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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-001759-17
    Sponsor's Protocol Code Number:FGTW2101
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-08-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2022-001759-17
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo-controlled, parallel, phase 3 study to assess the efficacy and safety of fibrinogen concentrate (FGTW) in the management of bleeding in patients undergoing complex cardiac surgery (involving CPB)
    Estudio en fase III, multicéntrico, aleatorizado, con doble enmascaramiento, controlado con placebo y de grupos paralelos para evaluar la eficacia y la seguridad del concentrado de fibrinógeno (FGTW) en el tratamiento de las hemorragias en pacientes sometidos a una intervención quirúrgica cardíaca compleja (con CEC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of fibrinogen concentrate (FGTW) compared to placebo in the management of bleeding in patients undergoing complex cardiac surgery
    Estudio de un concentrado de fibrinógeno (FGTW) en comparación con placebo en el tratamiento del sangrado en pacientes sometidos a cirugía cardíaca compleja
    A.4.1Sponsor's protocol code numberFGTW2101
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLaboratoire français du Fractionnement et des Biotechnologies (LFB BIOTECHNOLOGIES)
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLaboratoire français du Fractionnement et des Biotechnologies (LFB BIOTECHNOLOGIES)
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLFB BIOTECHNOLOGIES
    B.5.2Functional name of contact pointClinical Trial information desk
    B.5.3 Address:
    B.5.3.1Street Address3, avenue des Tropiques, BP 40305 - LES ULIS
    B.5.3.2Town/ cityCOURTABOEUF CEDEX
    B.5.3.3Post code91958
    B.5.3.4CountryFrance
    B.5.4Telephone number+33169 82 70 10
    B.5.5Fax number+33169 82 72 72
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name FibCLOT
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire français du Fractionnement et des Biotechnologies
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFibCLOT®/ FibriCLOTte®
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Infusion (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman fibrinogen
    D.3.9.1CAS number 9001-32-5
    D.3.9.2Current sponsor codeFGTW (or FGT1)
    D.3.9.3Other descriptive nameHUMAN FIBRINOGEN
    D.3.9.4EV Substance CodeSUB12502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Yes
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bleeding in patients undergoing complex cardiac surgery (involving CPB)
    Sangrado en pacientes sometidos a cirugía cardíaca compleja (con CEC)
    E.1.1.1Medical condition in easily understood language
    Bleeding in patients undergoing complex cardiac surgery involving Cardiopulmonary bypass
    Sangrado en pacientes sometidos a cirugía cardiaca compleja con circulación extracorpórea
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10017501
    E.1.2Term Functional disturbances following cardiac surgery
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the efficacy of FGTW in combination with Standard of care in reducing the need for allogeneic transfusions within the first 24 hours after randomization in complex cardiac surgery patients.
    El objetivo principal del estudio es evaluar la eficacia del FGTW en combinación con el tratamiento habitual para reducir la necesidad de transfusiones alogénicas durante las primeras 24 horas después de la aleatorización en pacientes que se han sometido a una intervención quirúrgica cardíaca compleja.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy associated with the use of FGTW versus Placebo in reducing the number and volume of RBC, FFP, and platelet concentrate transfusions in the 24 hours after randomization
    until hospital discharge
    - To evaluate the efficacy associated with the use of FGTW versus Placebo in reducing the blood drainage volume within 12 hours after randomization
    - To evaluate the number of patients with total avoidance of allogeneic transfusions after randomization
    - To evaluate the safety of FGTW
    - To evaluate the impact of FGTW on mortality and surgical morbidity
    Los objetivos secundarios del estudio son los siguientes:
    • Evaluar la eficacia del uso del FGTW en comparación con la del placebo para reducir el número y el volumen de transfusiones de eritrocitos (ERI), plasma fresco congelado (PFC) y concentrado de plaquetas durante las 24 horas siguientes a la aleatorización y hasta recibir el alta hospitalaria
    • Evaluar la eficacia del uso del FGTW en comparación con la del placebo para reducir el volumen de drenaje sanguíneo durante las 12 horas siguientes a la aleatorización
    • Evaluar el número de pacientes que han podido evitar por completo las transfusiones alogénicas después de la aleatorización
    • Evaluar la seguridad del FGTW
    • Evaluar los efectos del FGTW en la mortalidad y en la morbilidad quirúrgica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient must meet all the following criteria to be eligible to participate in this study:
    1. Male or female adult patients ≥18 years
    2. Patients undergoing a planned complex cardiac surgery procedure involving CPB, including reoperation and/or complex surgical procedures. Complex surgical procedures are defined as any procedure other than first time isolated coronary artery bypass grafting (CABG), single valve
    repair/replacement and repair of atrial septal defect (ASD). This criterion represents the main eligibility criterion and so used in the definition of the full analysis set.
