So, it’s kind of difficult, I think, for companies coming from outside Europe to evaluate all this risk and perform this research. Do they do it independently or just use consultants? What is your experience with this?
It’s really a matter of regulatory science. So, yes, you can definitely rely on consultants, or your regulatory department can have knowledge and guide the R&D process effectively.
Speaking of actors involved in European registration, a major role is played by the Marketing Authorization Holder. Could you provide the definition of the marketing authorization holder and whether European guidelines define the role as the owner of all responsibilities related to a product within the EU territory?
This differs from the manufacturer because ultimately the responsibility for a product on the EU market lies with the marketing authorization holder. Regarding the question of whether there are any documents related to such responsibilities, the answer is yes. Firstly, all the obligations of the M.A. holder are clearly defined in the EU Directive 83/2001, which includes PV, Scientific Service, GMP, and others. It is worth noting that a new pharmaceutical regulation is expected to be released soon, covering several updates and obligations of the marketing authorization holder. Additionally, the marketing authorization holder can rely on external manufacturers and suppliers for the supply of products and services of the finished product. However, this does not absolve the marketing authorization holder from the responsibilities outlined in the reflection paper concerning good manufacturing practice and marketing authorization holder responsibilities.