Narcotics: Licences and Control in Switzerland

How are the schedules structured?

The Narcotics Schedules Ordinance maintains several schedules: controlled substances with a medical use, prohibited substances, precursors, and auxiliary chemicals. The assignment determines licensing duties, record-keeping duties and dispensing rules.

What licences does an operation need?

In addition to the establishment licence under therapeutic products law, a narcotics licence from Swissmedic is needed for the intended activities. A separate licence per shipment must be obtained for every import and every export, matching the international control system.

1. Secure the establishment licence under therapeutic products law covering the relevant activities.
2. Apply for the narcotics licence from Swissmedic, stating the substances.
3. Set up storage and access control to the requirements, including a safe and logging.
4. Set up record-keeping per substance and batch, with a running balance.
5. Apply for an import or export licence for every shipment before transport.
6. Submit annual reports and stock reports on time.
7. Destroy only with a protocol and, where required, under supervision.

What applies to prescribing and dispensing?

Narcotic-containing medicinal products are prescribed on special prescription forms, with a limited quantity and limited validity. The pharmacy documents every dispensing in the narcotics control record. Additional cantonal licensing and reporting duties apply to substitution treatments.

• Prescription on the prescribed form, with the quantity stated in words where required.
• Limited validity of the prescription and limited quantity dispensed per prescription.
• Documentation of every dispensing with date, quantity and dispensing person.
• Substitution treatments: cantonal authorisation of the treating doctor required.
• Travelling with narcotics: medical certificate, plus further documents depending on the destination country.

What applies to cannabis medicinal products?

Since the 2022 amendment to the Narcotics Act, prescribing cannabis medicinal products for medical purposes is possible without an exemption from the FOPH. Cultivation, manufacturing and trade remain subject to licensing, and reimbursement by health insurance must be clarified separately.