No. We do not recommend that full ✔ pharmaceutical industry GMP standards should be required, as this is unlikely to be feasible for EC manufacturers (particularly independent manufacturers) in NZ or elsewhere. An alternative that has been proposed is that EC specific standards are developed that are practicable whilst ensuring a reasonable Good manufacturing practice standard of specific EC manufacturing practices such as handling of chemicals, levels of nicotine purity etc. This would again require an analysis of best international practice, and requiring compliance with these standards as a condition for products to be approved for sale in New Zealand. ✔ Yes. We recommend that requirements for purity and grade of nicotine are introduced aligned with best international practice, and that Purity and of nicotine compliance with these standards is a condition for products to be approved for sale in New Zealand. Yes We recommend that registration of ✔ products and demonstration of compliance with international Registration of products standards is a condition for products to be approved for sale in New Zealand. ✔ No. Resources to implement a comprehensive high quality testing A testing regime to confirm product safety regime in New Zealand are unlikely to and contents purity be available. ✔ Yes. We recommend a maximum purchase/sale regulation is introduced in line with what is reasonable for personal use. The rationale for this is that bulk purchase is likely to be for the purposes of supplying/selling to Maximum allowable volume of e-liquid in others, which would circumvent the retail sales restrictions on sales and supply (particularly to minors) and the requirement that sales staff can provide expert advice in use of ECs and brief smoking cessation advice and referral.
Good manufacturing practice ✔ No. We do not recommend that full pharmaceutical industry GMP standards should be required, as this is unlikely to be feasible for EC manufacturers (particularly independent manufacturers) in NZ or elsewhere. An alternative that has been proposed is that EC specific standards are developed that are practicable whilst ensuring a reasonable standard of specific EC manufacturing practices such as handling of chemicals, levels of nicotine purity etc. This would again require an analysis of best international practice, and requiring compliance with these standards as a condition for products to be approved for sale in New Zealand. Purity and of nicotine ✔ Yes. We recommend that requirements for purity and grade of nicotine are introduced aligned with best international practice, and that compliance with these standards is a condition for products to be approved for sale in New Zealand. Registration of products ✔ Yes We recommend that registration of products and demonstration of compliance with international standards is a condition for products to be approved for sale in New Zealand. A testing regime to confirm product safety and contents purity ✔ No. Resources to implement a comprehensive high quality testing regime in New Zealand are unlikely to be available. Maximum allowable volume of e-liquid in retail sales ✔ Yes. We recommend a maximum purchase/sale regulation is introduced in line with what is reasonable for personal use. The rationale for this is that bulk purchase is likely to be for the purposes of supplying/selling to others, which would circumvent the restrictions on sales and supply (particularly to minors) and the requirement that sales staff can provide expert advice in use of ECs and brief smoking cessation advice and referral.
all_submissions_61-90.docx