SOCIAL QUESTIONS|health|pharmaceutical industry
- plean bainistithe riosca Reference "Rialachán (AE) 2017/745 ó Pharlaimint na hEorpa agus ón gComhairle an 5 Aibreán 2017 maidir le feistí leighis Faomhadh an téarma seo mar chuid de Thionscadal Lex"
- ga
- Context 'plean bainistithe riosca maidir le gach feiste a bhunú agus a dhoiciméadú' Reference "Rialachán (AE) 2017/745 ó Pharlaimint na hEorpa agus ón gComhairle an 5 Aibreán 2017 maidir le feistí leighis"
- risk management plan | RMP
- en
- Definition document submitted as part of the dossier that is evaluated by regulatory authorities before a medicine can be authorised, which includes information on a medicine's safety profile and explains measures that are taken in order to prevent or minimise the medicine's risks in patients, and which is regularly updated as new information becomes available Reference "EMA, Questions and answers on the risk management plan (RMP) summary, http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/05/WC500166101.pdf [21.11.2014]"