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    Summary
    EudraCT Number:2017-004886-29
    Sponsor's Protocol Code Number:MN39158
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-17
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-004886-29
    A.3Full title of the trial
    A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN
    PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL
    STUDIO DI ESTENSIONE MULTICENTRICO, A BRACCIO SINGOLO, IN APERTO, PER
    VALUTARE EFFICACIA E SICUREZZA DI OCRELIZUMAB IN PAZIENTI AFFETTI DA SCLEROSI MULTIPLA PRECEDENTEMENTE ARRUOLATI IN
    UNO STUDIO CLINICO DI FASE IIIB/IV SPONSORIZZATO DA F. HOFFMANN-LA ROCHE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial
    Uno studio per valutare l'efficacia e la sicurezza di Ocrelizumab
    in pazienti con sclerosi multipla precedentemente registrati in uno studio con Ocrelizumab sponsorizzato da A F. Hoffmann-la Roche
    A.3.2Name or abbreviated title of the trial where available
    A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis
    Uno studio per valutare l'efficacia e la sicurezza di Ocrelizumab in pazienti con sclerosi multipla
    A.4.1Sponsor's protocol code numberMN39158
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    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 supportF. Hoffmann-La Roche Ltd - Svizzera
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBase
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number000000
    B.5.5Fax number000000
    B.5.6E-mailglobal.rochegenentechtrials@roche.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.2.5The 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 nameOcrelizumab
    D.3.2Product code RO4964913
    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 INNOcrelizumab
    D.3.9.1CAS number 637334-45-3
    D.3.9.2Current sponsor codeRO4964913
    D.3.9.3Other descriptive nameOCRELIZUMAB
    D.3.9.4EV Substance CodeSUB121707
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 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 Yes
    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
    Multiple sclerosis (MS)
    Sclerosi Multipla
    E.1.1.1Medical condition in easily understood language
    MS is a chronic autoimmune, neurological disease that affects the brain and spinal cord (central nervous system)
    La SM è una malattia neurologica autoimmune cronica che colpisce il cervello e il midollo spinale (sistema nervoso centrale)
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10048393
    E.1.2Term Multiple sclerosis relapse
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10039720
    E.1.2Term Sclerosis multiple
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ¿ To evaluate the effectiveness of ocrelizumab therapy in MS patients who were previously enrolled in a Roche sponsored phase IIIb/IV-trial
    ¿ Valutare l'efficacia della terapia con ocrelizumab nei pazienti con sclerosi multipla
    precedentemente arruolati in uno studio clinico di fase IIIb / IV sponsorizzato da Roche
    E.2.2Secondary objectives of the trial
    ¿ Different effectiveness measures evaluated for ocrelizumab in MS patients who were previously enrolled in a Roche sponsored phase IIIb/IV-trial
    ¿ To evaluate the safety and tolerability of ocrelizumab therapy in MS patients who were previously enrolled in a Roche sponsored phase IIIb/IV-trial
    ¿Diverse misure di efficacia vengono valutate per ocrelizumab nei pazienti con sclerosi multipla
    precedentemente arruolati in uno studio clinico di fase IIIb / IV sponsorizzato da Roche
    ¿ Valutare la sicurezza e la tollerabilit¿ della terapia con ocrelizumab nei pazienti con sclerosi multipla precedentemente arruolati
    in uno studio clinico di fase IIIb / IV sponsorizzato da Roche
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Able to comply with the study protocol, in the investigator’s judgment
    - Completed the treatment period of Roche sponsored ocrelizumab Parent-trial (including the female patients who were pregnant during study and are still in the safety follow up period) and who in the opinion of the investigator may benefit from treatment with ocrelizumab
    -Patient who became pregnant by chance between the last visit of the parent study and screening of this study, as confirmed by pregnancy tests at screening, will enter the safety follow-up immediately and re-start the treatment after birth and breastfeeding are over, as per re-treatment criteria
    - Meet re-treatment criteria with ocrelizumab
    - For women of childbearing potential: agreement to remain abstinent or use an acceptable birth control method during the treatment period and for at least 6 months or longer after the final dose of ocrelizumab, as applicable in the local ocrelizumab package leaflet.
    - In grado di rispettare il protocollo dello studio, a giudizio dello sperimentatore
    - Aver completato il periodo di trattamento con ocrelizumab dello studio sorgente sponsorizzato da Roche (incluse le pazienti di sesso femminile gravide durante gli studi iniziali e ancora in periodo di follow-up di sicurezza) e che secondo il parere dello sperimentatore può trarre beneficio dal trattamento con ocrelizumab
    - Rispettare i criteri di ri-trattamento con ocrelizumab
    - le pazienti che hanno iniziato una gravidanza non programmata tra l’ultima visita dello studio iniziale e lo screening del presente studio, come confermato da tests di gravidanza effettuati allo screening, entreranno immediatamente nel periodo di follow-up e ricominceranno il trattamento dopo la nascita e quando il periodo di allattamento sarà concluso, così come indicato nella Sezione 3.1.3 criteri di ri-trattamento.
