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1–50/108
notification of the authorisation
1 Pravna redakcija
DRUGO
Notification of the authorisation to the Commission
Priglasitev dovoljenja Komisiji.
2 Objavljeno
promet
Ur. l. RS, št. MP 2006-48
The acquisition of vineyards by non-Community controlled companies is subject to notification, or, as necessary, authorisation.
Nakup vinogradov morajo družbe, ki niso pod nadzorom Skupnosti, priglasiti ali po potrebi zanj pridobiti odobritev.
3 Objavljeno
finance
Ur. l. RS, št. MP 2003-68
Where the requirements of Article 133, paragraph 2, have not been satisfied, the same period shall be specified for the notification of the appointment of a representative and for the filing of the authorisation.
Če zahteve iz drugega odstavka 133. člena niso izpolnjene, se isti rok določi za uradno obvestilo o imenovanju zastopnika in za vložitev pooblastila.
4 Objavljeno
finance
Ur. l. RS, št. MP 2003-68
(8) If several representatives are appointed by a party, they may, notwithstanding any provisions to the contrary in the notification of their appointment or in the authorisation, act either jointly or singly.
(8) Če je stranka imenovala več zastopnikov, lahko ti delujejo skupno ali posamezno ne glede na morebitne nasprotne določbe v uradnem obvestilu o njihovem imenovanju ali v pooblastilu.
5 Objavljeno
Ur. l. RS, št. MP 2011-16
Each state may, in a declaration deposited with the instrument of ratification or at any subsequent time, waive the requirement of information, notification or authorisation referred to in paragraph metricconverterProductID4, in4, in general, or for specific categories of territorial communities or authorities or for specific types of co-operation.
Vsaka država se lahko z izjavo, ki jo deponira z listino o ratifikaciji ali pozneje, odreče zahtevi po seznanjanju, uradnem obveščanju ali odobritvi iz četrtega odstavka za vse ali le za posamezne vrste skupnosti ali oblasti ali za posamezno vrsto sodelovanja.
6 Končna redakcija
CELEX: 32004R0641
Such rules should facilitate the task of operators, in preparing applications for authorisations and in the preparation of notifications of existing products, and the Authority in evaluating such applications and verifying such notifications.
Ta pravila naj bi olajšala nalogo podjetij pri pripravi vlog za odobritve in pri pripravi uradnih obvestil za obstoječe proizvode, ter Agenciji pri oceni teh vlog in preverjanju uradnih obvestil.
7 Končna redakcija
CELEX: 32004L0028
The concerned Member States and the reference Member State shall either grant or withdraw marketing authorisation, or vary the terms of a marketing authorisation as necessary to comply with the decision within 30 days of its notification and shall refer to it.
Zadevne države članice in referenčna država članica izdajo ali odvzamejo dovoljenje za promet z zdravilom ali spremenijo pogoje za dovoljenja za promet z zdravilom kot je potrebno v skladu z odločbo, v roku 30 dni po uradnem obvestilu in se nanjo sklicujejo.
8 Končna redakcija
CELEX: 32004R0641
In addition to the requirements of Article 10, notifications of feed produced from GMOs which have been placed on the market in accordance with Articles 3 and 4 of Directive 82/471/EEC shall include a copy of the authorisation at Community level or, where applicable, the authorisation granted by a Member State.
Poleg zahtev iz člena 10 uradna obvestila o krmilih, proizvedenih iz GSO, ki so bila dana na trg v skladu s členoma 3 in 4 Direktive 82/471/EGS, vključujejo tudi kopijo izdanega dovoljenja na ravni Skupnosti, ali, kadar je to ustrezno, dovoljenja, ki ga je izdala država članica.
9 Končna redakcija
CELEX: 32004R0641
In addition to the requirements of Article 10, notifications of genetically modified food which have been placed on the market in accordance with Articles 6 and 7 of Regulation (EC) No 258/97 shall include a copy of the authorisation of that food.
Poleg zahtev iz člena 10 uradna obvestila o gensko spremenjenih živilih, ki so bila dana na trg v skladu s členoma 6 in 7 Uredbe (ES) št. 258/97, vključujejo kopijo izdanega dovoljenja za navedena živila.
