The Cannabis Act and Regulations

Transcription

1 The and Regulatins OVERVIEW The and Regulatins cme int frce n Octber 17, 2018 and replaces the Access t Cannabis fr Medical Purpses Regulatins (ACMPR), and any mentin f Cannabis and Marihuana in the Narctics Cntrl Regulatins (NCR) and Cntrlled Drug and Substance Act. The Cannabis Act and Regulatins cver recreatinal, medical, and industrial hemp cannabis prducts. This QuickNte fcuses n the requirements fr cannabis related activities, including: Licensing Security Quality Assurance WHO DOES THIS APPLY TO? Existing Licensed Prducers and Licensed Dealers f medical cannabis in its varius frms, i.e., dried marihuana, cannabis il, fresh marihuana, seeds, plants Current Prducers Licence applicants fr medical cannabis in its varius frms, i.e., dried marihuana, cannabis il, fresh marihuana, seeds, plants Thse wh want t prvide gds and services t the Cannabis Industry (e.g., security firms, packaging and labelling cmpnent suppliers, device manufacturers, etc.) Prspective new applicants wh want t: Grw cannabis Perfrm testing f cannabis Make cannabis prducts Perfrm research with cannabis Sell cannabis fr medical Prduce drugs cntaining Mississauga, Ont ari, Canada and/r recreatinal purpses cannabis pliance.cm 1 QCQuickNteTemplate-R0Sep15

2 KEY POINTS Health Canada nw regulates cannabis under the Edible cannabis prducts, cannabis infused drinks and cannabis cncentrates are nt within the scpe f the and cannt be sld legally. Health Canada is currently reviewing these types f prducts. Licences Licence Class Sub-classes Allwed Activities Licence fr Cultivatin Licence fr Prcessing Standard Cultivatin Micr-Cultivatin (smaller than 200m 2 ) Nursery Standard Prcessing Micr-Prcessing (less than 600kg f dried cannabis, r equivalent, per year) Prduce dried and fresh cannabis, and cannabis plants and seeds* Prduce plants, and seeds in area up t 50m 2 * Manufacture cannabis prducts (i.e., dried cannabis, cannabis ils, packaging f cannabis, etc.)* Licence fr Sale fr Medical Purpses Licence fr Analytical Testing Sell cannabis t registered clients Any testing f a cannabis prduct (i.e., prviding third party testing services) Mississauga, Ont ari, Canada pliance.cm Licence fr Research Cannabis Drug Licence Industrial Hemp Licence Perfrm any research and develpment activities with cannabis Prduce and sell cannabis as a drug, with Drug Identificatin Number (DIN) Cultivate, prcess and sell hemp *These licences include ther activities including sale, and are utlined in the regulatins ** An individual wh is registered with a licence hlder, n the basis f a medical dcument fr cannabis 2 QCQuickNteTemplate-R0Sep15

3 Health Canada licence requirements fr medical and recreatinal cannabis include the fllwing areas: Security Qualified persnnel, such as Quality Assurance Persn (QAP), respnsible persn (RP), Head f Security, etc. Defined quality system, such as Gd Prductin Practices (GPP), Gd Agricultural Cllectin Practices (GACP), Gd Manufacturing Practices (GMP), etc. Facility/Site design Quality Assurance A QAP, wh meets required qualificatins, and is respnsible fr GPP quality versight at prcessing sites including: Apprval f facility design, fcusing n: Flw f material and persnnel Equipment & utilities Material f cnstructin Apprval f quality assurance system, which must include: Prcedures, quality recrds, recrd keeping via electrnic systems Finished prduct specificatins Validated analytical methds Mississauga, Ont ari, Canada pliance.cm Apprval f every lt r batch f substances befre it is made available fr sale Only use pesticides apprved as per the Pest Cntrl Prducts Act. Nte, a pesticide used fr fd may nt be acceptable fr medical cannabis Security Yu must design yur facility security t prevent unauthrized access A Head f Security is required, except fr analytical and research licence hlders 3 QCQuickNteTemplate-R0Sep15

4 Packaging and Labelling All infrmatin n the label must be in bth English and French. Prduct label must cntain: THC and CBD cntent in % w/w. Brand name Lt number Warning messages Standardized cannabis label (as seen belw) Advertising activities are very limited; the regulatins specify allwed activities. WHAT DO I NEED TO DO? Develp yur business strategy Apply fr the applicable Health Canada cannabis licences Design, build and qualify yur facility Mississauga, Ont ari, Canada pliance.cm Establish and maintain a cmpliant GPP quality system Prepare fr yur Health Canada inspectins 4 QCQuickNteTemplate-R0Sep15

