The FOPH may basically only issue exceptional licences for the medical use of banned narcotics for patients resident in Switzerland. Only the physician treating the patient may submit a corresponding application, which must include the patient’s written consent.
Requirements for limited medical use of banned narcotics
The limited medical use of a banned narcotic may be permitted if, in the concrete case concerned, no equivalent alternative therapy is available and the requisite stipulations are met (special case warranting an exceptional individual lifting of the prohibition concerned, subsidiary application of a banned narcotic as a last resort, restriction of the banned narcotic’s use to a small number of symptoms for certain diseases, etc.). In such cases, all the conditions below must further be cumulatively met:
- the patients are suffering from a usually incurable disease,
- their suffering can be alleviated through consumption of the banned narcotic,
- the available therapies have been exhausted and/or no alternative treatments are available, and
the provision of the banned narcotic will give the patient a more independent lifestyle, e.g by enabling them to avoid inpatient treatment.
Requirements for the application
All applications for the limited medical use of a banned narcotic must be compiled electronically, printed out, signed by hand and sent to:
Confidential
Federal Office of Public Health
Prevention of Non-Communicable Diseases Division
Implementation & Data Systems Section
Schwarzenburgstrasse 157
3003 Bern
Only applications personally signed by the physician treating the patient concerned can be considered. Applications with an electronic or facsimile signature and email applications cannot be accepted. Applications submitted directly by the patient are not permitted.
The application must provide a full and complete account of the case concerned. The FOPH may also demand the provision of supplementary details and/or documentation for clarification purposes at any time. Incomplete applications will not be considered.
The FOPH will monitor the holders of all such exceptional licences. Such monitoring will extend in particular to studying reports on the progress of the therapy concerned. If deemed necessary, a check may also be conducted on-site with the prescribing physician.
Exceptional licences will only be issued to physicians authorised to practise their profession in Switzerland and for the treatment of patients resident in Switzerland.
With effect from 1 August 2022, the medical use of cannabis and cannabinoids is no longer subject to an exceptional licence requirement.
Exceptional licence application details and documentation
The initial application for a patient must contain:
- details of the patient
- name
- gender
- date of birth
- address
- details of the physician making the application
- name
- address
- email address
- phone number (preferably direct line)
- if this is the physician’s first application for the limited medical use of banned narcotics: the applicant’s professional experience, e.g., through:
- further training in limited medical applications
- membership of corresponding professional bodies
- professional exchanges with physicians experienced in the field
- medical information (as per checklist)
- the (pharmacy) source of the banned narcotic requested
- treatment financing details
- e.g., possible assumption of treatment costs by the patient’s health insurance and financing of the costs of the banned narcotic
- confirmation by the physician submitting the application by handwritten signature that
- all the details have been correctly stated
- as required by the FOPH, a report will be provided of the therapy’s progress before the exceptional licence expires
- in the event of a serious adverse event (SAE), the FOPH will be notified of this within seven working days
- declaration of consent by the patient with:
- the patient’s first and last name in block capitals
- the patient’s dated handwritten signature
- specification of the banned narcotic for whose use the patient is giving such consent.
Extension of the exceptional licence
If treatment is supposed to be continued beyond the expiry of the original exceptional licence, an appropriate application must be submitted to the FOPH two weeks at the latest before the licence expiry date, together with a report on the progress of the therapy to date.
Any application for such a continuation of a patient’s treatment must contain:
- details of the patient and the physician submitting the application as specified for the initial application above
- medical information (as per checklist for continuation of treatment)
- the source of the narcotic and treatment financing details (if now different from those given in the initial application)
- confirmation by the physician submitting the application by handwritten signature that
- all the details have been correctly stated
- as required by the FOPH, a report has been provided of the therapy’s progress to date
- in the event of a serious adverse event (SAE), the FOPH will be notified of this within seven working days.
If the treatment is to be continued with a different banned narcotic from that provided following the initial application, a new declaration of consent by the patient is also required.
Completion of treatment
Upon completion of the treatment, a final report (see checklist) must be compiled and submitted to the FOPH.
Serious adverse events (SAEs)
In the event of a serious adverse event (SAE), the FOPH must be notified of this within seven working days.
Links
Specialist associations (as at december 2024)
Legislation
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812.121 Federal Act on Narcotics and Psychotropic Substances (NarcA)Article 8, Paragraph 5 of the Federal Act on Narcotics and Psychotropic Substances of 3 October 1951
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812.121.1 Narcotics Control OrdinanceArticle 8 of the Ordinance on Narcotics Control of 25 May 2011
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812.121.6 Narcotics Addiction OrdinanceArticles 28 and 29 of the Ordinance on Narcotics Addiction and Other Addiction-Related Disorders of 25 May 2011
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812.21 Therapeutic Products ActFederal Act on Medicinal Products and Medical Devices of 15 December 2000
- 812.212.1 Medicinal Products Licensing Ordinance, MPLO
Last modification 07.02.2025
Contact
Federal Office of Public Health FOPH
Prevention Non-communicable diseases Division
Schwarzenburgstrasse 157
3003
Bern
Switzerland
Tel.
+41 58 463 88 24