Manufacture of cannabis products for pilot trials under Article 8a NarcA

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

To manufacture cannabis products used in the pilot trials under Art. 8a NarcA, an exceptional licence from the FOPH is required, in accordance with Art. 8 para. 5 NarcA.

The public or private organisations responsible for conducting a pilot trial designate their own manufacturer(s). Interested manufacturers should apply for an exceptional licence to manufacture cannabis products together with the responsible organisation that intends to conduct a pilot trial and plans to submit a corresponding application to the FOPH.

Manufacturing requirements for cannabis products

The manufacture of cannabis products that are used in the pilot trials is understood to mean the processing of narcotics containing an effective concentration of cannabinoids as a raw material in finished cannabis products. This includes all processing steps after cultivation and harvesting of the raw material, such as processing through sifting or extraction (processed cannabis products), mixing with additives (mixed cannabis products), quality control, and packaging and labelling.

The manufacture of cannabis products must meet the product quality requirements set out under Art. 9 NarcPT, including:

• Maximum THC content of 20%
• Compliance with residue levels for contaminants (Annex, Art. 9 para. 3 NarcPT)
• No toxic or psychotropic additives
• Compliance with the food safety and quality requirements for edibles

The packaging and product information specifications (Art. 11 NarcPT) must also be complied with, including:

• Packaging must be sealed and cannabis products to be orally ingested must be child-safe
• Ingredients must be declared (THC, CBD)
• Products must carry a health risk warning

In addition, it should be noted that the cannabis used in such products must comply with the cultivation requirements for pilot trials (see Art. 8 NarcPT).

 

Self-regulation

To ensure compliance with the provisions on product quality (Art. 9 NarcPT) and packaging as well as product information (Art. 11 NarcPT), a duty of self-regulation applies (Art. 30 NarcPT). The requirements on e.g. product quality inspection relating to sampling, samples for spot checks and analysis methods must be complied with (Art. 10 NarcPT).

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 manufacturers

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

Being added to the list does not guarantee that manufacturers will receive a supply contract from the responsible public or private organisation for pilot trials, or that the manifacturers will be granted an exceptional licence. The conditions for an exceptional licence for manufacture 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 manufacturers, please 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 manufactures finished cannabis products but would also like to cultivate cannabis, an exceptional licence can be issued that covers the whole production process (cultivation and manufacture; see cultivation of cannabis for pilot trials)

Please note: if a manufacturer would like to produce 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 the manufacture, 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 manufacture of cannabis products that are used in the pilot trials must contain at least the following information and supporting documents:

• Company name as per the commercial register
• First and last name, vocational qualifications and career history of person responsible for the manufacture and the deputy
• Document stating for which specific pilot trial cannabis products will be manufactured and a corresponding contract of mandate, if applicable. The supporting document should contain precise details of the type and quantity of cannabis products to be manufactured, and, if applicable, assurance from the ordering party that they will acquire the contractually defined quantity.
• Proof of compliance with the quality requirements and quality inspections in accordance with Articles 9-10 NarcPT
• Desired duration of exceptional licence (in accordance with the term of the supply contract with the study centres)
• Production volume (type and quantity of cannabis products manufactured) per year
• Supplier of cannabis raw materials for the manufacture of products (if not self-grown)
• Required quantity of cannabis raw material, quality (type, including THC and CBD content) and total THC (converted into grams)
• Description of storage, protection and logging of cannabis products, and archiving of records (management system), including evidence of a system to guarantee adequate protection against theft
• Explanation of how the self-regulation duty (under Art. 30 NarcPT) will be implemented
• Proof of compliance with the packaging and product information specifications, in accordance with Art. 11 NarcPT.

If the licence needs to cover the cultivation of cannabis as a raw material for the products for the pilot trial as well as manufacture, the application requirements for an exceptional licence for cultivation 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