Centralised procedure

One marketing authorisation for the entire EU

Would you like to pursue centralised marketing authorisation under a single product designation? We will tell you whether the centralised procedure is suitable for your product – or is compulsory. We will gladly take charge of planning and implementation and contribute our many years of experience in the area of eCTDs. In addition, we can assist you with documentation tasks before and during the centralised procedure, as well as during the linguistic review.

The centralised procedure is required not only for high-tech medicinal products and advanced therapies. It is also compulsorily for orphan drugs – and is suitable for generics on a case-by-case basis.

We have the necessary experience to identify the best approach.