WAREHOUSING AND DISTRIBUTION OF CANNABIS PRODUCTS. RACI Pharmaceutical Science Group (NSW) Supply and Use of Medicinal Cannabis

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1 WAREHOUSING AND DISTRIBUTION OF CANNABIS PRODUCTS RACI Pharmaceutical Science Group (NSW) Supply and Use of Medicinal Cannabis 28 March 2017 Bruce Battye Director Pharmaceutical Regulatory Unit, NSW Health

2 PRODUCTS Pharmaceutical Regulatory Unit Legal and Regulatory Services Branch NSW Ministry of Health Poisons and Therapeutic Goods Act 1966 Poisons and Therapeutic Goods Regulation 2008 Risk-based approach to regulation and compliance

3 PRODUCTS LICENSING LEGISLATION - POISONS & THERAPEUTIC GOODS REGULATION 2008 Part 8 Division 2 of the Regulation provides for licences to supply by wholesale poisons and restricted substances Applications, licences, conditions of licences and licence fees Part 8 Division 3 of the Regulation provides for licences to manufacture or supply drugs of addiction Applications, licences, conditions of licences and licence fees

4 PRODUCTS SCHEDULE 4 (RESTRICTED SUBSTANCES) - SCHEDULE 8 (DRUGS OF ADDICTION) Schedule 4 CANNABIDIOL in preparations for therapeutic use containing 2 per cent or less of other cannabinoids found in cannabis. Schedule 8 NABIXIMOLS (botanical extract of Cannabis sativa which includes the following cannabinoids: tetrahydrocannabinols, cannabidiol, cannabinol, cannabigerol, cannabichromene, cannabidiolic acid, tetrahydrocannabinolic acids, tetrahydrocannabivarol, and cannabidivarol, where tetrahydrocannabinols and cannabidiol (in approximately equal proportions) comprise not less than 90 per cent of the total cannabinoid content) in a buccal spray for human therapeutic use. Schedule 8 CANNABIS (including seeds, extracts, resins and the plant, and any part of the plant) when prepared or packed for human therapeutic use, when: a) cultivated or produced, or in products manufactured [1], in accordance with the Narcotic Drugs Act 1967; and/or b) for use in products manufactured in accordance with the Narcotic Drugs Act 1967; and/or c) imported as therapeutic goods, or for use in therapeutic goods, for supply, in accordance with the Therapeutic Goods Act 1989; and/or d) in therapeutic goods supplied in accordance with the Therapeutic Goods Act 1989, except when: i) it is a product to which item 4, 8, 10, 11 or 12 of Schedule 5A to the Therapeutic Goods Regulations 1990 applies; or ii) separately specified in Schedule 4; or iii) separately specified in the NABIXIMOLS entry in this Schedule; or iv) in hemp seed oil for purposes other than internal human therapeutic use containing 50 mg/kg or less of cannabinoids.

5 PRODUCTS LICENSING PROCESS Licence application - RCU ASIC documents Statutory Declarations Fitness and Probity Check Forms National Criminal Record Check forms Certificate of the registration of business name Details of drugs requested Payment of fee PRU Contact Drugs and Poisons Control Procedure Compliance with TGA Code of Good Wholesaling Practice for Schedules 2, 3, 4 and 8 Compliance with Poisons and Therapeutic Goods legislation Security Risk Assessment Report (if necessary) Inspection (if necessary) Report Licence issuance - RCU

6 PRODUCTS SCHEDULE 8 DRUGS Drug register Storage in safe or strongroom Security in accordance with Security Risk Assessment Supply based on written order & signed and dated receipt Obtain and keep written evidence of consignment Arrangement with carrier to obtain receipt, dated and signed Packaging requirements Report lost/stolen drugs Destruction of Schedule 8 drugs

7 PRODUCTS LICENCE CONDITIONS Supply only from nominated premises Supply only to authorised persons Compliance with approved DPCP Supply in unopened packs as supplied (Cannabis) Limited to supply of products authorised under Therapeutic Goods Act (Cannabis) Quarterly returns to Ministry of Health

8 PRODUCTS Contact details: Pharmaceutical Regulatory Unit Legal and Regulatory Services Branch NSW Ministry of Health Locked Mail Bag 961 North Sydney NSW 2059 Tel:

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