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    Summary
    EudraCT Number:2018-005030-38
    Sponsor's Protocol Code Number:PAT-CR-302
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-005030-38
    A.3Full title of the trial
    A Multicenter, Double-blind, Placebo controlled, Randomized Withdrawal, Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin Angiotensin Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND)
    Studio multicentrico, in doppio cieco, controllato con placebo, di ritiro randomizzato, a gruppi paralleli, su patiromer per la gestione dell’ipercaliemia in soggetti che ricevono farmaci inibitori del sistema renina-angiotensina-aldosterone (RAASi) per il trattamento dello scompenso cardiaco (DIAMOND)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A placebo controlled Study of Patiromer for the Management of high potassium serum levels in Subjects Receiving a certain group of medications called Renin-Angiotensin-Aldosterone System Inhibitor for treatment of Heart failure.
    Uno studio di Patiromer controllato con placebo per la gestione dei livelli alti di potassio nel siero in soggetti che ricevono un gruppo di farmaci chiamati Inibitori del sistema Renina-Angiotensina-Aldosterone per il trattamento dello scompenso cardiaco.
    A.3.2Name or abbreviated title of the trial where available
    DIAMOND
    DIAMOND
    A.4.1Sponsor's protocol code numberPAT-CR-302
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03888066
    A.5.4Other Identifiers
    Name:IND numberNumber:075615
    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 SponsorRelypsa Inc
    B.1.3.4CountrySwitzerland
    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 supportRelypsa, Inc a Vifor Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRelypsa, Inc.
    B.5.2Functional name of contact pointExec. Medical Director
    B.5.3 Address:
    B.5.3.1Street Address100 Cardinal Way
    B.5.3.2Town/ cityRedwood City
    B.5.3.3Post code94063 (CA)
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018447359772
    B.5.5Fax number0016507796389
    B.5.6E-maildgarza@relypsa.com
    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 No
    D.2.1.1.1Trade name Veltassa®
    D.2.1.1.2Name of the Marketing Authorisation holderVifor Fresenius Medical Care Renal Pharma France for Europe and Relypsa, Inc. for USA
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namePatiromer
    D.3.2Product code [RLY5016]
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPatiromer per sospensione orale
    D.3.9.2Current sponsor codeRLY5016
    D.3.9.4EV Substance CodeSUB182272
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8400
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for oral suspension
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Management of hyperkalemia due to renin-angiotension-aldosterone system medications in patients treated for heart failure.
    Gestione dell'iperkaliemia causata da farmaci del sistema renina-angiotensina-aldosterone in patienti trattati per insufficienza cardiaca
    E.1.1.1Medical condition in easily understood language
    Serum potassium levels increase in patients with heart failure
    Aumento dei livelli di potassio nel siero in pazienti con insufficienza cardiaca
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10005725
    E.1.2Term Blood potassium increased
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if patiromer treatment of subjects who developed hyperkalemia while receiving RAASi medications will result in continued
    use of RAASi medications in accordance with heart failure (HF) treatment guidelines and thereby decrease the occurrence of the
    combined endpoint of cardiovascular (CV) death and CV hospitalization events compared with placebo treatment
    Stabilire se il trattamento con patiromer di soggetti che hanno sviluppato iperkaliemia mentre ricevevano farmaci RAASi comporterà la continuazione dell’uso di farmaci RAASi in conformità alle linee guida per il trattamento dell’insufficienza cardiaca (IC) e quindi una diminuzione della comparsa dell’endpoint combinato di decesso cardiovascolare (CV) ed eventi di ricovero CV rispetto al trattamento con placebo.
    E.2.2Secondary objectives of the trial
    Not applicable.
