CHE/220
WTO/TBT
CH Schweiz
  • 11 - Medizintechnik
2017-09-23
2017-07-24
Medicinal products
Draft Ordinance on Medicinal Products (VAM) (40 pages incl. additional annexes, available in German, French and Italian)

The revision contains e.g. the new requirements for the application for a market authorization which have been introduced with the latest revision of the TPA (Therapeutic Products Act) adopted on 18 March 2016.

Major proposed elements are:

On the basis of the latest revision of the TPA a new instrument, paediatric investigation plan, and its regulatory details will be implemented in accordance with the European Regulation on medicinal products for paediatric use (Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004) .

Regulations concerning pharmacovigilance planning with implementing details are also a new element. Furthermore, the requirements for a market authorization will be simplified for certain categories of medicinal products (especially medicinal products approved in an EU or EFTA country, medicinal products with "traditional use" and medicinal products already approved in a canton, as well as various medicinal products used in complementary medicine) . Additional alterations concern the simplification of the examination process with regard to a medicinal product already authorized in a country with comparable control of medicinal products and the alignment of the requirements for variations and changes of the market authorizations of medicinal products with the EU requirements (EU Variation Regulation) .

The draft contains further regulations, which are, however, not subject of notification.