Once you have decided to market a medicinal product in the EU, you need to submit a marketing authorization application (MAA) to the European Medicines Agency (EMA).
The MAA procedure is regulated by EU law and starts with the submission of an application form including:
– detailed information about the medicinal product,
– information on manufacturing sites and quality control,
– clinical data supporting the efficacy and safety of the medicine.
The application is then assessed by the EMA’s scientific committees. If they conclude that the benefits of the medicinal product outweigh its risks, a marketing authorization is granted.
The marketing authorization is valid in all EU Member States and allows the medicinal product to be marketed throughout the EU.
If you want to market your medicinal product in more than one EU country, you can submit a centralized MAA. This procedure starts with a scientific assessment by the EMA, followed by a political decision-making process involving the Member States. If the centralized procedure is successful, a single marketing authorization is granted that is valid in all EU countries.