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Who is subject to control

Which facilities are concerned?

Companies working and possessing poliovirus or materials potentially infectious for poliovirus, are subject to the amendment of the Law on Health (Control measures on poliovirus and other biological substances) from 18/12/2018.
These can for example include:

  • Manufacturers of polio vaccine
  • Reference laboratories
  • Research institutions (for example performing research on the respiratory or digestive tract, nutrition, pharmacology, neurology)
  • Biobanks
  • Hospitals

 

If you are one of these facilities

Contact CBB

Requirements for companies with poliovirus or PIM vary depending on which material they possess, and which stage of the eradication campaign has been reached (see decision-trees below). Companies with poliovirus or PIM are therefore required to contact CBB for guidance on retention or destruction of the materials.

Retention of infectious or potentially infectious material

Companies that wish to continue storing, working and possessing material in Denmark must fulfill the legal requirements regarding poliovirus.

Entities retaining infectious poliovirus must apply for containment certification from WHO, though GAPIV.

Entities that retain potentially infectious matierals must report this to the Danish NAC, Centre for Biosecurity and Biopreaparedness and adhere to WHO PIM-Guidance. (See link below)

WHO certificate

Companies possessing poliovirus material must apply for a certificate from WHO.

CBB coordinates the certification process according to WHO’s guidelines and "Containment Certification Scheme" (CCS).

Inspections

As part of the legislation on poliovirus containment, CBB will perform inspections to ensure that companies comply with the legal requirements. For companies that are in the process of obtaining a certificate from WHO, audits will be performed according to WHO’s "Containment Certification Scheme" (CCS).

Poliovirus Containment Legislation

Law on Health:
 LBK nr 903 af 26/08/2019 (Non UK version)

The Executive Order on containment of poliovirus: 
BEK nr 1247 af 28/11/2019 (Non UK version)