Permit to Import Quarantine Material

Transcription

1 Quarantine Act 1908 Section 13(2AA) Permit to Import Quarantine Material Phone: Fax: File Ref: Permit: IP Valid From: 9 Jul 2014 Valid To: 9 Jul 2016 Page 1 of 7 Importer Dr Ian Barr WHO Collaborating Centre for Reference & Research on Influenza Peter Doherty Institute 792 Elizabeth Street Melbourne Attn: Katie Milne Exporter Various Suppliers Exporters Various Addresses In All countries You are authorised to import the following material under the listed conditions Note: This permit covers DAFF quarantine requirement only. All imports may be subject to quarantine inspection on arrival to determine compliance with the listed permit conditions and freedom from contamination. Imports not in compliance or not appropriately identified or packaged and labelled in accordance with the import conditions they represent may be subject to seizure, treatment, re-export or destruction at the importer s expense. Additionally, all foods imported into Australia must comply with the provisions of the Imported Food Control Act 1992, and may be inspected and/or analysed against the requirements of the Australia New Zealand Food Standards Code. All imports containing or derived from Genetically Modified material must comply with the Gene Technology Act It is the importer s responsibility to identify, and to ensure it has complied with, all requirements of any other regulatory organisations and advisory bodies prior to and after importation including The Australian Customs and Border Protection Service, The Department of Health and Ageing, Therapeutic Goods Administration, Australian Pesticides and Veterinary Medicines Authority, Department of Sustainability, Environment, Water, Population and Communities, Food Standards Australia New Zealand and any state agencies such as Departments of Agriculture and Health and Environmental Protection authorities. Importers should note that this list is not exhaustive. This permit is granted for the purposes of the Quarantine Act 1908 and Quarantine Proclamation 1998 of the Commonwealth of Australia. The laws of Australian States and Territories may also impose restrictions on the import of animals, plants and other goods into those States and Territories. This import permit does not prevent the application of those State and Territory laws. The importer should seek its own advice on any restrictions that may apply in any State or Territory into which it is proposed to import the animals, plants or other goods to which this permit relates. Import conditions are subject to change at the discretion of the Director of Quarantine. This permit may be revoked without notice. Notification of the import must be provided to DAFF for all imported goods other than goods imported as accompanied baggage or goods imported via the mail and not prescribed under the Customs Act Notification must be consistent with Quarantine Regulations 2000 (examples include a Quarantine Entry or a Quarantine declaration). Commodity Name Number(s) Country End Use Microorganisms (As listed in PC0010 List A) PC0010 AND PC0017 AND PC1672 All countries In-vitro use or in-vivo use in laboratory organisms only Microorganisms (As listed in PC0010 List B) PC0017 AND PC0010 AND PC0717 All countries In-vitro use or in-vivo use in laboratory organisms only Microorganisms (As listed in PC0010 List C) PC0017 AND PC0010 AND PC0714 AND PC6866 AND PC1672 All countries In-vitro use or in-vivo use in laboratory organisms only PC0010 Text This permit allows for the import of the following products only: This permit is granted subject to the condition that fees determined under Section 86E are paid Stamp:

2 Permit: IP Page 2 of 7 Text LIST A: - Influenza viral isolates of human origin type A and type C (excluding avian influenza H7 and H5 subtypes) - Influenza viral isolates of human origin (not suspected of being avian influenza H7 and H5 subtypes) - Clinical samples from humans (not suspected of being infected with avian influenza H7 and H5 subtypes) LIST B: - Influenza viral isolates of human origin type B LIST C: - Modified influenza viruses of either human or avian origin reassorted with PR8 or WSN strains of human influenza virus (excluding avian influenza H7 and H5 subtypes). PC0017 Biological Imports Program (BIP) - Administrative conditions 1. This import permit (or number) and all required documentation must accompany each consignment and must be valid at the time the cargo is landed. 2. In order to facilitate clearance of mail shipments, the import permit (or number) and all documentation should be securely attached to the outside of the package and marked Attention Quarantine. 3. The importer must meet all costs associated with the import of this product. 4. The importer (or agent) must lodge a quarantine entry for each consignment. 5. Documents must be provided with each consignment which: a) identify the consignment e.g. entry number: and b) identify all goods being imported as part of this consignment e.g. invoice or waybill or importers manifest; and c) describe the goods being imported (where not clear) Example 1: Product XRab = Purified protein derived from rabbits. Example 2: Product AX = Synthetic antibiotic. Example 3: Comte = Cheese. Note: It is the importer s responsibility to provide any additional information which is requested in order to demonstrate that the import permit covers all goods being imported. 6. Consignments that do not meet the import conditions will remain under the Department s control pending export or destruction at the importers expense. 7. For further information please contact:

