labeling
Formulation drugs such as cannabis extracts and cannabis flowers must be labelled in accordance with Section 14 Apothekenbetriebsordnung (ApBeTro).
Outer packaging and containers must contain at least the following information:
- Name of the medicinal product
- Method of application
- Instructions for use, unless otherwise provided
- Shelf life information
- Date of manufacture
- Pharmacy name and address
- Name of treating doctor
§ 14 ApbetRO | Instance | |
|---|---|---|
| 1 | Name and address of the donor pharmacy and, as far as it varies, of producer | Name and address of the donor pharmacy and, as far as it varies, of producer |
| 2 | Content by weight, nominal volume or number of pieces | 10 mL |
| 3 | Kind of application | Oral ingestion |
| 4 | Instructions for useunless the medicinal product is delivered directly to the prescriber | In the morning: 1 drop In the evening: 1 drop Drizzled under the tongue or taken with water. |
| 5 | active ingredients By type and quantity and other ingredients by type and information on the concentration or quantity of the other ingredient, insofar as this is necessary according to the current state of scientific knowledge | THC/CBD: 10mg/ml |
| 6 | Date of manufacture | 01/01/2024 |
| 7 | Availability period with the words “usable until” or with the abbreviation “used until”, giving the day, month and year and, where necessary, an indication of the shelf life after opening the container or after making the ready-to-use preparation, | used until 12/12/2024 (see shelf life notes) |
| 8 | where necessary, Instructions for special precautionary measures, for storing or disposing of unused medicinal products or other special precautionary measures to avoid risks to the environment, and | Keep out of the reach of children If you experience side effects such as drowsiness or dry mouth, contact your doctor or pharmacist. (Can be specified on accompanying document) |
| 9 | insofar as the formulation medicinal product was manufactured on the basis of a prescription for human use, Patient's name. | Max Musterpatient |