- Access t Cannabis fr Medical Purpses Regulatins Part 1 Cmmercial Prductin September 2017 OVERVIEW Yu must cmply with regulatins t supply medical cannabis as f August 24, 2016 There are fur parts t the regulatins this QuickNte fcuses n the Part 1 requirements t be a licensed prducer, including: Facility design Security Quality assurance WHO DOES THIS APPLY TO? Licensed prducers f medical cannabis in its varius frms, i.e., dried marihuana, cannabis il, fresh marihuana, seeds, plants Vendrs and Suppliers t the Medical Cannabis Industry (e.g., security firms, packaging & labelling cmpnent suppliers, etc.) KEY POINTS Assign a Quality Assurance Persn (QAP), wh is respnsible fr quality verview f all aspects f Part 1 Cmmercial Prductin befre made available fr sale, including apprving all prcedures fr prducing, packaging, labelling, testing, shipping, and prduct release. They als address custmer cmplaints, and crrective and preventive actins Mississauga, O nt ar i, C anada www.qualit yandcmpliance.cm Licensed prducers must cmply with the entire Part 1 Cmmercial Prductin, in particular, Divisins 1, 4 & 5 1 QCQuickNteTemplate-R0Sep15
Divisin 1 Licensed Prducers SUBDIVISION A - Authrized Activities and General Obligatins Outlines activities that apply t a licensed prducer SUBDIVISION B - Licensing A licensed prducer must designate: One senir persn in charge (SPIC) t have verall respnsibility fr management f the activities cnducted by the licensed prducer under their licence at their site this culd be the licensed prducer One respnsible persn in charge (RPIC) t wrk at the licensed prducer s site and have respnsibility fr supervising the activities with respect t cannabis cnducted by the licensed prducer under their licence at that site and fr ensuring that the activities cmply with the Act and its regulatins and the Fd and Drugs Act this culd be the senir persn in charge SUBDIVISION C - Security Measures Mississauga, O nt ar i, C anada www.qualit yandcmpliance.cm Yu must design yur facility security t prevent unauthrized access Yu must have access cntrls (i.e., access t areas within a site where cannabis is present must be restricted t persns whse presence in thse areas is required by their wrk respnsibilities) The respnsible persn in charge (RPIC) must be physically present while ther persns are in thse areas SUBDIVISION D - Gd Prductin Practices (GPP) The QAP is respnsible fr implementing the requirements f the regulatins, nt limited t but including: Facility design Flw f material and persnnel Equipment & utilities 2 QCQuickNteTemplate-R0Sep15
Material f cnstructin September 2017 Quality assurance system Prcedures, quality recrds, electrnic systems Finished prduct specificatins Validated analytical methds Analytical Methds must be validated (e.g., assay, impurities, cntaminants, disintegratin and slvent residue testing) Accuracy f weight and vlume f prducts must be between 95% t 105% Only use pesticides apprved as per the Pest Cntrl Prducts Act. Nte, a pesticide used fr fd may nt be acceptable fr medical cannabis Test fr pesticide residue n the final prduct where pesticides are used during prductin Nte: Mst recalls are due t pesticide residue issues (e.g., nt identified when used) Recall ntificatins must be submitted t the Minister f Health prir t cmmencing the recall Mississauga, O nt ar i, C anada www.qualit yandcmpliance.cm SUBDIVISION E - Dried Marihuana Equivalency Factr The dried marihuana equivalent is the quantity f cannabis ther than dried marihuana that is equivalent t a given quantity f dried marihuana SUBDIVISION F - Packaging, Labelling and Shipping Packaging/labelling Strict labeling and packaging requirements apply; labeling criteria are based n the frm f cannabis 3 QCQuickNteTemplate-R0Sep15
