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myyntiluvan haltijan tulee varmistaa, että kansallisille potilasorganisaatioille tuotetaan opetusmateriaalia, jonka potilasorganisaatiot tarkistavat.
the mah should ensure that the educational materials are provided to and reviewed by the national patients’ organisations or if such an organisation does not exist or can not be involved, by a relevant patients group.
Ultimo aggiornamento 2017-04-26
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jäsenvaltiot varmistavat, että myyntiluvan haltija toimittaa tiedotusmateriaalin tarkastettavaksi kansallisille potilasorganisaatioille tai, ellei tällaista organisaatiota ole tai sitä ei voida käyttää, sopivalle potilasryhmälle.
the member states should ensure that the mah provides the educational materials to the national patients’ organisations for review or if such an organisation does not exist or can not be involved, to a relevant patients group.
Ultimo aggiornamento 2012-04-10
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potilasorganisaatioille ja eturyhmille (yliopistot, terveydenhuollon ammattilaiset, sponsorit) tarjottava tiedottaminen lisääntyy, mukaan lukien lausuntojen tiivistelmien julkaiseminen samaan aikaan kuin euroopan komissio hyväksyy myyntiluvan.
increase in number of applications for orphan medicinal product designation in 2002 to 85 full implementation of the orphan drug legislation (regulation (ec) no 141/ 2000) with new activities such as annual reports for designated products, follow-up and assessment of designation criteria at the time of application for marketing authorisation increased activities in relation to the provision of information to patient organisations and interested parties (academia, health professionals and sponsors), including the publication of summaries of opinion at the time of the european commission decision
Ultimo aggiornamento 2011-10-23
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myyntiluvan haltijan tulee varmistaa, että kansalliset potilasorganisaatiot tuottavat ja tarkistavat tiedotusmateriaalin tai, ellei tällaista organisaatiota ole tai sitä ei voida käyttää, sen suorittaa sopiva potilasryhmä.
the mah should ensure that the educational materials are provided to and reviewed by the national patients’ organisations or if such an organisation does not exist or can not be involved, by a relevant patients group.
Ultimo aggiornamento 2012-04-10
Frequenza di utilizzo: 3
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