Dossier Submission Review

Centralised Procedure

Regulatory Affairs

Manufacturers willing to place their products onto the european market may wish to do so via the centralised procedure.

The centralised procedure allows companies to submit a single application to the European Medicines Agency to obtain a centralised or ‘Community’ marketing authorisation (MA) valid in all EU and European Economic Area (EEA)-European Free Trade Association (EFTA) states (Iceland, Liechtenstein and Norway). The centralised procedure is compulsory for all medicines derived from biotechnology and other high-tech processes, as well as for human medicines for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases, and for veterinary medicines for use for growth or yield enhancers. The centralised procedure is also open to products that bring a significant therapeutic, scientific or technical innovation, or is in any other respect in the interest of patient or animal health. As a result, the majority of genuinely novel medicines are authorised through the EMA.

We offer regulatory and procedural guidance at every step of the way. From advice on  pre authorisation procedures such as pre submission and dossier format to post authorisation pharmacovigilance and marketing and cessation notification.