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post-authorisation
post-authorisation post-authorisation
Last Update: 2011-10-23
Usage Frequency: 1
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definitive authorisation
acreditación definitiva
Last Update: 2013-05-07
Usage Frequency: 1
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administrationpost-authorisation
post-authorisation post-authorisation evaluation of evaluation of
Last Update: 2008-03-04
Usage Frequency: 1
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marketing authorisation holder
holder
Last Update: 2011-10-23
Usage Frequency: 1
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evaluaciÓn deevaluaciÓn de pre-authorisation
pre--authorisation preauthorisation evaluation of evaluation of
Last Update: 2008-03-04
Usage Frequency: 1
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at upon receiving authorisation from the buyer for
at upon receiving authorisation from the buyer for
Last Update: 2011-10-23
Usage Frequency: 1
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fecha de la primera authorisation: 10 mayo 2010
date of first authorisation: 10 may 2010
Last Update: 2017-04-26
Usage Frequency: 1
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plan de autorizaciones previas (advance authorisation scheme);
advance authorisation scheme;
Last Update: 2018-03-04
Usage Frequency: 5
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nuevo principio activo, conditionial authorisation, estudios adicionales
new active substance, conditionial authorisation, pass
Last Update: 2018-02-13
Usage Frequency: 1
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stability testing for variation to a marketing authorisation type ii marzo de 1997
stability testing for variation to a marketing authorisation type ii
Last Update: 2011-10-23
Usage Frequency: 1
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sistema de autorización previa (advance authorisation scheme, «aas»)
advance authorisation scheme (aas)
Last Update: 2018-03-04
Usage Frequency: 6
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advance authorisation scheme («aas») (sistema de autorización previa);
advance authorisation scheme (‘aas’);
Last Update: 2018-03-04
Usage Frequency: 4
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sistema de autorizaciones previas («advance authorisation scheme», «aas»)
advance authorisation scheme ('aas')
Last Update: 2018-03-04
Usage Frequency: 2
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autorización de importación libre de derechos (duty free import authorisation, «dfia»);
duty free import authorisation (dfia);
Last Update: 2018-03-04
Usage Frequency: 2
Quality:
standard operating procedure on the release of assessment reports to applicants / marketing authorisation holders
standard operating procedure on the release of assessment reports to applicants/ marketing authorisation holders
Last Update: 2011-10-23
Usage Frequency: 1
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13the european agency for the evaluation of medicinal products pre-authorisation evaluation of medicines for human use
cpmp/4082/0016/16the european agency for the evaluation of medicinal products pre-authorisation evaluation of medicines for human use
Last Update: 2008-03-04
Usage Frequency: 1
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pre-authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products
pre-authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products
Last Update: 2011-10-23
Usage Frequency: 1
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carcinogenicity testing pre-authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products
carcinogenicity testing pre-authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products
Last Update: 2011-10-23
Usage Frequency: 1
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cpmp/ qwp/ 576/ 96 note for guidance on stability testing for a type ii variation to a marketing authorisation
note for guidance on stability testing for a type ii variation to a marketing authorisation
Last Update: 2011-10-23
Usage Frequency: 1
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position paper on the regulatory requirements for the authorisation of low-dose modified release asa formulations in the secondary prevention of cardiovascular events.
position paper on the regulatory requirements for the authorisation of low-dose modified release asa formulations in the secondary prevention of cardiovascular events.
Last Update: 2011-10-23
Usage Frequency: 1
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