What is the translation of " REFERENCEMEDLEMSSTATEN " in English?

• reference member state
• RMS

Examples of using Referencemedlemsstaten in Danish and their translations into English

Referencemedlemsstaten var Danmark og den berørte medlemsstat var.
The Reference Member State was Denmark and the Concerned Member States were.

Undersøgelsesprotokollen blev sendt til referencemedlemsstaten og alle de berørte medlemsstater.
The study protocol was submitted to the RMS and all CMSs.

Referencemedlemsstaten var Danmark og de berørte medlemsstater var.
The Reference Member State was Denmark and the Concerned Member States were.

Markedsføringstilladelse afslået 2 Referencemedlemsstaten for den gensidige anerkendelsesprocedure.
Marketing Authorisation not granted 2 Reference Member State for the Mutual recognition Procedure.

Referencemedlemsstaten var Finland og den berørte medlemsstat var Tyskland.
The Reference Member State was Finland and the Concerned Member State was Germany.

Resultaterne af den fjerde analyse af EPC- data indberettes til referencemedlemsstaten og til de.
The outcome of the 4th analysis of the EPC data should be provided to the RMS and the NCAs where.

Referencemedlemsstaten var Det Forenede Kongerige og de berørte medlemsstater var.
The Reference Member State was United Kingdom and the Concerned Member States were.

Indehaveren af markedsføringstilladelsen udfører nedenstående undersøgelser og indberetter resultaterne heraf til referencemedlemsstaten.
The MAH should perform the following studies and report the results to the RMS.

Referencemedlemsstaten og de andre positive berørte medlemsstater ønskede at bevare disse indikationer.
The RMS and the other positive CMSs were in favour of retaining these indications.

Ansøgeren forpligter sig til at fremsende følgende oplysninger til den nationale kompetente myndighed for referencemedlemsstaten.
The Applicant commits to provide the following information to the National Competent Authority of the Reference Member State.

Referencemedlemsstaten var Tyskland og de berørte medlemsstater var Finland og Det Forende Kongerige.
The Reference Member State was Germany and the Concerned Member States were Finland and the United Kingdom.

For andre mindre ændringers vedkommende bør det stadig kræves, at referencemedlemsstaten vurderer den indgivne dokumentation.
For other types of minor variation evaluation of the submitted documentation by the reference Member State should still be required.

Referencemedlemsstaten var Finland, og de berørte medlemsstater var Østrig, Danmark, Tyskland og Sverige.
The Reference Member State was Finland and the Concerned Member States were Austria, Denmark, Germany and Sweden.

CHMP vedtog følgende forslag til betingelser for fornyelse af den markedsføringstilladelse, der tidligere blev fremlagt af referencemedlemsstaten.
The CHMP agreed on the following proposal for conditions of the renewal of the Marketing Authorisation previously presented by the RMS.

Referencemedlemsstaten var Nederlandene, og de berørte medlemsstater var Belgien og Det Forenede Kongerige.
The Reference Member State was Netherlands and the Concerned Member States were Belgium and the United Kingdom.

I direktivet, og alle yderligere oplysninger, der er blevet forelagt referencemedlemsstaten under den 60 dage lange CMD( v)- procedure kun rapportører og EMEA.
A copy of the information and documents referred to in the first subparagraph of Article 32(1) of the Directive and any additional information provided to the Reference Member State during the 60 day CMD(v) procedure rapporteurs and EMEA only.

Referencemedlemsstaten var Nederlandene, og de berørte medlemsstater var Estland, Grækenland, Portugal og Spanien.
The Reference Member State was the Netherlands and the Concerned Member States were Estonia, Greece, Portugal and Spain.

Ansøgningen om UMAN BIG 180 IE/ ml injektionsvæske blev indgivet via proceduren for gensidig anerkendelse og på baggrund af markedsføringstilladelsen udstedt af referencemedlemsstaten(Italien) den 2. juni 1979.
The application for UMAN BIG 180 IU/ ml solution for injection was submitted through the Mutual Recognition Procedure, on the basis of the marketing authorisation granted by the RMS(Italy) on the 2nd of June 1979.

Referencemedlemsstaten var Det Forenede Kongerige, og de berørte medlemsstater var Danmark, Finland, Norge og Sverige.
The Reference Member State was United Kingdom and the Concerned Member States were Denmark, Finland, Norway and Sweden.

Indehaveren af markedsføringstilladelsen underretter agenturet om ansøgningen, giver det oplysning om, hvilke medlemsstater det drejer sig om, og om datoerne for ansøgningens indgivelse og sender det en genpart af den tilladelse, som referencemedlemsstaten har udstedt.
The holder of the marketing authorization shall transmit the application to the Agency, inform it of the Member States concerned and of the dates of submission of the application and send it a copy of the authorization granted by the reference Member State.

Referencemedlemsstaten var Finland, og de berørte medlemsstater var Belgien, Tyskland, Luxembourg og Nederlandene.
The Reference Member State was Finland and the Concerned Member States were Belgium, Germany, Luxembourg and the Netherlands.

Anvendelse af humane præparater eller apoteksfremstillede lægemidler indeholdende ephedrin vil udgøre et langt farligere alternativ ved behandling af urininkontinens hos hunde, hvis der ikke findes et produkt med markedsføringstilladelse og med påvist mangeårig virkning i referencemedlemsstaten over mange år.
The use of human labelled preparations or dosage forms obtained from a compounding pharmacy which contain ephedrine constitute a much more dangerous alternative for treatment of urinary incontinence in dogs if the product with a marketing authorisation and a proved efficacious use in the RMS for many years is not available.

