The Danish Medicines Agency launches a new concept for individual scientific advice

On 31 August 2018 The Danish Medicines Agency launched a new concept for individual scientific advice for businesses, hospitals or others seeking a more targeted and individual advice on the requirements imposed by the authorities for applications on clinical testing and marketing authorizations for medicinal products for human and veterinarian use.

Initially, the scientific advice will focus on the use of test results already achieved as well as future development programs. Eventually, the concept will also include other areas such as Personalized Medicine, good manufacturing practice and medical devices.

The business etc. in question bears the costs connected to the specific advice.

The concept is launched as part of the Danish government's Growth Plan for Life Science.
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Read more about the launch of the new concept here (in Danish)

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, September 2018 Issue (Thomson Reuters).