6. Biological Specimens

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment.

Please refer to Section 2.7 of this guidebook. No export license is required.

6.2 Does local regulation require any separate consent for biological specimen collection, storage, and future research? If yes, please explain if there are any templates and/or links to be followed.

Yes – various templates of ICFs are available in the Swiss national languages of French, German, and Italian.

6.3 Does the local authority require any specific documents for customs clearance?

For imports, Swissmedic’s CTA approval also includes an import authorization, valid for the duration of the clinical trial, given in the authorization letter.

See Swissmedic’s Clinical Trial Application Dossier Guideline, section 00F (10): 

“In case the IMP(s) is/are imported from a foreign country and intended to be sent directly to the Swiss centre(s) involved in the clinical trial, Swissmedic will grant an authorisation of import based on the information provided in the CTA Form. This authorisation concerns exclusively the IMP(s) used in the clinical trial concerned and is valid only for the duration of the clinical trial. This authorisation of import is given in the authorisation letter for the clinical trial. The same applies for import of auxiliary medicinal products…. used in the clinical trial, based on the information provided in the cover letter.” 

“In case of import of the IMP(s) by a distributor located in Switzerland (for example a hospital pharmacy or packaging company), this distributor must have the appropriate licences from Swissmedic to import, store and distribute the IMP(s). In case such a company is not in possession of the licences required, the licence(s) need to be applied for. The instructions and forms for such application are available on www.swissmedic.ch [...]. Meanwhile, this company can pursue its activities until the decision with regard to licences has been taken. The same applies for import of auxiliary medicinal products [….] used in the clinical trial, based on the information provided in the cover letter.” 

“If substances which are under the control of the narcotics law (narcotics like opioids or psychotropics like benzodiazepines) must be imported, an import authorisation according to the narcotics law is required for each import. This authorisation can only be issued by the Narcotics Division of Swissmedic.”

“If substances capable of emitting ionising radiation must be imported, the import for this substance must be covered by the handling licence of the Federal Office of Public Health (FOPH)."