Anthony writes
The Spanish decree to legalize and regulate medical cannabis has now been published in the official gazette, meaning that it comes into force tomorrow.
I ran a document comparison with what was notified to the EU through TRIS, and there don’t appear to be any major changes. There are some wording changes and some procedural changes (mostly in Article 6 regarding registering preparations), but the major points of the framework are intact.
One point that lacks clarity to me still is which medical conditions cannabis can be prescribed for.
The health minister earlier this week signaled that there would be a closed list of conditions, but that does not appear in the text of the published decree. Although the preface to the regulation notes several conditions for which there is ample evidence that they can be alleviated with cananbis, it does not limit prescriptions to those conditions anywhere in the decree. Rather, it states that AEMPS must produce monographs for the indications within three months. Perhaps the ones listed in the preface of the decree are the ones that AEMPS will start with, but it does at least outline a procedure for expanding on those conditions
Sean Hocking
Source link