On 17 March 2024, the Federal Office for Customs and Border Security (FOCBS) introduced the new Passar goods traffic system for exports. During the transition phase until 31 December 2025, export customs declarations can be submitted either in the e-dec or Passar system. Effective 1 January 2026, only the Passar goods traffic system can be used.
- General information on Passar: Passar (admin.ch)
- Additional information on declaring goods subject to restrictions, including narcotics and medicinal products: Declaring goods subject to restrictions
Passar is scheduled for rollout for imports starting Q3/25 (Roadmap Passar 2.0 (Einfuhr) (admin.ch)) [information in DE, FR and IT only]. Information on the import of medicinal products, narcotics and clinical trials will be published in due course on the Swissmedic website.
Changes to the declaration of medicinal products and narcotics – general information from Swissmedic
There will be changes in the declaration process for medicinal products and narcotics for export. In future, additional attributes must be entered into the Passar system for both types of product. Furthermore, goods that generally require a licence, but can be carried without a licence pursuant to a licence exception, will have to be declared as a “Licence exception”. The details are as follows:
1. Medicinal products
All companies engaging in export activities with medicinal products under Art. 18 Therapeutic Products Act (TPA) must obtain an establishment licence from Swissmedic. As of the end of 2023, this licence references the business identification number (UID)
Effective 4 November 2024, when declaring goods, the applicant must indicate the restriction/licence requirement in the Passar system[1] and enter the number of the establishment licence as well as the licence holder.
2. Narcotics
As of 17 March 2024, the following additional attributes must be entered when declaring narcotics in the Passar system:
- Restriction code “500 SMC” (until 30 October 2024);
“501 SMC – Narcotics” (from 1 November 2024) - Licence holder (GLN)
- Licence item no. (first substance/product: 1, second substance/product: 2, etc.)
- Quantity to be depreciated
- Quantity to be depreciated Unit
The licence format will be updated with the required additional information in the next few months.
- GLN of the licence holder
- Licence item no. (first substance/product: 1, second substance/product: 2, etc.)
- Unit of quantity to be depreciated
Further changes will apply to the procedures in international goods traffic of controlled substances in order to replace the current paper-based processes at the FOCBS with a digitalised system. The changes will be communicated to the relevant companies in due course on the Swissmedic website and directly by Swissmedic’s Narcotics Division.
3. Restrictions on export pursuant to Art. 21 TPA
The relevant companies will be notified directly by Swissmedic's Narcotics Division, about the changes regarding the export of medicinal products that are subject to Art. 21 TPA.
4. Medicinal products (including ATMPs) for clinical trials
Advanced therapy medicinal products (ATMPs)
The procedure applies to the export of ATMPs (such as CAR T cells or other tissue products) that are exported to foreign countries as non-ready-to-use medicinal products, processed there, and subsequently reimported into Switzerland as a finished product. Effective 4 November 2024, for declaration in the Passar system, information must be entered regarding the clinical trial (Restriction code 511 SMC – Medicinal products, clinical trials, UID, licence number).
Medicinal products
For the time being, medicinal products used in clinical trials in Switzerland are not affected. For the export of medicinal products manufactured in Switzerland that will be used in clinical trials in foreign countries, the provisions under “Medicinal products” will apply.
5. Licence exceptions for medicinal products and narcotics that must be declared:
If a licence exception is asserted, the restriction code that applies to the goods and the corresponding licence exception must be declared:
Medicinal products:
- Exports of medicinal products in small quantities by doctors who are licensed to practice their profession on both sides of the border (under Art. 20 MPLO)
- Returns to foreign distributors/manufacturers
- Contract manufacturers without an export licence
Narcotics:
- Humanitarian aid
- Tolerance annual quantity
- Homeopathic products containing controlled substances, dilution >D8/C4
- Precursors/auxiliary chemicals in pharm. products/mixtures, not easily recovered
- Controlled substances to be imported/exported in solution for analytical purposes in a conc. < 1 mg per 1 mL
- Cannabis extract and tincture with a total THC content of less than 1.0%
- Cannabis seedlings for growing cannabis plants (hemp) with a total THC content of less than 1.0%
- Cannabis plants or parts thereof (hemp) with an average THC content of less than 1.0%