Standardized /quality controlled          cannabis         The Dutch way            Washinton DC February 23 2013         ...
Standardized/ quality controlled           cannabis                                         • Dutch model                 ...
Regulatory complianceCannabis can, and should, go through the drug approval processCannabis can, and should, go through th...
Dutch model               Supervision           OMC (national agency)               CULTIVATION             QUALITY CONTRO...
Dutch model             Supervision                OMC             CULTIVATION           QUALITY CONTROL             PACKA...
Dutch model             Supervision                OMC             CULTIVATION           QUALITY CONTROL             PACKA...
Dutch model             Supervision                OMC             CULTIVATION           QUALITY CONTROL             PACKA...
Quality controlled production of standardized cannabis 1. Standard genetic plant material 2. Fixed schedules for growing /...
Reproducibility             Variety BEDROCAN: 19% THC        25                        allowed deviation        20THC %   ...
Validated externalquality control  Dutch Monograph on Medicinal Cannabis  1. Appearance, foreign material, fineness  2. Mi...
Varieties available Variety name      THC       CBD        TERPENES Bedrocan          19         -            sativa Bedro...
Terpenes    Mono-terpenes by GC-analysis var. Bedica1         Batch 2        Batch 3                Mean         Batch 1  ...
Current statusPharmacy:   • Well established in the Netherlands   • Multiple standardized varieties   • Full reimbursement...
Current status Europe Italy     • Available from 2006     • Herbal cannabis,     • pharmaceutical extracts     • back in I...
Current status Europe Germany    • Available since 2008    • patient driven    • Herbal cannabis,    • pharmaceutical extr...
Current status Europe Coming up: Czech Republic    • government controlled production    • similar to Dutch program    • s...
Growing demand                                                 30% Total prescriptions                                   1...
•   Established 1984•   Cannabis seed plant production since 1991•   2002 first license for medicinal cannabis production•...
Bedrocan staff•   1 General manager•   1 Head of nursery (horticulturalist)•   1 Head of Processing (GMP/HACCP educated)• ...
Standardized cannabis          of   Pharmaceutical       Quality    from the Netherlands
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Tjalling and george pappas presentation

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  • OMC = office of medicinal cannabis. Cultivation only done by one company; could be more. Cultivation rules are very strict to have a standardized product in the end. Cannabis must be available by law for: research and production of medicines. Cannabis in pharmacy: as long as no proper medicine is available.
  • External independent quality control: standardized amounts of active compounds, no moulds, pesticide residues, heavy metals or other hazardous substance.
  • Small containers of 5 gram. Done by a pharmaceutical company that is also responsible for distribution
  • To the pharmacy, only available to patients on doctorsprescription. No standard reimbursement, but now appr. 40 % reimbursed.
  • Tjalling and george pappas presentation

    1. 1. Standardized /quality controlled cannabis The Dutch way Washinton DC February 23 2013 Tjalling Erkelens / George Pappas
    2. 2. Standardized/ quality controlled cannabis • Dutch model • Standardization/quality control • Europe at a glance • Bedrocan BV Washington DC February 23 2013 Tjalling Erkelens / George Pappas
    3. 3. Regulatory complianceCannabis can, and should, go through the drug approval processCannabis can, and should, go through the drug approval process• UN Single Convention on Narcotic Drugs• National program / OMC• Standardized cannabis• Standard procedures -GAP -SOPs• External quality control / Audits
    4. 4. Dutch model Supervision OMC (national agency) CULTIVATION QUALITY CONTROL PACKAGINGRESEARCH EXPORT PHARMACY
    5. 5. Dutch model Supervision OMC CULTIVATION QUALITY CONTROL PACKAGINGRESEARCH EXPORT PHARMACY
    6. 6. Dutch model Supervision OMC CULTIVATION QUALITY CONTROL PACKAGINGRESEARCH EXPORT PHARMACY
    7. 7. Dutch model Supervision OMC CULTIVATION QUALITY CONTROL PACKAGINGRESEARCH EXPORT PHARMACY
    8. 8. Quality controlled production of standardized cannabis 1. Standard genetic plant material 2. Fixed schedules for growing /processing 3. Active substances within standard limits 4. Predictable yields 5. Free of chemical and microbial contaminants NO PESTICIDES (RESIDUE)
    9. 9. Reproducibility Variety BEDROCAN: 19% THC 25 allowed deviation 20THC % 15 10 5 0 1 2 3 4 5 6 7 8 9 10 11 Different batches 
    10. 10. Validated externalquality control Dutch Monograph on Medicinal Cannabis 1. Appearance, foreign material, fineness 2. Microbiological contamination 3. Pesticides 4. Heavy metals 5. Water content 6. Cannabinoid content / profile Methodology similar to Canada
    11. 11. Varieties available Variety name THC CBD TERPENES Bedrocan 19 - sativa Bedrobinol 12 - sativa Bediol 6 7.5 sativa Ai94 (research) - 8 sativa Bedica 14 - indica Contents in % of dry weight
    12. 12. Terpenes Mono-terpenes by GC-analysis var. Bedica1 Batch 2 Batch 3 Mean Batch 1 Batch 2 Batch 3 Mean Fischedick et al. Phytochemistry (2010), 71, 2058-2073
    13. 13. Current statusPharmacy: • Well established in the Netherlands • Multiple standardized varieties • Full reimbursement from largest Dutch healthcare provider (5.4 m people)Export: • Italy, Germany, Finland, Switzerland ….. • Reimbursement problemsResearch: • Standardized content  long-term projects
    14. 14. Current status Europe Italy • Available from 2006 • Herbal cannabis, • pharmaceutical extracts • back in Italian pharmacopoeia Finland: • Available since 2007 • patient driven • decentralized import through pharmacies
    15. 15. Current status Europe Germany • Available since 2008 • patient driven • Herbal cannabis, • pharmaceutical extracts • tightly controlled Switzerland : • Available since 2013 • herbal cannabis • pharmaceutical extracts • centralized import through wholesale companies
    16. 16. Current status Europe Coming up: Czech Republic • government controlled production • similar to Dutch program • start of local production expected 2014
    17. 17. Growing demand 30% Total prescriptions 10% Sept-Dec 11 12 20 20 Source: Farmaceutisch Weekblad 19 Mei 2011
    18. 18. • Established 1984• Cannabis seed plant production since 1991• 2002 first license for medicinal cannabis production• 2003 start of sales on prescription• 2008 ISO 9001 certified• Annual production 2013 450 kilo cannabis flos
    19. 19. Bedrocan staff• 1 General manager• 1 Head of nursery (horticulturalist)• 1 Head of Processing (GMP/HACCP educated)• 1 Quality Assurance manager (pharmacist)• 1 Head of R&D• 10 co-workers for processing and packaging
    20. 20. Standardized cannabis of Pharmaceutical Quality from the Netherlands

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