What is the translation of " DECENTRALISED PROCEDURE " in Slovenian?

• decentralizirani postopek
• decentraliziranim postopkom
• decentraliziranem postopku
• decentraliziranega postopka

Examples of using Decentralised procedure in English and their translations into Slovenian

A decentralised procedure.
Decentralizirani postopek.

Chapter 4 Mutual recognition and decentralised procedure".
Poglavje 4 Medsebojno priznavanje in decentraliziran postopek“.

(b) the decentralised procedure laid down in Articles 45 and 46;
(b) decentraliziranim postopkom iz členov 45 in 46;

Mutual recognition procedure/decentralised procedure.
Postopek z medsebojnim priznavanjem/ Decentralizirani postopek.

The Decentralised Procedure UK/ H/ 0892/ 01/ DC started on 12 April 2006.
Decentralizirani postopek UK/ H/ 0892/ 01/ DC se je pričel 12. aprila 2006.

Mutual recognition and decentralised procedure.
Postopku z medsebojnim priznavanjem ali decentraliziranem postopku ali.

The Decentralised Procedure, SE/ H/ 575/ 07/ DC, started on 1 September 2006.
Decentralizirani postopek SE/ H/ 575/ 07/ DC se je začel 1. septembra 2006.

Mutual recognition procedure or decentralised procedure.
Postopek z medsebojnim priznavanjem/ Decentralizirani postopek.

Decentralised procedure subject to an Article 33 Referral(CD 17 April 2008).
Decentralizirani postopek na podlagi napotitve v skladu s členom 33(CD 17. april 2008).

Mutual recognition procedure and decentralised procedure.
Postopku z medsebojnim priznavanjem ali decentraliziranem postopku ali.

The decentralised procedure should be replaced by a centralised procedure at EU level.
Decentralizirani postopek je treba nadomestiti z centraliziranim postopkom na ravni EU.

Mutual recognition procedure or decentralised procedure, or.
Postopku z medsebojnim priznavanjem ali decentraliziranem postopku ali.

Decentralised procedure is used when the medicinal product has not yet obtained marketing authorisation in the EU.
Decentralizirani postopek se uporabi v primeru, če zdravilo še nikjer v EU ni pridobilo DZP.

Mutual recognition procedure or decentralised procedure, or.
Postopku medsebojnega priznavanja ali po decentraliziranem postopku in so bila.

In August 2006 a decentralised procedure started with The Netherlands as Reference Member State and 17 Concerned Member States.
Nizozemska kot referenčna država članica je skupaj s 17 zadevnimi državami članicami avgusta 2006 sprožila decentralizirani postopek.

The mutual recognition procedure and the decentralised procedure.
Postopku z medsebojnim priznavanjem in po decentraliziranem postopku v skladu z.

It has therefore proposed that the decentralised procedure be integrated into the centralised procedure..
Zato je predlagal vključitev decentraliziranega postopka v centralizirani postopek..

The decentralised procedure applies in cases where a medicine has not received a marketing authorisation in any Member State.
Decentralizirani postopek se uporablja v primerih, ko v nobeni državi članici ni bilo izdano dovoljenje za promet z zadevnim zdravilom.

For all types of applications submitted in accordance with this Regulation, the decentralised procedure or the procedure for mutual recognition, the formats made available by the Agency shall be used.
Za vse vrste vlog, predloženih v skladu s to uredbo, decentraliziranim postopkom ali postopkom vzajemnega priznavanja, se uporabijo predloge, ki jih določi Agencija.

In August 2006 a Decentralised Procedure started with The Netherlands as Reference Member State and thirteen Concerned Member States.
Decentraliziran postopek se je na Nizozemskem kot referenčni državi članici in trinajstih zadevnih državah članicah začel avgusta 2006.

Paragraphs 1 and 2 shall not apply to veterinary medicinal products that have been authorised through a mutual recognition or decentralised procedure before the date of the application of this Regulation.
Odstavka 1 in 2 se ne uporabljata za zdravila za uporabo v veterinarski medicini, ki so bila odobrena v okviru postopka vzajemnega priznavanja ali decentraliziranega postopka pred datumom začetka uporabe te uredbe.

The Netherlands, reference member state in the decentralised procedure, notified the EMEA on 24 September 2007 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures- Veterinary(CMD(v)) failed to reach an agreement for Equibactin vet.
Nizozemska, referenčna država članica, je v decentraliziranem postopku dne 24. septembra 2007 obvestila agencijo EMEA, da Koordinacijska skupina za medsebojno prepoznavanje in decentralizirane postopke- veterina CMD( v) ni dosegla sporazuma o zdravilu Equibactin vet.

