Draft Ordinance on the Simplified Authorization Procedure and the Notification Procedure for Medicinal Products (VAZV) (18 pages, incl. additional annexes, available in German, French and Italian)

Partial revision of the Ordinance on the Simplified Authorization Procedure and the Notification Procedure for Medicinal Products (VAZV) . The VAZV contains the essential implementing provisions for the Articles 14 and 15 of the Therapeutic Products Act (TPA) . The VAZV includes rules regarding admission and simplified authorization of medicinal products as so-called orphan drugs (important drugs for rare diseases: Art. 14 para. 1 let. f TPA) . It also outlines rules on the simplified authorization procedure for medicinal products with known active pharmaceutical ingredients, hospital exemptions, and drugs manufactured by using a formula recognized by the Swiss Federal Agency for Therapeutic Products.

Major proposed revisions are as follows:

To introduce minor adjustments to the criteria for the designation of a medicinal product as an orphan medicinal product and to the rules of withdrawal of orphan designations;

To implement new and simplified access opportunities for certain medicinal product categories (especially medicinal products approved in an EU or EFTA country, medicinal products with traditional use and medicinal products already approved in a canton) .

To introduce adjustments regarding conditional marketing authorizations (especially requirements for the application, imposing of specific [scientifically based] obligations and renewal of a conditional marketing authorization) .

To simplify the regulation on the notification procedure for medicinal products for certain small pet animals not intended to produce food for human consumption.