© 2022 KOMAND Consulting
Producer Authorisation
Tilray Brands ToexportGMPcertifiedmedicalcannabis(inrawmaterial)fromPortugaltoSpaintodevelop
medicalcannabisproductsforclinicaltrialsfordiseasessuchasAlzheimers,Parkinson’sandskin
inflammation
GW Pharmaceuticals
(Sativex, Epidyolex)
ForprescriptiontotreatmusclestiffnessassociatedwithMSandepilepticseizures.
Bausch Health (formerly
Vleant Pharmaceuticals)
Nabilone
Forprescriptioninexceptionalcircumstances
Solvay Pharmaceuticals
(Dronabinol)
Forprescriptioninexceptionalcircumstances
Cannabasa Agro & Pharma Cultivationofcannabisplantstoobtainthenecessarybatchesforthevalidationofthe
manufacturingprocessofnarcoticactiveingredients(cannabisextract)formedicalpurposes
Linneo Health Cultivationproductionmanufacture,distribution,importandexportofcannabissativa
Medalchemy Cultivationandproductionofcannabissativaanditsproducts
Oils4Cure Cultivationandproductionofcannabissativaforclinicaltrialauthorizationrequests
Phytoplant Research Cultivationofcannabisplansfortheproductionofcannabisseedsandcuttingsformedical
purposes
Naturhemp Cultivationofcannabisplantstoobtainthebatchesnecessaryforthevalidationofthe
manufacturingprocessofnarcoticactiveingredientsformedicalpurposes
SPAIN
Population:47,558,231
GDP/Capita: USD$30,115
Wholesale Medical Flower Price/Gram: €8-13 (street price
2021)
Current Med/Rec Usage (15-64yrs):10.5%
Potential Patient Count 2022 EST
>300,000
Patient Universe
b
Sources : World Population Review, World Bank, EMCDDA, UNODC
STATUS
• Thecountrycurrentlylacksamedicalcannabisprogrammeata
nationallevel,buttheHealthCommitteeofSpain’sCongressof
Deputieshasapprovedaproposaltocreateasubcommittee
thatwillpavethewayforwardformedicalcannabis
legalisation.
• InJune2022,approveduseofmedicalcannabiswaswidened
anditisexpectedthatcannabis-basedpreparations(including
magistralformulas)willbecomeavailableinpharmaciesbythe
endof2022.
NEWS
• GeneralPharmaceuticalCouncilofSpainproposepilotproject
• Kanaboformsnewsubsidiary(signsMOU)forSpanishindoorcultivation
• Congresscallsforacentralisedregistryofmedicalcannabispatients
Status Quo & Recent News
Patien
ts
Produc
ts
Product
Epidyolex(authorisedMay2019)
Sativex(authorisedJuly2010)
Extractsorstandardisedpreparationsareanticipatedtobemadeavailable
forsalethroughpharmaciesbyendof2022
List of Available Products
a
Back to Europe
Ministry for Health Indication Guidance
Updated Jan 2022
c
1. MusclestiffnesslinkedtoMS
2. Epilepsyseizures
Additionalconditions*
1. Fibromyalgia
2. IBD
3. CancerCachexia
4. Glaucoma
5. Sideeffectsofchemo
6. Cancer
7. Chronicpain
8. Endometriosis
c
SOURCE
For conditions beyond MS muscle stiffness and epilepsy, approval by
medical tribunal is required and is subject to variations among localities
c
Spanish Observatory of Medical Cannabis (OECM)
Current authorisations for Cannabis for medicinal/ scientific purposes
d
Product
Channels
Last Updated – Oct 2022
Spanish Agency for Medicines and Health Products (AEMPS)
Stateagencyattachedtotheministryofhealththatissuesthe
relevantlicences(supervisionandcontrol)tocultivatecannabis(for
medical/researchpurposes).Itisalsoresponsibleforthe
authorisingofCBMPs.ItadherestotheEUframeworkforcannabis.
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
a
Source …
Cannabis Social Clubs (CSC) are not legal but tolerated and medical cannabis
patients who acquire cannabis through CSCs are afforded some level of
protection from the law
d
Tilray, AEMPS
Indications
Clinical trials
Sponsor Name
MedicalCondition
TrialStart
date
Results
status
FundaciaInstitut
Catalade
Farmacologia
Chemotherapyinduced
nauseaandvomiting
15-09-2005
Noresults
available
Minoryx
TherapeuticsS.L.
Adrenomyeloneuropathy 14-09-017
Noresults
available
Laboratorios
InibsaS.A.
Painindental
intervention
1-03-2006
Noresults
available
FundacióClínic
perlaRecerca
Biomèdica
Endometriosis 27-05-2019
Noresults
available
GWResearchLtd Schizophrenia 2-06-2020
Noresults
available
Current clinical trials for cannabis in Spain
a
C
Clinical Trials Register