Updated 06.02.2017

Who must apply for a licence?

Companies who wish to possess or work with one or more of the biological substances or materials listed in Annex 1 to Executive Order no. 475 of 25 May 2016 and Annex 1 to Executive Order no. 981 of 15 October 2009 with subsequent amendments may only do so if they have applied for and obtained a licence.

Examples of companies that may need a licence in pursuance of the Orders 

  • Research and development institutions (including universities)
  • Biotechnology companies
  • Pharmaceutical companies
  • Companies producing chemical / biological process equipment
  • Companies producing laboratory equipment
  • Companies which are countering the development or use of biological weapons 
  • Retailers of biological substances or materials on the control list

and

Diagnostic laboratories which might get possession of controlled biological substances during diagnostic investigations.

 

Laws and Regulations

The Danish biosecurity system is based on Act no.53 of 11. January on control of animal pathogens and Act no. 474 of 17 June 2008 on securing specific biological substances, delivery systems and related materials.

Act no. 474 of 17 June 2008 empowers the Minister of Health to implement relevant regulation concerning possession, production, use, storage, acquisition, sale, and other forms of transferal, distribution, transport, and movement of specific biological substances as well as delivery systems and related materials. The biological substances, delivery systems, and related materials are in general the same as listed in the EU regulation for export control of products and technology with dual-use, which can be used in biological attacks on people and thus represent a danger to public safety and security.

Act no. 474 of 17 June 2008 has been followed by the Executive Order no. 981 of 15 October 2009. The Executive Order sets out the specific regulations for companies who wish to obtain a licence to hold, produce, use and store etc. biological substances, delivery systems and related materials listed in Annex 1 to Executive Order no. 981 of 15 October 2009 with subsequent amendments.

The duties and powers of Act no. 53 of 11 January on control of animal pathogens that are assigned to the Danish Veterinary and Food Administration by the Ministry of Environment and Food of Denmark are exercised by the Danish Centre for Biosecurity and Biopreparedness on behalf of the Danish Veterinary and Food Administration. Executive Order no. 475 of 25 May 2016 sets out the specific regulations that Centre for Biosecurity and Bioprepareness administers. This means that companies who wish to hold, produce, use and store etc animal pathogens that can be used in connection with biological attacks on animals must apply Centre for Biosecurity and Biopreparedness to obtain a licence. The controlled animal pathogens are listed in the Annex 1 of Executive Order no. 475 of 25 May 2016.

 

Confidentiality

According to Section 27 of the Danish Public Administration Act, the Center for Biosecurity and Biopreparedness has a duty of confidentiality in relation to companies regarding all confidential or otherwise sensitive information. Examples are financial information that is not available from public sources, information about operational conditions, business relations, trade secrets, patent information etc.

Contact us

Centre for Biosecurity and Biopreparedness 
Statens Serum Institut

5 Artillerivej
DK-2300 Copenhagen S

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