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject provides written informed consent prior to study participation
    2. Age at least 18 years or greater
    3. History of New York Heart Association (NYHA) Class II–IV HF
    4. Left ventricular ejection fraction <40%, measured by any echocardiographic, radionuclide, or computerized tomography method in the last 12 months
    without subsequent measured ejection fraction =40% during this interval)
    5. Receiving any dose of a beta blocker (BB) for the treatment of HF or unable to tolerate BB (reason documented)
    6.Estimated glomerular filtration rate (eGFR) =30 mL/min/1.73 m2 at Screening (based on a single local laboratory calculation using the Chronic Kidney
    Disease Epidemiology Collaboration (CKD-EPI) equation; see Section 9.2 of the protocol)
    7. Hyperkalemia at Screening (defined by 2 local serum K+ values of >5.0 mEq/L each obtained from a separate venipuncture, e.g., one in each arm)
    while receiving ACEi, ARB, ARNi, and/or MRA,
    OR
    Normokalemia at Screening (serum K+ 4.0–5.0 mEq/L) with a history of hyperkalemia documented by a usual care serum K+ measurement >5.0
    mEq/L while on RAASi treatment in the 12 months prior to Screening with a subsequent dose decrease or discontinuation of one or more
    RAASi medications
    8. Females of child-bearing potential must be non-lactating, must have a negative pregnancy test at Screening, and must agree to continue using contraception (see Section 9.8 of the protocol) throughout the study and for 4 weeks after study completion
    9. Hospitalization for HF or equivalent (e.g., urgent emergency room or outpatient visit for worsening HF during which the patient received intravenous medications for the treatment of HF) within last 12 months
    1. Il soggetto fornisce il consenso informato scritto prima della partecipazione allo studio
    2. Età pari o superiore a 18 anni
    3. Anamnesi di IC di classe II–IV secondo la New York Heart Association (NYHA)
    4. Frazione di eiezione ventricolare sinistra <40%, misurata con qualsiasi metodo ecocardiografico, con radionuclidi, o tomografia computerizzata negli ultimi 12 mesi (senza successiva frazione di eiezione misurata =40% durante questo intervallo)
    5. Assunzione di qualsiasi dosaggio di un beta-bloccante (BB) per il trattamento dell’IC o incapacità di tollerare BB (motivo documentato)
    6. Velocità di filtrazione glomerulare stimata (eGFR) =30 ml/min/1,73 m2 allo screening (in base a un singolo calcolo del laboratorio locale eseguito tramite la formula dell’epidemiologia della malattia renale cronica [CKD EPI]; vedere Sezione 9.2)
    7. Iperkaliemia allo screening (definita da 2 valori locali di K+ sierico >5,0 mEq/l, ciascuno ottenuto da una venipuntura separata, ad es., una per braccio) durante il trattamento con ACE-inibitori, ARB, ARNi, e/o MRA,
    OPPURE
    Normokaliemia allo screening (K+ sierico 4,0–5,0 mEq/l) con un’anamnesi di iperkaliemia documentata da un livello del K+ sierico misurato nell’ambito delle cure abituali >5,0 mEq/l durante il trattamento con farmaci RAASi nei 12 mesi precedenti lo screening, con una successiva riduzione del dosaggio o l’interruzione di uno o più farmaci RAASi
    8. I soggetti di sesso femminile in età fertile non devono essere in fase di allattamento al seno, devono eseguire un test di gravidanza allo screening con risultato negativo e devono accettare di continuare a usare metodi contraccettivi (vedere Sezione 9.8) per tutta la durata dello studio e per 4 settimane dopo il completamento dello studio
    9. Ricovero per IC o equivalente (ad es., ammissione d’urgenza al pronto soccorso o visita ambulatoriale per il peggioramento dell’IC durante la quale il paziente ha ricevuto farmaci endovenosi per il trattamento dell’IC) entro gli ultimi 12 mesi
    E.4Principal exclusion criteria
    1.Current acute decompensated HF. Subjects with a discharge from a hospitalization for acute decompensation of HF at least 4 weeks before
    Screening may be included
    2. Symptomatic hypotension or systolic blood pressure <90 mmHg
    3. Significant primary aortic or mitral valvular heart disease (except mitral regurgitation due to left ventricular dilatation)
    4. Heart transplantation or planned heart transplantation (i.e., currently on a heart transplant list) during the study period
    5. Diagnosis of peripartum or chemotherapy-induced cardiomyopathy or acute myocarditis in the previous 12 months
    6. Implantation of a cardiac resynchronization therapy device in the previous 4 weeks
    7. Restrictive, constrictive, hypertrophic, or obstructive cardiomyopathy
    8. Untreated ventricular arrhythmia with syncope in the previous 4 weeks
    9. History of, or current diagnosis of, a severe swallowing disorder, moderate-to-severe gastroparesis, or major gastrointestinal (GI)
    surgery (e.g., bariatric surgery or large bowel resection)
    10. A major CV event within 4 weeks prior to Screening, including acute myocardial infarction, stroke (or transient ischemic attack), a lifethreatening
    atrial or ventricular arrhythmia, or resuscitated cardiac arrest.
