EU Product Registration Ep.5

Do marketing authorization holders need to have a license to distribute products around Europe?

Yes, definitely. Several authorizations need to be in place. Among them is the requirement for the marketing authorization holder to have an EU batch testing and release site. This information is included in the same dossier we mentioned earlier in the previous question. In one section of the dossier, the EU batch testing and release site should be listed, and a valid GMP certificate needs to be obtained. The site would have been inspected and approved by EU authorities. 

Additionally, an EU QPPV (Qualified Person for Pharmacovigilance) must be appointed to cover the Pharmacovigilance requirements. The Pharmacovigilance system should encompass all aspects of legislation, following the regulations outlined in the EU regulation five to zero of 2012. 

Finally, in order to sell and distribute the product within the EU, a GDP (Good Distribution Practice) license is required. This is commonly referred to as a wholesale dealer’s license, which permits the marketing authorization holder to purchase and sell the product if necessary. It also allows for the storage of warehouse products within the EU. 

How are API dossiers submitted to the competent authorities in Europe?

First of all, let us clarify that the active pharmaceutical ingredient (API) includes information about the entire supply chain of the active ingredient, including control and manufacturing control information about the drug substance. The API of the finished dosage form, known as the drug master file, must be submitted as requested. 

The drug master file should only be submitted to the European authorities involved in the evaluation of the finished product dossier. For example, if you submit a marketing authorization application to the Maltese Authority only, and I am your API supplier, I would have to submit the drug master file to the Maltese Authority exclusively. 

Another crucial aspect is that the European authorities will not evaluate the drug master file unless it is linked to the evaluation of a finished product. You can submit your drug master file, but they will only check and evaluate it when it is associated with a finished product. 

It’s important to note that there is an option for a limited application, but it applies only to active ingredients that have a substance monograph in the European Pharmacopoeia. For API companies developing such active ingredients, they can also apply with their active substance master file to the European Directorate for the Quality of Medicines (EDQM), which is a central authority that can evaluate the drug master file and issue a certificate certifying compliance with the European Pharmacopoeia monograph. This option is particularly interesting because it expedites the evaluation of the API when a finished product needs to be approved.