“The Decentralised and Mutual Recognition procedures are European authorisation procedures based on the principle of recognition of the assessment by the Reference Member State (RMS)” ( cbg-meb.nl). Mutual recognition procedures occur when a company has already approved the marketing plan in the reference member state and is now requesting the recognition of other states for the purpose of marketing authorization. It is usually a simple procedure unless the other member states are significantly concerned about the safety of a specific drug. The decentralized procedure is attempted when a marketing plan has not yet been approved in any member state and Continue reading...
