Imprt Health Standard fr Bilgical Prducts (including samples) Shrt name: BIOPRODIC.ALL Ministry fr Primary Industries P.O Bx 2526 Wellingtn 6140 New Zealand Imprt Health Standard BIOPRODIC.ALL 05 Nvember 2015 Page 1 f 8 Bilgical Prducts (including samples)
ISSUING AUTHORITY This standard is issued under sectin 24A f the Bisecurity Act 1993 (the Act). Dated at Wellingtn this fifth day f Nvember 2015. Directr-General Ministry fr Primary Industries (Issued under delegated authrity) IMPORTANT INFORMATION FOR IMPORTERS AND BORDER STAFF Date: 03 Nvember 2015 The fllwing infrmatin relates t Chief Technical Officer (CTO) Directin CTO 2015 079 [B] which grants equivalence under clause 19: Bilgical prducts intended t be used n r in humans such as, but nt limited t; antibitics, vaccines, and surgical implants/equipment, are eligible t receive bisecurity clearance prvided that They are cmmercially manufactured r manufactured in a GMP facility fr nn-cmmercially manufactured prducts; and The packaging identifies that the prducts are intended fr human use r the imprt is accmpanied by a signed and dated manufacturer s declaratin stating the prducts are intended fr human use, linking the batch numbers f the prduct t thse being imprted; and The packaging f surgical implants als identifies that the prduct(s) is sterile. Imprt Health Standard BIOPRODIC.ALL 05 Nvember 2015 Page 2 f 8 Bilgical Prducts (including samples)
Table f Cntents PART A. INTRODUCTION... 4 Backgrund... 4 Scpe... 4 Outcmes... 4 Definitins... 5 PART B. GENERAL REQUIREMENTS... 6 Dcumentatin... 6 Inspectin... 6 Packaging and Transprt... 6 PART C. SPECIFIC REQUIREMENTS... 7 Bilgical Prducts fr Human Use... 7 Milk and Milk Prducts... 7 Negligible Risk Gds fr Clearance... 8 Risk Gds fr Use within a Transitinal Facility... 8 PART D. EQUIVALENCE... 8 Imprt Health Standard BIOPRODIC.ALL 05 Nvember 2015 Page 3 f 8 Bilgical Prducts (including samples)
PART A. Intrductin Backgrund 1. Under sectin 24A f the Act, this dcument is the Imprt Health Standard ( the standard ) fr Nn-Viable Bilgical Prducts (including samples). 2. If this standard needs t be amended r revked urgently, r the Directr General cnsiders that an amendment is minr, the amendment r revcatin may be carried ut withut prir cnsultatin. 3. A Guidance Dcument will be issued by MPI t accmpany this Imprt Health Standard. The dcument will prvide guidance infrmatin relevant t hw the requirements may be met. 4. Pursuant t sectin 26 f the Bisecurity Act 1993, a bisecurity clearance will be issued fr bilgical prducts that are eligible fr bisecurity clearance, when the requirements f this standard are met. 5. Pursuant t sectin 25 f the Bisecurity Act 1993, a bisecurity authrity, will be issued fr bilgical prducts that are eligible t mve t a transitinal facility. Scpe 6. This standard specifies the requirements that must be met t effectively manage the risks assciated with the imprtatin f nn-viable bilgical prducts (including animal prduct samples) int New Zealand. 7. Fr the purpses f this standard, bilgical prducts means prducts imprted fr ne f the fllwing purpses: Labratry research, diagnstic and analytical purpses (including equipment calibratin and validatin) Animal prduct samples fr evaluatin and/r prficiency testing. Envirnmental use; OR Use in, r n, humans, animals and/r plants (e.g. medical, veterinary r hrticultural use). NOTE: See Guidance Dcument fr eligibility and exclusins f bilgical prducts. 8. Bilgical prducts derived frm humans are nt subject t this imprt health standard and are eligible fr bisecurity clearance. Outcmes 9. The desired utcme f this standard is that the bisecurity risks assciated with bilgical prducts are effectively managed t eliminate any adverse effects these may have n New Zealand s natural and physical resurces, the ecnmy r human health and safety. 10. T achieve this utcme, bilgical prducts must be subject t risk assessment t identify thse that require risk management and t exclude thse cnsidered t be f negligible risk. Imprt Health Standard BIOPRODIC.ALL 05 Nvember 2015 Page 4 f 8 Bilgical Prducts (including samples)
11. Prducts imprted under this standard must meet the general requirements cntained in Part B f this standard and any specific requirements included in Part C that are applicable. Definitins 12. The definitins belw relate t the requirements fr imprting cnsignments under this imprt health standard: Bilgical Prduct Nn-viable (nt capable f living, replicating, reprducing r develping) prducts derived frm living rganisms, including samples f animal rigin (Nte: Bilgical prducts derived frm humans are nt subject t this imprt health standard). Medicine Has the same meaning as that defined in the Medicines Act 1981. Milk and Milk Prducts Includes all prducts manufactured frm the milk f animals. Fr example; cream, cheese, yghurt, butter, milk pwder. Micrrganism A micrscpic rganism including prtza, fungi, bacteria, viruses, unicellular algae and prins. Sample A small part intended as a representative f the whle Imprt Health Standard BIOPRODIC.ALL 05 Nvember 2015 Page 5 f 8 Bilgical Prducts (including samples)
