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    Summary
    EudraCT Number:2012-002554-23
    Sponsor's Protocol Code Number:GENA-05
    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:2021-01-21
    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 number2012-002554-23
    A.3Full title of the trial
    Immunogenicity, Efficacy and Safety of Treatment with Human-cl rhFVIII in Previously Untreated Patients with Severe Haemophilia A.
    Immunogenicit¿, efficacia e sicurezza del trattamento con Human-cl rhFVIII in pazienti, non trattati in precedenza, affetti da emofilia A grave.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The ability to induce an immune response, efficacy and safety of treatment with Human-cl rhFVIII in previously Untreated Patients, affected by inherited gender-related coagulation disorder ,in which affected males do not produce functional coagulation factor VIII (FVIII) in sufficient quantities to achieve satisfactory blood clotting.
    La capacit¿ di indurre una risposta immunitaria, l'efficacia e la sicurezza del trattamento con Human-cl rhFVIII in pazienti precedentemente non trattati, affetti da malattia ereditaria della coagulazione legata al genere, in cui i maschi non producono un funzionale fattore VIII della coagulazione (FVIII) in quantit¿ sufficienti per raggiungere una soddisfacente coagulazione del sangue.
    A.3.2Name or abbreviated title of the trial where available
    Not available
    Non disponibile
    A.4.1Sponsor's protocol code numberGENA-05
    A.5.4Other Identifiers
    Name:N/ANumber:N/A
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/92/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOCTAPHARMA AG
    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 supportOCTAPHARMA AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInVentiv Health Clinical UK Ltd.
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressThames House, 17-19 Marlow Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 7AA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441628587430
    B.5.5Fax number00441628408428
    B.5.6E-mailRegOpsEurope@inVentivHealth.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 Yes
    D.2.1.1.1Trade name Nuwiq
    D.2.1.1.2Name of the Marketing Authorisation holderOctapharma AB Sweden
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHuman cell line recombinant factor VIII
    D.3.2Product code Human-cl rhFVIII
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    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 INNHuman-cl rhFVIII
    D.3.9.2Current sponsor code140
    D.3.9.3Other descriptive nameHuman Coagulation Factor VIII
    D.3.9.4EV Substance CodeSUB13815MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number250 to 2000
    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
    Severe Haemophilia A
    Emofilia A grave
    E.1.1.1Medical condition in easily understood language
    An inherited gender-related coagulation disorder in which affected males do not produce functional coagulation factor VIII (FVIII) in sufficient
    quantities to achieve satisfactory blood clotting.
    Un disturbo ereditario della coagulazione, correlato al genere, in cui i maschi affetti non producono un funzionale fattore VIII della coagulazione (FVIII) in adeguate quantit¿ tali da permettere una
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10018938
    E.1.2Term Haemophilia A (Factor VIII)
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the immunogenicity of Human-cl rhFVIII in 100 PUPs suffering from severe haemophilia A (FVIII:C < 1%).
    Investigare l'immunogenicit¿ di Human-cl rhFVIII (Fattore VIII ricombinante umano da linea cellulare umana) in 100 pazienti non trattati in precedenza (PUP) affetti da emofilia A grave (FVIII:C < 1%).
    E.2.2Secondary objectives of the trial
    ¿ To assess the efficacy of Human-cl rhFVIII during prophylactic treatment (based on the frequency of spontaneous break-through bleeds);
    ¿ To assess the efficacy of Human-cl rhFVIII during treatment of bleeds;
    ¿ To assess the efficacy of Human-cl rhFVIII in surgical prophylaxis;
    ¿ To assess the safety and tolerability of Human-cl rhFVIII.
    ¿ Valutare l'efficacia di Human-cl rhFVIII durante il trattamento profilattico (sulla base della frequenza con cui si manifestano le emorragie spontanee nell'intervallo tra due infusioni);
    ¿ Valutare l'efficacia di Human-cl rhFVIII durante il trattamento di emorragie;
    ¿ Valutare l'efficacia di Human-cl rhFVIII nella profilassi chirurgica;
    ¿ Valutare la sicurezza e la tollerabilit¿ di Human-cl rhFVIII.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: 1. Recovery investigation (optional).
    2. RNA Expression (optional).
    3. Analysis of gene mutation of FVIII (optional).
    4. Immunogenotyping (Partly Optional).
    5. In vitro immunogenicity of FVIII products (optional).
    6. Epitope mapping in case of inhibitor development.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: 1. Indagine sul recupero (opzionale).
    2. Analisi dell'espressione dell'RNA (opzionale).
    3. Analisi di mutazione del gene del FVIII (obbligatoria).
    4. Immunogenotipizzazione (opzionale): tipizzazione HLA, profilo dei geni della risposta immunitaria e aplotipo etnico del FVIII.
    5. Immunogenicit¿ in vitro dei prodotti FVIII (opzionale).
    6. Mappatura degli epitopi (opzionale).
    E.3Principal inclusion criteria
    In order to qualify for study enrolment, the following criteria must be fulfilled before study entry:
    1. Male patients;
    2. Severe haemophilia A (FVIII:C < 1%);
    3. No previous treatment with FVIII concentrates or other blood products containing FVIII;
    4. Voluntarily given, fully informed written and signed consent given before any study related procedures are conducted (obtained from the patient's parent(s)/legal guardian(s)).