Shipping September 2017 Yu need Health Canada-apprved stability data t assign an expiry date Yu must test yur prduct against technical specificatins and the QAP must release the prduct prir t being made available fr sale A prducer cannt fulfill mre than the equivalent f 150 grams f dried marihuana in 30 days t a patient Regardless f the amunt prescribed, a patient can nly receive a maximum equivalent f 30 grams f dried marihuana per single shipment SUBDIVISION G - Imprt and Exprt Describes applicatin prcess fr imprt and exprt permits SUBDIVISION H - Security Clearances Yur key persnnel must pass a stringent security clearance prcess SUBDIVISION I - Cmmunicatin f Infrmatin Yu must prvide recrds t a Canadian plice frce, if requested Divisin 4 Sale r Prvisin by a Licensed Prducer t a Persn Other than a Client Yu can nly sell r prvide prduct t a persn (ther than a client) wh is authrized per the regulatins, and with a written rder Divisin 5 Recrd Keeping by Licensed Prducers Mississauga, O nt ar i, C anada www.qualit yandcmpliance.cm Keep recrds f all transactins 4 QCQuickNteTemplate-R0Sep15
WHAT DO I NEED TO DO? Assign a QAP and key persnnel (e.g., SPIC, RPIC) fr yur applicatin Establish and maintain a cmpliant GPP quality system Qualify yur Facility Design and Security Design Prepare fr yur Health Canada inspectin DEFINITIONS Access t Cannabis fr Medical Purpses Regulatins Equivalency Equivalency in dried marihuana is the quantity f cannabis ther than dried marihuana that is equivalent t a given quantity f dried marihuana GMPs (Gd Manufacturing Practices) Health Canada regulatins that apply t pharmaceuticals, natural health prducts, and APIs that are apprved fr therapeutic use GPPs Gd Prductin Practices Licensed prducer Mississauga, O nt ar i, C anada www.qualit yandcmpliance.cm The hlder f a licence that permits pssessin, prductin, sale/prvisin, shipping, transprtatin, delivery, and destructin f cannabis Marihuana The substance referred t as Cannabis (marihuana) Marijuana, dried Harvested marihuana that has been subjected t any drying prcess, but des nt include seeds 5 QCQuickNteTemplate-R0Sep15
Marihuana, fresh Freshly harvested marihuana buds and leaves, but des nt include plant material that can be used t prpagate marihuana Quality Assurance Persn (QAP) A licensed prducer must have a QAP wh: a) is respnsible fr assuring the quality f the fresh r dried marihuana, cannabis il r marihuana plants r seeds befre they are made available fr sale, and b) investigates every cmplaint received in respect f the quality f thse substances and, if necessary, takes crrective and preventative measures Thse substances must be prduced, packaged, labelled and stred using methds and prcedures that, prir t their implementatin, have been apprved by a QAP Every lt r batch f thse substances must be apprved by a QAP befre it is made available fr sale RPIC Respnsible persn in charge SPIC Senir persn in charge Written rder The written rder must: Mississauga, O nt ar i, C anada www.qualit yandcmpliance.cm (a) be signed and dated by a persn described in subsectin (1) r (2) and indicate their name; (b) indicate the shipping address in Canada; and (c) specify the substance being rdered and include the fllwing infrmatin: (i) in the case f fresh r dried marihuana r cannabis il, its quantity and brand name, r (ii) in the case f cannabis ther than cannabis referred t in subparagraph (i), its quantity, descriptin and, if applicable, brand name 6 QCQuickNteTemplate-R0Sep15
