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    Summary
    EudraCT Number:2020-002537-15
    Sponsor's Protocol Code Number:R10933-10987-COV-2066
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-09-30
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2020-002537-15
    A.3Full title of the trial
    A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS CoV 2 Monoclonal Antibodies for the Treatment of Hospitalized Patients with COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, Tolerability, and Efficacy of Anti-Spike SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19
    A.4.1Sponsor's protocol code numberR10933-10987-COV-2066
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04426695
    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 SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trials information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post codeNY 10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.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 nameREGN10933
    D.3.2Product code REGN10933
    D.3.4Pharmaceutical form Solution for injection/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 INNREGN10933
    D.3.9.2Current sponsor codeREGN10933
    D.3.9.3Other descriptive nameREGN10933
    D.3.9.4EV Substance CodeSUB215763
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product 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.IMP: 2
    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 nameREGN10987
    D.3.2Product code REGN10987
    D.3.4Pharmaceutical form Solution for injection/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 INNREGN10987
    D.3.9.2Current sponsor codeREGN10987
    D.3.9.3Other descriptive nameREGN10987
    D.3.9.4EV Substance CodeSUB215764
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Coronavirus disease 2019 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level HLT
    E.1.2Classification code 10084510
    E.1.2Term Coronavirus infections
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1:
    • To evaluate the safety and tolerability of REGN10933+REGN10987 (REGN-COV2) compared to placebo
    • To evaluate the virologic efficacy of REGN-COV2 compared to placebo in reducing viral shedding of SARS CoV 2
    Phase 2:
    • To evaluate the virologic efficacy of REGN-COV2 compared to placebo in reducing viral shedding of SARS CoV 2
    • To evaluate the clinical efficacy of REGN-COV2 compared to placebo in improving clinical status
    Phase 3:
    • To evaluate and confirm the clinical efficacy of REGN-COV2 compared to placebo in improving clinical status.
    E.2.2Secondary objectives of the trial
    Phase 1:
    • Evaluate additional indicators of virologic efficacy of REGN-COV2 vs placebo
    • Estimate the clinical efficacy of REGN-COV2 vs placebo in improving clinical outcomes
    • Compare RT-qPCR results acquired with different sample types
    • Characterize the PK profiles of REGN10933 and REGN10987 in serum
    • Assess the immunogenicity of REGN10933 and REGN10987
    Phase 2:
    • Evaluate additional indicators of virologic efficacy of REGN-COV2 vs placebo
    • Evaluate additional indicators of clinical efficacy of REGN-COV2 vs placebo
    • Evaluate the safety and tolerability of REGN-COV2 vs placebo
    • Characterize the concentrations of REGN10933 and REGN10987 in serum
    • Assess the immunogenicity of REGN10933 and REGN10987
    Phase 3:
    • Evaluate the clinical efficacy of REGN-COV2 vs placebo
    • Evaluate the safety and tolerability of REGN-COV2 vs placebo
    • Characterize the concentrations of REGN10933 and REGN10987 in serum
    • Assess the immunogenicity of REGN10933 and REGN10987
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    •Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal [OP], or saliva) ≤72 hours prior to randomization and no alternative explanation for current clinical condition. A historical record of positive result from test conducted ≤72 hours prior to randomization is acceptable.
