New medicines to display « black triangle » from September 1st
From next week, new medicines will have a black inverted triangle displayed in their package leaflet, indicating that they are monitored particularly closely by regulatory authorities. The scheme was set up by MEPs in order to inform patients better and to allow for potential side-effects to be identified and acted upon quickly.
« If people are taking drugs that the medical establishment is closely monitoring for potential side-effects then patients have a right to know » said Linda McAvan (S&D, UK), who has been steering the legislation through Parliament. « There’s absolutely no reason why this information needs to be locked away from the public. It is often patients’ own experiences that alert the authorities to potentially dangerous side-effects » she added.
The scheme was adopted within a set of reforms to make it easier for potentially dangerous side-effects of drugs to be spotted and acted upon quickly.
Encourage reporting of side-effects
If a medicine is labelled with the inverted black triangle, it does not mean that it is unsafe; the purpose of the symbol is to actively encourage healthcare professionals and patients to report any suspected adverse reactions to the medicine, either because it has been newly introduced to the market or because there are only limited data available on its safety.
In April, the European Medicines Agency published an initial list of medicines subject to additional monitoring. Medicines containing new active substances or new biological ingredients remain on the list for five years. The EMA press release is available here: http://bit.ly/13wZhqs
Links:
Profile: Linda McAvan (S&D, UK) http://bit.ly/17m6IpT
Medicinal products for human use: pharmacovigilance of products – legislative observatory file http://bit.ly/12Pc2Pd
Committee of Environment, public health and food safety http://bit.ly/1dUx40p
Press contact
Baptiste CHATAIN
Brussels: (+32) 2 28 40992
Mobile: (+32) 498 98 13 37
envi-press@europarl.europa.eu
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