Questionnaire – Medical cannabis products
1. General information
1.1 Which product categories are you interested in?
Cannabis flowers Full extracts Distillates (e.g., THC, CBD, CBG) Isolates Other:
1.2 What are the products intended for?
Direct sale to pharmacies Manufacturing of custom formulations Further processing Export Other:
2. Quality & certification requirements
2.1 Which certifications are mandatory?
EU-GMP GACP GDP ISO (e.g., ISO 9001, 13485): Other:
2.2 Which documents are required per batch?
COA GMP certificates Batch production reports SDS Stability data Terpene profile Other:
3A. Product specifications – Flowers
3a.1 Desired cannabinoid content (%):
THC % CBD % Ratio: >20%
Tolerance range: ±10%
(Note: For cannabinoid contents >15.0%, a relative tolerance of ±10% applies.
Example: 20.0% allows a range of 18.0–22.0%.
For values ≤1% the previous standards apply.
For contents <15.0% an absolute tolerance of ±1.5% is accepted.
Example: 7.5% allows a range of 6.0–9.0%.)
3a.2 Preferred strain(s) or phenotypes?
• Maximum residual moisture: 11%
3a.3 Must the flowers be registered with BfArM (Federal Opium Agency)?
Yes No Not necessarily, if quality is sufficient Not applicable
3a.4 Is the terpene profile relevant?
Yes (please specify): No Not applicable
3B. Product specifications – Extracts & distillates
3b.1 Preferred concentrations (%):
THC % CBD % CBG % CBN % CBC %
3b.2 Processing level:
Crude full extract Partially purified oil Distillate Isolate Water-soluble
3b.3 Carrier substances:
MCT Ethanol Vegetable oil Solvent-free Other:
• Residual solvent: max. according to ICH guidelines (e.g., <5000 ppm for ethanol)
3b.3 Terpene enrichment desired?
Yes No Not applicable
3C. Product specifications – Irradiation / Microbiological safety
3c.1 Is irradiation required?
Yes No Depends on microbial status Not applicable
3c.2 Method:
Gamma Electron beam Other: Isolate
Dose (max. kGy) (EU maximum: 10 kGy – standard typically 7–10 kGy)
3c.3 Should irradiation be documented in the COA?
Yes No Not applicable
3c.4 Are alternatives acceptable?
Yes (e.g., UV-C, ozone) No Not applicable
• Microbiological limits (per Ph. Eur.):
TAMC: ≤10³ CFU/g
TYMC: ≤10² CFU/g
Pathogens: E. coli, Salmonella – absent in 1 g
4. Quantities & logistics
4.1 Initial volume:
Flowers (kg) Extracts/Distillates (kg/L)
4.2 Planned monthly purchasing volume:
Short term: Long term:
4.3 Preferred packaging:
Vacuum sealed Canister Glass Custom:
4.4 Minimum shelf life (recommended at least 6–12 months):
4.5 Cold chain
Yes No Not applicable
5. Import & regulation
5.1 Do you have an import license under §72 AMG/BtMG?
Yes No Not applicable
5.2 Do you need support with import/registration?
Yes No Not applicable
5.3 Documentation required per batch?
Yes No Not applicable
6. Prices & contract framework
6.1 Price expectations:
Flowers: € 1,000 /kg
Extracts (€/kg):
Distillates (€/kg):
Isolates (€/kg):
6.2 Payment terms:
Advance payment Letter of credit Other:
6.3 Interested in framework agreements?
Yes (term:) No Not applicable
6.4 Interested in exclusive supply agreements?
Yes No Not applicable
7. Collaboration & other
7.1 Regular samples desired?
Yes No Not applicable
7.2 Technical support required?
Yes No Not applicable
7.3 White-label / co-branding options?
Yes No Not applicable
Appendix: Abbreviations
• AMG – German Medicines Act
• BtMG – German Narcotics Act
• B2B – Business to Business
• COA – Certificate of Analysis
• EU-GMP – Good Manufacturing Practice (EU)
• GACP – Good Agricultural and Collection Practice
• GDP – Good Distribution Practice
• ISO – International Organization for Standardization
• SDS – Safety Data Sheet
• Ph. Eur – European Pharmacopoeia
• TAMC – Total Aerobic Microbial Count
• TYMC – Total Yeast and Mold Count
• kGy – kiloGray (unit of ionizing radiation)
• MCT – Medium-chain triglycerides
• ppm – Parts per million
• BfArM – Federal Institute for Drugs and Medical Devices