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pre-authorisation
ΓΙΑ ΑΝΘΡΩΠΙΝΗ ΧΡΗΣΗ

marketing authorisation
emea 2004

marketing authorisation holder
Κράτος µέλος

name of the marketing authorisation holder
ΟΝΟΜΑ ΤΟΥ ΚΑΤΟΧΟΥ ΤΗΣ Α∆ΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ

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

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

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 au thorisation 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 Κοινή οµάδα εργασίας cpmp/ cvmp για την ποιότητα

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

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.

linee guida notice to marketing authorisation holders (for inclusione in volume 9 of the rules governing medicinal products for human use)
Κατευθυντήριες γραµµές 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

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)