Documents to download


Documents to download

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  • Medicinal and agrochemical products can be granted a Supplementary Protection Certificate, an intellectual property right associated with patents, to provide up to five years of additional rights and protections once their patents have expired. In order to apply for an SPC, a product must receive approval to be sold on the UK market. Under the Northern Ireland/Ireland Protocol, products to be sold in Northern Ireland must obtain approval under EU law, whilst products to be sold in the rest of the UK will obtain approval under UK law. Currently, this marketing authorisation is only given on a UK-wide basis. This regulation amends the market authorisation process to enable authorisations to be granted for the Northern Ireland market only and for the Great Britain market only.

  • There is currently a system for mutual recognition of health and social care qualifications within and between European Economic Area states and Switzerland. The UK has passed legislation amending its provisions in this area to take account of its exit from the EU. In recent agreements with Switzerland and the European Free Trade Area states, the UK committed to conditions for these countries which go further than the legislation that has already been passed. The European Qualifications (Health and Social Care Professions) (EFTA States) (Amendment etc.) (EU Exit) Regulations 2020 would implement these commitments.

  • The UK will no longer be part of EU reciprocal and cross-border healthcare arrangements after the transition period ends on 31 December 2020. However, some groups of people will retain rights after this under the terms of the withdrawal agreement. The Government made regulations in 2019 to deal with reciprocal and cross-border healthcare if the UK left the EU with no ‘divorce’ deal. It is now planning to update these regulations to reflect the withdrawal agreement.