    11. Brain natriuretic peptide (BNP) <125 pcg/mL or N-terminal pro btype brain natriuretic peptide (NT-proBNP) of <500 pcg/mL
    12. Liver enzymes (alanine aminotransferase, aspartate aminotransferase) >5 times upper limit of normal at Screening based on
    the local laboratory
    13. Diagnosis or treatment of a malignancy in the past 2 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix, or a
    condition highly likely to transform into a malignancy during the study
    14. Presence of any condition (e.g., drug/alcohol abuse; acute illness), in the opinion of the Investigator, that places the subject at undue risk,
    or prevents complete participation in the trial procedures, or potentially jeopardizes the quality of the study data
    15. Use of any investigational product for an unapproved indication within 1 month prior to Screening or currently enrolled in any other type
    of medical research judged not to be scientifically or medically compatible with this study
    16. Known hypersensitivity to patiromer (RLY5016) or its components
    17. Prior use of commercial patiromer or previous participation in a study assessing patiromer
    18. Subjects currently being treated with or having taken any one of the following medications in the 7 days prior to Screening: sodium or
    calcium polystyrene sulfonate or sodium zirconium cyclosilicate
    19. An employee of Relypsa, Vifor Pharma, investigational site or the contract research organization (CRO)
    1. Attuale IC acuta scompensata. I soggetti dimessi da un ricovero per scompenso acuto dell’IC almeno 4 settimane prima dello screening possono essere inclusi
    2. Ipotensione sintomatica o pressione arteriosa sistolica <90 mmHg
    3. Cardiopatia primaria aortica o mitralica significativa (fatta eccezione per il rigurgito mitralico dovuto a dilatazione ventricolare sinistra)
    4. Trapianto di cuore o trapianto di cuore programmato (ovvero, attualmente in lista per trapianto di cuore) durante il periodo dello studio
    5. Diagnosi di cardiomiopatia peripartum o indotta da chemioterapia o miocardite acuta nei 12 mesi precedenti
    6. Impianto di un dispositivo per la terapia di risincronizzazione cardiaca nelle precedenti 4 settimane
    7. Cardiomiopatia restrittiva, costrittiva, ipertrofica o ostruttiva
    8. Aritmia ventricolare non trattata con sincope nelle precedenti 4 settimane
    9. Anamnesi di, o diagnosi attuale di, grave disturbo della deglutizione, gastroparesi da moderata a grave, o intervento chirurgico gastrointestinale (GI) maggiore (per es., chirurgia bariatrica o resezione dell’intestino crasso)
    10. Un evento CV maggiore nelle 4 settimane precedenti lo screening, tra cui infarto acuto del miocardio, ictus (o attacco ischemico transitorio), un’aritmia atriale o ventricolare potenzialmente letale, o arresto cardiaco rianimato.
