Vous avez cherché: authorisation (Danois - Portugais)

post- authorisation
post- authorisation

name of the marketing authorisation holder
nome do titular da autorizaÇÃo de introduÇÃo no mercado

advance authorisation scheme (aas) (forhåndstilladelsesordningen)
regime de autorização prévia (advance authorisation scheme — «aas»)

notice to marketing authorisation holders – pharmacovigilance guidlines
notice to marketing authorisation holders – pharmacovigilance guidlines

european medicines agency post- authorisation evaluation of medicines for human use
european medicines agency post- authorisation evaluation of medicines for human use

excipients in the dossier for application for marketing authorisation for veterinary medicinal products
excipients in the dossier for application for marketing authorisation for veterinary medicinal products

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

the european agency for the evaluation of medicinal products pre- authorisation evaluation of medicines for human use
the european agency for the evaluation of medicinal products pre- authorisation evaluation of medicines for human use

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

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

notice to marketing authorisation holders (for inclusion in volume 9 of the rules governing medicinal products for human use)
linhas de orientação notice to marketing authorisation holders (for inclusion in volume 9 of the rules governing medicinal products for human use)

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.

contribution to part s. 2. 3 of the structure of the dossier for applications for marketing authorisation – control of starting materials for the production of plasma- derived medicinal products
contribution to part s. 2. 3 of the structure of the dossier for applications for marketing authorisation – control of starting materials for the production of plasma- derived medicinal products

med henblik på indsendelse af de krævede oplysninger skal ansøgeren anvende 'guidelines of the european food safety authority for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation'.
para a apresentação dos dados solicitados, o requerente deve consultar as directrizes da autoridade europeia para a segurança dos alimentos para a apresentação de um pedido de avaliação da segurança de uma substância a utilizar em materiais que entram em contacto com os alimentos antes da sua autorização ('guidelines of the european food safety authority for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation').

concept paper on the development of an addendum on the clinical requirements of modified release medicinal products submitted as a line- extension of an existing marketing authorisation to the cpmp note for guidance on modified release oral and transdermal dosage forms: section ii (pharmacokinetic and clinical evaluation) (cpmp/ ewp/ 280/ 96)
concept paper on the development of an addendum on the clinical requirements of modified release medicinal products submitted as a line- extension of an existing marketing authorisation to the cpmp note for guidance on modified release oral and transdermal dosage forms: section ii (pharmacokinetic and clinical evaluation) (cpmp/ ewp/ 280/ 96)