RELATED DOCUMENTS Applicatins T btain an Licensed Prducer Applicatin Frm, yu must email: -RACFM@hc-sc.gc.ca Regulatins (Access t Cannabis fr Medical Purpses Regulatins) http://laws.justice.gc.ca/eng/regulatins/sor-2016-230/ Health Canada Testing f Cannabis fr Medical Purpses fr Unauthrized Pest Cntrl Prducts https://www.canada.ca/en/healthcanada/services/drugs-health-prducts/medical-use-marijuana/licensedprducers/plicies-directives-guidance-infrmatin-bulletins/testingcannabis-medical-purpses-unauthrized-pest-cntrl-prducts.html Additinal Infrmatin fr Licenced Prducers under the Access t Cannabis fr Medical Purpses Regulatins https://www.canada.ca/en/health-canada/services/drugs-healthprducts/medical-use-marijuana/licensed-prducers/additinal-infrmatinlicensed-prducers-under-access-cannabis-medical-purpsesregulatins.html Authrized Licensed Prducers f Cannabis fr Medical Purpses https://www.canada.ca/en/health-canada/services/drugs-healthprducts/medical-use-marijuana/licensed-prducers/authrized-licensedprducers-medical-purpses.html Security Mississauga, O nt ar i, C anada www.qualit yandcmpliance.cm Directive On Physical Security Requirements Fr Cntrlled Substances https://www.canada.ca/en/health-canada/services/health-cncerns/reprtspublicatins/cntrlled-substances-precursr-chemicals/directive-physicalsecurity-requirements-cntrlled-substances-licensed-dealers-securityrequirements-strage.html Security Clearance Applicatin Frm: Access t Cannabis fr Medical Purpses Regulatins () https://www.canada.ca/cntent/dam/hcsc/migratin/hc-sc/dhp-mps/alt_frmats/pdf/marihuana/inf/securit-eng.pdf 7 QCQuickNteTemplate-R0Sep15
FAQ 1. What is Health Canada s rle? Licensing and verseeing the cmmercial industry (including inspectins f Licensed Prducers) Registering individuals t prduce a limited amunt f cannabis fr their wn medical purpses 2. When can I expect a Health Canada inspectin? Yu shuld expect t prvide evidence f a cmpliant GPP quality system during yur applicatin prcess Yu can expect at least ne audit befre yu can start selling Health Canada is applying a risk-rating system t determine hw ften they inspect Licensed prducers There are different types f Health Canada, Office f Medical Cannabis Inspectins: Intrductry Pre-Sales Targeted Annual 3. Hw is GPP different than GMP? Oversight by Health Canada is less defined, but cnsistent with Health Canada cntrlled drug prcedures Mississauga, O nt ar i, C anada www.qualit yandcmpliance.cm 8 QCQuickNteTemplate-R0Sep15
4. Licensed prducers must cmply with the entire Part 1 Cmmercial Prductin, in particular, Divisins 1, 4 & 5. What are the ther parts f the regulatins? Divisin 2 applies t client registratin and rdering. Divisin 3 applies t clients and ther authrized users. Part 2 applies t prductin fr wn medical purpses and prductin by a designated persin Part 3 applies t transitinal prvisins Part 4 applies t cnsequential amendments, repeal, applicatin, and cming int frce 5. Hw many licensed prducers are there in Canada? As f Oct 1, 2017, there are 14 Licensed Prducers in BC and 35 in Ontari (62 ttal in Canada) Licensing statistics as f May 25, 2017: 1665 applicatins received 265 have been refused 428 applicatins are in prgress 69 have been withdrawn 858 were incmplete and have been returned 6. Hw d I get a licence? What are the steps? Mississauga, O nt ar i, C anada www.qualit yandcmpliance.cm Cmplete the Applicatin t Becme A Licensed Prducer Under The Access T Cannabis Fr Medical Purpses Regulatins () Yur applicatin must demnstrate hw the security, recrd keeping, inventry cntrl measures, and Gd Prductin Practices at the facility meet all the regulatry requirements 7. Is a stability prgram required fr medical cannabis prducts? N, unless a labelled expiratin date claim is made. 9 QCQuickNteTemplate-R0Sep15
8. What medical cannabis dsage frms are allwed? Dried marihuana lse r rll Cannabis il capsule r similar additinal dse cntrls apply Fresh marihuana Seeds Plant 9. D I need t meet Health Canada Gd Manufacturing Practices (GMPs) fr medicinal prducts/drugs? Yes, if yu wish t exprt t Australia r EU, yu will need t meet GMPs 10. What happened t the MMPR regulatins? (Access t Cannabis fr Medical Purpses Regulatins, SOR 2016-230) fr cannabis prducers replaced MMPR (Marihuana fr Medical Purpses Regulatins) as f August 24, 2016 We can help yu. Call us tday at 1-877-877-5152 ext. 232 r visit www.qualityandcmpliance.cm Mississauga, O nt ar i, C anada www.qualit yandcmpliance.cm 10 QCQuickNteTemplate-R0Sep15