    11. Peptide natriuretico cerebrale (BNP) <125 pcg/ml o peptide natriuretico cerebrale di tipo B con frammento N-terminale (NT-proBNP) <500 pcg/ml
    12. Enzimi epatici (alanina aminotransferasi, aspartato aminotransferasi) >5 volte il limite superiore della norma allo screening in base alle analisi del laboratorio locale
    13. Diagnosi o trattamento di un tumore maligno negli ultimi 2 anni, ad eccezione di tumore cutaneo non-melanoma e carcinoma in situ del collo dell’utero, o una condizione con alta probabilità di trasformazione in neoplasia maligna durante lo studio
    14. Presenza di qualsiasi condizione (ad es., farmaco/abuso di alcol, malattia acuta) che, a giudizio dello sperimentatore, espone il soggetto a un rischio eccessivo, o impedisce la completa partecipazione alle procedure della sperimentazione, o rappresenta un potenziale rischio per la qualità dei dati dello studio
    15. Uso di qualsiasi prodotto sperimentale per un’indicazione non autorizzata entro 1 mese prima dello screening o arruolamento attuale in qualsiasi altro tipo di ricerca medica giudicata come non scientificamente o clinicamente compatibile con questo studio
    16. Ipersensibilità nota a patiromer (RLY5016) o ai suoi componenti
    17. Precedente uso di patiromer commerciale o precedente partecipazione a uno studio di valutazione di patiromer
    18. Soggetti attualmente trattati con o che hanno assunto uno qualsiasi dei seguenti farmaci nei 7 giorni precedenti lo screening: sodio o calcio polistirensolfonato o ciclosilicato di sodio e zirconio
    19. Dipendenti di Relypsa, Vifor Pharma, del centro di sperimentazione o dell’organizzazione di ricerca a contratto (CRO)
    E.5 End points
    E.5.1Primary end point(s)
    Time to first occurrence of CV death or CV hospitalization (or equivalent in outpatient clinic)
    Tempo al primo decesso CV o ricovero CV (o equivalente in regime ambulatoriale)
    E.5.1.1Timepoint(s) of evaluation of this end point
    See endpoint description
    si faccia riferimento alla descrizione dell'endpoint
    E.5.2Secondary end point(s)
    •Proportion of subjects on =50% of guideline-recommended target dose
    of ACEi, ARB, or ARNi and =50% of guideline-recommended target dose of MRA
    at the End of Study (EoS) Visit
    • Total HF hospitalizations (or equivalent in outpatient clinic)
    • Patient reported outcome: Kansas City Cardiomyopathy Questionnaire
    (KCCQ)
    • Percentuale di soggetti che assumono =50% del dosaggio target di ACE-inibitori, ARB, o ARNi raccomandato dalle linee guida e =50% del dosaggio target di MRA raccomandato dalle linee guida alla visita di fine studio (EoS)
    • Totale ricoveri per IC (o equivalente in regime ambulatoriale)
    • Esiti riferiti dal paziente: Questionario per la cardiomiopatia di Kansas City (KCCQ)
    E.5.2.1Timepoint(s) of evaluation of this end point
    See endpoint description
    si faccia riferimento alla descrizione dell'endpoint
    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 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 Yes
    E.8.1.7.1Other trial design description
    Singolo cieco durante la fase di Run-In e doppio cieco durante la fase di trattamento
    Single blind during Run-in phase and double blind during treatment phase
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA156
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Georgia
    Israel
    Mexico
    Russian Federation
    Serbia
    Ukraine
    United States
    Bulgaria
    Czechia
    Denmark
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    Sweden
    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
    The study will continue until the required number of composite endpoint events have occurred.
    La sperimentazione continuerà fino a quando si sarà verificato il numero di eventi degli endpoint compositi
    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 months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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: 1194
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1194
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Illiterate or blinded patients
    Pazienti analfabeti o non vedenti
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state57
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 794
    F.4.2.2In the whole clinical trial 2388
    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
    nessuna
    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 Decision2020-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
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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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