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Application Form for a Statement to Foreign Governments for Dietary Supplements A statement to Foreign Governments explaining the regulatory setting for dietary supplements can be obtained upon request from Medsafe, the government agency with responsibility for administration of the Dietary Supplements Regulations 1985. The Dietary Supplements Regulations 1985 (the 'Regulations'), in summary, defines a dietary supplement as something normally found in food, that is intended to supplement the amount of that substance normally derived from food. See Regulation 2A for the complete text. For further information please contact dietarysupplements@t.nzProduct detailsName of the product(s) to appear on the same certificate (exactly as you wish to see it appear on the certificate):(NB: Additional products can only be included on the same certificate if the manufacturing sites are identical for all products).Destination country (if you wish this to appear on the certificate):Section 1: Tick all statements that apply to the availability of your product:The product freely available for purchase in New Zealand? (complete Section 2) The product been specifically formulated and/or packaged to be marketed overseas? The product exported in bulk and intended for packaging and labelling in another country? Tick FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX Section 2: Evidence of AvailabilityIf the product if freely available for purchase in New Zealand, please provide web link(s) to the New Zealand retailer that is commonly used by New Zealand consumers. there is no web link available for the product(s), please provide the following information:a list of New Zealand-based distributors (wholesalers or retailers) that distribute the product(s) in New Zealand sales records or evidence of sales of the product(s) from the New Zealand-based distributor(s) for the previous two years. FORMCHECKBOX FORMCHECKBOX Section 3: Labelling requirementsPlease tick to confirm the following have been provided with your application:New Zealand Label (please provide as a PDF label proof).Exported product Label(s) (if exported labelling is different to the labelling used in New Zealand). FORMCHECKBOX FORMCHECKBOX Manufacture detailsCompany name(exactly as you wish to see it appear on the certificate)Site address(exactly as you wish to see it appear on the certificate)Product owner: (the name and address of the New Zealand company who is responsible for the product)Manufactured by:Capsulated by: (if applicable)Labelled by:Packaged by:Ingredient detailsPlease list each ingredient in order of decreasing weight:Weight (mg):Ingredient: (continued from previous column)Weight (mg):Applicant detailsCompany name and physical address:Postal address (if different from the physical address):Company and physical address to be invoiced (if different from above):Certificate to be sent by courier (street address required) : YES FORMCHECKBOX NO FORMCHECKBOX (NB: an additional fee will be included on the invoice if the certificate is to be sent by courier)Purchase order number:Contact person:Contact email: Phone:I declare that the above is an accurate description of the product I intend to export. I declare that this product complies with the Dietary Supplement Regulations 1985. Specifically:This product is not intended for a therapeutic purpose (refer to section 4 of the Medicines Act 1981The product does not contain a substance which is scheduled as a medicine () The product does not exceed maximum daily dosses as defined in regulation 3 of the Dietary Supplement Regulations 1985.Labelling and marketing of this product does not include therapeutic claims (refer to regulation 11 of the Dietary Supplement Regulations 1985).Signed ______________________ Date: ................
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