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    Summary
    EudraCT Number:2010-022949-17
    Sponsor's Protocol Code Number:ET-D-009-10
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-11-04
    Trial results View 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 ConcernedAustria - BASG
    A.2EudraCT number2010-022949-17
    A.3Full title of the trial
    A Phase III international, randomized study with Trabectedin plus Pegylated Liposomal Doxorubicin (PLD) versus Carboplatin plus PLD in patients with ovarian cancer progressing within 6-12 months of last platinum.
    Eine internationale, randomisierte, Phase III Studie mit Trabectedin plus Pegylated Liposomal Doxorubicin (PLD) versus Carboplatin plus PLD bei Patientinnen mit progredientem Ovarialkarzinom innerhalb von 6-12 Monaten nach der Platintherapie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III international, randomized study with Trabectedin and Pegylated Liposomal Doxorubicin (PLD) compared to chemotherapy with Carboplatin and PLD in patients with ovarian cancer which reappeared within 6-12 months after the last platinum-based chemotherapy.
    Eine internationale, randomisierte, Phase III Studie mit Trabectedin und Pegylated Liposomal Doxorubicin (PLD) im Vergleich zu Carboplatin und PLD bei Patientinnen mit Eierstockkrebs, der innerhalb von 6-12 Monate nach der letzten Platintherapie wiedergekehrt ist.
    A.3.2Name or abbreviated title of the trial where available
    AGO 46 INOVATYON
    AGO 46 INOVATYON
    A.4.1Sponsor's protocol code numberET-D-009-10
    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 SponsorMario Negri Gynecology Oncology Group - MaNGO
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIstituto Mario Negri
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto di Ricerche Farmacologiche
    B.5.2Functional name of contact pointStudy Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressVia La Masa 19
    B.5.3.2Town/ cityMilan
    B.5.3.3Post code20156
    B.5.3.4CountryItaly
    B.5.4Telephone number003902390141
    B.5.5Fax number003902354 6277
    B.5.6E-mailmnegri@marionegri.it
    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 Yondelis 1 mg powder for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderPharmaMar S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/03/171
    D.3 Description of the IMP
    D.3.1Product nameTrabectedin
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRABECTEDIN
    D.3.9.1CAS number 114899-77-3
    D.3.9.4EV Substance CodeSUB20756
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameCarboplatin
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCarboplatin
    D.3.9.1CAS number 41575-94-4
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ovarian cancer
    Ovarialkarzinom
    E.1.1.1Medical condition in easily understood language
    Cancer of the ovaries
    Eierstockkrebs
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10033130
    E.1.2Term Ovarian cancer NOS
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that the combination of trabectedin (Yondelis) and pegylated liposomal doxorubicin (PLD) prolongs overall survival (OS) over carboplatin and PLD in patients with relapsed ovarian cancer progressing within 6-12 months after end of last platinum.
    Es soll gezeigt werden, dass Trabectedin (Yondelis) in Kombination mit pegiliertem Liposomalen Doxorubicin (PLD) das Gesamtüberleben gegenüber der Therapie Carboplatin + PLD bei Patientinnen mir wiederkehrendem Ovarialkarzinom innerhalb von 6-12 Monaten nach der letzten Platingabe verlängert.
    E.2.2Secondary objectives of the trial
    - to evaluate the time from randomization to subsequent chemotherapy and the overall survival counted from the administration of subsequent chemotherapy.
    - To evaluate serological response of CA-125 in each arm.
    - To compare the quality of life (QoL) in each arm using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ-C30) and the Quality of Life Questionnaire-OV28 (QLQ-OV28).
    - To compare safety profile, progression freee survival (PFS), objective response rate (ORR), the type and length of remission (response rate and PFS) after subsequent therapies following each of the two combinations.
    - Evaluierung der Zeit vond er Randomisierung bis zur nachfolgenden Chemotherapie und des Gesamtüberleben ab dem Zeitpunkt der Verabreichung der darauffolgenden Chemotherapie.
    - Evaluierung des serologischen Ansprechens anhand des CA-125 im jeweiligen Arm
    - zum Vergleich der Lebensqualität im jeweiligen Arm anhand von standardisierten EORTC-Fragebögen (QLQ-C30, QLQ-OV28)
    - zum Vergleich der Sicherheitsprofile, des Progressionsfreien Überlebens (PFS), der objektiven Anspruchrate (ORR), der Art und Länge des Remission (Anspruchrate und PFS) nach der nachfolgenden Chemotherapie in der jeweiligen Therapie
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-study in selected centers: To perform pharmacokinetic (PK) analyses in both plasma and ascites in a subset of patients receiving trabectedin and PLD.
