CHE/221
WTO/TBT
CH Switzerland
  • 11 - Health care technology
2017-09-23
2017-07-24

Medicinal products

Draft Ordinance on the Authorization of Medicinal Products (AMZV) (37 pages incl. additional annexes, available in German, French and Italian)

Partial revision of the Ordinance on the Authorization of Medicinal Products (AMZV) . In the AMZV the Swiss Agency for Therapeutic Products describes in detail the information and documentation that must be provided as part of an application for a marketing authorization. The ordinance applies both to human and to veterinary medicines outlining the elements of the authorization that need to be supported by scientific evidence. It also describes the requirements for labelling and package inserts.

Major proposed revisions are as follows:

To incorporate the new requirements for the application for a marketing authorization which have been introduced with the latest revision of the TPA (Therapeutic Products Act) adopted on 18 March 2016 (paediatric investigation plan, pharmacovigilance plan) .

To introduce a legal basis for a new process to label medicinal products that are being monitored particularly closely by regulatory authorities.

To introduce adjustments to the rules on the grouping of variations to medicinal products.

To separate the requirements for the labelling and for the design of the Summary of Product Characteristics (SmPC) and package leaflet of medicinal products for human and veterinary use and to regroup all requirements for veterinary medicinal products in a single new annex.

To harmonize the requirements for the declaration of active substances and pharmaceutical excipients ofmedicinal products for human and veterinary use with the corresponding provisions of the European Excipients-Guideline (CPMP/463/00 Final, July 2003)