10 Končna redakcija
CELEX: 32004R0726
Notification of marketing authorisation shall be published in the Official Journal of the European Union, quoting in particular the date of authorisation and the registration number in the Community Register, any International Non-proprietary Name (INN) of the active substance of the medicinal product, its pharmaceutical form, and any Anatomical Therapeutic Chemical Code (ATC).
Obvestilo o dovoljenju za promet se objavi v Uradnem listu Evropske unije in zlasti navede datum pridobitve dovoljenja ter registracijska številka v registru Skupnosti, kakršno koli mednarodno nelastniško ime (INN) zdravilne učinkovine zdravila, njegova farmacevtska oblika in kakršna koli anatomsko terapevtsko kemijska oznaka (ATC).
11 Končna redakcija
CELEX: 32004R0726
Notification of marketing authorisation shall be published in the Official Journal of the European Union, quoting in particular the date of authorisation and the number in the Community Register, any International Non-proprietary Name (INN) of the active substance of the medicinal product, its pharmaceutical form, and any Anatomical Therapeutic Chemical Veterinary Code (ATC Vet Code).
Obvestilo o dovoljenju za promet se objavi v Uradnem listu Evropske unije, zlasti navede datum pridobitve dovoljenja ter registracijska številka v registru Skupnosti, kakršno koli mednarodno nelastniško ime (INN) zdravilne učinkovine zdravila, njegova farmacevtska oblika in kakršna koli anatomsko terapevtsko kemijska veterinarska oznaka (ATC Vet Code).
12 Končna redakcija
CELEX: 32004L0027
In the case of products which have not been granted an authorisation pursuant to Regulation (EC) No 726/2004, the notification to the competent authority shall be without prejudice to additional procedures provided for in the legislation of that Member State.";
V primeru zdravil, za katere ni bilo izdano dovoljenje za promet na podlagi Uredbe (ES) št. 726/2004, obvestilo pristojnim organom ne vpliva na dodatne postopke, ki jih predvideva zakonodaja te države članice.”;
13 Končna redakcija
CELEX: 32004L0028
In the case of products which have not been granted an authorisation pursuant to Regulation (EC) No 726/2004, the notification to the competent authority shall be without prejudice to additional procedures provided for in the legislation of that Member State.";
V primeru zdravil, ki niso pridobila dovoljenja v skladu z Uredbo (ES) št. 726/2004, obveščanje pristojnega organa ne posega v dodatne postopke iz zakonodaje te države članice.";
14 Končna redakcija
CELEX: 32004L0027
The holder of a marketing authorisation may not communicate information relating to pharmacovigilance concerns to the general public in relation to its authorised medicinal product without giving prior or simultaneous notification to the competent authority.
Imetnik dovoljenja za promet z zdravilom širši javnosti ne sme sporočati informacij o zadevah v zvezi s farmakovigilanco zdravila, za katero se izda dovoljenje, ne da bi o tem predhodno ali istočasno obvestil pristojni organ.
15 Končna redakcija
CELEX: 32004L0027
The Member States shall ensure that reports of suspected serious adverse reactions that have taken place on their territory are promptly made available to the marketing authorisation holder, and in any case within 15 days after their notification at the latest.
Države članice zagotovijo, da so poročila o domnevnih resnih neželenih učinkih, ki so se pojavili na njihovem ozemlju, takoj na voljo imetniku dovoljenja za promet, najpozneje pa v 15 dneh od njihovega obvestila.
16 Končna redakcija
CELEX: 32004L0028
The holder of a marketing authorisation may not communicate information relating to pharmacovigilance concerns to the general public in relation to its authorised veterinary medicinal product without giving prior or simultaneous notification to the competent authority.
Imetnik dovoljenja za promet z zdravilom ne sme posredovati javnosti informacij, povezanih z zadevami farmakovigilance, glede svojega zdravila za uporabo v veterinarski medicini, ne da bi predhodno ali hkrati obvestil pristojni organ.
17 Končna redakcija
finance
CELEX: 32002L0020
Those aims can be best achieved by general authorisation of all electronic communications networks and services without requiring any explicit decision or administrative act by the national regulatory authority and by limiting any procedural requirements to notification only.
