Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument 2018

Transcription

1 Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument 2018 I, {insert author} make the following instrument. Dated 1 st April 2018 {insert author} Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

2 Contents 1 Name 2 2 Commencement 2 3 Authority 2 4 Short Description 3 5 Regulations 4 1 Name This instrument is the Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument Commencement (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms. Commencement information Column 1 Column 2 Column 3 Provisions Commencement Date/Details 1. The whole of this instrument. Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument. (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument. 3 Authority This instrument is made under the Therapeutic Goods Act Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

3 4 Short Description These regulations are organised into 3 sections. Section 1: Changes to existing regulations; Section 2: Changes to guidance posted only on the Therapeutic Goods Administration website; Section 3: New regulations to provide clearer guidance to the meaning of the Act as it relates to medical cannabis. Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

4 Section 1: Changes to existing Regulations 1. Regulation to add medical cannabis expertise to the Advisory Committee on Medicines Add one member skilled in medical cannabis to the Advisory Committee on Medicines. This person should never have held a position with any company with a drug on the ARTG, and should be qualified as a medical practitioner, current or former. Applicant must demonstrate practical experience in the medical use of cannabis. Additional clause to temporarily increase the maximum number of members to 21 to facilitate an immediate appointment. Part 6 Committees Division 1A Advisory Committee on Medicines To the end of 35B add (x) Medical Cannabis 2. Temporary increase in number 35B Membership withdraw (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B). Replace with (1) The Minister may appoint, in writing, up to 21 persons to the committee in accordance with subregulations (1A) and (1B). 3 Regulation to create a Subcommittee on Medical Cannabis. Convene a subcommittee on medical cannabis to assist the committee review applications for cannabis medications and provide input to the Medical Devices Committee on devices if asked. RESET! anticipates that the volume of applications will require this additional support to get the applications determined in a timely manner. Pursuant to Part 6 (1F) (42) The Secretary is to convene a Subcommittee on Medical Cannabis under the Chair of the Committee member appointed under (1) above. Responsibilities of this subcommittee include: 1. Advising the Medical Committee on all applications received for medical cannabis registrations without limiting the ordinary operation of the Committee in respect of medical cannabis; 2. Monitoring the effectiveness of the regulatory framework and making recommendations directly to the Australian Advisory Council on the Medicinal Use of Cannabis (AACMC) on a quarterly basis. 3. The rulings of the Sub Committee shall be made available to the applicant. Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

5 Section 2: Changes to regulations only appearing on the website 1. Add Israel to acceptable countries Add Israel to the list of Acceptable Countries for the purposes of the Fast Track scheme. 2. Explicitly state Medical Cannabis may be dealt with under the Fast Track Scheme An application for inclusion in the ARTG may be determined under the Fast Track Access Scheme. 3. Explicitly State the Fee for a Medical Cannabis application under the Fast Track Scheme An application for medical cannabis to be included in the ARTG under the Fast Track Scheme shall be $12,300 per application. This does not preclude the charging of the listing fee, variation fees and other fees charged in the normal operation of the scheme provided no fee shall exceed $12, Exemption to allow multiple Fast Track Applications Generally only one fast track application can be processed for the same medication and/or from the same applicant. As we anticipate multiple applications for different formulations of medical cannabis targeting different conditions, which may be from the same or different companies, this condition must be waived for medical cannabis. Multiple applications under the Fast Track Scheme are acceptable for medical cannabis applications, from the same or different applicants. 5. Statement of the role of the Sub Committee The Medical Cannabis Sub Committee to the Advisory Committee on Medicines must be asked to make a recommendation on each application for medical cannabis. 6. Statement as to standard of evidence required When providing evidence under the Fast Track Scheme that medical cannabis can reduce patient harm sufficiently to qualify for listing under 2(ii), empirical evidence of harm reduction in jurisdictions in Approved Countries shall be taken as proof of harm reduction. The question of sufficiency remains one for the Secretary. Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

