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Country's Decision or any other Communication
Record information and status
Record ID
Date of creation
2017-06-03 20:49 UTC (tim.strabala@epa.govt.nz)
Date of last update
2018-02-23 09:52 UTC (tim.strabala@epa.govt.nz)
Date of publication
2018-02-23 09:52 UTC (tim.strabala@epa.govt.nz)

General information
Country submitting the decision or communication
  • New Zealand
Competent National Authority(ies) responsible for the decision or communication
Environmental Protection Authority
215 Lambton Quay
Private Bag 63002
New Zealand
Phone:+64 (0)4 474 5591
Fax:+64 (0)4 914 0433
Url:New Organisms, Environmental Protection Authority
Title / Reference number of the decision or communication
Decision - APP202601
Date of the decision
Is the decision taken prior to entry into force of the Protocol?
  • New Zealand
Is this an amendment to a previous decision / communication?
Decision or communication details
Subject(s) of the decision
  • Decision on LMOs for intentional introduction into the environment (according Article 10 or domestic regulatory framework)
Was the decision triggered by a request for a transboundary movement of LMOs into the country?
Does the decision apply to transboundary movements of LMO(s) into the country?
Importer’s or Applicant’s contact details
11th Floor, HP bldg
83 Uisadang-daero, Yeongdeungpo-gu
Republic of Korea
Phone:+82 (2) 368-2600
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Control 1 - The applicant must ensure that the organism (Pexa-Vec, pexastimogene devacirepvec; JX-594; as described in Table 1) is only administered:
a) to individuals enrolled in a Phase 3 clinical trial approved under the Medicines Act 1981 to examine the safety and efficacy of Pexa-Vec in patients with hepatocellular carcinoma;
b) intratumourally;
c) by a suitably trained medical practitioner(s); and
d) at a Phase 3 clinical trial site
Control 2 - The New Zealand sponsor of the Phase 3 clinical trial must notify the EPA and Ministry for Primary Industries (MPI), in writing, and at least one calendar month before Pexa-Vec is administered for the first time at each clinical trial site, of:
a) the location of the Phase 3 clinical trial site; and
b) the qualifications of the suitably trained medical practitioner(s) who will administer the organism.
Control 3 - The New Zealand sponsor must ensure a suitably qualified person(s), before treatment:
a) educates the individual who will be treated with the organism about the potential for Pexa-Vec to be transmitted to untreated individuals and animals (and potential adverse effects of Pexa-Vec transmission);
b) advises such individuals to report any adverse effects suspected to be related to Pexa-Vec transmission; and
c) instructs such individuals on pustule management practices (particularly to avoid contact with immunocompromised people if pustules form following treatment).
Control 4 - The New Zealand sponsor must ensure that a suitably qualified person(s):
a) before treatment, provides the individual who will be treated with the organism with a biohazard container for disposal of used pustule dressings;
b) before treatment, instructs such individuals to return these containers to a Phase 3 clinical trial site for medical waste disposal; and
c) disposes of such containers in accordance with medical waste disposal procedures in place at that Phase 3 clinical trial site.
To manage environmental risk associated with the LMO.
Does the decision involve field trials?
Does the decision involve commercial release?
LMO identification
Pexa-Vec Vaccine
Production of medical or pharmaceutical compounds (human or animal) - Vaccines Selectable marker genes and reporter genes
Risk assessment
Pexa-Vec hepatocellular carcinoma therapy in clinical trial
Pexa-Vec Vaccine
Production of medical or pharmaceutical compounds (human or animal) - Vaccines
Selectable marker genes and reporter genes
Decision document