© 2021 KOMAND Consulting
FRANCE
Population: 67,022,000
GDP/Capita: USD$41,761
Cannabis Flower Price/Gram: 10.2 (Street Price 2017)
Current Med/Rec Usage (15-64yrs): 11% (2017 Prevalence)
ANSM # (see above)
International Cannabis Company French Pharma Partner
Lot 1.1
Main supplier
Alternative supplier
AURORA EUROPE GmbH
TILRAY
LABORATOIRES ETHYPHARM SAS
MEDIPHA SANTE
Lot 1.2
TILRAY
PANAXIA PHARMACEUTICAL INDUSTRIES
MEDIPHA SANTE
NEURAXPHARM FRANCE
Lot 1.3
PANAXIA PHARMACEUTICAL INDUSTRIES
EMMAC LIFE SCIENCES
NEURAXPHARM FRANCE
LABORATOIRES BOIRON
Lot 2.1
AURORA EUROPE GmbH
TILRAY
LABORATOIRES ETHYPHARM SAS
MEDIPHA SANTE
Lot 2.2
TILRAY
LITTLE GREEN PHARMA Ltd
MEDIPHA SANTE
INTSEL CHIMOS SAS
Lot 2.3
PANAXIA PHARMACEUTICAL INDUSTRIES
EMMAC LIFE SCIENCES
NEURAXPHARM FRANCE
LABORATOIRES BOIRON
Lot 3.2
LITTLE GREEN PHARMA Ltd
ALTHEA COMPANY PTY Ltd
INTSEL CHIMOS SAS
LABORATOIRES BOUCHARA RECORDATI
Lot 3.4
AURORA EUROPE GmbH
No alternative supplier
LABORATOIRES ETHYPHARM SAS
No alternative supplier
Lot 3.5
LITTLE GREEN PHARMA Ltd
PANAXIA PHARMACEUTICAL INDUSTRIES
INTSEL CHIMOS SAS
NEURAXPHARM FRANCE
ANSM Pilot Program Products– 2021
Allowable products, forms & potencies
a
a
ANSM questions dedicated to the supply and distribution of medical cannabis
ANSM Pilot Medical Cannabis Program
c
5 Listed Indications, Patient Quantity (3,000)
c
ANSM, 2 year pilot programme for 3,000 patients, commencing in 2021
Sources : European Monitoring Centre for Drugs & Drug Addiction (EMCDDA)
Insee.fr, IMF
Companies selected to provide and distribute free of charge cannabis-based medicines
d
d
ANSM
Cannabis Flower
CATEGORY POTENCY RANGES ANSM #
THC Dominant (20/1 target) THC> 8%, CBD <1% Lot 1.1
Balanced Ratio (1/1 target) THC and CBD> 5% Lot 2.1
CBD Dominant (1/20 target)
THC <1% CBD> 5%
THC <5% CBD> 5%
Lot 3.1
Lot 3.4
Form:
Flower must be prepared in a form for inhalation by vaporization (such as
dried flowering tops or granules)
1. Refractory neuropathic pain - 750 patients
2. Drug-resistant epilepsy - 500 patients
3. Oncology symptoms (e.g. vomiting) - 500 patients
4. Palliative care - 500 patients
5. Spasticity, MS, Nervous system pathologies - 750 patients
Back to Europe
Patient Count 2020
<100
Patient Count (estimate)
b
STATUS
France has announced a pilot program with specific indications
and medical cannabis product specifications limited to 3,000
patients, launching in Q1 2021
Pre-pilot, products are limited to cannabis-based drug
imports via individual Temporary Authorisations for Use (ATU)
NEWS
List of companies selected by ANSM to provide medical cannabis
Panaxia And Neuraxpharm Partnership, Medical Cannabis To France
Decree of 7-Oct-2020 relating to pilot of medical cannabis program
Status Quo & Recent News
Patients
b
The Patient Count is the total population of patients that have been
prescribed cannabis based drugs at some point since legalisation
KOMAND estimate is based on research of the ATU approvals from the
ANSM
Products
Product Channels
L’Agence nationale de sécurité du médicament (ANSM)
ANSM has full control over supply and distribution of cannabis-based
drugs for a pilot program, and is responsible for selecting the
suppliers themselves. All medical cannabis will be imported
The European Medicines Agency
Compliance guidelines for EU GMP, EU GDP & EU GACP,
inspection procedures and forms agreed by all EU Member States
Regulatory Agencies
Cannabis
Pharma
Last Updated – Jan 2021
Cannabis Extracts
THC Dominant (20/1 target) THC 5mg/ml, CBD<1 mg/ml Lot 1.2
Balanced Ratio (1/1 target) THC and CBD oil> 5 mg/ml Lot 2.2
CBD Dominant (1/20 target)
THC<1mg/ml, CBD>5 mg/ml
THC<5mg/ml, CBD>5 mg/ml
Lot 3.2
Lot 3.5
Form:
An oral form based on extracts solubilized in an oily matrix
Cannabis Capsules
THC Dominant (20/1 target) THC 5mg/ml, CBD<1 mg/ml Lot 1.3
Balanced Ratio (1/1 target) THC & CBD ingest>5 mg/ml Lot 2.3
CBD Dominant (1/20 target)
THC<1mg/ml, CBD>5 mg/ml
THC<5mg/ml, CBD>5 mg/ml
Lot 3.3
Lot 3.6
Form:
An oral form based on extracts dissolved in oily matrix in form of capsules