    •Has symptoms consistent with COVID-19, as determined by investigator, with onset ≤10 days before randomization
    •Hospitalized for COVID-19 illness for ≤72 hours with at least 1 of the following at randomization; patients meeting more than one criterion will be categorized in the most severely affected category:
    a. Cohort 1A: With COVID-19 symptoms but not requiring supplemental oxygen
    b. Cohort 1: Maintains O2 saturation >93% on low-flow oxygen as defined in the protocol
    c.Cohort 2: High-intensity oxygen therapy without mechanical ventilation as defined in the protocol
    d.Cohort 3: On mechanical ventilation
    NOTE: Other protocol defined inclusion criteria apply
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    •Phase 1 only: Patients maintaining O2 saturation >94% on room air
    •In the opinion of the investigator, unlikely to survive for >48 hours from screening
    •Receiving extracorporeal membrane oxygenation (ECMO)
    •Has new-onset stroke or seizure disorder during hospitalization
    •Initiated on renal replacement therapy due to COVID-19
    NOTE: Other protocol defined exclusion criteria apply
    E.5 End points
    E.5.1Primary end point(s)
    1. Proportion of patients with treatment-emergent Serious Adverse Events (SAEs)
    (Primary: Ph 1: C1 Secondary: Ph 1: C1, Ph 2: C1A, C1, C2, C3)
    2. Proportion of patients with infusion-related reactions
    (Primary: Ph 1:C1, Secondary: Ph 2: C1A, C1, C2, C3)
    3. Proportion of patients with hypersensitivity reactions
    (Primary: Ph 1:C1, Secondary: Ph 2: C1A, C1, C2, C3)
    4.Time-weighted average change from baseline in viral shedding as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples (Ph 1:C1, Ph 2: C1A, C1, C2, C3)
    5. Proportion of patients with at least 1-point improvement on a 7-Point Ordinal Scale in clinical status (Primary: Ph 2: C1A, C1, C2, C3, Ph 3:C1, C2, C3 Secondary: Ph 1:C1, Ph 2: C1A, C1, C2, C3)

    7-point Ordinal Scale:
    - Death;
    - Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);
    - Hospitalized, requiring non-invasive ventilation or high flow oxygen devices;
    - Hospitalized, requiring supplemental oxygen;
    - Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
    - Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
    - Not hospitalized
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Through Day 169 (Primary: Ph.1: Up to Day 169, Secondary: Ph.1: Up to Day 29, Ph.2: Up to Day 29 and 57)
    2. Through Day 4
    3. Through Day 29
    4. Baseline up to Day 22
    5. From Day 1 up to Day 29 (Primary: Ph 2: C1A and C1, Ph3: C1: Day 8, Ph. 2: C2 and C3, Ph.3: C2 and C3: Day 22, Secondary: Ph. 1: Day 8 and Day 29, Ph. 2: Day 29)
    E.5.2Secondary end point(s)
    1.Time-weighted average change from baseline in viral shedding as measured by RT-qPCR in saliva samples (Ph 1: C1)
    2.Time-weighted average change from baseline in viral shedding as measured by RT-qPCR in nasal samples (Ph 1: C1)
    3.Time to negative RT-qPCR in all tested samples with no subsequent positive RT-qPCR in any tested samples (Ph 1: C1)
    4.Time to negative RT-qPCR in NP swabs with no subsequent positive RT-qPCR (Ph 2: C1A, C1, C2, C3)
    5.Change from baseline in viral shedding as measured by RT-qPCR in NP swabs (Ph 1: C1 Ph 2: C1A, C1, C2, C3)
    6.Time-weighted average change in viral shedding (Ph 1: C1 Ph 2: C1A, C1, C2, C3)
    7.Change from baseline in viral shedding as measured by RT-qPCR in saliva samples (Ph1:C1)
    8.Change from baseline in viral shedding as measured by RT-qPCR in nasal swabs(Ph 1: C1)
    9.Correlation of RT-qPCR results over time between different sample types (Ph 1: C1)
    10.Concordance of RT-qPCR results over time between different sample types (Ph 1: C1)
    11.Proportion of patients with at least 2-point improvement on a 7-Point Ordinal Scale in clinical status (Ph 1: C1 Ph 2: C1A, C1, C2, C3)
    12.Time to no longer requiring oxygen supplementation (Ph 1: C1 Ph 2: C1, C2, C3)
    13.Number of days of supplemental oxygen use (Ph 1: C1 Ph 2: C1A, C1, C2, C3)
    14.Proportion of patients initiating high-intensity oxygen therapy (Ph 1: C1 Ph 2: C1A, C1, C2, C3)
    15.Number of days of high-intensity oxygen therapy (Ph 1: C1 Ph 2: C1A, C1, C2, C3)