Ti cilji se lahko najbolje dosežejo s splošno odobritvijo za vsa elektro nska komunikacijska omrežja in storitve, za katero se ne zahteva posebna odloeba ali upravni akt nacionalnega regulativnega organa, vse postopkovne zahteve pa so omejene samo na uradno obvestilo.
18 Končna redakcija
kmetijstvo
DRUGO: 025-10-0241-2010-1
Each state may, in a declaration deposited with the instrument of ratification or at any subsequent time, waive the requirement of information, notification or authorisation referred to in paragraph 4, in general, or for specific categories of territorial communities or authorities or for specific types of co-operation.
Vsaka država se lahko z izjavo, ki jo deponira z listino o ratifikaciji ali pozneje, odreče zahtevi po seznanjanju, uradnem obveščanju ali odobritvi iz četrtega odstavka za vse ali le za posamezne vrste skupnosti ali oblasti ali za posamezno vrsto sodelovanja.
19 Končna redakcija
CELEX: 32004L0025
4.For the purpose of obtaining the prior authorisation, approval or confirmation of the holders of securities referred to in paragraphs 2 and 3, Member States may adopt rules allowing a general meeting of shareholders to be called at short notice, provided that the meeting does not take place within two weeks of notification's being given.
Za namene pridobitve predhodnega dovoljenja, odobritve ali potrditve imetnikov vrednostnih papirjev iz odstavkov 2 in 3, lahko države članice sprejmejo predpise, ki omogočajo sklic skupščine delničarjev v krajšem času, pod pogojem, da skupščina ne bo prej kot dva tedna po sklicu.
20 Končna redakcija
CELEX: 32004R0641
In addition to the requirements of Article 10, notifications of feed produced from GMOs which have been lawfully placed on the market in the Community, which are not covered by Articles 11, 14 and 15, and for which the GMO(s) has been notified for authorisation for use as animal feed under part C of Directive 2001/18/EC shall:
Poleg zahtev iz člena 10 uradna obvestila o krmilih, proizvedenih iz GSO, ki so bila zakonito dana na trg v Skupnosti, ki niso zajeta s členi 11, 14 in 15, in za katera so bila dana uradna obvestila za GSO za izdajo dovoljenja za uporabo v živalski krmi na podlagi dela C Direktive 2001/18/ES:
21 Končna redakcija
CELEX: 32004L0027
In exceptional circumstances and following consultation with the applicant, the authorisation may be granted subject to a requirement for the applicant to meet certain conditions, in particular concerning the safety of the medicinal product, notification to the competent authorities of any incident relating to its use, and action to be taken.
V izjemnih okoliščinah in po posvetu z predlagateljem se dovoljenje za promet lahko izda, pod pogojem da predlagatelj izpolni določene pogoje, predvsem v zvezi z varnostjo zdravila, obveščanjem pristojnih organov o vseh dogodkih v zvezi z uporabo zdravila, ter potrebnimi ukrepi.
22 Končna redakcija
CELEX: 32004L0028
In exceptional circumstances, and following consultation with the applicant, the authorisation may be granted subject to a requirement for the applicant to introduce specific procedures, in particular concerning the safety of the veterinary medicinal product, notification to the competent authorities of any incident relating to its use, and action to be taken.
V izjemnih okoliščinah ter po posvetu s predlagateljem, se lahko izda dovoljenje za promet pod pogojem, da predlagatelj izvede posebne postopke, zlasti v zvezi z varnostjo zdravila za uporabo v veterinarski medicini, obveščanjem pristojnih organov o vsakem dogodku v zvezi z njegovo uporabo ter ukrepom, ki ga je treba sprejeti.
23 Končna redakcija
CELEX: 32004R0364
Aid schemes implemented before the date of entry into force of this Regulation, and aid granted under such schemes in the absence of a Commission authorisation and in breach of the notification requirement of Article 88(3) of the Treaty, shall be compatible with the common market within the meaning of Article 87(3) of the Treaty and shall be exempt if they fulfil the conditions laid down in Article 3(2)(a) and Article 3(3) of this Regulation.
Sheme pomoči, ki se izvajajo pred začetkom veljavnosti te uredbe, in pomoči, ki se po teh shemah dodelijo v odsotnosti dovoljenja Komisije in se z njimi krši obveznost priglasitve iz člena 88(3) Pogodbe, so združljivi s skupnim trgom v smislu člena 87(3) Pogodbe in so izvzeti teh obveznosti, če izpolnjujejo pogoje iz člena 3(2)(a) in člena 3(3) te uredbe.
