Eksempler på brug af Reference member state på Engelsk og deres oversættelser til Dansk
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AMENDED SUMMARY OF PRODUCT CHARACTERISTICS OF THE REFERENCE MEMBER STATE.
Revideret produkt resumé for reference medlemslandet.The Reference Member State was Denmark and the Concerned Member States were.
Marketing Authorisation not granted 2 Reference Member State for the Mutual recognition Procedure.
Markedsføringstilladelse afslået 2 Referencemedlemsstaten for den gensidige anerkendelsesprocedure.The Reference Member State was Denmark and the Concerned Member States were.
Referencemedlemsstaten var Danmark og de berørte medlemsstater var.The Applicant commits to provide the following information to the National Competent Authority of the Reference Member State.
Ansøgeren forpligter sig til at fremsende følgende oplysninger til den nationale kompetente myndighed for referencemedlemsstaten.The Reference Member State was Finland and the Concerned Member State was Germany.
Referencemedlemsstaten var Finland og den berørte medlemsstat var Tyskland.In June 2007 a mutual recognition procedure started with Germany as Reference Member State and 5 Concerned Member States. .
I juni 2007 blev en gensidig anerkendelsesprocedure indledt med Tyskland som referencemedlemsstat og med 5 berørte medlemsstater.The Reference Member State was United Kingdom and the Concerned Member States were.
Referencemedlemsstaten var Det Forenede Kongerige og de berørte medlemsstater var.In August 2006 a decentralised procedure started with The Netherlands as Reference Member State and 17 Concerned Member States. .
I august 2006 blev en decentraliseret procedure indledt med Nederlandene som referencemedlemsstat og med 17 berørte medlemsstater.The Reference Member State was Germany and the Concerned Member States were Finland and the United Kingdom.
Referencemedlemsstaten var Tyskland og de berørte medlemsstater var Finland og Det Forende Kongerige.In June 2006 a Mutual Recognition Procedure started with The Netherlands as Reference Member State and six Concerned Member States. .
I juni 2006 blev der indledt en gensidig godkendelsesprocedure med Nederlandene som referencemedlemsstat og seks berørte medlemsstater.The Reference Member State was Finland and the Concerned Member States were Austria, Denmark, Germany and Sweden.
Referencemedlemsstaten var Finland, og de berørte medlemsstater var Østrig, Danmark, Tyskland og Sverige.Monthly Periodic Safety Update Reports should be provided to the Reference Member States and/ or National Competent Authorities for the next 2 years.
Periodiske sikkerhedsindberetninger skal hver 6. måned tilsendes referencemedlemsstaterne og/ eller de nationale kompetente myndigheder i de næste 2 år.The Reference Member State was Netherlands and the Concerned Member States were Belgium and the United Kingdom.
Referencemedlemsstaten var Nederlandene, og de berørte medlemsstater var Belgien og Det Forenede Kongerige.A Mutual Recognition Procedure started on 29 June 2006 with The Netherlands as Reference Member State and Belgium, Germany, Spain, France, Italy and the United Kingdom as Concerned Member States. .
En gensidig anerkendelsesprocedure blev indledt den 29. juni 2006 med Nederlandene som referencemedlemsstat og Belgien, Tyskland, Spanien, Frankrig, Italien og Det Forenede Kongerige som berørte medlemsstater.The Reference Member State was the Netherlands and the Concerned Member States were Estonia, Greece, Portugal and Spain.
Referencemedlemsstaten var Nederlandene, og de berørte medlemsstater var Estland, Grækenland, Portugal og Spanien.The applicant, Gideon Richter, sought a Marketing Authorisation in several member states(CZ, EE, LT, LV, PL, RO, and SK,)through the Mutual Recognition Procedure with Hungary acting as the reference member state.
Ansøgeren, Gideon Richter, søgte om markedsføringstilladelse i flere medlemsstater(CZ, EE, LT, LV, PL, RO og SK)via den gensidige godkendelsesprocedure med Ungarn, der fungerede som referencemedlemsstat.The Reference Member State was United Kingdom and the Concerned Member States were Denmark, Finland, Norway and Sweden.
