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Sprememba zakonodaje zaradi farmacije?

OdgovorNapisal/-a skorc » 30 Avg 2010, 11:29

Germany: Changes in the narcotics law to allow for the approval of Sativex intended

The government wants to allow pharmaceutical companies to apply for approval of cannabis-based medicines in Germany. In a commentary, the government writes: "Since in Europe (Great
Britain) a medicinal drug with cannabis extract for the symptomatic treatment of spasticity in multiple sclerosis was approved, it is currently necessary to lift the general ban on cannabis for medicinal purposes for a forthcoming application for an approval of this medicine." As in other European countries, which have approved or want to approve Sativex the law change is restricted to cannabis-based medicines approved by the health authorities. The approval in Germany is expected in 2011 and is restricted to the treatment of spasticity in multiple sclerosis.

The government is following the recommendations of the expert committee for narcotics of 3 May, that is the reclassification of "Cannabis (marijuana, plants and parts of plants belonging to the species cannabis)" from Annex I to Annex II of the narcotics law, as long as they "are intended for the production of preparations for medicinal purposes." The committee also recommended adding the following item to Annex III of the narcotics law: "Cannabis extract (extract obtained from plants and parts of plants belonging to the species cannabis)" and only "in preparations approved as medicines." Annex I of the German narcotic law includes substances that cannot be prescribed and are not marketable, such as heroin, cocaine, LSD and cannabis. The inclusion of cannabis extract in Annex III of the narcotics law refers to the expected approval of Sativex.

Extended comment on the changes by the ACM in German:
http://www.cannabis-med.org/nis/data/file/stellungnahme_2010.pdf

(Source: Bill of a 25th ordinance for the change of the regulations for the German narcotics law)

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