Hard Brexit Impact Analysis

Page 68 of 106 Category If no agreement is reached: Consequence EU Document Medicine Human Materials Organs: exchange of organs with the United Kingdom will need to be supervised by a EU 27 competent authority or European organ exchange organisations (where the Member State delegates the supervision to them) and meet quality and safety requirements equivalent to those laid down in the Union legislation. EU standards and regulations remain in force for items of this type being imported to the EU. WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF SUBSTANCES OF HUMAN ORIGIN (BLOOD, TISSUES AND CELLS, AND ORGANS) Medicine Human Materials Traceability: In accordance with the EU legislation, in all cases, blood, tissues and cells, and organs will need to be traceable from donor to recipient and vice versa. EU traceability standards and regulations remain in force. WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF SUBSTANCES OF HUMAN ORIGIN (BLOOD, TISSUES AND CELLS, AND ORGANS) Pensions As of the withdrawal date, the EU rules for IORPs, and in particular Directive (EU) 2016/2341 of the European Parliament and of the Council of 14 December 2016 on the activities and supervision of institutions for occupational retirement provision no longer apply to the United Kingdom. Occupational pension funds or Institutions for Occupational Retirement Provision (IORPs) are financial institutions which manage collective retirement schemes for employers, in order to provide retirement benefits to their employees (the scheme members and beneficiaries). WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF INSTITUTIONS FOR OCCUPATIONAL RETIREMENT PROVISION Pensions As of the withdrawal date, this means that those UK IORPs will no longer be allowed to operate, on the basis of their current registration/authorisation as IORPs for members or beneficiaries whose relationship with the sponsoring undertaking is governed by the social and labour law relevant to the field of occupational pension schemes of an EU 27 Member State (hereafter "EU 27 members and beneficiaries"). The assets will be in the United Kingdom and members and beneficiaries will have to rely on UK national law to have access to their assets. WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF INSTITUTIONS FOR OCCUPATIONAL RETIREMENT PROVISION

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