Referencemedlemsstaten var Det Forenede Kongerige, og de berørte medlemsstater var Danmark, Finland, Norge og Sverige.Therefore the CHMP issued a positive opinion on 24 January 2007 recommending the granting of the Marketing Authorisation and the amendments of theSummary of Product Characteristics, labelling and package leaflet of the Reference Member State.
Den 24. januar 2007 vedtog CHMP en positiv udtalelse,som anbefalede udstedelse af markedsføringstilladelsen og ændring af referencemedlemsstatens produktresumé, etikettering og indlægsseddel.The Reference Member State was Finland and the Concerned Member States were Belgium, Germany, Luxembourg and the Netherlands.
Referencemedlemsstaten var Finland, og de berørte medlemsstater var Belgien, Tyskland, Luxembourg og Nederlandene.These include a proposal for a harmonised summary of product characteristics for influenza vaccines, a standard operating procedure on urgent safety restrictions anda best practice guide for reference Member States in the mutual recognition procedure.
Dokumenterne omfatter et forslag om et harmoniseret produktresumé for influenzavacciner, en operationel standardprocedure for presserende sikkerhedsbetingede begrænsninger ogen vejledning i bedste praksis for referencemedlemsstater i den gensidige anerkendelsesprocedure.The Reference Member State was Denmark and the Concerned Member States were Germany, Spain, Ireland, Italy and the United Kingdom.
Referencemedlemsstaten var Danmark og de berørte medlemsstater var Tyskland, Spanien, Irland, Italien og Det Forenede Kongerige.It is appropriate to allow national authorities of the reference Member States to reduce the evaluation period in urgent cases or to extend it in the case of a major variation entailing important changes.
De nationale myndigheder i referencemedlemsstaterne bør have mulighed for at afkorte fristen for vurdering The Reference Member State was the United Kingdom and the Concerned Member States were Belgium, Greece, Ireland, Poland and Spain.
Referencemedlemsstaten var Det Forenede Kongerige, og de berørte medlemsstater var Belgien, Grækenland, Irland, Polen og Spanien.These data have been evaluated by the Reference Member State(MHRA) and has identified an increased risk of suicidal thoughts and behaviour in children treated with Atomoxetine.
Disse data er blevet evalueret af referencemedlemsstaten(MHRA), og der er blevet identificeret en øget risiko for selvmordstanker og suicidal adfærd hos børn behandlet med atomoxetin.The Reference Member State was the Netherlands and the Concerned Member States were Austria, Germany, Ireland, Italy, and United Kingdom.
Referencemedlemsstaten var Nederlandene, og de berørte medlemsstater var Østrig, Tyskland, Irland, Italien og Det Forenede Kongerige.The Reference Member State was Germany and the Concerned Member States were Austria, France, the Netherlands, Spain and the United Kingdom.
Referencemedlemsstaten var Tyskland, og de berørte medlemsstater var Østrig, Frankrig, Nederlandene, Spanien og Det Forenede Kongerige.The Reference Member State was France and the Concerned Member States were Belgium, the Czech Republic, Germany, Italy, Spain and the United Kingdom.
Referencemedlemsstaten var Frankrig, og de berørte medlemsstater var Belgien, Den Tjekkiske Republik, Tyskland, Italien, Spanien og Det Forenede Kongerige.The Reference Member State was Hungary and the Concerned Member States were Czech Republic, Estonia, Hungary, Lithuania, Latvia, Poland, Romania and Slovak Republic.
Referencemedlemsstaten var Ungarn, og de berørte medlemsstater var Den Tjekkiske Republik, Estland, Ungarn, Litauen, Letland, Polen, Rumænien og Slovakiet.The Reference Member State was United Kingdom and the Concerned Member States were Austria, Germany, Finland, Ireland, Italy, Luxembourg, Netherlands and Sweden.
Referencemedlemsstaten var Det Forenede Kongerige, og de berørte medlemsstater var Østrig, Tyskland, Finland, Irland, Italien, Luxembourg, Nederlandene og Sverige.
