Scientific advice on development of medicinal products

Updated 07 May 2018

On request, the Danish Medicines Agency can advice and give guidance on statutory requirements in connection with applications for marketing authorisations for medicinal products ("Scientific Advice").

The scope of the advice

The Danish Medicines Agency gives advice in questions on procedural issues as well as pharmaceutical, pre-clinical or clinical matters. The advice is based on current knowledge of the area, and it is not binding with regard to the Danish Medicines Agency's final decision in the case. Advice is currently not subject to fees.

The Danish Medicines Agency does not normally give advice about applications that are already in process via the centralised or decentralised procedure and where Denmark is not a Reference Member State or (Co)-Rapporteur.

The Danish Medicines Agency cannot offer advice in cases where similar is requested from the Scientific Advice Working Party (SAWP) under CHMP/EMA.

The advice is provided as follows

As a general rule, the Danish Medicines Agency does not offer any written advice. Instead, we set up a meeting with the applicant, the applicant writes the minutes of the meeting and sends these to the Danish Medicines Agency for approval.

Human medicinal products

Irrespective of whether central or national procedures are to be used, applications should be sent to nationalscientificadvice@dkma.dk

Veterinary Medicinal Products

Questions of a scientific nature should be sent to Head od Unit Asbjørn Brandt, asb@dkma.dk

A request for advice must include

  1. A precise description of the questions that the applicant wishes to discuss with the Danish Medicines Agency
  2. Background to the questions (usually no more than 30 pages)
  3. Proposed date of meeting, if possible.

The Danish Medicines Agency must receive the request for advice no later than 2-3 months before the date of meeting.

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