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A legal requirement to use DKMAnet for submission of clinical trial applications

09 July 2013

During fall 2013, it becomes a requirement to submit applications via DKMAnet. With this change it also becomes easier to apply for authorisation of a clinical trial of human medicines: Companies and researchers will only be required to submit one application instead of the two applications they must presently submit to the Danish Health and Medicines Authority and the ethics committee system¬, respectively.

During fall 2013, it will also be sufficient to submit one application when a company needs to apply for an amendment of a previously authorised clinical trial. 

Simplified procedure makes submissions easier

When a company submits an application via the new DKMAnet set-up, the system automatically sorts and distributes the content and attached documentation between the Danish Health and Medicines Authority and the ethics committee system. Besides simplifying procedures and ensuring efficiency for companies and researchers, the purely electronic solution makes sure that the Danish Health and Medicines Authority and the ethics committee system receive valid and homogeneous data and only just the information each of them needs to process the application.

Your company will need to register as a user on DKMAnet

During fall 2013, you will need to register as a user on DKMAnet. Otherwise you will not be able to submit applications concerning clinical trials for human medicines. We encourage you to register now even though it is possible to postpone registration until the next time your company needs to apply for authorisation of a clinical trial. Please note that the registration can take up til 3 weeks.

Companies without a Danish CVR number must use a CUG certificate

Security Administrators and users must have a CUG certificate issued by the Danish Health and Medicines Authority if they work for a company that does not have a CVR number. You can find more information about this on www.dkma.dk.

Companies with a Danish CVR number must appoint a Security Administrator

In order to use DKMAnet, your company must appoint a so-called Security Administrator. The Security Administrator must have an employee signature from Nets DanID installed on his/her computer. The employee signature must be registered in the name of the company. You can find more information about this on www.dkma.dk.

Once registered, the Security Administrator can appoint employees in your company who should be allowed to submit documentation on clinical trials of medicines via DKMAnet. The security administrator must have an employee signature installed on his/her computer. A Digital Signature is ordered from www.nets-danid.dk.