1. Standardized /quality controlled
cannabis
The Dutch way
Washinton DC February 23 2013
Tjalling Erkelens / George Pappas

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. Regulatory compliance
Cannabis can, and should, go through the drug approval process
Cannabis 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. Dutch model
Supervision
OMC (national agency)
CULTIVATION
QUALITY CONTROL
PACKAGING
RESEARCH EXPORT
PHARMACY

5. Dutch model
Supervision
OMC
CULTIVATION
QUALITY CONTROL
PACKAGING
RESEARCH EXPORT
PHARMACY

6. Dutch model
Supervision
OMC
CULTIVATION
QUALITY CONTROL
PACKAGING
RESEARCH EXPORT
PHARMACY

7. Dutch model
Supervision
OMC
CULTIVATION
QUALITY CONTROL
PACKAGING
RESEARCH EXPORT
PHARMACY

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. Reproducibility
Variety BEDROCAN: 19% THC
25
allowed deviation
20
THC %
15
10
5
0
1 2 3 4 5 6 7 8 9 10 11
Different batches 

10. Validated external
quality 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. 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. Terpenes
Mono-terpenes by GC-analysis var. Bedica
1 Batch 2 Batch 3 Mean
Batch 1 Batch 2 Batch 3 Mean
Fischedick et al. Phytochemistry (2010), 71, 2058-2073

13. Current status
Pharmacy:
• 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 problems
Research:
• Standardized content  long-term projects

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. 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. Current status Europe
Coming up:
Czech Republic
• government controlled production
• similar to Dutch program
• start of local production expected 2014

17. Growing demand
30%
Total prescriptions
10%
Sept-Dec
11
12
20
20
Source: Farmaceutisch Weekblad 19 Mei 2011

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. 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. Standardized cannabis
of
Pharmaceutical
Quality
from the Netherlands