Results for worksharing procedure translation from English to Slovenian

worksharing procedure
postopek delitve dela

procedure
postopek

psur assessment worksharing
1 066 667

the worksharing procedure is intended to avoid duplication of work.
namen postopka za delitev dela je preprečevanje podvajanja dela.

worksharing for signal management
delitev dela pri obravnavi signalov

it should be possible to process variations to purely national marketing authorisations in accordance with the worksharing procedure under certain conditions.
pod nekaterimi pogoji je treba omogočiti obravnavo sprememb izključno nacionalnih dovoljenj za promet v skladu s postopkom za delitev dela.

variations covered under (a), (b) or (c) may be subject to the same worksharing procedure.
za spremembe iz (a), (b) ali (c) lahko velja enak postopek delitve dela.

increased worksharing at member state level for assessing applications for authorisation.
večje delitve dela na ravni držav članic za oceno zahtevkov za registracijo.

given that the paediatric worksharing group is still ongoing, a definite working can only be implemented with respect to studies in children and adolescents after the procedure is finalised.
ker pediatrična delovna skupina še izvaja svoje delo, se lahko dokončna oblika dela glede študij pri otrocih in mladostnikih vnese šele po dokončanju postopka.

where the use of the worksharing procedure has lead to the harmonisation of a section of the summary of product characteristics, it should not be possible for the holder to later undermine the harmonisation achieved by submitting applications for variations to the section thus harmonised in some of the concerned member states only.
kadar postopek za delitev dela privede do uskladitve oddelka povzetka glavnih značilnosti zdravila, se imetniku ne sme omogočiti, da naknadno oslabi doseženo uskladitev s predložitvijo vlog za spremembe oddelka, ki je bil na tak način usklajen le v nekaterih zadevnih državah članicah.

where harmonisation of a section of the summary of product characteristics of a purely national marketing authorisation has been achieved through a worksharing procedure, any subsequent variation submission affecting the harmonised section shall be transmitted simultaneously to all member states concerned.’;
kadar je bila uskladitev oddelka povzetka glavnih značilnosti zdravila izključno nacionalnega dovoljenja za promet dosežena s postopkom za delitev dela, se kakršna koli nadaljnja predložitev za spremembo, ki vpliva na usklajen oddelek, hkrati pošlje vsem zadevnim državam članicam.“

in order to avoid duplication of work in the evaluation of variations to the terms of several marketing authorisations, a worksharing procedure should be established under which one authority, chosen amongst the competent authorities of the member states and the agency, should examine the variation on behalf of the other concerned authorities.
da se prepreči podvajanje dela pri presoji sprememb pogojev več dovoljenj za promet z zdravili, je treba vzpostaviti postopek za delitev dela, po katerem bi en organ, izbran izmed pristojnih organov držav članic in agencije, presodil spremembo v imenu drugih zadevnih organov.

by way of derogation from articles 7(1), 9, 10, 13b, 13c, 13d, 15 and 16 the holder of a marketing authorisation may choose to follow the worksharing procedure laid down in paragraphs 3 to 9 in the following cases:
z odstopanjem od člena 7(1) ter členov 9, 10, 13b, 13c, 13d, 15 in 16 lahko imetnik dovoljenja za promet izbere postopek za delitev dela iz odstavkov od 3 do 9 v naslednjih primerih:

procedures
postopki