Updated 02.09.2015

Background

The biopreparedness obligations of the Centre for Biosecurity and Biopreparedness are based on the following laws and regulations. Please note that the English translations are made by the Centre for Biosecurity and Biopreparedness for information purposes only and that they are not legally binding. The official Danish versions of the laws can be found at http://www.retsinfo.dk

  • The Biosecurity Act (no. 474 of 17 June 2008) 
    Executive Order (no. 981 of 15 October 2009), article 20, paragraph 2.
    “Unauthorised persons are to be kept out of all areas where there are uncontrolled occurrences of biological substances included in this Executive Order, until the Centre for Biosecurity and Biopreparedness has ensured that measures have been implemented to counter the potential danger. “

  • Health Act (Consolidation Act No. 95 of 7 February 2008 with later amendments), paragraph 222
    "Statens Serum Institut is an institution under the Ministry of Health and Prevention, and its purpose is to prevent and control infectious diseases, biological threats and congenital disorders. Statens Serum Institut is the national institute for health data and disease control and the central national laboratory of Denmark for diagnostic assays, including reference features. The institute ensures the supply of vaccines, including vaccines for the childhood vaccination programme in Denmark, and emergency response products through manufacturing and procurement. The Institute takes part in the operational and preparedness capability against infectious diseases and bioterrorism. The Institute is engaged in scientific research and provides guidance and assistance on matters within the field of the Institute."

    Notes to the law
    "... Statens Serum Institut also takes part in the national preparedness organisation against bioterrorism, or suspected bioterrorism, through various types of investigations etc., including threat assessments, sampling, analyses, dispersal assessments and training ...."

  • Finance Committee document 19 of 2 October 2001
    Statens Serum Institut shall establish a centre for biological preparedness: diagnostic investigations, expert advice, training, countering of biological warfare agents, 24 hours response capability.

  • Danish Preparedness Act (Consolidated act no. 137 of 1 March 2004)
    "The incident coordinator can seek additional information and guidance from the Center for Biological Preparedness at Statens Serum Institut, including assistance in identifying the biological agents and planning of the incident response...”

  • Medicines Act (Consolidation Act No. 1180 of 12 December 2005) paragraph 30
    "In specific instances, and in limited quantities, Statens Serum Institut and the Danish National Food Institute, may, upon request, sell or supply serums, vaccines, immunoglobulin, and other specific immunological test preparations not covered by the authorization. The Medicines Agency must be notified of all sales and deliveries".

Contact us

Centre for Biosecurity and Biopreparedness 
Statens Serum Institut

5 Artillerivej
DK-2300 Copenhagen S

Telefon: +45 32688127
Email: cbb@ssi.dk