German Federal Council approves Cannabis Law

Recommendation

5/6 June 2024

GMP for Cannabis – what you need to know - Live Online Conference
All relevant GMP/GDP/GACP aspects for Medical Cannabis

The German federal states have cleared the way for the legalization of cannabis. On Friday, 22 March 2024 in Berlin, the "Bundesrat" decided against appealing to the mediation committee and thus approved the Cannabis Law (CanG). The law passed by the "traffic light coalition" authorizes the consumption, possession and cultivation of Cannabis in limited quantities for adults. Thus, the law came into force as planned on 1 April.

What will change for medical Cannabis?

• Medical Cannabis should be clearly separated legally from cannabis for non-medical purposes. Medical Cannabis will therefore not be regulated in the "Consumer Cannabis Act" (KCanG), but in a separate "Medicinal Cannabis Act" (MedCanG). The requirements of the existing regulations on Medical Cannabis will remain essentially unchanged. Medical Cannabis wil continue to be prescribed as a medicinal product. However, a prescription on a special prescription for narcotics will no longer be necessary. A regular prescription will suffice.
  
  
• Companies wishing to cultivate medical Cannabis will continue to require prior authorization from the German Federal Institute for Drugs and Medical Devices (BfArM). However, it will no longer be necessary to carry out a Europe-wide tendering procedure. The pharmaceutical quality requirements under pharmaceutical law (e.g, GMP/GACP/GDP, Pharmacopoeial Monographs etc.) will remain in place.
  
  
• Companies that cultivate Medical Cannabis will be allowed to market and distribute their harvest themselves. They are subject to monitoring by the German Federal Institute for Drugs and Medical Devices (BfArM) and the competent state authorities ("GMP Inspectorates"). In particular, the BfArM must carry out regular inspections of the companies in order to ensure the safety and control of the cultivation of Medical Cannabis in Germany.
  
  
• The special requirements for prescribing and safety measures that apply to narcotics will no longer apply. In this respect, medicinal cannabis is to be treated as a prescription-only medicinal product that is not a narcotic. For records and notifications by licence holders to the BfArM, the obligations set out in Section 16 of the MedCanG apply.
  
  
• "Narcotics Officer": A Responsible Person with a corresponding proof of expertise must still be appointed, and must be reported to the BfArM when applying for a distribution licence.
  
  
• Cannabis in the form of dried flowers or extracts in standardized quality can be prescribed, provided it has been analyzed according to the provisions of the German Pharmacopoeia (Deutsches Arzneibuch, DAB) and has a tetrahydrocannabinol (THC) content of at least 0.3 %.

More information is available on the BfArM website "Questions and Answers on the new Cannabis Law".