Referencemedlemsstaten og de berørte medlemsstater gav afslag på ansøgningen om udvidelse af indikationerne den 3. august 2005.
The Reference and Concerned Member States rejected the variation to extend the indication on 3 August 2005.

Resultaterne skal indberettes til referencemedlemsstaten og til de nationale kompetente myndigheder i de stater, hvor bicalutamid, 150 mg, er godkendt.
The results should be reported to the RMS and the NCAs where bicalutamide 150 mg is authorised.

Referencemedlemsstaten var Danmark og de berørte medlemsstater var Tyskland, Spanien, Irland, Italien og Det Forenede Kongerige.
The Reference Member State was Denmark and the Concerned Member States were Germany, Spain, Ireland, Italy and the United Kingdom.

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.
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.

Referencemedlemsstaten var Det Forenede Kongerige, og de berørte medlemsstater var Belgien, Grækenland, Irland, Polen og Spanien.
The Reference Member State was the United Kingdom and the Concerned Member States were Belgium, Greece, Ireland, Poland and Spain.

I den endelige vurderingsrapport(dateret den 14. 2. 2005) blev den af referencemedlemsstaten foreslåede indikation begrænset til"Reduktion af risiko for recidiv af MI hos patienter med tidligere MI" i betragtning af, at risikoreduktion kun var påvist for komponenten"ikke dødelig MI" i det primære endepunkt, og at virkningen af perindopril kun var klart godtgjort hos patienter med tidligere MI.
In the Final Assessment report(dated on 14.02.2005), the indication proposed by the RMS was restricted to“ Reduction of risk of recurrent MI in patients with a history of MI” considering that the risk reduction was only demonstrated on the“ non fatal MI” component of the primary endpoint and that the effect of perindopril was only clearly established in patients with previous MI.

Referencemedlemsstaten var Nederlandene, og de berørte medlemsstater var Østrig, Tyskland, Irland, Italien og Det Forenede Kongerige.
The Reference Member State was the Netherlands and the Concerned Member States were Austria, Germany, Ireland, Italy, and United Kingdom.

Referencemedlemsstaten var Tyskland, og de berørte medlemsstater var Østrig, Frankrig, Nederlandene, Spanien 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.

How to use "referencemedlemsstaten" in a Danish sentence

Til dette formål anmoder indehaveren af markedsføringstilladelsen referencemedlemsstaten om at udarbejde en evalueringsrapport eller i givet fald ajourføre den eksisterende evalueringsrapport.

Senest 12 dage efter modtagelsen af afgørelsen og den i stk. 3 omhandlede vurderingsrapport godkender de relevante myndigheder afgørelsen og underretter referencemedlemsstaten kompetente myndighed herom.

Når alle berørte medlemsstater er nået til enighed med referencemedlemsstaten om gensidig anerkendelse, jf.

DA 3 DA 4 (4) Når alle berørte medlemsstater er nået til enighed med referencemedlemsstaten om gensidig anerkendelse, jf.

Referencemedlemsstaten påtager sig ansvaret for undersøgelse og opfølgning af sådanne bivirkninger. 5.

Referencemedlemsstaten udarbejder disse udkast senest 120 dage efter modtagelsen af den gyldige anmodning herom og fremsender dem til de berørte medlemsstater og ansøgeren. 4.

Sagen blev henvist til den humanmedicinske koordineringsgruppe CMD(h), og en vurdering blev gennemført af referencemedlemsstaten.

Rapportøren arbejder tæt sammen med den rapportør, der er udnævnt af Udvalget for Humanmedicinske Lægemidler, eller referencemedlemsstaten for det pågældende lægemiddel.

Referencemedlemsstaten udarbejder eller ajourfører evalueringsrapporten senest 90 dage efter modtagelsen af den gyldige anmodning herom.

Senest 90 dage efter modtagelsen af dokumenterne omhandlet i stk. 2 og 3 godkender de berørte medlemsstater evalueringsrapporten, produktresuméet samt etiketteringen og indlægssedlen, og underretter referencemedlemsstaten herom.

How to use "reference member state" in an English sentence

The reference Member State shall record the agreement of all parties, close the procedure and inform the applicant accordingly. 5.

The UK will not be a Reference Member State and authorization applicants and holders will not be based in an EU/EEA state.

The Reference Member State (RMS) must be a member state of the EU (EEA).

Applications for mutual recognitions can be made either in parallel to the application in the reference member state (RMS) or in sequence to the authorisation in the RMS.

The company asks a single country to become a reference member state in the procedure.

Besides there is also a difference in not every HA has extensive experience acting as an Reference Member State at all.

The assessment of the fulfilment of the condition(s) will be the responsibility of the Member States, co-ordinated by the reference Member State unless otherwise stated.

In so-called mutual recognition procedures (MRP), one of the concerned languages has to be tested, preferably the official language of the Reference Member State (RMS).

The agency is also planning to reduce fees for applications using the decentralized procedure where the UK is listed as the reference member state by 15%.

In such cases legislation requires that the decision of the Reference Member State (RMS) is recognised.