6 Section 3: New Regulations and/or Guidance as the Parliamentary Office considers appropriate 5 Regulations 1. Requirements for growing and processing medical cannabis Forms of medical cannabis Limit on medical Cannabis production Packaging and labelling of medical cannabis Transportation of medical cannabis Transport manifest Evidence of theft, diversion, or discrepancy during transport Disposal of cannabis and medical cannabis Pesticides, fungicides and herbicides Treatment and Quarantine Orders Insurance requirements License Duration 17 APPENDIX A Acceptable pesticide active ingredients for use 18 Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

7 Section 1. Requirements for growing and processing medical Cannabis. (a) The cultivator/processor shall use good agricultural practices in conformance with the best industry practise. (b) The cultivator/processor shall use only pesticides, fungicides or herbicides that are approved for use for food products. (c) The cultivator/processor shall use those pesticides, fungicides or herbicides listed under subsection (b) in a manner that is approved by the Minister. (d) The cultivator/processor shall maintain records of the type and amounts of fertilizer and any growth additives used, including source. (e) The cultivator/processor shall perform visual inspection of the harvested plant material to ensure there is no mould, mildew, pests, rot or grey or black plant material. (f) The cultivator/processor may not add any additional active ingredients or materials to any medical cannabis that alters the colour, appearance, smell, taste, effect or weight of the medical cannabis other than as may be approved by the Minister. (g) The cultivator/processor shall create a secure ad hoc quarantine area for any cannabis or medical cannabis that needs to be destroyed, clearly marked as a quarantine area. (h) The cultivator/processor shall only process a part of a cannabis plant that is: (1) Well-cured and free of seeds and stems as appropriate. (2) Free of dirt, sand, debris or other foreign matter. (3) Free of mould, rot or other fungus or bacterial diseases. (i) The cannabis plants shall be processed in a safe and sanitary manner. (1) The dried cannabis shall be handled on food-grade stainless steel benches or tables. (2) Proper sanitation shall be maintained. (3) Proper rodent, bird and pest exclusion practices shall be employed at all times. (j) A cultivator/processor shall install a system to monitor and where possible regulate and record temperature, humidity, lighting and ventilation. Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

8 Section 2. Forms of medical cannabis. (a) A cultivator/processor/manufacturer may only produce or dispense medical cannabis in any of the following forms: (1) Pill in powdered tablet or liquid capsule form; (2) Oil; (3) A form medically appropriate for administration by vaporization or nebulization; (4) Topical forms, including gel, creams or ointments. (b) A cultivator/processor may produce medical cannabis in a plant, processed or partially processed form for distribution or sale to other licensed cultivators or processors for the purposes of propagation, research, strain improvement, incineration or processing into medical cannabis in one of the approved forms above, and as otherwise specified in these regulations. For clarification this section prevents the supply of cannabis in plant or edibles form as a prescription product. (c) Limit to package size. A package may not contain more than 3 month s supply unless otherwise allowed by the Minister. (d) Limit to repeats. No repeats shall be allowed on a prescription for medical cannabis. Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

9 Section 3. Limit on medical Cannabis production. (a) A cultivator/processor shall only produce the forms of medical cannabis outlined in Section 8 according to the following requirements: (1) In its final form, medical Cannabis shall be defined as having a specific concentration of total Tetrahydrocannabinol (THC) and total Cannabidiol (CBD) and shall have a consistent cannabinoid profile. The concentration of the following cannabinoids, at a minimum, must be reported: (i) (ii) (iii) (iv) (v) (vi) (vii) (viii) (ix) (x) Tetrahydrocannabinol (THC). Tetrahydrocannabinol acid (THCA). Tetrahydrocannabivarin (THCV). Cannabidiol (CBD). Cannabinadiolic acid (CBDA). Cannabidivarine (CBDV). Cannabinol (CBN). Cannabigerol (CBG). Cannabichromene (CBC). Any other cannabinoid component at > 0.1 percent. Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

