Translation of "Authorisation application " (English → French) :

authorisation application | authorisation application procedure

application for a centralised marketing authorisation | centralised marketing authorisation application

decentralised marketing authorisation application

Payment Authorisation for Permit Applications

assess authorisations for construction plans | construction plans authorisations assessing | review authorisations for construction plans | review construction plans authorisations

authorisation for appeal | appeals authorisation

draw up flight dispatch release | draw up official flight authorisation documentation | complete official flight authorisation documentation | prepare flight dispatch release

authorise occupancy of railroad lines | issue railroad track warrants | authorise occupancy of rail tracks | issue rail track warrants

authorisation scheme

Authorisation Code Call Detail Report

With respect to fees for applications under Article 62 of Regulation (EC) No 1907/2006 and charges for reviews of authorisations under Article 61 of that Regulation, each exposure scenario should no longer automatically be considered as one use since the number of additional uses applied for in an authorisation application or authorisation review report may not necessarily be identical to the number of exposure scenarios included in those submissions.

- One-stop authorisation agencies should be established to take charge of processing authorisation applications and providing assistance to applicants.

It is necessary to introduce a requirement for new medicinal products and for authorised medicinal products covered by a patent or a supplementary protection certificate to present either the results of studies in the paediatric population in accordance with an agreed paediatric investigation plan or proof of having obtained a waiver or deferral, at the time of filing a marketing authorisation application or an application for a new indication, new pharmaceutical form or new route of administration.

90% reduction on a number of fees payable to the EMEA, such as: scientific advice, inspections, and other scientific services; Exemption of the fee for administrative services; Exemption of the fee for scientific advice in respect of orphan medicines; Deferral of the fee for the marketing authorisation application until the end of the evaluation procedure; Conditional fee exemptions where scientific advice has been sought and effectively implemented; A system for outsourcing translations of the documents required for the granting of the marketing authorisation; The establishment of an SME Office, within the EMEA, to offer administr ...[+++]ative assistance, facilitate communication and answer enquiries; A user guide on the administrative and procedural aspects of the Community marketing authorisation procedure, which are of particular relevance for SMEs.