National Scientific Advice

31 August 2018, Updated 04 October 2018

The Danish Medicines Agency offers advice on development and procedural issues relating to applications for clinical trial and marketing authorisations for both human and veterinary medicinal products.  Advice is offered irrespective of the ultimate choice of approval procedure.

The scope of the advice

The aim of our National Scientific Advice meetings is to promote an open and active dialogue on the issues presented to us, so that the scientific advice given is as competent and effective as possible. The Agency can give advice on all areas relating to procedural issues as well as pharmaceutical, pre-clinical or clinical matters.

As innovation has a prominent position in the Government’s plan for Life Sciences, we are also focused on assisting start-up companies, small companies and academic groups with early phase project development (pharmaceutical or pre-clinical aspects, Phase I clinical research). 

Scientific Advice can be provided via a face to face meeting, via telephone conference or in writing, depending on the nature and complexity of the issues to be addressed.

Which issues are not covered by national Scientific Advice?

  1. Medical devices that are not intended to be used directly with or in association with medicinal products e.g. pacemakers. Companion diagnostics can however be addressed.
  2. GxP issues should be addressed directly with our Inspectorate.
  3. Patent issues.
  4. Health technology assessment issues.

The concept of National Scientific Advice does not apply to applications that are already in process via  centralised or national procedures, or where Denmark is formally appointed as (Co)-Rapporteur or Reference Member State. Requests for presubmission or scientific meetings under these circumstances may be submitted as described below, though without the completion of the application form.

Advice is also not possible in cases where similar advice is requested from the Scientific Advice Working Party (SAWP) under CHMP/EMA.

How to apply for scientific advice

Requests must be submitted to nationalscientificadvice@dkma.dk

The request must include the following:

  • A completed application form
  • A precise description of the questions to be discussed with the Danish Medicines Agency
  • Where possible, background to the questions (usually no more than 30 pages)
  • Proposed dates for the meeting. It is advised that the advice request is received no later than 2-3 months before the proposed meeting date.

Following receipt, the request will be assessed and a notification given within 2 weeks whether or not the request for advice has been accepted. 

If the request is accepted, a meeting date will be proposed that is mutually accepted for both parties. The maximum meeting duration will be 1½ hours.

The final presentation and/or briefing book must be submitted electronically no later than 2-3 weeks prior to the meeting.

Meeting minutes

For face to face and telephone conference meetings, the applicant should prepare and submit the meeting minutes to the Agency.  These should be submitted preferably within a week following the meeting to nationalscientificadvice@dkma.dk. The minutes will be commented and when agreed, will be formally ratified by the Agency.

Written advice

Application for a written advice must be sought as described above.  If the request is accepted, a written advice will be issued no later than 2 months following receipt of the complete documentation package.

Status of resultant Scientific Advice

The advice given is not legally binding on either the Agency or the Company.

Payment

Payments (DKK) apply as follows (including VAT):

Clinical trial, FIH: 31,500
Simple advice (Regulatory or CMC or Non-clinical): 17,800
Partial multidisciplinary
- Clinical only; or
- Clinical + CMC; or
- Non-clinical.
Regulatory included per default):
28,000
Complete multidisciplinary (All areas) 35,000

No reductions or exemptions apply. Payment is equally applicable to microenterprises, small and medium-sized enterprises and hospital-based researchers.

Payment is not applicable under the following circumstances:

  • advices sought where Denmark is the formally appointed Rapporteur/Co-rapporteur for a product submitted or to be submitted centrally
  • where we are RMS for upcoming or on-going DCP/MRP procedures
  • for ongoing assessment procedures

The invoice will be sent to the company/person specifically named on the accompanying application form when the scientific advice meeting has taken place. Payment must take place within 30 calendar days from the date of the invoice.

Which payment applies for advice on clinical trials other than first in man?

Payments will apply in the range 17,800 – 35,000 DKK (including VAT) depending on the disciplines to be covered by the advice.

 

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