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Medicinal cannabis was legalized in Germany in 2017. The regulatory framework to launch pharmaceuticals with cannabinoids, however, is hard to navigate for producers and distributors that want to excel in the German market.
We successfully launched multiple products and understand the regulatory requirements and the quickest pathways to market.
 
We can help you with:

Pharmaceutical regulation in Germany and Europe

  • pharmaceutical quality systems
  • regulatory set-ups (producers, servicers, distributors)
  • processes to market authorisation 
  • laws, permits and licenses required to operate

Authorities, Guidelines, Laws

  • BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)
  • EMA (European Medicines Agency)
  • GxP
    • GACP / EU-GACP (Good Agricultural And Collection Practice) 
    • GDP / EU-GDP (Good Distribution Practice)
    • GMP / EU-GMP (Good Manufacturing Practice)
    • MRA (Mutual Recognition Agreements)
    • PIC/S (Pharmaceutical Inspection Co-operation Scheme)
  • German Particularities
    • AMRadV (Verordnung über radioaktive oder mit ionisierenden Strahlen behandelte Arzneimittel)
    • AMG (Arzneimittelgesetz)
    • AMVV (Arzneimittelverschreibungsverordnung)
    • HWG (Heilmittelwerbegesetz)

Quality requirements for pharmaceuticals and cannabinoid medicines 

  • Ph.Eur (European Pharmacopoeia)
  • DAB (Deutsches Arzneibuch, German Pharmacopoeia)
  • all cannabis relevant monographs
  • all cannabis pharmaceutical dosage forms (dry flower/flos, extracts / cannabis extractum normatum, capsules, suppositories, resin/dronabinol, isolates)
  • all regulated cannabinoids, in particular THC and CBD
  • medical cannabis as an API
  • medical cannabis as magistral preparation
  • medical cannabis as finished product / proprietary medicinal products

Company set-up to operate with pharmaceuticals and medical cannabis in Germany and Europe

  • obtain all permits and licenses
  • communication with authorities (municipality, state and federal agencies)
  • launch and market products