5 DEFINITIONS Mississauga, Ont ari, Canada pliance.cm ACMPR CBD DIN GMP GPP Head f Security Head f Labratry Licensed Prducer Marihuana Master Grwer QAP RP RPIC SPIC THC % w/w (unit f measure) Access t Cannabis fr Medical Purpses Regulatins. Cannabidil. A main cannabinid present in cannabis. Drug Identificatin Number. Gd Manufacturing Practices. Health Canada regulatins that apply t pharmaceuticals, natural health prducts, and APIs that are apprved fr therapeutic use. Gd Prductin Practices. The quality system required by the Cannabis Regulatins A specified individual wh is respnsible fr the licensed facility s rganizatinal security plan and physical security measures. The individual wh is respnsible fr the testing f cannabis fr a Licence fr Analytical Testing hlder. The hlder f a licence, under the ACMPR, that permits pssessin, prductin, sale/prvisin, shipping, transprtatin, delivery, and destructin f cannabis. Nw superseded by new Cannabis licence classes. The substance referred t as Cannabis (Marihuana). Als knwn as Marijuana. The individual respnsible fr the cultivatin, prpagatin and harvesting f cannabis. Quality Assurance Persn. Respnsible Persn. Respnsible Persn In Charge. Senir Persn In Charge. Nw superseded by RP. Tetrahydrcannabinl. A main cannabinid present in cannabis. The rati f the mass f a substance t the ttal mass f the whle prduct, represented as a percentage (e.g., the rati f mass f THC t ttal mass f the cannabis prduct). 5 QCQuickNteTemplate-R0Sep15

6 RELATED DOCUMENTS Regulatins Cannabis Regulatins Pest Cntrl Prducts Act and Regulatins Security Directive On Physical Security Requirements Fr Cntrlled Substances And Drugs Cntaining Cannabis FAQ Licensing: 1. What will change as f Octber 17 th, 2018? The sale f recreatinal cannabis will becme legal in Canada, and the and Regulatins will cme int frce. 2. What happened t the ACMPR regulatins? The and Regulatins (SOR/ ) will replace the ACMPR as f Octber 17, Hw d I apply fr a licence? The applicatin fr a licence under the is dne thrugh the nline Cannabis Tracking and Licensing System (CTLS). Mississauga, Ont ari, Canada pliance.cm Yur applicatin must demnstrate hw the security, recrd keeping, inventry cntrl measures, and GPP at the facility meet all the regulatry requirements. 4. Why is a Dealer s Licence n lnger needed fr cannabis drugs and/r R&D? Health Canada will regulate cannabis under the and cannabis will n lnger be regulated under the Cntrlled Drug and Substance Act. Under the new all activities previusly permitted under the Dealer s Licence will be cvered by ne r mre f the 7 new licence classes. 6 QCQuickNteTemplate-R0Sep15

7 5. What d I need t d if I have already applied r already am a Licensed Prducer r Licensed Dealer? Health Canada will transitin all current Licensed Prducers and Licensed Dealer s t licences under the ; Health Canada will cntact yu directly. 6. What licences d I need if I am servicing the recreatinal market nly? All licences, except fr the sale fr medical purpses and cannabis drug licences, are applicable t the recreatinal markets. 7. Can I imprt/exprt cannabis t and frm Canada? Only imprt/exprt f cannabis fr medical and scientific purpses is allwed. It is pssible t imprt/exprt, if yu have the applicable cannabis licence, and are granted an imprt/exprt permit by Health Canada. Apprval f imprt/exprt permits is dependent n the freign cuntry s laws arund cannabis. Quality Systems: 8. What is the difference between the previus ACMPR and the new Cannabis Regulatins? The main differences between the previus ACMPR and the new Cannabis Regulatins are as fllws: The Senir Persn In Charge (SPIC) rle will be remved and existing SPIC s will be transitined int the RP rle, which replaces the previus Respnsible Persn In Charge (RPIC) rle. The RP des nt have t be physically present when activities are cnducted in the peratins and strage areas. Security requirements remain; hwever, vary by licence type. Mississauga, Ont ari, Canada pliance.cm Master Grwer, Head f Security, and Head f Labratry rles have been added. The previus QAP rle will nly required fr prcessing licence hlders. Key investrs will have t be identified n the licence applicatin. The new Cannabis Regulatins will allw utdr grwing f cannabis. 7 QCQuickNteTemplate-R0Sep15

8 9. Is GPP the same as GMP? N, GPP is the quality system required by the Cannabis Regulatins. GMP is the quality system required by Health Canada s Fd and Drug Regulatins fr drug prducts. GPP des nt include GMP critical prcesses, such as system validatin, prduct stability, self-inspectin, Annual Prduct Quality Reviews, quality agreement requirements, and frmalized change cntrl prcesses. 10. D I need t meet Health Canada GMPs fr medicinal prducts/drugs? If yu wish t exprt t a freign market, yu may need t cmply with GMP standards based n the applicable regulatins f the freign cuntry. 11. Will Health Canada inspect my Canadian licensed cannabis facility t GMP standards? N Health Canada is nt inspecting cannabis facilities t drug GMP standards at this time. 12. My cannabis prduct has a DIN. D I need t cmply with the Cannabis Regulatins? Yes, yu must fllw bth drug and cannabis regulatins. 13. Is a stability prgram required fr medical cannabis prducts sld in Canada? It depends. Stability is nt required if yu d nt have an expiratin date n yur cannabis prduct label. If yu d state an expiratin date n yur prduct label, yu must have stability study data t supprt yur claim. 14. Can I grw cannabis utdrs? Yes, utdr activities are limited t cultivating, harvesting and prpagating under the cultivatin licences. Mississauga, Ont ari, Canada pliance.cm 15. Can I legally prduce edible cannabis prducts r cannabis cncentrates? N, this is currently ut f the scpe f the and Regulatins. Health Canada is reviewing edibles and cncentrates at this time. We can help yu. Call us tday at ext. 271 r visit 8 QCQuickNteTemplate-R0Sep15