Hard Brexit Impact Analysis

Page 66 of 106 Category If no agreement is reached: Consequence EU Document Medical Products Impact: 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. 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. Marketing authorisation holders will need to act sufficiently in advance to avoid any impact on the continuous supply of medicines for human and veterinary use within the European Union. Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the EU Medical Products An authorisation to place the product on the market granted by a United Kingdom competent authority before the withdrawal date is to be considered as the first authorisation to place the product on the market in the European Union WITHDRAWAL OF THE UNITED KINGDOM AND EU LEGISLATION IN THE FIELD OF SUPPLEMENTARY PROTECTION CERTIFICATES FOR MEDICINAL PRODUCTS AND PLANT PROTECTION PRODUCTS Medical Products APPLICATIONS FOR SUPPLEMENTARY PROTECTION CERTIFICATES AS OF THE WITHDRAWAL DATE IN THE UNITED KINGDOM: As of the withdrawal date, Regulation (EC) No 469/2009 and Regulation (EC) No 1610/96 no longer apply to the United Kingdom. WITHDRAWAL OF THE UNITED KINGDOM AND EU LEGISLATION IN THE FIELD OF SUPPLEMENTARY PROTECTION CERTIFICATES FOR MEDICINAL PRODUCTS AND PLANT PROTECTION PRODUCTS