    La popolazione di pazienti comprenderà principalmente neonati e lattanti; tuttavia, non vi sono limiti di età per l'ammissione allo studio.
    Criteri di inclusione:
    1. pazienti di sesso maschile;
    2. emofilia A grave (FVIII:C < 1%);
    3. nessun precedente trattamento con concentrati di FVIII o altri prodotti ematici contenenti FVIII;
    4. il consenso pienamente informato, dato volontariamente per iscritto e firmato deve essere ottenuto prima della conduzione di qualsiasi procedura relativa allo studio (tale consenso verrà dato dal genitore/tutore legale del paziente).
    E.4Principal exclusion criteria
    Patients will not be included if any of the following exclusion criteria are
    met:
    1. Diagnosis of a coagulation disorder other than haemophilia A;
    2. Severe liver or kidney disease (ALT or AST levels >5 times of upper limit of normal (ULN), creatinine >120 µmol/L);
    3. Concomitant treatment with any systemic immunosuppressive drug;
    4. Participation in another interventional clinical study currently or during the past 4 weeks.
    1. diagnosi di un disturbo della coagulazione diverso dalla emofilia A;
    2. malattia renale o epatica grave (livelli di alanina aminotransferasi (ALT) o di aspartato transaminasi (AST) >5 volte il limite superiore di normalità, creatinina >120 µmol/l);
    3. terapia concomitante con qualsiasi farmaco immunosoppressore sistemico;
    4. partecipare attualmente o aver partecipato nelle ultime 4 settimane ad un altro studio clinico interventistico.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity of Human-cl rhFVIII is the primary endpoint. Inhibitor activity will be determined by the modified Bethesda assay (Nijmegen
    modification), using congenital FVIII deficient human plasma, spiked with Human-cl rhFVIII. In case of a positive inhibitor result, an inhibitor
    retesting, using a second separately drawn sample, should be performed. A FVIII inhibitor is defined as "positive", if the retesting confirms the positive result, otherwise the result is considered as being
    "negative".
    L' immunogenicità di Human-cl rhFVIII è l'end point primario. L'attività dell'inibitore verrà determinata mediante il metodo di Bethesda (modificato secondo Nijmegen), utilizzando plasma umano con deficit congenito del FVIII a cui è stato aggiunto Fattore VIII ricombinante umano da linea cellulare umana. In caso di risultato positivo al test degli inibitori, il test deve essere eseguito nuovamente utilizzando un secondo campione di sangue prelevato separatamente.

    In caso di risultato positivo al test degli inibitori, il test deve essere eseguito nuovamente utilizzando un secondo campione di sangue prelevato separatamente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • At baseline (Screening Visit)
    • Every 3-4 EDs until ED 20
    • Every 10-12 EDs or every 3 months ± 2 weeks (whichever comes first)
    after ED 20 until 100 EDs are reached
    • Any time in the case of suspicion of an inhibitor development.
    • al basale (visita di screening);
    • ogni 3-4 giorni di esposizione fino al giorno di esposizione 20;
    • ogni 10-12 giorni di esposizione oppure ogni 3 mesi ± 2 settimane (l'evento che si verifica prima) dal giorno di esposizione 20 al giorno di esposizione 100;
    • a fine studio;
    • in qualsiasi momento, se si sospetta lo sviluppo di inibitori.
    E.5.2Secondary end point(s)
    1)Efficacy
    a) Efficacy of prophylactic treatment
    The efficacy of Human-cl rhFVIII in the prophylactic treatment will be investigated by calculating the frequency of spontaneous break-through
    bleeds under prophylactic treatment.
    Study drug consumption data (FVIII IU/kg per month, per year) per patient and in total will be evaluated. The dates and times of study drug infusions, the details of dose(s), and the product batch numbers used for the prophylactic treatment will be documented.
    b) Efficacy of treatment of bleeds
    The efficacy of Human-cl rhFVIII in the treatment of bleeds will be investigated by using a 4-point ordinal haemostatic efficacy scale.
    Details of the bleed, the amount of Human-cl rhFVIII needed and the number of injections necessary to stop the bleed will be documented.
    c) Efficacy of surgical prophylaxis
    In surgical procedures, the following parameters will be documented:
    ¿ Overall efficacy assessment (taking into account the intra- and postoperative assessment) after the end of surgical prophylactic treatment phase, performed by the surgeon and by the haematologist.
    ¿ Average and maximum expected estimated blood loss, compared to the actual estimated blood loss.
    ¿ Details on surgical procedure: location, severity, type, expected and actual duration
    ¿ Pre-, intra-, and post-operative FVIII plasma levels, if appropriate
    ¿ Details of administered dose(s) of Human-cl rhFVIII given pre-, intra- and/or postoperatively including dates, times and batch numbers
    ¿ Details on concomitantly administered drugs, including all blood and blood product
    transfusions, excluding standard anaesthetic drugs
    ¿ Details on all wound haematomas in terms of capturing, analysing, and reporting these, including any need for surgical evacuation
    ¿ Outcome of the intervention, described by means of a brief narrative
    2.Safety
    Safety and tolerability will be assessed by monitoring vital signs, standard laboratory parameters, and by monitoring adverse events
    (AEs).
