Updated 08.09.2015

Application process

ansogningsprocedure

 


1. Application form including vulnerability assessment and security plan

Licences are to be applied for using the forms prepared by the Centre for Biosecurity and Biopreparedness (CBB). See Forms and guides

An application form must include information about the company, the purpose and scope of the application. An application must also include information about the employee(s) appointed as biosecurity officer(s) by the company. These employees are also to be approved by CBB and documentation is to be submitted confirming that they accept that information on their criminal record will be obtained.

Vulnerability assessment

A vulnerability assessment is made to identify potential risks and security vulnerabilities of the company in relation to controlled dual-use materials. 


Security plan

The security plan forms the basis of the measures and steps that need to be taken to prevent, detect and respond to theft or misuse of controlled materials. Thus, there is a close connection between the vulnerability assessment and the security plan.

Please contact CBB to obtain the form for the vulnerability assessment and the security plan.

2. Processing of applications

When the Centre for Biosecurity and Biopreparedness (CBB) receives an application, the application is checked for missing documents and a confirmation e-mail is sent to the applicant.

All applications are reviewed individually and by an overall assessment, CBB reaches a final conclusion regarding the issuing of a licence or not. The conclusion is sent to the responsible manager.

3. Training course and approval of the biosecurity officer

The Centre for Biosecurity and Biopreparedness (CBB) provides courses for future biosecurity officers. The course is mandatory and free of charge.The course takes place at the Centre for Biosecurity and Biopreparedness and the purpose is to inform future biosecurity officers about biosecurity, biosecurity legislation and the reasons why it is necessary to register companies working with or possessing controlled materials. 
 
The course also includes elements regarding how to fill in the vulnerability assessment and security plan; how to implement and update lists on the company’s stock of controlled materials; biosecurity training of the company’s employees, and procedures for personnel security. The course takes place at Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark. For further information: Biosecurity courses

Approval of the biosecurity officer is dependent on satisfactory participation in the course and the persons criminal record. Approval of participation in the course is a mandatory requirement for a licence.

4. Implementation of measures and requirements, internal training, stockpile checking, etc.

Potential initiatives to be taken

Based on the application, vulnerability assessment, and security plan, the Centre for Biosecurity and Preparedness (CBB) decides whether the company has to implement additional procedures and measures to improve the security level. If CBB decides that a company has to implement additional measures, a deadline for implementation and completion of the work is specified in the licence terms.


Internal training

Employees that have access to controlled materials are trained by the biosecurity officer. The purpose of the training is to ensure that they are aware of the legislation and know how to act according to the Executive Order no. 981 of 15 October 2009 with subsequent amendments. Employees who have access to controlled materials must verify that they have received internal training.


Inventory

An inventory list may contain information on several types of controlled related materials but only on a single type of controlled biological substance. The stocktake must always be up to date and the period in between stocktakes must never exceed three months. 


Reporting
 

Any purchase, sale or transfer of biological substances, delivery systems, and related materials included in the Executive Order no. 981 of 15 October 2009 with subsequent amendments are to be reported to the Centre for Biosecurity and Biopreparedness within 14 working days. CBB must be informed immediately by telephone in case of theft, loss, accidents, spills or suspected misuse of controlled materials. Subsequently, the biosecurity officer must report the incident to CBB. 

Changes

Changes which influence a valid licence must be notified to CBB, before the change takes place.

Inspections

The Centre for Biosecurity and Biopreparedness (CBB) conducts inspections at companies with a biosecurity licence. The purpose of inspections is to guide the companies and biosecurity officials to ensure that they are in compliance with the biosecurity obligations according to the Executive Order no. 981 of 15 October 2009 with subsequent amendments

Contact us

Centre for Biosecurity and Biopreparedness 
Statens Serum Institut

5 Artillerivej
DK-2300 Copenhagen S

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