Denmark Drug Product Registration

Safeguarding Public Health Through Comprehensive Regulation

MoH

The Danish Ministry of Health (Danish: Sundhedsministeriet)

The Danish Medicines Agency

Danish Medicines Act

Yes

5 years

9 months before the expiration date.

Before being made available locally, any pharmaceuticals that are intended for national distribution must receive approval from the Danish Medicines Agency.
Any new pharmaceutical product must be registered through a Marketing Authorization Application (MAA) in accordance with Directive 2001/83/EC, which requires the following steps to be taken:
1. New Chemical Entity (NCE) Article 8(3)
2. Article 10 for biological medicines that are hybrid, generic, and comparable
With the UK becoming a third nation after March 30, 2019, the Market Authorization Holder (MAH) must fulfill all conditions set out by the European Union (EU) and the European Economic Area (EEA).
With the UK becoming a third nation after March 30, 2019, the Market Authorization Holder (MAH) must fulfill all conditions set out by the European Union (EU) and the European Economic Area (EEA).
Finding a dependable local representative is only one of the procedural challenges that may increase with regulatory procedures due to special regional needs and the EU’s submission requirements. Furthermore, applicants may need to prepare for revised legislation because of Brexit, which might have unprecedented effects.

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

The medicinal product is authorized in the entire EU simultaneously.

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

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

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.

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.

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

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.

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.