    - per le donne in età fertile: impegnarsi a praticare l’astinenza o utilizzare un metodo contraccettivo accettabile durante il periodo di trattamento e per almeno 6 mesi o più a lungo dopo l’ultima dose di ocrelizumab, come indicato nel foglietto illustrativo di ocrelizumab.
    E.4Principal exclusion criteria
    - Hypersensitivity to ocrelizumab or to any of its excipients
    - Patients in a severely immunocompromised state until the condition resolves
    - Evidence of any adverse event potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation
    - Existence of a contra-indication as per ocrelizumab package leaflet
    - Prohibited concomitant medication use
    - Patient intending to become pregnant during the study or within 6 month after the last dose of the study drug in the parent study
    - Patients who discontinued ocrelizumab, exemption made for treatment discontinuation due to pregnancy and breastfeeding for patients who
    continued clinical study assessments in the safety follow-up of the parent study.
    - Ipersensibilità a ocrelizumab o ad uno qualsiasi dei suoi eccipienti
    - Pazienti in uno stato gravemente immunocompromesso finché la condizione non si risolve
    - Evidenza di qualsiasi evento avverso potenzialmente attribuibile a ocrelizumab, per il quale l'etichetta locale raccomandi la sospensione permanente
    - sussistenza di una controindicazione come da RCP
    - farmaci concomitanti proibiti così come specificato nella Sezione 4.4.1.
    - pazienti che intendono iniziare una gravidanza durante lo studio o nei 6 mesi successivi l’ultima dose del farmaco in studio nello studio iniziale.
    - Pazienti che hanno interrotto l'assunzione di ocrelizumab nello studio parentale (ad eccezione per le interruzioni del trattamento dovute a gravidanza
    e allattamento per le pazienti che hanno proseguito le valutazioni cliniche nel periodo di follow-up dello studio iniziale).
    E.5 End points
    E.5.1Primary end point(s)
    1. Evaluate clinical measures related to
    disease progression over two years in MS patients
    1.Valutare parametri clinici correlati alla progressione della malattia nell’arco di due anni in pazienti
    con SM
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to 2 years
    1. Fino a 2 anni
    E.5.2Secondary end point(s)
    1. Time to onset of Confirmed disability progression (CDP) sustained for at least 24 weeks and for at least 48 weeks
    2. Proportion of patients who have confirmed disability improvement (CDI), CDP for at least 24 weeks and for at least 48 weeks yearly and over the duration of the study
    3.Proportion of patients who have improved, stable or worsened disability compared with baseline(inclusion in the study)measured by expanded disability status scale (EDSS)
    4.Mean change from inclusion in Extension study in EDSS score over the course of the study
    5.Time to 20% increase in timed 25-foot walk test(T25FWT); time to 20% increase in timed nine-hole peg test(9HPT)sustained for at least 24 weeks and for at least 48 weeks, and proportion of patients achieving a sustained increase
    assessed yearly and at the end of the Extension study
    6.Time to first protocol-defined event of disease activity
    7. Time to first relapse
    8.Annualised relapse rate 9. Proportion of patient relapse free, yearly and over the course of the study 10. Proportion of
    patients with no evidence of protocol-defined disease activity (NEDA) yearly and over the course of the study 11. Proportion of
    patients with no evidence of progression, measured by EDSS, 9HPT and T25FW (if assessments are available) 12. Proportion of
    patients with no evidence of progression sustained for at least 24 weeks and no active disease (if assessments are available) 13.