    3. With a FIBTEM MCF ≤8 mm during the last 20 minutes of CPB.
    4. Patients requiring an IMP dose ≤8 g calculated with the formula based on patient’s weight and the value of FIBTEM MCF
    5. Signed and dated informed consent form (ICF)
    6. Willingness to comply with all study procedures and availability for the duration of the study
    7. Covered by healthcare insurance in accordance with local requirements
    Los pacientes deben cumplir todos los criterios siguientes para que se les considere aptos para participar en este estudio:
    1. Pacientes adultos de ambos sexos ≥18 años
    2. Pacientes que se van a someter a un procedimiento quirúrgico cardíaco complejo con CEC, incluida la repetición de operaciones o procedimientos quirúrgicos complejos. Se consideran procedimientos quirúrgicos complejos todos aquellos que no sean un primer injerto aislado de derivación en una arteria coronaria (IDAC), la reparación o sustitución de una sola válvula y la reparación de una comunicación interauricular (CIA). Este criterio es el principal a la hora de determinar la aptitud para el estudio y así se ha usado en la definición del conjunto completo de análisis
    3. Con un MCF en el FIBTEM 8 mm durante los últimos 20 minutos de la CEC
    4. Pacientes que necesitan una dosis 8 g de PMI calculada con la fórmula basada en el peso y el valor del MCF en el FIBTEM
    5. Documento de consentimiento informado (DCI) firmado y fechado
    6. Predisposición para someterse a todos los procedimientos del estudio y disponibilidad durante el transcurso del estudio
    7. Cubierto por un seguro sanitario de acuerdo con los requisitos locales
    E.4Principal exclusion criteria
    A patient who meets any of the following criteria will be excluded from participation in this study:
    1. Heart transplantation
    2. Repair of complex congenital abnormalities
    3. Any known pulmonary, hepatic, or renal disease or any other major concomitant significant medical condition that might interfere with treatment evaluation according to the Investigator’s judgment
    4. Known hypersensitivity or other severe reaction to any component of the IMP
    5. Patients at high risk of thrombotic events unable to stop prophylactic low-molecular-weight heparin
    (LMWH) 12 hours and fondaparinux 24 hours before surgery (longer interval in case of impaired renal function)
    6. Patients unable to stop treatment by vitamin K antagonists 3-5 days before surgery to obtain an international normalized ratio (INR) <1.5
    7. Patients unable to stop treatment by direct oral anticoagulant at least 48 hours before surgery (except aspirin)
    8. Patients unable to stop treatment by P2Y12 inhibitors before surgery (discontinuation duration before surgery: ticagrelor 3 days, clopidogrel 5 days, and prasugrel 7 days) [30]
    9. Severe anemia with hemoglobin (Hb) ≤10 g/dL
    10. Excessive hemodilution during CPB with hematocrit (Ht) <22% in men and women
    11. Congenital coagulation deficiencies (von Willebrand disease, factor V Leiden, Protein C deficiency, cryoglobulinemia, antiphospholipid syndrome…)
    12. Any known thromboembolic disorder
    13. Female of reproductive potential not using effective contraception (condoms; occlusive caps with
    spermicide; injectable, patch, or combined oral estro-progestative or progestative contraceptives; depot intramuscular medroxyprogesterone; or subcutaneous implants of progestative contraceptive implants) for at least one month prior to screening
    14. Known pregnancy or positive blood pregnancy test for women of childbearing potential and/or breast-feeding women
    15. Participation in another clinical study involving an investigational medicinal product within 30 days prior to screening or concomitantly with this study
    16. Previous cardiac surgical procedure within three months before randomization
    17. Evidence or suspicion of infection (fever >38.5°C and white blood cell count >11/mm3)
    18. Active endocarditis
    19. Emergency surgery, patients in cardiogenic shock, or expected mortality within 24 hours of surgery
    20. Pre-existing thrombocytopenia with platelet count < 150 000/ mm3
    Se excluirá de participar en el estudio a los pacientes que cumplan alguno de los siguientes criterios:
    1. Trasplante de corazón
    2. Reparación de anomalías congénitas complejas
    3. Enfermedades pulmonares, hepáticas o renales conocidas, u otras afecciones médicas significativas concomitantes importantes que puedan interferir en la evaluación del tratamiento a juicio del investigador
    4. Hipersensibilidad conocida u otras reacciones graves a los componentes del PMI
    5. Pacientes con un riesgo elevado de sufrir acontecimientos trombóticos que no pueda interrumpir el uso profiláctico de heparina de bajo peso molecular (HBPM) 12 horas antes de la intervención quirúrgica y fondaparinux 24 horas antes de la intervención quirúrgica (intervalos mayores en caso de disfunción renal)
    6. Pacientes que no puedan interrumpir un tratamiento con antagonistas de la vitamina K entre 3 y 5 días antes de la intervención quirúrgica para obtener un índice internacional normalizado (INR) <1,5
    7. Pacientes que no puedan interrumpir un tratamiento con anticoagulantes orales directos 48 horas antes de la intervención quirúrgica (excepto aspirina)
    8. Pacientes que no puedan interrumpir un tratamiento con inhibidores de P2Y12 antes de la intervención quirúrgica (duración de la interrupción antes de la intervención quirúrgica: ticagrelor 3 días, clopidogrel 5 días y prasugrel 7 días)
    9. Anemia grave con concentraciones de hemoglobina (Hb) ≤10 g/dl
    10. Hemodilución excesiva durante la CEC con hematocrito (Hto) <22 % en ambos sexos
    11. Deficiencias de coagulación congénitas (enfermedad de von Willebrand, factor V Leiden, carencia de proteína C, crioglobulinemia, síndrome antifosfolipídico, etc.)