10 Section 4. Packaging and labelling of medical cannabis. (a) The manufacturer shall package the final form of the medical cannabis at the manufacturing site. The original seal of any package shall not be broken except for quality testing at a facility approved by the Minister, or for adverse loss investigations by the Minister or by a dispensary to which the medical cannabis is delivered. (b) The manufacturer shall package the medical cannabis in a package that is: (1) Child-resistant in the case of preparations intended for children. (2) Tamper-proof or tamper-evident. (3) Light-resistant and opaque. (4) Re-sealable. (5) Minimizes exposure to oxygen. (c) The manufacturer shall identify each lot of medical cannabis with an identifier that is unique to that lot. (d) The manufacturer shall affix a product label to the medical cannabis at the manufacturing facility. Each product label shall be easily readable, made of weather resistant and tamper resistant materials, conspicuously placed on the package, and shall include the following: (1) The name and permit number of the manufacturer. (2) The form of medical cannabis. (3) The single dose THC and CBD content for the medical cannabis set forth in milligrams (mg) as specified in Section 3. (4) An identifier that is unique to a particular batch of medical cannabis, including the lot number. (5) The quantity of medical cannabis included in the package, including by weight or volume as appropriate. (6) The date packaged and a suggested use by date, which is for guidance only. (e) The Pharmacist shall attach a second label with the following information: (1) Their name and Suburb. (2) Patient s name. (3) Date of dispensing (4) The proper storage conditions this may be included in a package insert or attached document at the Pharmacists discretion. (5) Language stating the following: Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

11 This medical cannabis is for medicinal use only. Women should not consume during pregnancy or while breastfeeding except with your Doctor s consent. This product may impair the ability to drive or operate heavy machinery. Keep out of reach of children. Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

12 Section 5. Transportation of medical cannabis. (a) Medical Cannabis may be transported by an approved transporter, being: (1) An approved cultivator/processor/manufacturer. (2) An approved Transport Company already registered for transport of Narcotic drugs. (3) A Medical Practitioner in the normal course of their duties. (b) An approved transporter may transport medical cannabis to an approved destination, being: (1) A registered Pharmacist currently licensed for narcotics. (2) A medical wholesaler currently authorised to handle narcotics. (3) A Medical Practitioner at their surgery. (4) The approved transporters premises in the event of a non-delivery (per (j)) (5) Another cultivator/processor/manufacturer for the purposes defined elsewhere in these regulations. (6) A hospital or care facility under the supervision of a Medical Practitioner. The following conditions apply: (1) In order to transport medical cannabis, an approved transporter shall comply with the terms of this section. (2) An approved transporter may deliver medical cannabis to an approved destination only between the hours of 7 a.m. and 9 p.m. (3) A cultivator/processor/manufacturer may contract for delivery of medical cannabis to an approved transporter. (c) Vehicles allowed to transport medical Cannabis shall: (1) Be equipped with a secure lockbox or locking cargo area, which shall be used for the sanitary and secure transport of medical cannabis. Lockbox is to be contained within a locked vehicle. (2) Have no markings that would either identify or indicate that the vehicle is being used to transport medicinal cannabis. (3) Be capable of being temperature-controlled for perishable medical cannabis. (4) Have registration, compulsory third party and the insurances as set out in Section 24. (5) Be fitted with a GPS tracking device equipped with an emergency beacon. (6) Be fitted with dashboard camera and internal camera covering the storage location of the cannabis. Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

