Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000228

EU PAS number

EUPAS1000000228

Study ID

1000000228

Official title and acronym

DARWIN EU® - Drug utilisation study on medicinal use of cannabis flos

DARWIN EU® study

Yes

Study countries

Germany
Netherlands

Study description

Cannabis flos (dried, whole or fragmented, flowering tops of Cannabis sativa L.) is not registered as medicinal product in the European Union (EU).
However, there are different regulatory strategies among EU member states that enable some specific exemptions for its use and its supply by pharmacies, as a controlled substance under physician’s prescription only.
Scientific data is needed to inform and support regulatory work including a possible establishment of an EU herbal monograph.

Research question
What is the (real-world) use of Cannabis flos that is prescribed for medicinal purposes?

Study objectives
1. To estimate incidence rates and prevalence of use of Cannabis flos, overall and stratified by pre-specified medicinal product of interest, age, sex and country/database, during the study period from 2014 to 2023.
2. To characterise the cohort of patients being treated with the Cannabis flos at the time of new prescription/dispensation of the selected medicinal products in terms of demographics, indication for prescribing/dispensing, comorbidities and comedication.
Additionally, to determine duration of treatment with Cannabis flos products and optionally, to describe the route of administration. Results will be stratified by pre-specified medicinal product of interest and database.

Study status

Finalised
Research institutions and networks

Institutions

Networks

Contact details

Dina Vojinovic

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

DARWIN EU_D2.2.3_Protocol_P3-C1-006_DUS_Cannabis flos_V3.0.pdf

English (905.5 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable