Marketing Authorisation Applications

Swissmedic has opened a consultation period on simplifying the approval process for certain categories of marketing authorisation applications (MAAs). Applications for new approvals of complementary medicinal products and medicinal products for rare or life-threatening indications would be amongst those MAAs to benefit. Many of the complementary or alternative medicinal products that will be affected were not subject to approval before the new Therapeutic Products Law was approved at the beginning of 2002. The simplified review process is expected to come into force on 1 October 2006.

Swissmedic is elaborating the necessary simplified procedures in collaboration with interested parties. This applies in particular phytopharmaceuticals and similar ‘alternative’...