13 (d) Each transport vehicle shall have sufficient staff so that one person remains with the medical cannabis at all times. If conducting a point to point delivery where a stop including for refuelling is not necessary this can be one person. If conducting a delivery run, this should be 2 persons, and shall require the following: (1) At least one delivery team member shall remain with the vehicle at all times that the vehicle contains medical cannabis. (2) Each delivery team member shall have access to a secure form of communication with the point of origin warehouse or producer, such as a mobile phone, at all times that the vehicle contains medical cannabis. (3) Each delivery team member shall carry an employee identification badge at all times and shall, upon demand, produce it to the Minister, law enforcement or other state or federal government officials having reasonable cause to ask. (4) Each delivery team member shall have a valid Driver s License which is not provisional or learners. (5) While on duty, a delivery team member may not wear any clothing or symbols that may indicate ownership or possession of medical cannabis. (e) Medical Cannabis stored inside the transport vehicle shall not be visible from the outside of the transport vehicle. (f) A transport vehicle shall proceed in a manner that does not include any unnecessary stops or delays. This section does not prevent the creation of dedicated medical cannabis or narcotic goods transport operations, which may use a delivery route consisting of collections and deliveries conducted otherwise in accordance with these regulations. (g) An approved transporter shall report any vehicle accidents, diversions, losses, or other reportable events that occur during transport to the Minister within 24 hours. (h) An approved transporter shall complete a transport manifest as required by section 16. (i) Transport vehicles may only be stopped and inspected at any point of origin or destination. Stopping a vehicle en-route is not prescribed other than as deemed necessary by the Police in the normal operation of their duties. (j) The approved transporter must maintain a secure location to store any shipment that could not be made and that follows the requirements on the storage of cannabis otherwise required by the regulations. Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

14 Section 6. Transport manifest. (a) An approved transporter shall generate a printed transport manifest that accompanies every transport of medical cannabis and contains the following information: (1) The name, address and permit number of the cultivator/processor/manufacturer and the name of and contact information for a representative of the cultivator/processor/manufacturer. (2) The name, address and permit number of the approved destination receiving the delivery and the name of and contact information for a representative of the dispensary. (3) The quantity, by weight or unit, of each medical cannabis batch/lot contained in each transport, along with the lot number for every batch. (4) The date of departure and approximate time of departure. (5) The date of arrival and approximate time of arrival. (6) The transport vehicle s license plate number. (7) The name and signature of each member of the delivery team accompanying the transport. (b) An approved transporter may transport medical cannabis from an originating location to multiple dispensaries as long as each transport manifest correctly reflects specific inventory in transit and each recipient dispensary provides the transporter with a signed and print name receipt for the delivery. (c) All medical cannabis being transported must be packaged in suitable containers and labelled in accordance with Section 5. (d) An approved transporter shall provide a delivery document to accompany the delivery to an approved destination that includes the information specified in 6.a.1-5. (e) An approved transporter must, if requested, provide a copy of the printed transport manifest, and any printed receipts for medical cannabis being transported, to the Minister or other federal, state or local government officials having reasonable cause to require them. Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

15 Section 7. Evidence of theft, diversion, or discrepancy during transport. (a) An approved transporter must maintain their shipment in a tamper proof manner, such that any tampering is evident. (b) If an approved transporter finds evidence of a theft or diversion during transport, the approved transporter shall immediately report the theft or diversion to the Minister and to the appropriate law enforcement authorities. (c) If an approved transporter finds a discrepancy in the transport manifest, the approved transporter shall: (1) Conduct an investigation. (2) Amend the approved transporter s standard plan of operation, if necessary. (3) Send a report of the investigation to the Minister. (i) An approved transporter shall submit a written preliminary report of the investigation within seven days of discovering the discrepancy. (ii) An approved transporter shall submit a final written report of the investigation within 30 days of discovering the discrepancy. Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

16 Section 8. Disposal of cannabis and medical cannabis. Solid and liquid wastes generated during the production, processing and testing of medical Cannabis must be stored, managed, and disposed of in accordance with applicable state and local laws and regulations. In the absence of any suitable regulations the following applies; (1) Material that cannot be used to produce or grow a psychoactive substance and which presents no danger to other farms may be composted, buried or mulched. (2) Material that can be used to grow or produce a psychoactive substance, or that is contaminated with bacteria, fungus or similar biological agents must stored in the designated quarantine area and then incinerated. (3) In the event of (2) the material may be transported to a facility with a suitable incinerator in accordance with the provisions for transporting cannabis. Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

