Kaj je DOKUMENTACIJE VLOGE v Angleščini - Angleški prevod

• application dossier
• of application documents

Primeri uporabe Dokumentacije vloge v Slovenski in njihovi prevodi v Angleški

Ohrani se zaupnost dokumentacije vloge;
The confidentiality of application documents is preserved;

Postopek odobritve bi moral omogočati odložitev ocene, s čimer bi se sponzorju omogočilo, da odgovori na vprašanja ali pripombe, ki so se pojavila pri ocenjevanju dokumentacije vloge.
The authorisation procedure should provide for the possibility to suspend the assessment in order to allow the sponsor to address questions or comments raised during the assessment of the application dossier.

Naprave za elektronsko sprejemanje dokumentacije vloge s tehničnimi sredstvi in ustreznimi postopki zagotavljajo, da:.
Devices for the electronic receipt of application documents shall guarantee, through technical means and appropriate procedures, that:.

(c) kontaktni podatki za pridobitev celotnega sklopa dokumentacije vloge;
(c) contact details in view of obtaining the full set of application documents;

Udeleženci se s predložitvijo dokumentacije vloge strinjajo, da obvestilo o izidu postopka prejmejo po elektronski poti.
By submitting application documents, participants accept to receive notification of the outcome of the procedure by electronic means.

Je mogoče natančno določiti točno uro in datum prejema dokumentacije vloge;
The exact time and date of the receipt of application documents can be determined precisely;

V štirih dneh od predložitve dokumentacije vloge zadevna država članica prek portala EU obvesti sponzorja o naslednjem:.
Within four days following submission of the application dossier, the Member State concerned shall notify the sponsor through the EU portal of the following:.

Države članice bi same morale določiti jezik dokumentacije vloge.
It should be left to Member States to establish the language requirements for the application dossier.

V šestih dneh od predložitve dokumentacije vloge predlagana država članica poročevalka prek portala EU obvesti sponzorja o naslednjem:.
Within six days following submission of the application dossier, the proposed reporting Member State shall notify the sponsor through the EU portal of the following:.

Takšne informacije, pojasnila ali potrditve ne spremenijo bistveno dokumentacije vloge.
Such information, clarification or confirmation shall not substantially change the application documents.

Kadar odgovorni odredbodajalec dovoli elektronsko predložitev dokumentacije vloge, elektronski dokumenti, predloženi prek teh sistemov, štejejo kot izvirniki.
Where the authorising officer responsible authorises submission of application documents by electronic means, the electronic documents submitted by means of such systems shall be deemed to be the originals.

V skladu z načelom dobrega upravljanja bi moral odredbodajalec pojasnila ali manjkajoče dokumente zahtevati ob upoštevanju načela enakega obravnavanja in brez vsebinske spremembe dokumentacije vloge.
(89) In line with the principle of good administration the authorising officer should request clarifications or missing documents while respecting the principle of equality of treatment and without substantially changing the application documents.

Ocenjevalni pristojni organ je odgovoren za izvajanje validacije dokumentacije vloge in za evalvacijo dokumentacije, ki jo predložijo vlagatelji.
The evaluating competent authority is responsible for carrying out the validation of the application dossiers and for the evaluation of the dossier submitted by the applicant.

Vsebina dokumentacije vloge za odobritev kliničnega preskušanja bi morala biti usklajena zaradi zagotavljanja, da imajo vse države članice na voljo iste informacije in da se poenostavi postopek oddaje vlog za klinična preskušanja.
The content of the application dossier for authorisation of a clinical trial should be harmonised in order to ensure that all Member States have the same information available and to simplify the application process for clinical trials.

Vztraja, da bi bilo treba v primeru, če oceno pripravlja vlagatelj in če so deli vzeti iz dokumentacije vloge, jasno razlikovati med oceno organa in oceno vlagatelja;
Insists that, as long as the assessment is made by the applicant, should passages be taken from the application dossier a clear distinction should be made between the assessment of the authority and the assessment of the applicant;

Roki za oceno dokumentacije vloge za klinična preskušanja bi morali biti dovolj dolgi, da se oceni dokumentacija, hkrati pa bi tudi morali omogočati hiter dostop do novih in inovativnih postopkov zdravljenja ter ohraniti zanimanje za izvajanje kliničnih preskušanj v Evropski uniji.
The timelines for assessing an application dossier for clinical trials should be sufficiently long to assess the file, while ensuring quick access to new, innovative treatments and ensuring that the Union remains an attractive place for conducting clinical trials.

V spremnem dopisu se navede, kje so ustrezne informacije v dokumentaciji vloge.
The cover letter shall indicate where the relevant information is contained in the application dossier.

V primeru vložitve s pismom lahko udeleženci dokumentacijo vloge vložijo:.
Where submission is by letter, participants may choose to submit application documents:.

Dokumentacija vloge za bistveno spremembo.
APPLICATION DOSSIER FOR SUBSTANTIAL MODIFICATION.

Podatki, na katere se sklicuje dokumentacija vloge, morajo izvirati iz kliničnih preskušanj, izvedenih v skladu s to uredbo.
Where reference is made in the application dossier to data generated in a clinical trial, that clinical trial shall have been conducted in accordance with this Regulation.

Za odobritev vloge sponzor zadevnim državam članicam prek portala EU predloži dokumentacijo vloge.
In order to obtain an authorisation, the sponsor shall submit an application dossier to the Member States concerned through the EU portal.

Komisija s primernimi sredstvi in v skladu z odstavkom 1 člena 142 zagotovi, da lahko udeleženci vnesejo dokumentacijo vloge in vsa ustrezna dokazila v elektronski obliki.
The Commission shall ensure by appropriate means and in accordance with paragraph 1 of Article 142 that participants may enter the application documents and any supporting evidence in an electronic format.

Ustrezne informacije o sledljivosti, shranjevanju, uničenju in vračanju zdravil iz odstavka 1 je treba vključiti v dokumentacijo vloge.
The relevant information regarding the traceability, storage, destruction and return of medicinal products referred to in paragraph 1 shall be contained in the application dossier.

Odgovorni odredbodajalec lahko popravi očitne administrativne napake v dokumentaciji vlog po tem, ko udeleženec potrdi nameravani popravek.
The authorising officer responsible may correct obvious clerical errors in the application documents after confirmation of the intended correction by the participant.

Tako prehodno obdobje je navedeno v dokumentaciji vloge iz člena 94(1) Uredbe(EU) št. 1308/2013.
Such transitional periods shall be indicated in the application file referred to in Article 94(1) of Regulation(EU) No 1308/2013.

Enotno vstopno točko, preko katere prosilec vloži dokumentacijo vloge za dovoljenje za tip vozil, dovoljenje za dajanje vozila na trg ali enotno varnostno spričevalo.
A single entry point through which the applicant shall submit its application files for type authorisation, vehicle authorisations for placing on the market and single safety certificates.

Spremni dopis, priložen dokumentaciji vloge, se mora sklicevati na referenčne informacije o varnosti.
The covering letter which is submitted with the application dossier shall refer to the RSI.

Ugotavlja, da v zdajšnjem odobritvenem postopku vlagatelj(industrija) neposredno naroča študije, ki jih mora vsebovati dokumentacija vloge.
Observes that the current authorisation process is based on the applicant(industry) directly commissioning the studies required for application dossiers.

Drugi projekti so ustvarili delovna mesta, čeprav to v dokumentaciji vloge za donacijo ni bilo navedeno kot izrecen cilj.
Other projects created employment although it had not been an explicit objective included in the grant application documentation.