    Efficacia:
    Efficacia del trattamento profilattico: L'efficacia di Human-cl rhFVIII nel trattamento profilattico sar¿ valutata sulla base della frequenza delle emorragie spontanee che si manifestino nell'intervallo tra le infusioni, mentre il paziente ¿ sotto trattamento profilattico. Le date e gli orari delle infusioni del farmaco in studio, i dettagli della/e dose/i e i numeri di lotto dei prodotti utilizzati per il trattamento profilattico saranno documentati. I dettagli di eventuali episodi emorragici che si dovessero verificare durante il trattamento profilattico saranno documentati. Saranno valutati i dati relativi al consumo del farmaco in studio (UI di FVIII/kg/mese, anno) per ogni paziente e complessivo.
    Efficacia del trattamento delle emorragie: L'efficacia di Human-cl rhFVIII nel trattamento delle emorragie verr¿ valutata sulla base di una scala di efficacia emostatica obiettiva. I dettagli dell'emorragia (tipo, sede e gravit¿, nonch¿ data e ora di inizio e di fine), la quantit¿ di Human-cl rhFVIII richiesto e il numero di iniezioni necessarie per arrestare l'emorragia saranno documentate.
    Efficacia della profilassi chirurgica: L'efficacia di Human-cl rhFVIII nella profilassi chirurgica sar¿ valutata in base a quanto segue:
    ¿ Una valutazione complessiva dell'efficacia (considerando sia la valutazione intra-operatoria che quella post-operatoria) effettuata congiuntamente dal chirurgo e dall'ematologo dopo la fine del trattamento di profilassi chirurgica,.
    ¿ Stima della perdita ematica media e massima attesa rispetto alla perdita ematica effettiva.
    Sar¿ inoltre documentata la sede, la gravit¿ e il tipo di intervento chirurgico. Sar¿ registrata la durata prevista ed effettiva dell'intervento chirurgico cos¿ come i dettagli della/e dose/i di Human-cl rhFVIII (prima, durante e/o dopo l'intervento). Saranno misurati i livelli plasmatici di FVIII (prima, durante e dopo l'intervento). Saranno registrati i dettagli di eventuali prodotti somministrati in concomitanza (ad eccezione della normale anestesia), insieme con una breve descrizione dei risultati dell'intervento.
    Sicurezza:
    Parametri vitali: la pressione arteriosa, la frequenza cardiaca, la frequenza respiratoria e la temperatura corporea saranno valutate durante lo screening, trimestralmente e a fine studio. Se l¿IMP viene iniettato presso il Centro di studio nel corso di tali visite, ¿ obbligatorio un controllo prima e uno dopo il trattamento.
    Parametri di laboratorio di sicurezza: i seguenti parametri di laboratorio di sicurezza verranno testati durante lo screening e durante le visite di follow-up ogni 3 mesi (¿ 2 settimane): parametri ematologici (globuli rossi, globuli bianchi, emoglobina, ematocrito, conta piastrinica) e chimica clinica (ALT, AST, creatinina sierica). I campioni vengono analizzati nel laboratorio locale.
    Tollerabilit¿: l'occorrenza di eventuali eventi avversi sar¿ monitorata per tutta la durata dello studio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1)Efficacy
    In the prevention and the treatment of bleeds, the frequency of breakthrough bleeds in case of prophylactic treatment, the efficacy in surgical
    prophylaxis of Human-cl rhFVIII will be thoroughly assessed. In the course of the follow-up visits (i.e. every 3-4 EDs until ED 20, then every 10-12 EDs until ED 100), scheduled to be performed after the Screening Visit, FVIII inhibitor levels will be assessed.
    These visits may be combined with the additional regular 3 monthly (¿ 2 weeks) follow-up visits.
    2) Safety
    AEs and changes in concomitant medication, overall safety and tolerability will be checked and documented at each follow-up visit.
    1)Efficacy
    In the prevention and the treatment of bleeds, the frequency of breakthrough bleeds in case of prophylactic treatment, the efficacy in surgical
    prophylaxis of Human-cl rhFVIII will be thoroughly assessed. In the course of the follow-up visits (i.e. every 3-4 EDs until ED 20, then every 10-12 EDs until ED 100), scheduled to be performed after the Screening Visit, FVIII inhibitor levels will be assessed.
    These visits may be combined with the additional regular 3 monthly (¿ 2 weeks) follow-up visits.
    2) Safety
    AEs and changes in concomitant medication, overall safety and tolerability will be checked and documented at each follow-up visit.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Belarus
    Canada
    Georgia
    India
    Moldova, Republic of
    Morocco
    Russian Federation
    Ukraine
    United States
    Croatia
    France
    Germany
    Italy
    Poland
    Portugal
    Slovenia
    Spain
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    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 Yes
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 49
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 49
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 2
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children
    Bambini
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 100
    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
    Nessuno
    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 Decision2015-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-15
    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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