Poliovirus (material)

Amendment of the Decree on public health and the Regulation on public health due to the introduction of alicensing obligation and a reporting obligation in relation to performing acting with poliovirus

Articles 17(a) to 17(c) of the Decree on public health may contain technical regulations. In Chapter Va, thisDecree lays down authorisation requirement for carrying out actions with certain types of poliovirus. Thepurpose of the licence requirement is to implement World Health Organisation Resolution WHA71.16 on polioeradication effectively. This Resolution is part of the WHO Global Polio Eradication Initiative, a global responseapproach to achieving a polio-free world, including ensuring that any facility working with eradicatedpolioviruses must handle and store poliovirus in accordance with the WHO Global Action Plan for PoliovirusContainment (GAP requirements).

The authorisation requirement shall apply in particular to facilities carrying out actions involving poliovirus fordeveloping and producing vaccines, or for monitoring purposes. The types of poliovirus to which theauthorisation requirement applies and the requirements to be met in order to obtain an authorisation shall bedetermined in accordance with the WHO GAP requirements. This shall take the principle of mutual recognitioninto account.
Annex 2 to the Regulation on public health may contain technical requirements. This Annex to the regulationfurther develops the licence requirement, inter alia by laying down the requirements that must be met in orderto obtain a licence.