Cultivation of cannabis for pilot trials under Art. 8a NarcA

The cultivation of narcotics containing an effective concentration of cannabinoids (‘cannabis’), that is used in the pilot trials in accordance with Art. 8a of the Narcotics Act (NarcA), requires an exceptional licence from the FOPH.

In order to cultivate cannabis that is used in the pilot trials in accordance with Art. 8a NarcA, an exceptional licence is required from the FOPH in accordance with Art. 8 para. 5 NarcA.

The public or private organisations responsible for conducting pilot trials designate their own producer(s). Interested cultivators should submit an application for an exceptional licence to cultivate cannabis together with the responsible organisations that intend to conduct a pilot trial and who wish to submit a corresponding application to the FOPH.

Specifications regarding origin and cultiva-tion of cannabis

Cannabis that is used in the pilot trials must

• be produced in Switzerland;
• if possible be cultivated in accordance with the regulations set out in the Organic Farming Ordinance;
• be guided by the rules on good agricultural practice for the cultivation of medicinal plants (Guidelines on good agricultural and collection practice (GACP) for starting materials of herbal origin; see. Documents tab)

The specifications regarding origin and cultivation are set out in Articles 7 and 8 of the Ordinance on Pilot Trials Conducted under the Narcotics Act (NarcPT).

The specifications regarding Swiss origin and controlled organic production can only by diverted from in exceptional circumstances (see Art. 7 para. 2 and Art. 8 para. 2 NarcPT).

The cultivation of cannabis is also subject to the product quality requirements set out under Art.9 NarcPT, such as a total THC of maximum 20% for cannabis products, and a maximum residue limits for contaminants.

Self-regulation

To ensure compliance with the cultivation provisions (Art. 8 NarcPT), a self-regulation duty applies (Art. 30 NarcPT). If the harvested cannabis is delivered to a third party (e.g. manufacturer) for processing and/or packaging, the parties must define who will perform which product quality checks in accordance with Art. 10 NarcPT (e.g. analysis of pesticide residue levels).

The FOPH and the competent cantonal executing authorities will carry out spot checks to ensure compliance with licensing requirements and legal regulations.

List of interested growers

In order to assess whether adequate production meeting the organic cultivation standards can be guaranteed, the FOPH keeps a list of interested cultivators and manufacturers that may potentially be suitable for this type of cultivation. Interested cultivators and manufacturers can contact the FOPH. However, as the authorising body, the FOPH does not make any recommendations.

Eligible cultivators and manufacturers are in particular those who already produce agricultural products in accordance with the Organic Farming Ordinance, and who intend to produce cannabis in line with the rules on good agricultural practice for medicinal products (geared towards the GACP) for the pilot trials. Cultivators who specialise in cannabis production (e.g. CBD hemp) and who recently switched to organic production (converting holdings under Art. 8 Organic Farming Ordinance) can also contact the FOPH.

Being added to the list does not guarantee that cultivators will receive a supply contract from the responsible public or private organisation for pilot trials, or that they will be granted an exceptional licence. The conditions for an exceptional licence for cultivation will be reviewed after a corresponding application to conduct a pilot trial has been received.

If you wish to be added to the list of interested cultivators and manufacturers, download the form under the documents tab.

Please send the completed form to the following address:

[e-mail]

Coordination of applications

Provided the pilot trial in question has been authorized, exceptional licences for the import of cannabis and related products for the use in the pilot trials can be granted. The applications must therefore be coordinated through the public or private organisations. The FOPH coordinates the associated authorisation procedure.

If the same producer not only cultivates cannabis for a pilot trial but would also like to supply processed cannabis products (including processing, quality control, product packaging and labelling), an exceptional licence may be granted to cover the whole production process (cultivation and manufacture). See manufacture of cannabis products for pilot trials.

Please note: if a producer would like to cultivate cannabis for more than one pilot trial, a separate application is needed for each trial.

Submission of application

Applications must be signed by someone listed as an authorised signatory in the Swiss Commercial Register, or the person responsible for cultivation, or accompanied by a corresponding, legally valid authorisation, and submitted to the FOPH. Applications should be sent by post to the following address:

Confidential

Federal Office of Public Health
Prevention of Non-Communicable Diseases Division
Policy Bases and Implementation Section
Schwarzenburgstrasse 157
P. O. Box
3003 Berne

Switzerland

The FOPH can request additional information and documents at any time.

When submitting your application please take processing time into account.

Application requirements

Applications for an exceptional licence for the cultivation of cannabis that is used in the pilot trials must contain at least the following information and supporting documents:

• First and last name of the cultivator, producer or manufacturer, or company name
• First and last name, vocational qualifications and career history of person responsible for cultivation and their deputy
• Extract from the criminal excerpt for the responsible person and their deputy, issued within the last six months
• Document stating for which specific pilot trial cannabis is grown and a corresponding contract of mandate, if applicable. The supporting document should contain precise details of the type and quantity of cannabis cultivated, and, if applicable, assurance from the ordering party that they will acquire the contractually defined quantity
• Proof of compliance with the requirements of cultivation for pilot trials under Art. 8 NarcPT
• Proof of compliance with the quality requirements and quality inspections in accordance with Articles 9-10 Narc PT
• Number of seeds or seedlings, and purchase location
• Precise designation (types) of plants requested, including the expected yield, THC and CBD content, and total THC (converted into grams)
• Desired duration of exceptional licence (in accordance with the term of the supply contract with the study centres)
• Ownership of the plants and seeds if applicable (enclose owner’s exceptional licence if applicable)
• Designation and description of cultivation areas (sketch map, ground plan, cultivation area, etc.)
• Description of storage, protection and logging of seeds/plants/crops, and archiving of records (management system), including evidence of a system to guarantee adequate protection against theft
• Explanation of how the obligation to report and provide documentation on the cultivation and traffic of cannabis will be implemented (cf. Articles 57 – 65 NarcPT, which apply by analogy)
• Explanation of how the self-regulation duty (under Art. 30 NarcPT) will be implemented.

If the application not only covers the cultivation of cannabis but also the manufacture of cannabis products (including processing, packaging and labelling) for pilot trials, the requirements that apply to applications for an exceptional licence for manufacture should also be taken into account.

Documents

Application form for growers, producers and manufacturers for pilot trials with cannabis

• Application form for growers, producers and manufacturers for pilot trials with cannabis (PDF, 191 kB, 11.02.2022)

Basic documents

• EMA GACP guideline (PDF, 44 kB, 14.05.2021)European Medicines Agency, 2006
• Comparison between the Good Agricultural and Collection Practices (GACP) of the European Medicines Agency (EMA) and the Canadian Good Production Practices for Cannabis (PDF, 593 kB, 14.05.2021)in German
  Andreas Lardos
  Zürcher Hochschule für angewandte Wissenschaften

Legislation

• SR 812.121 Narcotics Act (NarcA) Art 8a
• 812.121.5 Ordonnance sur les essais pilotes au sens de la loi sur les stupéfiants (OSPStup)
• 812.121.1 Betäubungsmittelkontrollverordnung (BetmKV)

Further information

Last modification 14.07.2021