Swissmedic Guidance: Understanding Parallel Imports and the Authorisation of Asian Medicinal Products

Switzerland’s regulatory landscape for pharmaceuticals continues to evolve, balancing patient safety with market efficiency. Two pivotal updates from Swissmedic in 2024–2025 redefine requirements for parallel imports of medicinal products and the authorization of traditional Asian medicines. These are:

• Import of a Human Medicinal Product According to Art. 14 para. 2 and 3 TPA (Parallel Import)

• Authorisation of Asian Medicinal Products

Guidance: Parallel Imports under Art. 14 para. 2 and 3 TPA

Parallel Import refers to the importation of a medicinal product already authorized in Switzerland but sourced from another country within the EEA (European Economic Area), without the original marketing authorisation holder’s direct involvement.

Key Conditions:

• The product must be therapeutically equivalent to a Swiss-authorized version.

• It must be imported from an EEA country with a valid authorisation under comparable regulatory standards.

• Parallel import is permitted under Art. 14 para. 2 and 3 of the Therapeutic Products Act (TPA), which allows import without full authorisation if certain safety and quality standards are met.

Application Requirements:

• Submission through the eGov portal.

• A completed QA declaration form.

• Product information such as packaging, labels, and comparator data.

• Proof that the manufacturer holds a valid establishment licence under the Therapeutic Products Ordinance (TPLO).

Quality Assurance:

• Parallel importers must implement a robust GDP-compliant (Good Distribution Practice) system.

• Any re-packaging or relabelling must meet GMP (Good Manufacturing Practice) requirements.

• Pharmacovigilance responsibilities remain with the Swiss Marketing Authorisation Holder (MAH).

Not Permitted:

• Imports from countries outside the EEA.

• Changes to the product’s formulation or indications.

Guidance: Authorisation of Asian Medicinal Products

Asian medicinal products (AMPs), including traditional Chinese medicine (TCM), Ayurveda, and Unani, are increasingly used in Switzerland. These products fall under Swissmedic's remit and are governed by Herbal Medicinal Product (HMP) pathways.

Authorisation Pathways:

• Standard Authorisation: For products with comprehensive safety, efficacy, and quality data.

• Simplified Authorisation: For traditional use, where long-term safe use is documented.

• Notification Procedure: For non-prescription herbal products that meet criteria for safety and tradition.

Requirements for Submission:

• Detailed composition of herbal substances and extracts.

• GACP (Good Agricultural and Collection Practice) compliance for raw materials.

• Proof of traditional use over at least 30 years globally and 15 years in Switzerland or the EU for simplified pathways.

• Monographs from recognized pharmacopeias (e.g., Ph. Eur., Chinese Pharmacopeia).

Special Notes:

• Use of endangered species in AMP formulations must comply with CITES (Convention on International Trade in Endangered Species).

• Products marketed as food supplements or cosmetics cannot be authorised as medicinal products without proof of therapeutic intent.

References and Downloads

• Import of a Human Medicinal Product According to Art. 14 para. 2 and 3 TPA (Parallel Import)

• Authorisation of Asian Medicinal Products

Stay informed and always cross-check your submissions against the latest Swissmedic documentation.