Rarely, if there is evidence that the balance of risks and benefits is no longer favourable, it may be necessary to remove the medicine from the market.The MCA/CSM monitor the safety of all new medicines under the "black triangle scheme" where any of the following circumstances apply: if the medicine contains a new active substance or a combination of active substances; if the medicine is administered via a new route or drug delivery system; if the medicine is going to be used in a new population of patients.