17 Section 9. Pesticides, fungicides and herbicides (a) The use of any pesticide, fungicide or herbicide ( chemical ) by a cultivator/processor in the growth or manufacture of medical cannabis shall be conducted in such a way that the trace levels of that substance in the final product is less than 0.1% by weight/volume. (b) The Minister, in cooperation with the Department of Primary Industry, will inspect for and enforce the following requirements on cultivators/processors. (c) The following apply regarding record keeping requirements for pesticide applications: (1) The cultivator/processor shall keep for each application of a chemical maintain a record containing the following information: (i) The date of application. For a chemicals requiring a re-entry time, the date of application must include the hour completed. (ii) The place of application including the name and address of the cultivator/processor and the specific block, section, or plants treated. (iii) (iv) (v) (vi) (vii) The brand name of every chemical used. HAZMAT reference if appropriate. The total amount of every chemical used in grams or litres, applied to a treated area. The dosage or rate of application of every pesticide used. The names of all staff involved in mixing or applying the chemical. (ix) The cultivator/processor shall maintain a file containing copies of Material Safety Data Sheets or equivalent corresponding to all chemicals in use in the facility. (x) Any facility using a chemical must have a one employee in attendance who has a recognized first aid certificate. (xi) For clarity all the functions in this section may be carried out by the same person. (2) A record required to be kept under this section shall be completed within 24 hours of the completion of the application and maintained for at least 7 years and shall be made immediately available to medical personnel in the case of an emergency, the Minister or the Department of Primary Industry upon due notice and with reasonable reason for request. Clarification: 7 years will be necessary for research into the link between pesticides, fungicides or herbicides and unexpected medical outcomes. (d) Nothing in this section prevents a cultivator/processor from requirements on the general use and storage of agricultural chemicals as may be in force for the food industry with the further regulation that there is no minimum application, all applications must be documented. Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

18 Section 10. Treatment and quarantine orders. (a) Where a plant pest or biological agent is found, the Minister may issue and enforce a treatment order, including an order to eradicate, for any plant that may carry or harbor the plant pest or agent. Such order will be issued in writing and set forth the necessary treatment, control or eradication measures required. If a cultivator/processor who has been issued a treatment order fails or refuses to comply with such order, the Minister may carry out the control measures established in the treatment order with all expenses associated with such measures accruing to the cultivator/processor failing or refusing to comply. (b) The Minister may establish a Quarantine to prevent the dissemination of plant pests within the area or to prevent or delay the introduction of a plant pest into the area. The following apply: (1) Upon finding a plant pest or agent in a cultivator/processor operation that has the potential to cause serious damage to other cultivator/processors or agriculture, the geographic area in which the plant pest or agent was found and any adjacent areas as the Minister of Agriculture may deem necessary shall be quarantined. (2) The Quarantine Order shall establish conditions and restrictions considered necessary to prevent or reduce the movement of the plant pest or agent from the quarantine area. Vehicles or any means of conveyance suspected of carrying the plant pest may be subject to quarantine and a treatment order may be issued to as necessary to eradicate the plant pest or agent. (3) The Quarantine Order may regulate the planting, growing or harvesting of any crop that serves as a host or reservoir for the plant pest within the quarantined area and may include prohibiting the establishment of a specific batch of medical cannabis within a specific geographic area or during a specified time period. A crop suspected of harboring the plant pest or agent may be ordered to be treated or destroyed. Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