    16.Proportion of patients initiating mechanical ventilation (Ph 1: C1 Ph 2: C1A, C1, C2, C3)
    17.Number of days of mechanical ventilation (Ph 1: C1 Ph 2: C1A, C1, C2, C3)
    18.Number of Ventilator-free days (Ph 1: C1 Ph 2: C1A, C1, C2, C3)
    19.Number of days of hospitalization (Ph 1: C1 Ph 2: C1A, C1, C2, C3)
    20.Proportion of patients re-admitted to hospital after discharge through the end of study (Ph 1: C1 Ph 2: C1A, C1, C2, C3)
    21.Proportion of patients admitted into an intensive care unit (ICU) (Ph 1: C1 Ph 2: C1A, C1, C2, C3)
    22.Days of ICU stay (Ph 1: C1 Ph 2: C1A, C1, C2, C3)
    23.Number of deaths due to any cause (All-Cause Mortality) (Ph 1: C1 Ph 2: C1A, C1, C2, C3)
    24.Overall Survival (Ph 1: C1 Ph 2: C1A, C1, C2, C3)
    25.Serum concentration of REGN10933 over time (Ph 1: C1 Ph 2: C1A, C1, C2, C3)
    26.Serum concentration of REGN10987 over time (Ph 1: C1 Ph 2: C1A, C1, C2, C3)
    27.Incidence of anti-drug antibodies (ADA) to REGN10933 (Ph 1: C1 Ph 2: C1A, C1, C2, C3)
    28.Incidence of ADA to REGN10987 (Ph 1: C1 Ph 2: C1A, C1, C2, C3)
    29.Assessment of PK parameter: Cmax of REGN10933 (Ph1)
    30.Assessment of PK parameter: Cmax of REGN10987 (Ph1)
    31.Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) for REGN10933 (Ph1)
    32.Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) for REGN10987 (Ph1)
    33.Assessment of PK parameter: Time to Cmax (tmax) for REGN10933 (Ph1)
    34.Assessment of PK parameter: Time to Cmax (tmax) for REGN10987 (Ph1)
    35.Assessment of PK parameter: AUC computed from time zero to the time of the last positive concentration (AUClast) for REGN10933 (Ph1)
    36.Assessment of PK parameter: AUC computed from time zero to AUClast for REGN10987 (Ph1)
    37.Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for REGN10933(Ph1)
    38.Assessment of PK parameter: AUC from time zero extrapolated to AUCinf for REGN10987 (Ph1)
    39.Assessment of PK parameter: AUCinf-to-dose ratio (AUCinf/dose) of REGN10933 (Ph1)
    40.Assessment of PK parameter: AUCinf-to-dose ratio (AUCinf/dose) of REGN10987 (Ph1)
    41.Assessment of PK parameter: Observed t1/2 of REGN10933 (Ph1)
    42.Assessment of PK parameter: Observed t1/2 of REGN10987 (Ph1)
    43.Assessment of PK parameter: CL for REGN10933 (Ph1)
    44.Assessment of PK parameter: CL of REGN10987 (Ph1)
    45.Assessment of PK parameter: Vss of REGN10933 (Ph1)
    46.Assessment of PK parameter: Vss of REGN10987 (Ph1)
    47.Assessment of PK parameter: Mean residence time (MRT) of REGN10933 (Ph1)
    48.Assessment of PK parameter: MRT of REGN10987(Ph1)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Baseline up to Day 22
    2.Baseline up to Day 22
    3.Through Day 29
    4.Through Day 29
    5 - 8.Baseline up to Day 29
    9.Up to Day 29
    10.Up to Day 29
    11.From Day 1 up to Day 29
    12.Through Day 29
    13.Through Day 29
    14.Up to Day 29 or hospital discharge
    15.Through Day 29
    16.Up to Day 29 or hospital discharge
    17-19.Through Day 29
    20.Ph 1:Through Day 169 Ph 2:Through Day 57
    21.Up to Day 29
    22.Up to Day 29
    23.Ph 1:Through Day 29 and Day 169 Ph 2:Through Day 29 and Day 57
    24.Ph 1:Through Day 169 Ph 2:Through Day 57
    25-28.Phase 1:Through Day 169 Phase 2:Through Day 29
    29.-48.Through day 169
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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
    Brazil
    Chile
    Mexico
    United States
    Romania
    Moldova, Republic of
    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
    Last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months14
    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: 2079
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 891
    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 state800
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 2970
    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
    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 Decision2020-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-10-22
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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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