Case management, penalties and fees

Case management

Sanctions

ENLI´s Penalties and Fees Regulations (Valid from 01.01.2023)

Reports

For reporting an event or printed advertising material, a fee of DKK 425,- plus VAT is payable.

Pre-approval

The fee for a request for a pre-approval depends on the number of processing hours that the request will include. A basic fee of DKK 6,000 plus VAT (Professional events) and DKK 8,000 plus VAT (Promotional material) must be paid for the first 2 hours of processing the case. If, upon receipt of the request, it is estimated that the pre-approval will take more than two hours to process, the Investigator´s Panel will send an estimate of the maximum number of processing hours that the case may include which must be accepted before the processing can begin. In that case, an hourly rate of DKK 2,000 plus VAT per commenced hour will be charged in excess of the basic fee. The Investigator´s Panel is bound by the proposed maximum time estimate but bills less hours if the total time spent becomes less than the estimated time.

If a minor change is requested for an activity that has already been pre-approved, the fee is DKK 2,000 plus VAT.

Complaints

It is free of charge to complain if the company is successful with the complaint. The party who is not successful with a complaint will be charged a fee of 6,000 DKK plus VAT. If both parties are partially successful, the fee is shared with 6,000 DKK + VAT equally between the two parties.

For the rapid processing of complaints, a fee of 25,000 DKK plus VAT is paid.

Appeals

A fee of DKK 6,000 + VAT is required to appeal a decision made by the Investigation Panel.

Affiliation fee

Pharmaceutical companies who have chosen to join ENLI, even though they are not members of the following associations: Lif, IGL or the Danish Association for Parallel Importers of Medicines, pays an annual affiliation fee of 20,000 DKK plus VAT.