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1–22/22
ohranitev dovoljenja
1 Objavljeno
pravo
Ur. l. RS, št. MP 2005-73
Kadar država pogodbenica zakonsko ureja ali odloča o zadevah, povezanih z reševanjem, kot je dovoljenje za vplutje ladje v stiski v pristanišče ali zagotavljanje sredstev za reševalce, upošteva potrebo po sodelovanju med reševalci, drugimi zainteresiranimi stranmi in organi oblasti, da zagotovi učinkovito in uspešno reševanje za ohranitev ogroženih življenj ali premoženja ter za preprečitev škode v okolju na splošno.
A State Party shall, whenever regulating or deciding upon matters relating to salvage operations such as admittance to ports of vessels in distress or the provision of facilities to salvors, take into account the need for co-operation between salvors, other interested parties and public authorities in order to ensure the efficient and successful performance of salvage operations for the purpose of saving life or property in danger as well as preventing damage to the environment in general.
2 Končna redakcija
CELEX: 32004R0726
Prihodki agencije so sestavljeni iz prispevka Skupnosti in pristojbin, ki jih plačajo podjeta za pridobitev in ohranitev dovoljenj za promet Skupnosti ter za druge storitve, ki jih zagotavlja agencija.
The Agency's revenue shall consist of a contribution from the Community and fees paid by undertakings for obtaining and maintaining Community marketing authorisations and for other services provided by the Agency.
3 Pravna redakcija
DRUGO
da bi pospešili odobritev ali ohranitev dovoljenja Skupnosti, naj bi vsaj delno opustili pristojbine, ki jih je treba plačati Agenciji;
in order to facilitate the granting or the maintenance of a Community authorisation, fees to be paid to the Agency should be waived at least in part;
4 Pravna redakcija
DRUGO
Prihodki agencije so sestavljeni iz prispevka Skupnosti in pristojbin podjetij za pridobitev in ohranitev dovoljenja Skupnosti za promet ter za druge storitve agencije.
The revenues of the Agency shall consist of a contribution from the Community, and the fees paid by undertakings for obtaining and maintaining a Community marketing authorization and for other services provided by the Agency.
5 Pravna redakcija
DRUGO
ker je treba zato predvideti izdajanje ribiških dovoljenj s strani Komisije in sprejeti nekatere tehnične ukrepe za ohranitev virov, ki se uporabljajo brez vpliva na ukrepe, določene z Uredbo Sveta (EGS) št. 171/83 z dne 25. januarja 1983 o nekaterih tehničnih ukrepih za ohranitev ribolovnih virov fn, kakor je nazadnje spremenjena z Uredbo (EGS) št. 3625/84 fn;
Whereas it is therefore necessary to provide for the issue of fishing licences by the Commission and to adopt certain technical measures for the conservation of resources which shall apply without prejudice to the measures laid down in Council Regulation (EEC) No 171/83 of 25 January 1983 laying down certain technical measures for the conservation of fishery resources (3), as last amended by Regulation (EEC) No 3625/84 (4);
6 Pravna redakcija
DRUGO
Vse morske vrste, za katere je ohranitev upravičena zaradi redkosti vrst ali bioloških raziskav in ki jih ulovijo plovila Skupnosti, ki imajo na podlagi tega sporazuma dovoljenje za gospodarski ribolov v vodah Mozambika, so last državnega sekretariata za ribištvo, zato se čim prej in v najboljšem možnem stanju brezplačno izročijo državnemu sekretariatu za ribištvo v pristanišču Maputo.
All marine species for which preservation is justified due to rarity of the species or biological research and which are caught by a Community vessel authorized under the Agreement to fish in Mozambique's waters shall be the property of the Office of the Secretary of State for Fisheries and therefore shall be delivered as soon as possible, and in the best possible condition, to the Office of the Secretary of State for Fisheries at the port of Maputo free of charge.
7 Prevajalska redakcija
izobraževanje
CELEX: 32003R1647
Prihodki agencije so sestavljeni iz prispevka Skupnosti in pristojbin podjetij za pridobitev in ohranitev dovoljenja Skupnosti za promet z zdravili ter za druge storitve agencije.
