Basic↦Drug or Device↦Medicinal Product↦Market Authorization
What is it? Why is it important?
Prior to selling a Medical Product (MP) and its excipient (e.g. substances other than the active drug) on the open market, manufacturers must acquire a Marketing Authorisation (MA) from regulatory authorities (e.g. Swissmedic, EU).
Regulatory authorities verify that conditions granting MA are fulfilled. This may include product-specific inspections, such as:
- The inspection of any performed licensing studies with the aim to acquire MA
- The IMP production site (e.g. regarding compliance with Good Manufacturing Practices (GMP))
- Compliance with Good Distribution Practices (GDP), describing distribution processes of authorized MPs, including MPs defects, complaints, and recall procedures
What do I need to do?
Access Swiss and European Union websites, that provide information on required documents and procedures needed for a MA application.
Any person or organisation applying for a MA in Switzerland must:
- Prove that the MP with its indication(s) (e.g. a medical condition for which the product is intended) and procedures (e.g. dispensing, administration methods) is of high quality, safe, and effective
- Hold an applicable MP licence, issued by regulatory authority (e.g. Swissmedic, EU), enabling the organisation to manufacture, import, or conduct wholesale trade
- Have a registered address in Switzerland
A MA covering more than one country, requires that an application is submitted to each country`s respective regulatory authority. Each county
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
Swiss Law
TPA – see in particular articles
- Art. 4 Placing on the market definition
- Art. 8 Principle for placing products on the market
- Art. 10 Conditions for granting a marketing authorisation
- Art. 11 Application for a marketing authorisation