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marketing authorisation holder
marketing authorisation holder

ihmisille tarkoitettujen post- authorisation
post-authorisation

marketing authorisation number( s)
nÚmero(s) de autorizaciÓn de comercializaciÓn

ennakkolupajärjestelmä (advance authorisation scheme, aas)
sistema de autorizaciones previas («aas»)

notice to marketing authorisation holders – pharmacovigilance guidelines
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

use of near infra- red spectroscopy by the pharmaceutical industry and the data to be forwarded in part ii of the dossier for a marketing authorisation
use of near infra-red spectroscopy by the pharmaceutical industry and the data to be forwarded in part ii of the dossier for a marketing authorisation

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

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

komissio ehdottaa uutta kemikaalien sääntelyjärjestelmää, jota kutsutaan nimellä reach (registration, evaluation and authorisation of chemicals; kemikaalien rekisteröinti, arviointi ja lupamenettely).
la comisión propone un nuevo régimen normativo para las sustancias químicas: reach (registro, evaluación, autorización y restricción de sustancias y preparados químicos).

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)