Poll: Medicinal product Yes or No?

Let’s make a short intermezzo before we return to the subject of insurances. During the investigation of the Dutch authorities one of the questions was whether the PROPATRIA trial was a study with an investigational medicinal product (i.e., drug) or with a non-medicinal product. After considerable deliberation, the authorities finally concluded that in this particular case, the study with the probiotic preparation was with a non-medicinal product.

Do you agree with the conclusion of the Dutch authorities (i.e., the probiotics preparation is in this particular case not a medicinal product)?

The answer may not be as simple as you might think. Before answering this question you may want to study the algorithm in the Annex of the EU document ‘The rules governing medicinal products in the European Union – Volume 10 – Guidance documents applying to clinical trials – Questions & Answers’ Go to page 18-21 of this document and go through the questions and answers.

Click on the Yes button if you agree with the Dutch authorities. Hit the No button, if you do not agree with the Dutch authorities and thus consider the probiotics preparation as a medicinal product. Briefly explain your choice below.