Your Easy Guide to Clinical Studies

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

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

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