Exceptional licences related to pilot trials under Art. 8a NarcA
After consulting with the relevant cantons and communes, the FOPH can authorise scientific pilot trials with narcotics containing an effective concentration of cannabinoids. The applicable conditions are set out in the Federal Council’s implementing provisions (Ordinance on Pilot Trials Conducted under the Narcotics Act, NarcPT).
On 15 May 2021, an amendment to the Narcotics Act entered into force allowing a ten-year research phase for scientific pilot trials involving the controlled dispensing of cannabis for non-medicinal purposes (recreational cannabis).
Under Art. 8a para. 1 NarcPT, in order to be granted an exceptional licence for the cultivation, import or manufacture of narcotics containing an effective concentration of cannabinoids that are to be dispensed as part of the pilot trials, a complete and eligible pilot trial application must be submitted. Applications must therefore be submitted in a coordinated manner by the relevant public or private organisations. As the authorising body, the FOPH coordinates the associated authorisation procedure.
The responsible public or private organisers are responsible for designating cultivators and manufacturers for their pilot trials. The FOPH does not designate producers, or conduct its own pilot trials.
Documentation and reporting obligations
Authorisation holders must keep a record of all traffic of cannabis products and must report to the FOPH and cantonal authorities at the end of every year on the sale of cannabis products and on the quantity stored at individual points of sale. They must report any unforeseen events to the FOPH immediately (see Art. 27 NarcPT). As part of the authorisation procedure, the FOPH will ensure that the relevant processes are in place.
To ensure compliance with the provisions of the NarcPT on cultivation and product quality as well as on packaging and product information, distributors are required to self-regulate (Art. 30 NarcPT).
The FOPH ensures that authorisation holders comply with the provisions of the NarcPT for pilot trials. It may consult the competent cantonal executing authorities for this purpose. The cantonal authorities designate the responsible inspection bodies that will carry out spot checks to ensure compliance with the cannabis product quality requirements under Art. 9 NarcPT.
Compliance with the requirements for conducting pilot trials is primarily ensured through periodic inspections by the competent federal and cantonal authorities. Licence holders are required to grant inspectors access to sites and premises. This applies to all related areas, i.e. cultivation areas, production facilities, and sale and storage areas. The relevant stock and accompanying documents must be presented to inspection authorities upon request.