Medicinal cannabis in Germany - Business Report

2 Confidential __________________________________________________________________________________ Table of contents I List of abbreviations ......................................................................................................... 8 II List of tables .................................................................................................................. 11 III List of figures................................................................................................................ 12 IV Glossary ....................................................................................................................... 14 Introduction ..................................................................................................................... 15 1. Cannabis as medicine ................................................................................................... 16 2. Indications for the use of Cannabis............................................................................... 18 2.1 Approved indications and evidence ..........................................................................................19 2.2 Orphan drug indications and orphan designations for Cannabis...............................................24 2.3 Non-approved indications and available evidence....................................................................24 2.4 Off-label use indications............................................................................................................27 2.5 Aut-idem with narcotics ............................................................................................................27 2.6 Cannabis in the relevant guidelines...........................................................................................27 2.7 Fitness to drive under Cannabis therapy ...................................................................................28 3. Relevant legislation on the use of Cannabis.................................................................. 29 3.1 Use of Cannabis as a narcotic (BTx)...........................................................................................30 3.2 Use of Cannabis as a medicine (Btx and Rx) ..............................................................................32 3.3 Use of Cannabis as an OTC product (OTC) and OTx...................................................................32 3.4 Use as food supplements NEM (Food Supplement) and "Super Food “ .....................................33 3.5 Use as a cosmetic product (CosP)..............................................................................................35 3.6 Use as a consumer product (CP)................................................................................................37 3.7 Use of Cannabis in the outpatient sector ..................................................................................38 3.8 Use of Cannabis in the hospital sector ......................................................................................39 4. Regulation of the use of Cannabis in Germany.............................................................. 40 4.1 The authorisation of Cannabis medicines .................................................................................41 4.2 The narcotics licence .................................................................................................................42 4.3 The import permit (§ 72 AMG and BtMG § 11) .........................................................................43 4.4 The wholesale trade permit (§ 52a AMG) .................................................................................43 4.5 Price regulation and reimbursement.........................................................................................44 4.6 The BfArM's tender for the cultivation of Cannabis in Germany...............................................45