Deadlines
For all deadlines mentioned in the Code of Procedure for ENLI, the deadline is from the day a notification is received / decision is received, and the day in question counts as day one. However, weekends and public holidays are not included.
Most deadlines are set for 10 working days, however, the deadline for appeals are 21 working days.
• A pharmaceutical company is entitled to receive consultation within 10 working days if ENLI initiates a case on the basis of a report or a complaint to ENLI.
• Urgent cases are settled within 8 working days of receipt of the case by ENLI.
• The deadline for submitting a consultation response is 10 working days after a pharmaceutical company has received a consultation letter. In urgent cases, however, the consultation deadline is only 4 working days. When the written consultation is completed, the Investigator´s Panel makes a decision within 10 working days after receiving the last consultation response. In urgent cases, the decision is taken within 2 working days.
• The appeal deadline is no later than 21 working days after the company has received the decision from the Investigator´s Panel.
• Request for a pre-approval must be processed and settled by the Investigator Panel within 10 working days, or from ENLI has received the company's acceptance of a fee in addition to the basic fee of of DKK 6,000 plus VAT (Professional events) and DKK 8,000 plus VAT (Promotional material).