検索ワード: urgent safety restriction (英語 - デンマーク語)

urgent safety measures
nødsikkerhedsforanstaltninger

note for guidance on criteria for recall and repackaging following urgent safety restriction and variation procedures
titel på dokumentet note for guidance on criteria for recall and repackaging following urgent safety restriction and variation procedures cpmp points- to- consider document on xenogeneic cell therapy (cpmp/ 1199/ 02) ich- v1:

the urgent safety restriction shall be implemented within a timeframe, as agreed with the competent authorities.
den hastende sikkerhedsrestriktion indføres inden for en tidsfrist, der fastsættes i samråd med de kompetente myndigheder.

temporary safety restrictions
midlertidige sikkerhedsrestriktioner

all variations in the group are consequential to a given urgent safety restriction and submitted in accordance with article 22.
alle ændringer i gruppen er en følge af en given hastende sikkerhedsrestriktion og indgivet i overensstemmelse med artikel 22.

the financing of the most urgent safety improvement measures was evaluated at usd 700 million.
det skønnedes, at finansieringen af de mest hastende forbedringer af sikkerheden ville koste 700 millioner usd.

a procedure for temporary safety restrictions; and
en procedure for midlertidige sikkerhedsrestriktioner

take proportionate action to deal with failure to comply, including issuing any urgent safety alerts when necessary;
træffe passende foranstaltninger for at håndtere manglende overensstemmelse, herunder udstedelse af påtrængende sikkerhedsadvarsler (safety alerts)

the chmp agreed that an urgent safety restriction (usr) on cardiovascular safety was needed to introduce new contraindications and strengthen warnings and information on side effects in the spc.
der var i chmp enighed om, at det var nødvendigt at iværksætte en urgent safety restriction vedrørende den kardiovaskulære sikkerhed, med indførelse af nye kontraindikationer og skærpede advarsler og oplysninger om bivirkninger i produktresuméet.

enough flexibility should be provided for addressing special circumstances such as urgent safety measures, unforeseen or limited operational needs.
der bør udvises tilstrækkelig fleksibilitet med hensyn til løsning af særlige problemer såsom hastende sikkerhedsforanstaltninger eller uforudsete eller begrænsede operationelle behov.

whereas, it is appropriate to provide for a procedure to be followed in the case that the commission imposes urgent safety restrictions;
det er hensigtsmæssigt at fastlægge en procedure for behandling af sager, når kommissionen indfører hastende sikkerhedsrestriktioner;

the european medicines agency has the expertise to assess the need for urgent safety restrictions regarding medicinal products authorised under the centralised procedure.
det europæiske lægemiddelagentur har den nødvendige ekspertise til at vurdere behovet for hastende sikkerhedsrestriktioner vedrørende lægemidler, der er godkendt efter den centraliserede procedure.

if the agency has not raised any objections within 24 hours following receipt of that information, the urgent safety restrictions shall be deemed as accepted.
har lægemiddelagenturet ikke gjort indsigelse senest 24 timer efter modtagelsen af underretningen, anses de hastende sikkerhedsrestriktioner for at være godkendt.

(9) the time-frame for the procedure to be followed where the commission imposes urgent safety restrictions should be clarified.
(9) der bør ske en præcisering af tidsfristen for den procedure, der skal anvendes, hvis kommissionen pålægger hastende sikkerhedsrestriktioner.

(10) the time-frame for the procedure to be followed where the competent authority imposes urgent safety restrictions should be clarified.
(10) der bør ske en præcisering af tidsfristen for den procedure, der skal anvendes, hvis den kompetente myndighed pålægger hastende sikkerhedsrestriktioner.

the chmp agreed that an urgent safety restriction (usr) on cardiovascular safety was needed to introduce new contraindications and strengthen warnings and information on side effects in the spc and the package leaflet (pl).
der var i chmp enighed om, at det var nødvendigt at iværksætte en urgent safety restriction vedrørende den kardiovaskulære sikkerhed, med indførelse af nye kontraindikationer og skærpede advarsler og oplysninger om bivirkninger i produktresuméet.

document titlenote for guidance on criteria for recall and repackaging following urgent safety restriction and variation procedurescpmp points-to-consider document on xenogeneic cell therapy (cpmp/1199/02)
titel på dokumentet note for guidance on criteria for recall and repackaging following urgent safety restriction and variation procedures cpmp points-to-consider document on xenogeneic cell therapy (cpmp/1199/02) ich-v1:

need for post-marketing data contribution to cpmp points to consider document on xenogeneic cell therapy proposals for revision to standard operating procedure on urgent safety restrictions for medicinal products authorised through the mutual recognition procedure
need for post- marketing data contribution to cpmp points to consider document on xenogeneic cell therapy proposals for revision to standard operating procedure on urgent safety restrictions for medicinal products authorised through the mutual recognition procedure

these include a proposal for a harmonised summary of product characteristics for influenza vaccines, a standard operating procedure on urgent safety restrictions and a best practice guide for reference member states in the mutual recognition procedure.
afprøvningsprogrammet for 1999-2000 blev tilsyn med god fremstillingspraksis tilsyn med god klinisk praksis implementeret for 35 centralt godkendte produkter.

marketing authorisation holders of medicinal products authorised under regulation (ec) no 726/2004 should therefore inform the agency if they consider that urgent safety measures are necessary.
indehavere af markedsføringstilladelser for lægemidler, der er godkendt i henhold til forordning (ef) nr. 726/2004, bør derfor underrette agenturet, hvis de finder, at det er nødvendigt med hastende sikkerhedsforanstaltninger.