PART B. GENERAL REQUIREMENTS Dcumentatin 13. A permit t imprt is required fr bilgical prducts, with the exceptin f: Milk and milk prducts that meet the criteria cntained in Part C belw, OR Bilgical prducts that are listed n the Negligible Risk Register. See Guidance Dcument. 14. A cpy f the permit t imprt must accmpany each cnsignment. This shuld be securely attached t the utside f the external packaging. 15. All unaccmpanied prducts imprted under this standard must be transprted with infrmatin that identifies the rigin f the prduct (i.e. cuntry r zne), the destinatin in New Zealand, and adequately describes the nature f the prduct. Inspectin 16. Dcumentatin in relatin t a specific cnsignment f bilgical prducts must be inspected n arrival by an inspectr. The inspectr may als inspect the cnsignment, r part f the cnsignment t verify the dcumentatin and/r check fr cmpliance t the requirements f this standard. Packaging and Transprt 17. Packaging must be free f any cntaminants, and must be apprpriate given the nature f the gds t effectively cntain any ptential bisecurity risks during transprt. 18. It is the imprter s respnsibility t ensure that the exprter is infrmed f the transprt requirements accrding t the Internatinal Air Transprt Assciatin (IATA) Dangerus Gds Regulatins where necessary. These are available at http://www.iata.rg/ Imprt Health Standard BIOPRODIC.ALL 05 Nvember 2015 Page 6 f 8 Bilgical Prducts (including samples)
PART C. SPECIFIC REQUIREMENTS Bilgical Prducts fr Human Use 19. Bilgical prducts intended t be used n r in human such as, but nt limited t; antibitics, vaccines, and surgical implants/equipment, are eligible t receive bisecurity clearance prvided that: They are cmmercially manufactured; The packaging identifies that the prducts are intended fr human use; and The packaging f surgical implants als identifies that the prduct(s) is sterile. Milk and Milk Prducts Imprtant infrmatin fr imprters 20 March 2017 CTO 2017 014[B] gives directin t replace the MPI List f Ft & Muth Disease (FMD) Free Cuntries with the OIE List f FMD Free Member Cuntries fr clearance f specified prducts. http://www.ie.int/en/animal-health-in-the-wrld/fficial-disease-status/fmd/list-f-fmd-free-members/ Fr the purpses f this IHS, FMD free includes cuntries listed in these sectins: FMD free where vaccinatin is nt practised; and FMD free where vaccinatin is practised. It des nt include these sectins: FMD free zne where vaccinatin is nt practised; r FMD free zne where vaccinatin is practised. 20. Samples cntaining milk and milk prducts frm Ft and Muth Disease (FMD) free cuntries r znes (as per the MPI list f FMD free cuntries/znes) must: individually weigh n mre than 50kgs; AND be in tamper-prf packaging; AND be packed in; AND be shipped frm; AND nly cntain ingredients surced frm an FMD-free cuntry. 21. Milk and milk prducts must be packed by the manufacturer in sealed tamperprf packaging with the cuntry f rigin clearly stated n the packaging, r dcumentatin accmpanying the sample(s). 22. Prducts that cmply with the criteria specified in clauses 20 and 21 abve will be eligible fr bisecurity clearance. Imprt Health Standard BIOPRODIC.ALL 05 Nvember 2015 Page 7 f 8 Bilgical Prducts (including samples)
23. Prducts that d nt cmply with the criteria specified in clauses 20 and 21 abve will require a permit t imprt that specifies that the prducts are eligible fr bisecurity authrity t mve t a transitinal facility. Negligible Risk Gds fr Clearance 24. Other bilgical prducts may be eligible fr bisecurity clearance prvided that they: Meet all cnditins n the accmpanying permit t imprt, OR Have been assessed by MPI t be gds with a negligible risk, OR Are listed n the Negligible Risk Register. See Guidance Dcument. Risk Gds fr Use within a Transitinal Facility 25. Bilgical prducts (including samples) that are assessed by MPI t be risk gds may be eligible fr a bisecurity authrity t mve t a MPI apprved transitinal facility prvided they meet all cnditins n the permit t imprt. See Guidance Dcument n requirements fr prcessed and unprcessed risk gds. 26. Animal prduct samples may be eligible fr clearance if treated in a MPI apprved facility t eliminate risk rganisms as per the relevant imprt health standard fr that cmmdity. This ptin is nly applicable t samples that meet the eligibility criteria f the relevant imprt health standard. 27. In the case f bee prducts, the transitinal facility must be insect prf, r have an active cntrl prgramme t manage the risk f insect cntaminatin. PART D. EQUIVALENCE 28. The requirements fr imprtatin f bilgical prducts (including samples) are met if, in the pinin f the Directr General, the measures taken fr managing the risks assciated with the imprtatin f thse cnsignments are equally effective at managing thse risks as the requirements specified in (1) t (27) abve. If an equivalence measure(s) is apprved, MPI will issue a permit t imprt (under sectin 27(1)d(iii) f the Bisecurity Act). Imprt Health Standard BIOPRODIC.ALL 05 Nvember 2015 Page 8 f 8 Bilgical Prducts (including samples)