Scientific advice on development of medicinal products
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.
The centralised European procedure
With regard to advice on medicinal products that are expected to be authorised via the centralised European procedure or if it is uncertain which procedure should be used, the application should be sent to EMA-Coordinator Kristina Bech Jensen, email@example.com
The national procedure
With regard to advice on medicinal products that are planned to be authorised via the national procedure with or without subsequent mutual recognition, the request must be sent to Head of Unit Joan Boye, firstname.lastname@example.org
Veterinary Medicinal Products
Questions of a scientific nature should be sent to Head od Unit Asbjørn Brandt, email@example.com
A request for advice must include
- A precise description of the questions that the applicant wishes to discuss with the Danish Medicines Agency
- Background to the questions (usually no more than 30 pages)
- 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.