A medicine can be marketed in the European Union (EU) until the company has obtained a Marketing Authorisation (MA) for that medicine from the relevant regulatory authority. MAs are granted for medicines that are proved to be safe, effective and of high quality.
Marketing Authorization (MA)
Before a medicinal product can be marketed and sold, a marketing authorisation must be obtained from the relevent National Competent Authorities. The marketing authorisation application process can take one of two paths – the decentralised procedure, or the centralised procedure. In some cases in Europe, the centralised procedure is mandatory.