    E.3Principal inclusion criteria
    - Women age >18
    - Patients with cancer of the ovaries, fallopian tubes or primary peritoneal cancer.
    - Patients with 6 to 12 months PFS from the date of their last platinum-based treatment cycle to radiologically
    confirmed progression. Patients may have received more than 2 platinum-based treatment lines; at least one of which
    must have contained taxanes.
    - Measurable or assessable disease, radiologically confirmed by tests such as MRI, CT scan or PET/CT (CA-125
    alone is not acceptable) or histological evidence of recurrent ovarian cancer, even in case of absence of post-surgical
    measurable or assessable lesions.
    - ECOG ≤ 2
    - Life expectancy ≥ 12 weeks
    - Patients willing to commit to treatment and follow-ups.
    - Adequate bone marrow, renal and liver function as defined by the following tests (to be carried out 14 days prior to
    starting 1st treatment cycle):
    i. Haemoglobin ≥ 9g/dl
    ii. Neutrophils ≥ 1,5 x 109/L
    iii. Platelets ≥ 100 x 109/L
    iv. Glomerular filtration rate calculated using Cockroft-Gault formula > 60 ml/min
    v. Creatine phosphokinase (CPK) ≤ 2.5 x ULN
    vi. Total Bilirubin ≤ ULN
    vii. Total alkaline phosphatase ≤ 2.5 x ULN
    viii. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
    - Normal liver function levels
    - Patients able to receive desametasone or similar agents
    - Written informed consent provided by the patient prior to randomization
    Einschlusskriterien:
    1.Weiblich; ≥ 18 Jahre.
    2.Histologisch und/oder zytologisch gesichertes epitheliales Ovarial-, Tuben-, oder primäres Peritonealkarzinom.
    3.PFI (progressionsfreies Intervall) zwischen 6-12 Monaten (berechnet ab dem ersten Tag des letzten platinbasierenden Chemotherapie-Zyklus bis zum Tag der radiologisch gesicherten Progression). Patienten können bis zu 2 Platin-Chemotherapien erhalten haben, von denen mind. eine Taxane enthalten haben muss.
    4.Eine, durch radiologische Bildgebung (MRI, CT oder PET/CT) gesicherte oder durch histologisch gesicherte, messbare oder evaluierbare Progression des Ovarialkarzinom muss gegeben sein, auch wenn postoperative messbare oder evaluierbare Läsionen fehlen. Das Ansteigen des Tumormarkers CA-125 ist kein akzeptables Kriterium für eine Progression.
    5.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
    6.Eine Lebenserwartung ≥ 12 Wochen.
    7.Adäquate Complience.
    8.Adäquate Funktion der Organe innerhalb von 14 Tagen vor dem ersten Zyklus:
    a. Peripheral blood counts and serum chemistry values:
    i. Hemoglobin ≥ 9 g/dl
    ii. Absolute neutrophil count (ANC) ≥ 1,500/µl
    iii. Platelet count ≥ 100,000/µl
    iv. Estimated glomerular filtration rate > 60 ml/min according to the Cockroft - Gault formula
    v. CPK ≤ 2.5 x ULN
    b. Hepatic function variables:
    i. Total bilirubin ≤ ULN
    ii. Total alkaline phosphatase ≤ 2.5 ULN (consider hepatic isoenzymes 5- nucleotidase, if the elevation could be osseous in origin)
    iii. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be 2.5 x ULN
    9.Patienten müssen in der Lage sein Dexamethason zu erhalten oder das Äquivalent, was für die Behandlung mit Trabectedin und PLD verlangt ist.
    10.Eigenhändig unterschriebene und datierte Einwilligungserklärung des Patienten.
    E.4Principal exclusion criteria
    - Non epithelial or mixed ovarian cancer (Epithelial/non epithelial)
    - Patients who did not respond to last platinum-based treatment or patients who have experienced progression after
    less than 6 months or after more than 12 months from last dose of platinum-based treatment.
    - Intestinal occlusion or subocclusion or symptomatic brain metastasis
    - Pre-existing sensitive/motor neurological disorder, NCI-CTCAE degree > 1
    - Patients who have suffered myocardial infarction 6 months prior to enrolment (NYHA ≥ 2), angina pectoris, severe
    ventricular arrhythmia, clinically significant pericardial disease or acute ischemic disease confirmed by ECG.
