Hard Brexit Impact Analysis

Page 18 of 106 Category If no agreement is reached: Consequence EU Document Agriculture Veterinary medicines As of the withdrawal date, the EU rules in the field of medicinal products for human and veterinary use no longer apply to the United Kingdom. Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use Agriculture Veterinary medicines EU law requires that marketing authorisation holders are established in the EU (or EEA); Some activities must be performed in the EU (or EEA), related for example to pharmacovigilance, batch release etc. Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use Agriculture Veterinary medicines Marketing authorisation holders may be required to adapt processes and to consider changes to the terms of the marketing authorisation in order to ensure its continuous validity and exploitation, once the United Kingdom has left the Union. Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use Citizen Rights As of the withdrawal date, the EU rules on the European citizens' initiative ("ECI Regulation") will no longer apply to the United Kingdom. (This is the ability OF EU citizens to petition the EU to take certain actions. One million signatures are needed for a request to be considered) United Kingdom citizens can no longer be organisers of citizens' initiatives under the ECI Regulation which are ongoing on the withdrawal date or which have been launched on or after the withdrawal date. WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF THE EUROPEAN CITIZENS' INITIATIVE Citizen Rights ECI Regulation (This is the ability OF EU citizens to petition the EU to take certain actions. One million signatures are needed for a request to be considered) United Kingdom citizens or residents among the seven registered initiative organisers, must be replaced by other EU national individuals as of the withdrawal date WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF THE EUROPEAN CITIZENS' INITIATIVE