On January 1, 2021, the United Kingdom (UK) will be considered a “third\u00a0country” with important consequences regarding to Good Manufacturing Practices for drug products and\u00a0APIs. There is currently no MRA (Mutual Recognition Agreement) or any other agreement to regulate the future relationship between the UK and the Erope Union.<\/p>\n
Recently, the EMA published a\u00a0complementary\u00a0question and answer document that clarifies a series of questions\u00a0for\u00a0the transition in Nothern Ireland\u00a0(part of the United Kingdom)\u00a0that were raised during the Brexit negotiations.\u00a0Under\u00a0the\u00a0Protocol\u00a0on\u00a0Ireland\/Northern\u00a0Ireland,\u00a0Northern\u00a0Ireland\u00a0will\u00a0continue\u00a0to\u00a0apply\u00a0EU\u00a0customs\u00a0rules\u00a0and\u00a0follow its\u00a0rules\u00a0on\u00a0product\u00a0standards (known\u00a0as\u00a0the\u00a0single\u00a0market\u00a0for\u00a0products).<\/p>\n
And\u00a0that\u00a0will\u00a0make it\u00a0unnecessary\u00a0to\u00a0control\u00a0goods\u00a0traveling\u00a0from\u00a0Northern\u00a0Ireland\u00a0(a non-EU country) to the Republic of Ireland (an\u00a0EU country). The\u00a0protocol\u00a0is\u00a0due\u00a0to\u00a0come\u00a0into\u00a0effect\u00a0on\u00a0January\u00a01rst, 2021 – the first day of the new EU-UK\u00a0relationship.<\/p>\n
Until\u00a0then,\u00a0the\u00a0United\u00a0Kingdom\u00a0remains\u00a0in a\u00a0transition\u00a0period\u00a0with\u00a0the\u00a0EU,\u00a0which\u00a0means\u00a0that\u00a0its trade relationship remains the\u00a0same\u00a0as\u00a0before.<\/p>\n