The FOPH can issue exceptional licences for the cultivation, import, manufacture or placing on the market of banned narcotics.
Under the terms of Article 8, paragraph 5 of the Narcotics Act (NarcA; RS 812.121) the FOPH can issue exceptional licences for
- the cultivation
- placing on the market
of banned narcotics (List d, NarcLO-FDHA; CC 812.121.11) such as smoked opium, diacetylmorphine, LSD, cannabis, etc., provided that the request for such a licence does not run counter to an international agreement and these narcotics serve the following purpose:
Since 15 May 2021, the FOPH has also been able to issue exceptional licences for the cultivation, import and manufacture of cannabis and cannabis products in conjunction with scientific pilot trials as per Article 8a NarcA involving the controlled dispensing of cannabis for non-medicinal purposes:
This is a special case of scientific research as per Article 8, paragraph 5 NarcA, which will therefore be explained separately.
Import and export of banned narcotics
The import or export of prohibited narcotics always requires an exceptional licence from the FOPH (Art. 8 para 5 NarcA). On the basis of a corresponding exceptional licence, Swissmedic can issue the additionally required import or export licence for these substances (cf. Art. 5 NarcA in conjunction with Art. 24 para 1 c NarcCO).
It is important to note that trade in banned narcotics for general, limited medical use abroad does not correspond to any of the exceptional purposes under Article 8 para 5 NarcA and therefore cannot be authorised (cf. Limited medical use of banned narcotics).
If a banned narcotic is imported as an active ingredient of a medicinal product authorised by Swissmedic (e.g. Sativex® for the corresponding authorised indication), this does not require an exceptional licence from the FOPH. In this case, an import authorisation issued by Swissmedic will suffice (cf. Article 8, paragraph 7 in conjunction with Article 4 NarcA).
Additional requirements apply for the import of narcotics containing an effective concentration of cannabinoids for pilot trials with cannabis, as per Article 8a NarcA.
Cultivation, manufacture and placing on the market
An exceptional licence is required from the FOPH (Art. 8 para 5 NarcA) for the cultivation, manufacture and placing on the market of controlled substances on list d if these substances are not an active ingredient in a medicinal product authorised by Swissmedic (Art. 8 para 7 NarcA).
“Cultivation” includes all types of sowing as well as propagation by cloning of plants and fungi containing list d controlled substances, from the time of sowing or propagation until harvest.
“Manufacture” refers to all operations from extraction, production, preparation, treatment or processing, cleaning and conversion to packaging, storage and delivery of the final product, as well as quality controls and release (Art. 2 c NarcCO).
“Placing on the market” means all actions involving a change of possession or ownership as well as transport. This also includes trading and prescribing.
Additional requirements apply for the cultivation and manufacture of narcotics containing an effective concentration of cannabinoids in conjunction with pilot trials as per Article 8a NarcA.
An exceptional licence is not required for placing cannabis and cannabis products on the market for pilot trials which involve cannabis as per Article 8a NarcA. The licence for pilot trials with cannabis also covers their placing on the market.
Last modification 17.09.2021