- Product Defined
Product specifications, intended forms, THC/CBD content, and target German market are defined.
- Commission GACP Audit
Engage an ISO 17065-accredited certification body to audit the cultivation site against EU GACP or WHO GACP standard.
- EU GACP (EMEA/HMPC/246816/2006) or WHO GACP 2003
- ISO 17065-accredited certifying body required
- Audit covers cultivation, harvest, drying, storage
- GACP Certificate Issued
Certificate names the specific cultivation site (GPS/cadastral reference). Valid 1–3 years. Must remain current throughout the registration process.
- Commission GMP Audit
EEA or PIC/S competent authority audits the manufacturing site against EU-GMP Part I (finished product) or Part II (bulk API).
- EU-GMP Part I for finished product import
- EU-GMP Part II if supplying German finisher
- Scope must specifically cover cannabis manufacturing
- GMP Certificate Issued
Certificate issued by competent authority (ANSM, TGA, MHRA etc.). Any change to manufacturing scope requires an amended certificate.
- Identify German MAH / Importer
A German Marketing Authorization Holder (MAH) or licensed BtMG §3 importer must sponsor the product in Germany.
- MAH must hold AMG wholesale authorization
- OR: importer holds BtMG §3 license
- Importer takes QP batch release responsibility
- Prepare Product Dossier
Compile full technical documentation: specifications, analytical methods, stability data, GACP + GMP certificates, German-language labeling.
- Stability data per ICH Q1A
- German-language labeling per AMVV
- Full batch manufacturing record template
- Drug Master File (DMF) if applicable
- BfArM Approved?
BfArM reviews product dossier. May request additional analytical data, stability studies, or manufacturing clarifications.
- Respond to Queries
Provide additional analytical data, stability studies, or manufacturing clarifications within the specified timeframe.
- Product Authorized ✓
AMG authorization granted. Product may be supplied to German pharmacies against BtM prescriptions.