Your Easy Guide to Clinical Studies

A generic medicinal product is an additional brand of an already existing Medicinal Product (i.e. the original preparation).  

 

An “original preparation” is the first Medical Product with a specific active substance (i.e. the chemistry that makes the drug work) that has been authorised by regulatory authorities (i.e. including all authorised dosage forms).

 

A generic medicinal product:

• Is essentially the same as an original preparation as it contains the same active ingredient (e.g. bioequivalent)
• Is interchangeable with the original preparation due to its identical active substances, administration route (e.g. tablet, injection, infusion) and dosage form (e.g. x mg / day, x ml / per body weight)
• Complies with the same safety and quality criteria as the original preparation.

 

The acceptance criteria of the generic drug must be no less than 80% or no more than 125% of the original product, and must be authorised by regulatory authorities (e.g. Swissmedic)

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Note: The “Drug & Device” section addresses Medicinal Products and Medical Devices. “In Vitro Medical Devices” are not discussed In the Easy-GCS.

Swiss Law

TPA – see in particular article

• Art. 4 Definition generic medicinal products