Results for multicepas translation from Spanish to English

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multicepas

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Spanish

expediente multicepas

English

multi-strain dossier

Last Update: 2018-03-04
Usage Frequency: 2
Quality:

Spanish

la agencia publicará directrices científicas de presentación y evaluación de un expediente multicepas.

English

scientific guidelines for the submission and evaluation of multi-strain dossiers shall be adopted by the agency.

Last Update: 2018-03-04
Usage Frequency: 2
Quality:

Spanish

el procedimiento de presentación y evaluación de un expediente multicepas se ajustará a la orientación publicada por la comisión en las normas aplicables a los medicamentos en la unión europea, volumen 6b, nota a los solicitantes.

English

the procedure for the submission and evaluation of multi-strain dossiers shall follow the guidance published by the commission in the rules governing medicinal products in the european union, volume 6b, notice to applicants.

Last Update: 2018-03-04
Usage Frequency: 2
Quality:

Spanish

por “expediente multicepas” se entiende que un solo expediente contiene los datos pertinentes para una evaluación científica única y completa de las diversas opciones o combinaciones de cepas que permiten la autorización de vacunas contra virus antigénicamente variables.

English

a multi-strain dossier means a single dossier containing the relevant data for a unique and thorough scientific assessment of the different options of strains/combinations of strains permitting the authorisation of vaccines against antigenically variable viruses.

Last Update: 2018-03-04
Usage Frequency: 2
Quality:

Spanish

de cara a la autorización de vacunas contra virus con variabilidad antigénica, de manera que quede garantizado que la comunidad pueda tomar rápidamente las medidas más efectivas contra la aparición o la propagación de epizootias, procede introducir el concepto de «expediente multicepas».

English

to permit authorisation of vaccines against antigenically variable viruses in a way that ensures that the most effective measures can be taken swiftly by the community against the incursion or spread of epizootic diseases, the concept of multi-strain dossier should be introduced.

Last Update: 2018-03-04
Usage Frequency: 2
Quality:

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