Hard Brexit Impact Analysis

Page 67 of 106 Category If no agreement is reached: Consequence EU Document Medical Products As of the withdrawal date, Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products4 and Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products5 will 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 Medical Products CALCULATION OF DURATION OF SUPPLEMENTARY PROTECTION CERTIFICATES IN THE EU 27: As of the withdrawal date an authorisation to place the product on the market granted by a United Kingdom competent authority will not be considered a 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 Medicine Human Materials Blood and blood components: imports of blood and blood components from the United Kingdom will need to be tested in conformity with the Union testing requirements. They will also need to meet equivalent standards of quality and safety 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 Tissues and cells: Imports of tissues and cells from the United Kingdom will have to be undertaken by authorised importing tissue establishments and meet standards of quality and safety equivalent rules for export of tissues or cells to third countries. 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)