    Change from baseline in cognitive performance as measured by the Symbol digit modalities test (SDMT) 14. Total number of T1
    Gd-enhancing lesions as detected by brain MRI over time 15. Total number of new and/or enlarging T2 lesion as detected by brain
    MRI over time 16. Change in total T1 hypointense lesion volume over time 17. Total number of fluid-attenuated inversion-recovery
    (FLAIR) late enhancing lesions as detected by brain MRI over time 18. Change in brain volume (including white and grey matter
    fractions) as detected by brain MRI over time 19. Time to treatment discontinuation/switch 20. Employment status (Work
    Productivity and Activity Impairment Questionnaire [WPAI]) 21. SymptoMScreen score 22. Quality of life (Multiple Sclerosis Impact
    Scale [MSIS]-29) 23. Evaluation of cognition as measured by SDMT assessment 24. Rate and nature of adverse events 25. Changes
    in vital signs, neurological examinations, clinical laboratory results, locally reviewed MRI for safety (non-MS CNS pathology) and
    concomitant medications
    1.Tempo di insorgenza di progressione della disabilità confermata (CDP), sostenuta x almeno 24 settimane e x almeno 48 settimane 2.Proporzione di pz che mostrano un miglioramento della disabilità confermato (CDI), una CDP x almeno 24 settimane e x almeno 48 settimane annualmente e x l'intera durata dello studio 3.Proporzione di pz che mostrano una disabilità migliorata, stabile o peggiorata rispetto al basale (inclusione nello studio), misurata in base alla scala Expanded Disability Status Scale (EDSS) (annualm/x epoca e x l'intera durata dello studio) 4.Variaz media del punteggio EDSS nel corso dello studio rispetto all'inclusione nello studio di estensione. 5.Tempo a un aumento del 20% del punteggio del Timed 25-Foot Walk Test, (T25FWT); tempo a un aumento del 20% del punteggio del nine-hole peg test (9HPT), sostenuto x almeno 24 settimane e x almeno 48 settimane, e proporz di pz che hanno conseguito un aumento sostenuto, valutato annualm e al termine dello studio di estensione. 6.Tempo al primo evento di attività della malattia definito dal protocollo 7.Tempo alla prima recidiva 8.Tasso di recidiva annualizzato 9.Proporz di pz liberi da recidiva, annualm e nel corso dello studio 10.Proporz di pz senza evidenza di attivit¿ di malattia definita dal protocollo (NEDA) una volta l¿anno e durante lo studio 11.Proporz di pz senza evidenza di progressione sostenuta x almeno 24 settimane n¿ malattia attiva (No Evidence of Progression or Active Disease, NEPAD),
    definita dall¿assenza di una progressione in tutte e tre le componenti NEP (CDP, T25FWT, 9HPT) 12.Proporzione di pz senza
    evidenza di progressione (No Evidence of Progression, NEP), definita come assenza di progressione sostenuta x almeno 24
    settimane 13.Variaz dal basale delle prestazioni cognitive, misurate in base al test Symbol Digit Modalities Test (SDMT) 14.Numero
    totale di lesioni in T1 captanti il gadolinio, rilevate dalla RM cerebrale nel corso del tempo 15.Numero totale di lesioni in T2 nuove
    e/o in espansione, rilevate dalla RM cerebrale nel corso del tempo 16.Variaz volume totale delle lesioni ipointense in T1 nel corso
    del tempo 17.Numero totale di lesioni FLAIR (Fluid-Attenuated Inversion-Recovery) in fase tardiva rilevate dalla RM cerebrale nel
    corso del tempo 18.Variazione del volume cerebrale (incluse frazioni di materia bianca e grigia), rilevata dalla RM cerebrale nel
    corso del tempo 19.Tempo all¿interruzione/cambio del trattamento 20. ¿ Stato lavorativo (questionario Work Productivity and
    Activity Impairment Questionnaire [WPAI]) 21. SymptoMScreen 22. Qualit¿ di vita (QoL) (Multiple Sclerosis Impact Scale [MSIS]-29)
    23.Valutaz della capacit¿ cognitive misurata dal test SDMT 24.Incidenza e natura degli ev avversi 25.Variaz dei parametri vitali,
    degli esami neurologici, dei risultati clinici di laboratorio, della RM valutata localmente x la sicurezza (patologia non a carico del
    sistema nervoso centrale [SNC]) e farmaci concomitanti
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-24. Up to 2 years
    1-24 Fino a 2 anni
    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) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned32
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA200
    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
    Turkey
    Denmark
    Estonia
    Finland
    France
    Ireland
    Italy
    Netherlands
    Norway
    Spain
    Sweden
    United Kingdom
    Czechia
    E.8.7Trial has a data monitoring committee No
    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 end of the study is defined as the last patient last visit (LPLV) in the B-cell monitoring of the Follow-Up period i.e. until B-cell repletion and no longer than 2 years (If the patients are receiving other B-cell targeted therapies, then the Follow-up Period is only 48 weeks from the start of other B-cell targeted therapies).
    La fine dello studio è definita come l'ultima ultima visita del paziente (LPLV) nel monitoraggio delle cellule B del periodo di follow-up,
    ovvero fino alla rigenerazione delle cellule B e non più di 2 anni (se i pazienti ricevono altre terapie mirate con cellule B, quindi
    il periodo di follow-up è di solo 48 settimane dall'inizio di altre terapie mirate con cellule B).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years10
    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: 1224
    F.1.3Elderly (>=65 years) No
    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 state198
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 903
    F.4.2.2In the whole clinical trial 1224
    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)
    The Sponsor will offer continued access to Roche IMP (ocrelizumab) free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, as outlined in protocol section 4.3.5.
    Lo Sponsor offrir¿ un accesso continuo all'IMP di Roche (ocrelizumab) gratuitamente ai pazienti idonei in conformit¿ con la Politica
    globale di Roche sull'accesso continuo al prodotto medicinale sperimentale, come delineato nella sezione 4.3.5 del protocollo.
    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 Decision2018-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-10
    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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