EU Product Registration Ep.11

What happens, for example, when a state becomes a new member of the European Union?

How does it impact the existing procedures and how does it change the overall picture?

When a new EU state emerges, it is necessary for the state to establish its own authority, specifically its own EU authority, which will then undergo vetting by the EMA. This process enables the state to effectively address all the requirements that arise both internally and externally, in order to handle such requests. There is a list of recognized EU authorities, and one can assume that, in due course and upon meeting all the prerequisites, the aforementioned state will have its own EU authority established. Just like companies, authorities are also required to adhere to EU guidelines. 

How do we confirm a European reference product first, and how do we choose the product if a DCP procedure is planned for Germany, Malta, France, or Belgium? 

Considering the requirements discussed, here is what you need to do: check which products are authorized on the European market. There are some databases in Europe that you can rely on for this, known as the legal basis. The legal basis refers to different articles of the directive. Each of these articles corresponds to a full dossier or a generic and abridged dossier, which means a dossier that is not complete. Therefore, if a product’s dossier is not complete, it cannot be considered a European reference product. 

Regarding the source of the European reference product, there are two scenarios to consider. First, if you have a decentralized procedure or if you want to apply in a country but the only available reference product has also been registered in other European countries, not the one you intend to enter with your product, you can rely on the concept of the European reference product. This means that any product authorized in another member state can be considered a European reference product and used as a reference in any European member state. The key criterion is that the product has been authorized in any one of the countries within the European Economic Area. 

Now, let’s go back to the example of the decentralized procedure in four or five different member states mentioned by our attendee. My advice would be to first check the availability of the reference product in the country you wish to have as the reference member state. Although not mandatory, this step can expedite the evaluation of the dossier. Additionally, when applying for the generic dossier, you must declare if a version of the reference product exists in each individual market that you would like to include as part of your decentralized procedure.