24 Končna redakcija
CELEX: 32004R0363
Aid schemes implemented before the date of entry into force of this Regulation, and aid granted under such schemes, in the absence of a Commission authorisation and in breach of the notification requirement of Article 88(3) of the Treaty, shall be compatible with the common market within the meaning of Article 87(3) of the Treaty and shall be exempt if they fulfil the conditions laid down in Article 3(2)(a) and Article 3(3) of this Regulation.
Sheme pomoči, ki se izvajajo pred začetkom veljavnosti te uredbe, in pomoči, dodeljene na podlagi takšnih shem, brez potrditve Komisije in kot predmet kršitve obveznosti priglasitve iz člena 88(3) Pogodbe, so združljive s skupnim trgom v smislu člena 87(3) Pogodbe in so oproščene teh obveznosti, če izpolnjujejo pogoje iz člena 3(2)(a) in člena 3(3) te uredbe.
25 Končna redakcija
CELEX: 32004R0364
Individual aid outside any scheme granted before the date of entry into force of this Regulation in the absence of a Commission authorisation and in breach of the notification requirement of Article 88(3) of the Treaty, shall be compatible with the common market within the meaning of Article 87(3) of the Treaty and shall be exempt if it fulfils all the conditions of this Regulation, except the requirement in Article 3(1) that express reference be made to this Regulation.
Individualna pomoč, ki se dodeli zunaj sheme pomoči pred začetkom veljavnosti te uredbe, v odsotnosti dovoljenja Komisije in se z njo krši obveznost priglasitve iz člena 88(3) Pogodbe, je združljiva s skupnim trgom v smislu člena 87(3) Pogodbe in je oproščena te obveznosti, če izpolnjuje pogoje iz te uredbe, z izjemo zahteve iz člena 3(1), da se izrecno sklicuje na to uredbo.
26 Končna redakcija
CELEX: 32004R0363
Individual aid outside any scheme granted before the date of entry into force of this Regulation, in the absence of a Commission authorisation and in breach of the notification requirement of Article 88(3) of the Treaty, shall be compatible with the common market within the meaning of Article 87(3) of the Treaty and shall be exempt if it fulfils all the conditions of this Regulation, except the requirement in Article 3(1) that express reference be made to this Regulation.
Individualna pomoč, dodeljena zunaj sheme pomoči pred začetkom veljavnosti te uredbe, brez potrditve Komisije in kot predmet kršitve obveznosti priglasitve iz člena 88(3) Pogodbe, je združljiva s skupnim trgom v smislu člena 87(3) Pogodbe in je oproščena obveznosti priglasitve, če izpolnjuje pogoje iz te uredbe, z izjemo zahteve iz člena 3(1), da se izrecno sklicuje na to uredbo.
27 Končna redakcija
CELEX: 32004L0027
The marketing authorisation holder shall be required to record and report all other suspected serious adverse reactions which meet the notification criteria in accordance with the guidelines referred to in Article 106(1), of which he can reasonably be expected to have knowledge, promptly to the competent authority of the Member State in whose territory the incident occurred, and no later than 15 days following the receipt of the information.
Imetnik dovoljenja za promet z zdravilom vodi dokumentacijo in takoj poroča o vseh drugih domnevnih resnih neželenih učinkih, ki izpolnjujejo merila o poročanju v skladu s smernicami iz člena 106(1), za katere se utemeljeno pričakuje, da je o njih obveščen, pristojnemu organu države članice, na ozemlju katere so se pojavili, najpozneje v 15 dneh po prejetju informacije.
28 Končna redakcija
CELEX: 32004R0001
Individual aid and aid schemes implemented before the date of entry into force of this Regulation and aid granted under those schemes in the absence of a Commission authorisation and in breach of the notification requirement of Article 88(3) of the Treaty shall be compatible with the common market within the meaning of Article 87(3)(c) of the Treaty and shall be exempt if they fulfil the conditions laid down in Article 3 of this Regulation, except the requirements in paragraph 1 and paragraph 2(b) and (c) of that Article that express reference be made to this Regulation, and that the summary provided for in Article 19(1) has been submitted before granting aid.
