STELLA KYRIAKIDES
MEMBER OF THE EUROPEAN COMMISSION
HEALTH AND FOOD SAFETY
Rue de la Loi, 200
B-1049 Brussels
–
Berl 10/380
Brussels, 17 May 2021
Dear Ms Weiss,
Thank you for your letter of 5 March 2021 enquiring about the regulatory framework on
medicinal cannabis.
Let me stress that cannabis-based medicinal products should be placed on the market on the
basis of the same assessment as any other medicinal products. The safety, efficacy as well as
quality of product in question must be carefully assessed before the product is placed on the
market. The requirements as regards Good Manufacturing Practice are fully applicable to
these products. The EU pharmaceutical framework ensures that all medicinal products,
independently of the origin of an active pharmaceutical ingredient or a place of their
manufacturing, are of the required quality.
We are aware that in the absence of applications for marketing authorisations, some Member
States allow the use of cannabis-based preparations for medical purposes at the national level,
relying on the exceptions found in pharmaceutical legislation. The use of these preparations is
then subject to Member State legislation.
We consider that the EU legislative framework for medicinal products provides the highest
assurances for the quality, safety and efficacy of medicines. Therefore, we welcome the
clinical trials with the cannabis based medicinal products as they will generate data supporting
potential submissions of applications for marketing authorisations in the EU. This would
contribute to ensuring the availability of cannabis based medicinal products and at the same
time provide the highest assurance of the quality, safety as well as confirmed efficacy, of
these products for the European patients.
Yours sincerely,
MEP Pernille Weiss