Regulation 3 Amendment to Article 1

after point (g) insert—

“(ga)

“Windsor Framework” means the part of the EU withdrawal agreement known as the Windsor Framework by virtue of Joint Declaration No. 1/2023 of 24 March 2023 made between the European Union and the United Kingdom in the Joint Committee established by the EU withdrawal agreement;”;

in point (h), for “Directive 2001/83/EC or Directive 2001/82/EC” substitute “Directive 2001/83/EC^f1, Directive 2001/82/EC^f2 or Regulation (EU) 2019/6^f3”;

after point (ja) insert—

“(jaa)

“transitioned-UK authorisation” means a GB authorisation for a medicinal product in force immediately before 1 January 2025 which, pursuant to Schedule 33B to the Human Medicines Regulations 2012^f4 , has effect on and after that date as a UK authorisation;”;

in point (jb), substitute for “or Directive 2001/82/EC” to the end with “, Directive 2001/82/EC or Regulation (EU) 2019/6 as they have effect by virtue of the Windsor Framework;”;

after point (jb) insert—

“(jc)

“former NI authorisation” means a NI authorisation for a medicinal product for human use that is prohibited from being placed on the market in Northern Ireland by Article 4(1) of Regulation (EU) 2023/1182^f5 of the European Parliament and of the Council of 14 June 2023 on specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amending Directive 2001/83/EC;”.