3 Permit: IP Page 3 of 7 Text Regional - Clearance assistance: Canberra - Biological Import Program - Administrative assistance: bioadmin@daff.gov.au Canberra - Biological Import Program Technical assistance: biologicals@daff.gov.au PC0714 Manufacturer s declaration Certification Each consignment must be accompanied by a manufacturer s declaration. The declaration must meet the format described by this permit and state: a) that the product is a modified influenza virus of either human or avian origin produced through reassortment with the human influenza strain PR8 or WSN and contains at least six internal gene protein segments of PR8 virus and modified HA segment of the avian virus; and b) that the modified virus has been assessed and found negative for pathogenicity in the statutory chicken intravenous test (IVP index of 1.2 or less, OIE th edition or equivalent pathogenicity testing) in chickens. The declaration must be provided by: the Manufacturer PC0717 POST ENTRY CONDITIONS 1. This Import Permit allows for the importation of goods for in vitro laboratory studies, in vivo use in laboratory organisms only and in vivo use in ferrets only, unless approved by the Department of Agriculture for specific in vivo use in non-laboratory organisms. 2. Laboratory organisms are those defined in the following list and must be contained under laboratory or animal house conditions: guinea pigs, hamsters, mice, rabbits, rats or microorganisms. Work in all other animals (with the exception of ferrets) and plants is not permitted. 3. For in vivo use in non-laboratory organisms (e.g. chickens, sheep, cattle, etc.) other than ferrets or plants a separate application for in vivo use must be lodged with, and approved by the Department of Agriculture. This also applies if the product is to be used in veterinary vaccine or veterinary therapeutic manufacture. 4. It is the end user s responsibility to ensure that all laboratory products are used in accordance with the current AS/NZS 2243 Safety in Laboratory standards. This includes handling and disposal procedures. 5. It is the importer s responsibility to ensure compliance with all international (e.g. IATA) and domestic requirements concerning the safe handling, transport and labelling of biological material. 6. It is the end user s responsibility to ensure that all laboratory products are used in accordance with the Office of the Gene Technology Regulator (OGTR) requirements.

4 Permit: IP Page 4 of 7 Text 7. The Department of Health requirements include: a) The level of containment and management practices must be at least PC2 as recommended under the AS/NZS :2010 (both for in vitro and in vivo). Some of these management practices include: i) use of class II biological safety cabinets (BSCs) for working with tissues, fluids and all manipulations that may cause splashes, droplets or aerosols; ii) care must be taken in the use of syringes, needles and other sharps; iii) laboratory workers must wear adequate protective clothing and equipment, including disposable gloves, eye protection; iv) all materials transported within and between laboratories must be placed in a secondary container to minimise the potential for breakage or a spill. b. The imported material must not be removed from the premises, except for disposal or unless the samples are being transported to a laboratory with PC2 containment or higher. At the conclusion of the research all imported materials must be sterilised by steam under pressure in an autoclave or some other suitable method before disposal. c. All staff must be adequately trained in the relevant laboratory procedures. d. Personnel should be provided with prompt first aid and evaluation by a health care professional following any exposure incident. If personnel do become infected it is recommended that they do not travel to North Queensland or other areas where vectors are present. PC1672 This condition requires product to be directed to and held at Quarantine Approved Premises (QAP). POST ENTRY CONDITIONS 1. The Products are for use at: HEALTH (#V2379) Doherty Institute, Level 3, QC3 WHO & DMI Flu Labs, 792 Elizabeth Street, HEALTH (#V2416) Doherty Institute, Level 4 WHO Flu QC2 Specimen Reception, 792 Elizabeth Street HEALTH (#V2417) Doherty Institute, Level 4 VIDRL Entero & WHO Flu QC2 Labs, 792 Elizabeth Street HEALTH (#V2414)

5 Permit: IP Page 5 of 7 Text Doherty Institute, Level 3, HCF WHO Flu QC2 Labs, 792 Elizabeth Street BIOCSL PTY LTD (#V2203) 63 Poplar Rd, Building 17 WHO facility Room 9 BIOCSL PTY LTD (#V2204) 63 Poplar Rd, WHO Facility Room 10 BIOCSL PTY LTD (#V0279) 63 POPLAR ROAD BIOCSL PTY LTD (#V2091) 63 Poplar Road, Building 19 IVV-Seed facility GMP G03, GC1-GC3 BIOCSL PTY LTD (#V2128) Morgan Facility, Ground Floor, Building 08, Rooms G33 (PAL) and G32 63 Poplar Road 2. The premises must be approved as a Class 5 QAP. These premises must have current approval at the time of importation, and until such time that all imported material and its derivatives are removed for disposal or re-export. 3. The level of containment must be QC (PC) 2 or higher. 4. The goods and their derivatives shall not be removed from these premises, except for disposal or re-export, without the prior approval of the Director of Quarantine. 5. Disposal must be by incineration, autoclaving or other methods approved in writing by the Director of Quarantine. 6. Where more than one QAP is listed in point 1 above, the samples may be transferred between the listed premises. All records of transfer must be maintained for audit purposes. 7. This Import Permit allows for the importation of goods for in vitro laboratory studies, in vivo

