By request, the Danish Health and Medicines Authority gives advice and guidance about statutory requirement in connection with applications for marketing authorisations for medicinal products – scientific advice.
The advice includes
The Danish Health and Medicines Authority gives advice in questions about procedures as well as pharmaceutical, pre-clinical or clinical matters. The advice is based on the current knowledge of the area, and it is not binding with regard to the Danish Health and Medicines Authority's final decision in the case. So far, advice is not subject to fees.
Normally, the Danish Health and Medicines Authority does not 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 Health and Medicines Authority cannot offer advice in cases where advice is requested from the Scientific Advice Working Group (SAWG) under CPMP/EMA.
The advice is given in the following way
The Danish Health and Medicines Authority does not offer any written advice. Instead, the Danish Health and Medicines Authority sets up a meeting with the applicant. The applicant writes the minutes of the meeting and sends these to the Danish Health and Medicines Authority 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 must be sent to Chief Medical Officer Jens Ersbøll, jer@dkma.dk, and Chief Medical Officer Jens Heisterberg, jehe@dkma.dk.
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 authorisation, the request must be sent to Head of Department Joan Boye, jbo@dkma.dk.
A request for advice must include
- A precise description of the questions that the applicant wishes to discuss with the Danish Health and Medicines Authority
- Background to the questions (usually no more than 30 pages)
- Possible suggestion about date of meeting.
The Danish Health and Medicines Authority must receive the request for advice one month before the date of meeting at the latest.
