SwissMedic License
Certain activities within the pharmaceutical, biotech, medical device and healthcare industry require specific Swissmedic authorizations, and there are several licenses within the Swissmedic framework:
Manufacturing License (MPL)
For example for manufacturing medicines
Import License (IPL)
For example for importing or exporting medicinal products
Wholesa/Distribution license (WDL)
For storage and distribution
Marjeting Autorisation Holder (MAH)
For companies responsible for product marketing and safety monitoring
If you are planning a Swissmedic license application, tell us about what activity you want to carry out in Switzerland, and we can guide you as to which license and consultation you may need to apply.
We support your company seeking authorization within the Swissmedic framework and can advise of the right consultants to assist in:
Regulatory scoping
Dossier preparation to meet Swissmedic standards
Submission and correspondence with Swissmedic throughout your application
Q&A
What is a Swissmedic licence and do I need one?
A Swissmedic license is official authorization from the Swiss Agency for Therapeutic Products to manufacture, import, distribute, or market medicinal products, medical devices, or related healthcare products in Switzerland. You need it to legally operate, ensure compliance with Swiss laws, and gain market access.
What types of licenses does Swissmedic issue
- Manufacturing License (MPL):For producing medicinal products.
- Import License (IPL):For importing products into Switzerland.
- Wholesale/Distribution License (WDL):For storage and distribution.
- Marketing Authorization Holder (MAH) License:For companies responsible for product marketing and safety monitoring.
How long does it take to obtain a Swissmedic license?
The timeline varies based on the license type, completeness of your dossier, and the product category. Typically, approval can take 3–12 months. Early preparation, compliance checks, and thorough documentation can significantly shorten review times.
What documentation is required for a Swissmedic application?
Common documentation includes:
- Quality management system and GMP/GDP compliance evidence
- Product dossiers (composition, manufacturing, labeling, stability)
- Import/export authorizations if applicable
- Organizational and personnel qualifications
- Standard operating procedures (SOPs)
Our team helps ensure that all required documents are prepared correctly.
What are common reasons for delays or rejections?
Common pitfalls include:
- Incomplete or incorrectly formatted dossiers
- Missing GMP/GDP compliance evidence
- Insufficient organizational or personnel documentation
- Ambiguous product information
Our service helps identify gaps and correct them before submission, reducing the risk of delays.
Does Swissmedic require inspections before approval?
For manufacturing and wholesale licenses, Swissmedic may conduct on-site inspections to verify GMP/GDP compliance. Proper preparation, internal audits, and documentation can help ensure a smooth inspection process.
What are the ongoing obligations after obtaining a license?
License holders must maintain compliance, including:
- Adherence to GMP/GDP requirements
- Periodic updates to Swissmedic for product or process changes
- Reporting of safety issues or product defects
- Maintaining proper records and traceability
Do I need a physical office in Switzerland?
Yes. FINMA generally requires:
- A Swiss registered office
- Management located in Switzerland (fit & proper directors)
Key control functions operating from Switzerland.
How can a consulting service help with Swissmedic licensing?
We provide end-to-end support including:
- Regulatory strategy and license type assessment
- Gap analysis and compliance recommendations
- Dossier preparation, formatting, and review
- Interaction with Swissmedic during submission
Responses to questions and deficiency letters
This ensures your application meets Swissmedic standards and reduces the risk of delays or rejections.