The four procedures for obtaining authorisation to place a veterinary medicinal product on the market(centralised procedure, decentralised procedure, mutual recognition procedure and national procedure) are maintained with some changes.
V predlogu so ohranjeni štirje postopki za pridobitev dovoljenja za dajanje zdravila za uporabo v veterinarski medicini na trg(centraliziran postopek, decentraliziran postopek, postopek vzajemnega priznavanja in nacionalni postopek), ki so nekoliko spremenjeni.

Germany, reference member state in the decentralised procedure, notified the EMEA on 21 December 2008 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures- Veterinary(CMD(v)) failed to reach an agreement for Compagel gel for horses.
Nemčija, referenčna država članica v decentraliziranem postopku, je 21. decembra 2007 obvestila EMEA, da v Koordinacijski skupini za postopke medsebojnega priznavanja in decentralizirane postopke- zdravila za veterinarsko uporabo(CMD( v)) ni bilo doseženo soglasje o zdravilu Compagel gel za konje.

In response to question 1, the applicant provided a copy of the original dossier as submitted in support of the application of a decentralised procedure, and any supplementary data submitted during the decentralised procedure in response to the phase I and phase II assessment and the referral procedure in CMD(v) thereafter.
V odgovor na 1. vprašanje je predlagatelj priskrbel kopijo originalnega dosjeja, predloženega v podporo uporabi decentraliziranega postopka, in vse dodatne podatke, ki so bili predloženi med decentraliziranim postopkom v odgovor na I. in II. fazo ocenjevanja in napotitvenega postopka v CMD( v) za tem.

After completion of a mutual recognition procedure laid down in Article 48 or a decentralised procedure laid down in Article 46, the marketing authorisation holder may submit an application for a marketing authorisation for a veterinary medicinal product to additional Member States.
Po zaključku postopka vzajemnega priznavanja iz člena 48 ali decentraliziranega postopka iz člena 46 lahko imetnik dovoljenja za promet predloži vlogo za pridobitev dovoljenja za promet z zdravilom za uporabo v veterinarski medicini v dodatnih državah članicah.

In response to question 1, the applicant provided a copy of the original dossier as submitted in support of the application of a decentralised procedure, and the supplementary data submitted during the decentralised procedure in response to the phase I and phase II assessment and the referral procedure in CMD(v) thereafter.
V zvezi s 1. vprašanjem je predlagatelj predložil kopijo izvirne dokumentacije, ki je bila predložena kot utemeljitev vloge za decentralizirani postopek, in dodatne podatke, ki so bili predloženi med decentraliziranim postopkom kot odgovor na vrednotenje I. in II. faze ter nato med napotitvenim postopkom v CMD( v).

Without prejudice to specific provisions related to the mutual recognition procedure or the decentralised procedure, the competent authority or the Agency shall, within 15 days of receipt of the application, notify the applicant whether the formal requirements laid down in this Regulation for the application concerned have been met and whether the application can be subject to scientific assessment.
Brez poseganja v posebne določbe v zvezi s postopkom vzajemnega priznavanja dovoljenja ali decentraliziranim postopkom pristojni organ ali Agencija v 15 dneh od prejema vloge obvesti predlagatelja o tem, ali vloga izpolnjuje formalne pogoje iz te uredbe in ali je lahko predmet znanstvene ocene.

A homeopathic medicinal product marketing authorisation may be obtained under the national procedure, mutual recognition procedure or decentralised procedure in accordance with the ZZdr-2 and the Rules on marketing authorisation of medicinal products for human use(Official Gazette of the Republic of Slovenia[Uradni list RS], No. 57/2014).
Pridobitev dovoljenja za promet s homeopatskim zdravilom lahko poteka po nacionalnem postopku, po postopku z medsebojnim priznavanjem ali po decentraliziranem postopku v skladu z Zakonom o zdravilih in Pravilnikom o dovoljenju za promet z zdravilom za uporabo v humani medicini(Uradni list RS, št. 57/14 in 41/17).

Failure of a Member State to fulfil obligations- Directive 2001/82/EC- Veterinary medicinal products- Decentralised procedure for the grant of marketing authorisation for a veterinary medicinal product in a number of Member States- Generic medicinal products similar to the reference medicinal products already authorised- Refusal to approve request by a Member State- Composition and form of the medicinal product.
Neizpolnitev obveznosti države- Direktiva 2001/82/ES- Zdravila za uporabo v veterinarski medicini- Decentralizirani postopek z namenom dodelitve dovoljenja za dajanje v promet v več kot eni državi članici- Generična zdravila, ki so podobna že odobrenim referenčnim zdravilom- Zavrnitev validacije vloge s strani države članice- Sestava in oblika zdravila.