19 Section 11. Insurance requirements. Each cultivator/processor shall have appropriate insurance including but not limited to: (1) Theft and damage cover for the buildings, equipment and stock (2) Public liability insurance in the amount of $10,000,000 (3) Product liability insurance in the amount of $10,000,000 including $100,000 of recall insurance. (4) Comprehensive motor vehicle insurance on any vehicle used in the transport of medical cannabis (5) Goods in transit insurance to the likely value of a typical shipment. (6) Workers Compensation as appropriate Section 12. License Duration (1) A medical cannabis cultivation, processing or manufacturing license shall be for a period of 3 years unless surrendered or cancelled as otherwise provided in the regulations. Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

20 APPENDIX A Acceptable pesticide active ingredients for use: The following pesticides can be can be used in the production of medical cannabis. A chemical record is required for each application. EPA Status Pesticide Type Comments Active Ingredient 25(b) Insecticide Castor Oil 25(b) Insecticide Cedar Oil 25(b) Insecticide Cinnamon 25(b) Fungicide, Insecticide Cinnamon Oil 25(b) Fungicide, Insecticide Citric Acid 25(b) Bactericide, Fungicide Clove 25(b) Insecticide Clove Oil 25(b) Fungicide Corn Oil 25(b) Insecticide Cottonseed Oil 25(b) Insecticide Garlic 25(b) Insect Repellent Garlic Oil 25(b) Fungicide Geraniol 25(b) Insecticide Geranium Oil 25(b) Fungicide, Insecticide Lemon Grass Oil 25(b) Insecticide Peppermint Oil 25(b) Insecticide Peroxyacetic Acid 25(b) Fungicide Potassium Sorbate 25(b) Insecticide Rosemary 25(b) Insecticide Rosemary Oil Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

21 25(b) Fungicide, Insecticide, Miticide Sesame Oil 25(b) Fungicide, Insecticide Sodium Lauryl Sulfate 25(b) Insecticide Soybean Oil 25(b) Fungicide Thyme 25(b) Fungicide, Insecticide, Miticide Thyme oil 25(b) Insecticide White Pepper Insecticide Azadirachtin Fungicide Bacillus Amyloliquefaciens Strain D747 Fungicide Fungicide For use in protected growing environments only (e.g., greenhouses). Bacillus Pumilus Strain GHA 180 Bacillus Subtilis QST713 Strain Insecticide Bacillus Thuringiensis SSP. Aizawai Insecticide Canola Oil Insect Repellent Capsicum Oleoresin Extract Insecticide Ground application only to non-blooming plants. Chromobacterium Sub Strain PRAA4-1 Cells Fungicide, Insecticide Clarified Hydrophobic Extract of Neem Oil Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

22 Fungicide Copper Octanoate PGR Cytokinin (Kinetin) Insecticide Diatomaceous Earth PGR Gibberellins (Gibberellic Acid) PGR Harpin Alpha Beta Antimicrobial, Fungicide No foliar applications allowed. Hydrogen Peroxide PGR Insecticide, PGR Applications allowed in furrow at planting or in hydroponics only. IBA (Indole-3-Butyric Acid) Kaolin Insecticide Mineral Oil Fungicide Use only allowed prior to final transplant, unless grown in recirculating hydroponics systems. Mono- and Di-Potassium Salts of Phosphorous Acid Insecticide Monopotassium Phosphate Nematicide Myrothecium Verrucaria Fungicide, Insecticide Neem Oil, Cold Pressed Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument

23 Insecticide Insecticide Fungicide, Insecticide Use allowed prior to final transplant. Use allowed prior to final transplant. Piperonyl Butoxide Potassium Laurate Potassium Salts of Fatty Acids Insecticide Pyrethrins Insecticide Pyrethrins Molluscicide Sodium Ferric EDTA Fungicide Trichoderma Asperellum Strain ICC 012 Note 1. All legislative instruments and compilations are registered on the Federal Register of Legislation kept under the Legislation Act See Medical Cannabis Regulations Other Matters (2018 Measures No. 1) Instrument