Is the marketing authorization holder assigned per product or per company? Does a company need to have more than one?
So, one company can have several marketing authorization holders for multiple products, and a marketing authorization holder can hold multiple products. This depends on how they are registered. A marketing authorization holder, as mentioned earlier in the discussion, is required to have an office in the European Union to facilitate communication with EU authorities. The name of the company and the office are registered with European authorities, creating a direct link. It is possible for a company to establish multiple entities to interact with several authorities.
How much time do you think we should allocate and what factors should we consider when registering a product in Europe? Specifically, what timeline should I consider for registering a generic product in Europe?
Actually, the average time required to obtain the license and be able to launch the product on the market, starting from the Dossier application, is 18 months, which is equivalent to one year and a half. Of course, this is an estimation. What happens during these 18 months? I’m sure that the audience who already have experience registering in Europe knows that the procedural time, meaning the time the competent authorities take to evaluate the Dossier, is 210 days.
But in addition to this, we also need to consider about six months for competent authorities to ask for clarification or additional data and for companies or the applicants to provide a reply. Additionally, if GXT inspections are required, it will take time for the competent authorities to properly organize and execute the necessary inspections.
Furthermore, in the case of European procedures, once you have a positive opinion from the reference member state, you also need to go through the so-called national phase. At the end of the European procedure, you obtain a positive opinion with all the text, such as package leaflet labels and so on, approved by the authority only in the English language, which is the official language of Europe.
Then you have the national phase, which requires you to translate the approved text into all the languages of the concerned member states and for the competent authorities of those member states to review and agree on the final text, ensuring high-quality translation, so that you can properly package your drug for launch on the market. This is an average, but based on our experience, 18 months is a good estimation to confidently inform your management that we can launch the product on the market.
Let’s make an example. If I want to register in Germany alone or in Germany, France, and Italy, does it change the timeline to reach the market or not?
Not from a purely theoretical point of view, but obviously, in the case that you are involved in a procedure with three member states or 27, you can expect more questions and clarifications. This is because all the competent authorities involved in the procedure will examine the dossier, and apply their own mindset and approach to evaluate it. Therefore, in the end, you can anticipate greater complexity arising from this.