6 Permit: IP Page 6 of 7 Text use in laboratory organisms and in vivo use in ferrets only, unless approved by the Department of Agriculture for specific in vivo use in non-laboratory organisms other than ferrets. 8. Laboratory organisms are those defined in the following list and must be contained under laboratory or animal house conditions: guinea pigs, hamsters, mice, rabbits, rats or microorganisms. 9. For in vivo use in non-laboratory organisms (e.g. chickens, sheep, cattle, etc.) other than ferrets or in plants, a separate application for in vivo use must be lodged with, and approved by the Department of Agriculture. This also applies if the product is to be used in veterinary vaccine or veterinary therapeutic manufacture. 10. It is the end user s responsibility to ensure that all laboratory products are used in accordance with the current AS/NZS 2243 Safety in Laboratory standards. This includes handling and disposal procedures. 11. It is the importer s responsibility to ensure compliance with all international (e.g. IATA) and domestic requirements concerning the safe handling, transport and labelling of biological material. 12. It is the end user s responsibility to ensure that all laboratory products are used in accordance with the Office of the Gene Technology Regulator (OGTR) requirements. 13. The Department of Health requirements include: a) use of class II biological safety cabinets (BSCs) for working with tissues, fluids and all manipulations that may cause splashes, droplets or aerosols; b) care must be taken in the use of syringes, needles and other sharps; c) laboratory workers must wear adequate protective clothing and equipment, including disposable gloves, eye protection; d) all materials transported within and between laboratories must be placed in a secondary container to minimise the potential for breakage or a spill. e) all staff must be adequately trained in the relevant laboratory procedures. f) Personnel should be provided with prompt first aid and evaluation by a health care professional following any exposure incident. If personnel do become infected it is recommended that they do not travel to North Queensland or other areas where vectors are present. 14. The only goods and their derivatives that may be removed from these premises, except for disposal or re-export, without the prior approval of the Director of Quarantine, are Influenza isolates that have been typed as human influenza virus (A, B or C) and shown not to be derived from avian influenza viruses. These isolates may be transferred to other laboratories including laboratories that are not registered as a QAP providing all other post entry requirements are met. The importer must have on file a letter from recipient laboratories confirming the following: a) the laboratory has PC2 level containment facilities b) the laboratory will follow PC2 level precautions while working with the isolates. c) all work with the isolates will be conducted in Class 2 Biologicals Safety Cabinets d) on completion of work all isolates will be disposed of by incineration or autoclaving 15. Where a viral isolate or sample originates from a person showing signs or symptoms of a highly pathogenic strain of influenza, the isolate or sample must be subject to containment and management practices at the PC3 level.

7 Permit: IP Page 7 of 7 PC6866 Text Format of the manufacturer s declaration 1. Manufacturer - The declaration must be made by the manufacturer. 2. Letterhead - The declaration must be on manufacturer s letterhead. 3. Identification of goods. - The declaration must be specific to the product(s) listed on this permit. Product names must be included on the manufacturers declaration. - The declaration must have a unique identifiable link to the consignment i.e. container number, way bill number, commercial invoice number, preferential tariff certificate number, health certificate number, packing list number or letter of credit number, batch/serial number or date of manufacture. 4. Statements - All statements must be written in English. - All statements must be legible and appear above the signature of the issuing officer. - The declaration must contain the correct statement/s as required by the import conditions. - The declaration must be free from erasures and non certified alterations. All erasures and alterations must be endorsed by the issuer of the document. Note: The only acceptable endorsement of alterations is a company seal and the signature of the company officer responsible for signing the declaration, applied adjacent to the alteration. 5. Identification of the issuing officer. - The declaration must state the name, position and title of the issuing officer. - Declarations must bear the signature of the issuing officer 6. Date - The declaration must state the date of issue - Declarations must be issued within the last 6 months (unless otherwise specified in this import permit) General: All documentation must meet the requirements of the Department of Agriculture s minimum documentary requirements policy. For full details of the department s minimum documentary requirements, please refer to End of Text