The Regulatory Environment in New Zealand. Michelle Palmer Natural Products New Zealand
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1 The Regulatory Environment in New Zealand Michelle Palmer Natural Products New Zealand
2 Nieuw Zeeland You are here New Zealand? It s where?
3 Unique Product Offerings Botanical Origin Manuka honey Horopito (botanical) Flax Kumara (NZ sweet potato) Grape-seed extracts Avocado Boysenberry Feijoa Gold Kiwifruit/Zespri Kiwiberry Tamarillo Olive extracts Pip fruits (apple/pear) Animal Origin Green lipped mussel extracts Fish/marine oils Wool keratin Colostrum, immunoglobulin Animal organ extracts Deer velvet
4 The Regulatory Mine Field No Man s Land 2008 DSR 1985 Postponement of ANZTPA Establishment Project 2007 TTMRA 1998 Trans Tasman 1 st consultation 2002 NZFSA Recommendations 2004 NZ & Aus Govts Agreement for Trans Tasman Regulation 2003
5 Progress! Five meetings of industry and consumer groups December Industry and consumer groups agree on fundamental Principles for NZ Regulation of NHPs May Regulatory Proposal to NZ Government October Government agreement to most principles 9 March Government released high level consultation paper 17 June Summary of submissions released by Ministry of Health Today - Natural Health Products Bill before NZ Parliament
6 New regulatory scheme for natural health products Separate from regulation of pharmaceutical products and foods Joint National Government & Green Party deal First Reading in NZ Parliament on 15 September 2011 Referred to Health Committee Submissions closed on 24 February submissions received Health Committee must report back to Parliament by 30 May 2012 Bill to be enacted by the end of 2012 Date of commencement of the Act at latest December 2013 NZ Natural Health Products Bill Depends on availability of Regulations and online database
7 What is a Natural Health Product?* NHP or NaCP Herbal remedies, traditional treatments, homeopathic remedies, dietary supplements, extracted natural ingredients, synthetic equivalents Intended to bring about a health benefit Contains only natural health product ingredients and no prohibited ingredients Not a food, prescription medicine, pharmacy-only medicine or controlled drug Cannot be administered by injection or parenteral infusion; or to the eye or in the ear * Health Committee wants further work on the definition
8 Health Benefit Claims Maintenance or promotion of health or wellness Nutritional support Vitamin or mineral supplementation Affecting or maintaining the structure or function of the body Relief of symptoms of any condition that is not a serious condition Safe, true to claim, true to label NZ natural health products must be fit for human consumption or use Their regulation must be proportionate to the risks associated with their use Low risk = light touch, low cost regulation The products must be accompanied by information that is accurate and tells consumers about the risks and benefits of using the product
9 Regulatory Scheme Online database for product notification prior to product distribution Self certification against scheme requirements Contains only natural health product ingredients already listed on database Does not contain listed prohibited ingredients Manufacturer complies with code of manufacturing practice Product meets labeling requirements Evidence is held to support health benefit claims Traditional evidence vs scientific evidence Levels of evidence within each category All documentation to be kept for random audits Authority is able to recognise the decisions of other regulators
10 Implementation Require a suite of Regulations under the Act Work has already commenced on the Regulations Developed by the Regulator, with support of Interim Technical Expert Advisory Committee and Industry Reference Panel Public consultation document Cabinet approval prior to public consultation Regulations drafted in light of consultation Approved by Minister of Health Reviewed by Regulations Review Committee Adopted by Order in Council Transitional provisions for products already in the market Notification 1 year after commencement of Act Labelling 2 years after commencement Manufacturing standards 3 years after commencement
11 Trans-Tasman / NZ Solo Australia TGA New Zealand Ministry of Health Australia TGA ANZTPA NZ Natural Health Products Regulator Australia & NZ Medicines Australia & NZ Medical Devices NZ Natural Health Products
12 Information & Contact NZ Natural Health Products Bill SCF_00DBHOH_BILL11034_1-Natural-Health-Products-Bill.htm Dietary Supplements Regulations Ministry of Health Natural Products New Zealand Michelle Palmer Executive Director - Natural Products New Zealand michelle@naturalproductsnz.org
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