medicinal products from 1 January 2022 […]

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Supplying Medicines NI UK Post-Deal Guidance

Guidance Supplying authorised medicines to Northern Ireland What you need to do to supply authorised medicines from Great Britain to Northern Ireland. Published 31 December 2020 From: Medicines and Healthcare products Regulatory Agency Contents 1. Supply of authorised medicines until 31 December 2021 2. Supply of authorised medicines from 1 January 2022 3. Supply of […]

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Goods Marking NI Post-Deal Guidance

Guidance Using the UKNI marking Find out if you will need to use the new UKNI marking and how to use it. Published 31 December 2020 From: Department for Business, Energy & Industrial Strategy Applies to: Northern Ireland Contents Overview Check whether you need to use the UKNI marking When to use the UKNI marking […]

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Goods Standards NI UK Post-Deal Guidance

Guidance Placing manufactured goods on the market in Northern Ireland What you need to do to comply with regulations on manufactured goods you place on the Northern Ireland market. Published 31 December 2020 From: Department for Business, Energy & Industrial Strategy Applies to: Northern Ireland Contents Check which rules apply Check if you need to […]

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NI Product Standards + Metrology 2021 UK Guidance

Placing goods on the GB market from the EU market if you’re a business in Northern Ireland If you’re a Northern Ireland business selling goods on the GB market that have been supplied to you (as a distributor) from the EU market, you’ll become an importer under GB rules. You’ll need to make sure: goods are labelled with your company’s details (or accompanying documentation depending […]

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GB Goods for NI Market 2021 UK Guidance

Guidance Product safety and metrology from 1 January 2021: Northern Ireland Guides on specific product safety and metrology regulations for businesses placing goods on the market in Northern Ireland from 1 January 2021. Published 16 November 2020 Last updated 18 December 2020 — see all updates From: Office for Product Safety and Standards Applies to: Northern […]

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UKNI Marking UK 2021 Guidance

Using the UKNI marking from 1 January 2021 Find out if you will need to use the new UKNI marking and how to use it from 1 January 2021. Published 30 October 2020 From: Department for Business, Energy & Industrial Strategy New rules for January 2021 The UK has left the EU, and the transition […]

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Northern Ireland Goods Marking

Guidance Using the UKNI marking from 1 January 2021 Find out if you will need to use the new UKNI marking and how to use it from 1 January 2021. Published 30 October 2020 From: Department for Business, Energy & Industrial Strategy New rules for January 2021 The UK has left the EU, and the […]

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