Posamična pomoč in programi pomoči, ki so se začeli uporabljati pred začetkom veljavnosti te uredbe, ter pomoč, odobrena po teh programih brez dovoljenja Komisije in v nasprotju z zahtevo obvezne priglasitve iz člena 88(3) Pogodbe, so združljivi s skupnim trgom po členu 87(3)(c) Pogodbe in so izvzeti iz obveznosti priglasitve pod pogojem, da izpolnjujejo pogoje iz člena 3 te uredbe, razen zahtev iz odstavkov 1 in 2(b) ter (c) navedenega člena o izrecnem sklicevanju na to uredbo, ter da je bil pred odobritvijo pomoči predložen povzetek, opredeljen v členu 19(1).
29 Končna redakcija
finance
CELEX: 32002L0020
At the request of an undertaking, national regulatory authorities shall, within one week, issue standardised declarations, confirming, where applicable, that the undertaking has submitted a notification under Article 3(2) and detailing under what circumstances any undertaking providing electronic communications networks or services under the general authorisation has the right to apply for rights to install facilities, negotiate interconnection, and/or obtain access or interconnection in order to facilitate the exercise of those rights for instance at other levels of government or in relation to other undertakings.
Na zahtevo podjetja izdajo nacionalni regulativni organi v enem tednu standardizirane izjave, s katerim i potrdijo, kadar je to primerno, da je podjetje predložilo uradno obvestilo po elenu 3(2), in podrobno navedejo, v kakšnih okolišeinah lahko podjetje, ki zagotavlja elektronska komunikacijska omrežja ali storitve po splošni odobritvi, zaprosi za pravice do vgradnje naprav, do pogajanja o medsebojnem povezovanju in/ali za pridobitev dostopa ali medsebojnega povezovanja, da bi mu omogoeili uveljavljanje teh pravic, na primer na drugih državnih ravneh ali v odnosu do drugih podjetij.
30 Pravna redakcija
promet
The acquisition of vineyards by non-EC controlled companies is subject to notification, or, as necessary, authorisation.
Nakup vinogradov morajo družbe, ki niso pod nadzorom Skupnosti, priglasiti ali po potrebi zanj pridobiti odobritev.
31 Pravna redakcija
promet
The acquisition of vineyards by non-EC-controlled companies is subject to notification, or, as necessary, authorisation.
Od družb, katerih obvladujoča družba nima sedeža v ES, se za nakup vinogradov zahteva uradno obvestilo ali odobritev, kakor je primerno.
32 Pravna redakcija
promet
The acquisition of vineyards by non-Community-controlled companies is subject to notification, or, where necessary, authorisation.
Nakup vinogradov morajo družbe, ki niso pod nadzorom Skupnosti, priglasiti ali po potrebi zanj pridobiti odobritev.
33 Pravna redakcija
DRUGO
To guarantee such independence, Articles 11, 12, 13, and 14 of the Staff Regulations lay down a system of express authorisation and notification obligations.
Za zagotavljanje takšne neodvisnosti urejajo členi 11, 12, 13 in 14 kadrovskih predpisov sistem izrecnega pooblastila in uradnih dolžnosti.
34 Pravna redakcija
DRUGO
that authorisations for plant protection products containing DNOC are withdrawn within a period of six months from the date of notification of the present Decision;
da se registracije za fitofarmacevtska sredstva, ki vsebujejo DNOC, odvzamejo v roku šestih mesecev od datuma notifikacije te odločbe;
35 Pravna redakcija
DRUGO
that authorisations for plant protection products containing pyrazophos are withdrawn within a period of six months from the date of notification of the present Decision;
da se registracije za fitofarmacevtska sredstva, ki vsebujejo pirazofos, odvzamejo v roku šestih mesecev od datuma uradnega obvestila o tej odločbi;
36 Pravna redakcija
DRUGO
that authorisations for plant protection products containing monolinuron are withdrawn within a period of six months from the date of notification of the present Decision;
da se registracije za fitofarmacevtska sredstva, ki vsebujejo monolinuron, odvzamejo v roku šestih mesecev od datuma obvestila o tej odločbi;
Prevodi: en > sl
1–50/108
notification of the authorisation