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Controlled cultivation for assured quality

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With the aim of ensuring the future supply of seriously ill patients with pharmaceutical-grade cannabis grown in Germany, the BfArM will advertise EU-wide contracts to find suitable companies for the cultivation. Currently, medicinal cannabis is mainly imported from the Netherlands and Canada. Since the cultivation must first be implemented under the narcotics and pharmaceutical regulations, the first cannabis from German cultivation is expected to be available in 2019. Until then, demand will be covered by imports.

In order to be used as medicine, the cannabis must meet all the legal requirements for medicinal products and narcotics: Only cannabis that meets the requirements of the “Good Agricultural And Collection Practice, GACP ) has been installed accordingly and meets the requirements of the relevant monographs and guidelines.

To date, around 1,000 patients have had an exceptional permit to purchase cannabis for medical purposes. In addition to the previous therapy and prescription options, doctors will in future also be able to prescribe medicinal cannabis blossoms or cannabis extracts in pharmaceutical quality on a narcotic prescription. They must comply with pharmaceutical and narcotics legislation. The previous authorization procedure according to § 3 paragraph 2 BtMG for the purchase of medicinal cannabis for the purpose of medically supervised self-therapy will then be omitted.

An accompanying survey should provide further insights into effectiveness and safety. Doctors will report anonymized data on therapy with cannabis medicinal products to the BfArM, which will be collected over a period of five years and then evaluated.

For more information, see the BfArM press release.

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