    12. Trastornos tromboembólicos conocidos
    13. Mujeres en edad fértil que no usen anticonceptivos eficaces (preservativos; capuchones cervicales con espermicida; anticonceptivos por vía oral, en parches o inyectables gestágenos o estrogestágenos; medroxiprogesterona intramuscular de liberación lenta; o inserción subcutánea de implantes anticonceptivos gestágenos) durante al menos un mes antes de la selección
    14. Embarazo conocido o resultados positivos en la prueba del embarazo en el caso de mujeres en edad fértil o mujeres que estén dando el pecho
    15. Participación en otro ensayo clínico con un medicamento en investigación en los 30 días anteriores a la selección o al mismo tiempo que este estudio
    16. Procedimiento quirúrgico cardíaco anterior en los 3 meses anteriores a la aleatorización
    17. Infección presunta o confirmada (>38,5 °C de fiebre y número de leucocitos >11/mm3)
    18. Endocarditis activa
    19. Intervención quirúrgica de urgencia en pacientes con choque cardiógeno, o mortalidad esperada durante las 24 horas siguientes a la intervención
    20. Trombocitopenia preexistente con un número de plaquetas <150 000/mm3
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint
    The primary efficacy endpoint is the number of units of allogeneic blood products (RBC plus FFP plus platelet concentrate) given to patients between randomization and 24 hours thereafter.
    El criterio de valoración principal de la eficacia es el número de unidades de hemoderivados alogénicos (ERI, PFC y concentrado de plaquetas) administrado a los pacientes entre la aleatorización y 24 horas después.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated 24 hours after randomization.
    El criterio de valoración principal será evaluado 24 horas después de la aleatorización
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are defined as follows:
    1. Blood drainage volume within 12 hours after randomization
    2. Percentage of patients with total avoidance of allogeneic transfusions within 24 hours after randomization
    3. Number of transfusion units infused in the 24 hours after randomization until hospital discharge for each class of allogeneic blood product (RBC, FFP, and platelet concentrate)
    4. Volume of transfusion units infused in the 24 hours after randomization until hospital discharge for each class of allogeneic blood product (RBC, FFP, and platelet concentrate)
    5. Number of pre-donated autologous RBC concentrate units, RBC concentrate prepared by cell-saver, colloids, and crystalloids after randomization
    6. Mortality at 24 hours, 7 days, and 30 days after randomization
    7. Percentage of patients with each surgical morbidity at 24 hours, 7 days, and 30 days after randomization (see Section 9.2.8)
    8. Percentage of patients with post-surgery stage 1 AKI (with increase in creatinine by >50% from baseline until EoS visit)
    9. Percentage of patients with surgical re-exploration for bleeding within 24 hours after randomization
    10. Percentage of patients with fibrinogen concentration below the LLN until hospital discharge
    11. Percentage of patients receiving aPCCs, rFVIIa, cryoprecipitate or additional FC as rescue therapy within 24 hours after randomization
    E.5.2.1Timepoint(s) of evaluation of this end point
    The timepoints for the secondary end points listed under E.5.2 are as follows:
    1. Within 12 hours after randomization
    2. Within 24 hours after randomization
    3. In the 24 hours after randomization until hospital discharge for each class of allogeneic blood product (RBC, FFP, and platelet concentrate)
    4. In the 24 hours after randomization until hospital discharge for each class of allogeneic blood product (RBC, FFP, and platelet concentrate)
    5. After randomization
    6. At 24 hours, 7 days, and 30 days after randomization
    7. At 24 hours, 7 days, and 30 days after randomization
    8. From baseline until EoS visit
    9. Within 24 hours after randomization
    10. From the point fibrinogen concentration is below the LLN until hospital discharge
    11. Within 24 hours after randomization
    Los tiempos para los criterios de valoración secundarios listados en E.5.2.son:
    1. En las 12 horas posteriores a aleatorización
    2. En las 24 horas posteriores a aleatorización
    3. En las 24 horas posteriores a aleatorización hasta alta hospitalaria para cada clase de prod sanguíneo alogénico
    4. En 24 horas posteriores a aleatorización hasta alta hospitalaria para cada clase de prod sanguíneo alogénico
    5. Después de aleatorización
    6. A las 24 horas, 7 días y 30 días después de aleatorización
    7. A las 24 horas, 7 días y 30 días después de aleatorización
    8. Desde el inicio hasta la visita de fin
    9. En las 24 horas posteriores a aleatorización
    10. Desde que concentración de fibrinógeno está por debajo del LLN hasta el alta hospitalaria
    11. En las 24 horas posteriores a aleatorización
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Sweden
    Spain
    Germany
    Italy
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    ultima Visita del ultimo Paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 158
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 138
    F.4.2.2In the whole clinical trial 176
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None. Patients will return to standard of care treatment.
    Ninguna. Los pacientes volverán al tratamiento estándar
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-12
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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