    - History of liver disease
    - Severe comorbidities that are not cancer related and which would significantly limit full compliance to protocol, or
    that would put patients at risk or limit their life expectancy.
    - Pregnant or nursing women; women of childbearing age must use adequate contraception.
    - Patients previously exposed to Trabectedin
    - Resistance to treatment with anthracycline or PLD, i.e. progression within 6 months of completing treatment with
    these agents.
    - Patients with demonstrated severe PLD related toxicity.
    - Previous exposure to cumulative doses of doxorubicin > 400mg/m2 or epirubicin > 720 mg/m2
    - Patients treated with one of the study drugs 30 days prior to enrolment.
    1.Kein epitheliales Ovarialkarzinom oder gemischt epitheliales/ nicht epitheliales Ovarialkarzinom (z.B.: Mullerian Tumor).
    2.Patienten, die nicht auf die letzte Platin-Chemotherapie angesprochen haben oder Patienten mit einer Progression < 6 Monaten oder > 12 Monate nach der letzten Platin-Dosis.
    3.Darmobstruktion, sub-okklusive Erkrankungen oder Hirnmetastasen.
    4.Multifokale motorische Neuropathie/ Sensorische Neuropathie als Vorerkrankung, Grad > 1 nach NCI-CTCAE Version 4.0.
    5.Myokardialer Infarkt innerhalb von 6 Monaten vor Studieneinschluss, NYHA Klasse II oder schlimmere Herzfehler, unkontrollierte Angina, ernstzunehmende unkontrollierte ventrikuläre Arrhythmie, klinisch signifikante perikardiale Erkrankungen oder nachgewiesene ischemische oder Abnormitäten des aktiven Reizleistungssystems (nach EKG Nachweis).
    6.Lebererkrankungen
    7.Des Weiteren ähnliche ernstzunehmende medizinische Probleme und alle weiteren klinisch relevanten medizinischen Begebenheiten in der sich der Patient befindet und die die absolute Complience des Patienten während der Studie drastisch beeinträchtigen würden und/oder für den Patienten ein hohes Risiko oder Verringerung der Lebenserwartung durch die Teilnahme an der Studie gegeben wäre.
    8.Stillende Mütter. Frauen mit Gebärfähigkeit müssen während der aktiven Teilnahmephase und bis 3 Monate nach der Beendigung der Studie eine effektive Kontrazeption nachweisen. Sowie: rezeptpflichtige Anwendungen (oral, Injektion oder Plaster), intrauterine Mittel, doppel-barriere Methoden oder Vasektomie beim männlichen Partner.
    9.Frühere Verabreichung von Trabectedin.
    10.Vorangegangene Anthracyclin- oder PLD-Resistenz bestimmt durch Progression während einer Anthracyclin-basierten Chemotherapie oder Wiederkehren der Erkrankung während 6 Monaten nach Beendigung.
    11.Vorangegangene ernstzunehmende Toxizitäten in Verbindung mit PLD.
    12.Vorangegangene gesamtverabreichte Dosis von Doxorubicin >400mg/m2 oder Epirubicin >720mg/m2.
    13.Behandlung mit jeder anderen Prüfsubstanz innerhalb von 30 Tagen vor Studieneinschluss.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS)
    Gesamtüberleben
    E.5.1.1Timepoint(s) of evaluation of this end point
    To be measured from the date of randomization up to the date of death due to any cause or, for living patients, the date of last contact.
    Ab der Randomisierung bis zum Tod durch jegliche Ursachen und für lebende Patientinnen bis zum Zeitpunkt des letzten Kontaktes.
    E.5.2Secondary end point(s)
    Efficacy
    Wirksamkeit
    E.5.2.1Timepoint(s) of evaluation of this end point
    PFS: will be measured from the date of randomization to the date of documented PD or death (regardless of cause of death).
    PFS: wird ab dem Zeitpunkt der Randomisierung bis zum dokumentierten Datum einer Progression oder des Todes (egal welche Ursache) gemessen.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA110
    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
    Austria
    Belgium
    Denmark
    Finland
    Germany
    Greece
    Italy
    Netherlands
    Norway
    Poland
    Spain
    Sweden
    Switzerland
    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
    Date of death or the date of last contact
    Todestag oder Tag des letzten Kontaktes
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 420
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 570
    F.4.2.2In the whole clinical trial 600
    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)
    Expected and standard treatment of care for the condition
    Standard of Care nach Beendigung der Studienteilnahme
    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 Decision2014-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-17
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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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