Denmark Drug Product Registration

Authorization Procedures

1.  The National Procedure

The medicinal product is authorized in one EU or EEA country only.

2. The Centralized Procedure

The medicinal product is authorized in the entire EU simultaneously.

3. The Decentralized Procedure (DCP)

Companies apply for authorisation in several EU or EEA countries simultaneously.

4. The Mutual Recognition Procedure (MRP)

A national marketing authorisation for a medicine in one EU or EEA country forms the basis for authorisation in another EU or EEA country.

Application for Market Authorisation

• Documentation supporting a medication’s quality, safety, and efficacy must be included in a request for authorization.
• Marketing authorization will be given to the corporation if the medication is approved.
• Under the left-hand menu, businesses may find forms and guidelines for applications for marketing authorization or for the parallel import of pharmaceuticals.

National Procedure for Market Authorization in Denmark

• The procedure consists of three phases:
  Phase 1: Start-up phase
  Phase 2: Assessment phase
  Phase 3: Closing phase
• New and variation applications follow the same procedure, but with different time scales.
• Regarding applications for a parallel import authorisation or an IA variation, the case is closed after the assessment phase with a decision.

1.  Start-up phase

• Applications are received, registered, reviewed, and validated by the Danish Medicines Agency.

2. Assessment phase

• At the beginning of the assessment phase, the application is prepared and evaluated.
• An evaluation report provides a summary of the Danish Medicines Agency’s evaluation.
• Applications may be approved already at the end of this phase; however, this happens very rarely.
• Following the initial examination, the Danish Medicines Agency will notify the applicant of the anticipated denial and provide them a list of questions (LoQ).
• A new national application’s applicant has up to 6 months to reply to the LoQ.
• The Danish Medicines Agency may, on a case-by-case basis, extend the permitted time limit to a maximum of 12 months in exceptional situations.
• In the case of variation applications, the applicant has up to 24 weeks to respond to the LoQ, and in the case of parallel import applications, the export country is given up to 2 months to respond.

3. Closing Phase

• Following receipt of the applicant’s answer to the proposed rejection, the Danish Medicines Agency evaluates the provided information and decides whether to accept or reject the application.
• If no response is submitted within the stated time, the case is evaluated based on the available documentation – which will usually result in a refusal.