The Agency's revenue shall consist of a contribution from the Community and fees paid by undertakings for obtaining and maintaining Community marketing authorisations and for other services provided by the Agency.
8 Prevajalska redakcija
izobraževanje
CELEX: 31995R0297
Pristojbine za pridobitev in ohranitev dovoljenja Skupnosti za promet z zdravili za humano in veterinarsko uporabo ter druge storitve, ki jih opravlja Agencija, se pobirajo v skladu s to uredbo.
Fees for obtaining and maintaining a Community authorization to market medicinal products for human and veterinary use and for the other services supplied by the Agency shall be levied in accordance with this Regulation.
9 Prevajalska redakcija
izobraževanje
CELEX: 31998R2743
Pristojbine za pridobitev in ohranitev dovoljenja Skupnosti za promet z zdravili za humano in veterinarsko uporabo ter za druge storitve, ki jih opravlja Agencija, se pobirajo v skladu s to uredbo.
Fees for obtaining and maintaining a Community authorisation to market medicinal products for human and veterinary use and for other services supplied by the Agency shall be levied in accordance with this Regulation.
10 Prevajalska redakcija
izobraževanje
CELEX: 31995R0297
ker člen 57(1) uredbe določa, da so prihodki Agencije sestavljeni iz prispevka Skupnosti in pristojbin podjetij za pridobitev in ohranitev dovoljenja Skupnosti za promet ter za druge storitve Agencije;
Whereas Article 57 (1) of the Regulation establishes that the revenues of the Agency shall consist of a contribution from the Community, and the fees paid by undertakings for obtaining and maintaining a Community marketing authorization and for other services provided by the Agency;
11 Prevajalska redakcija
RS
EMEA
V skladu s tem je CHMP priporočil ohranitev dovoljenja za promet z zdravili, ki so navedena v Dodatku I in za katera so v Dodatku III podrobno predstavljene dopolnitve ustreznih točk v Povzetkih glavnih značilnosti zdravila in Navodilih za uporabo.
As a consequence, the CHMP has recommended the maintenance of the Marketing Authorisations for the medicinal products referred to in Annex I for which the amendments to the relevant sections of the Summaries of Product Characteristics and Package Leaflets are set out in Annex III.
12 Prevajalska redakcija
izobraževanje
CELEX: 31998R2743
ker po členu 57(1) Uredbe Sveta (EGS) št. 2309/93 z dne 22. julija 1993, ki določa postopke Skupnosti za pridobitev dovoljenja in nadzor zdravil za humano in veterinarsko uporabo ter ustanavlja Evropsko agencijo za vrednotenje zdravil [3] so prihodki Agencije sestavljeni iz prispevkov in pristojbin podjetij za pridobitev in ohranitev dovoljenja Skupnosti za promet ter za druge storitve Agencije;
Whereas under Article 57(1) of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (3), the revenues of the Agency consist of a contribution and the fees paid by undertakings for obtaining and maintaining a Community marketing authorisation and for other services provided by the Agency;
13 Prevajalska redakcija
izobraževanje
CELEX: 32003R0494
Na podlagi člena 57(1) Uredbe Sveta (EGS) št. 2309/93 z dne 22. julija 1993, ki določa postopke Skupnosti za pridobitev dovoljenja in nadzor zdravil za humano in veterinarsko uporabo ter ustanavlja Evropsko agencijo za vrednotenje zdravil [3], kakor je bila nazadnje spremenjena z Uredbo Komisije (ES) št. 649/98 [4], so prihodki Agencije sestavljeni iz prispevka in pristojbin podjetij za pridobitev in ohranitev dovoljenja Skupnosti za promet ter za druge storitve Agencije.
On the basis of Article 57(1) of Council Regulation (EEC) No 2309/93 of 22 July 1993, laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(3), as last amended by Commission Regulation (EC) No 649/98(4), the revenues of the Agency consist of a contribution and the fees paid by undertakings for obtaining and maintaining a Community marketing authorisation and for other services provided by the Agency.
14 Prevajalska redakcija
RS
EMEA
Posledično je Odbor za zdravila za uporabo v humani medicini (CHMP) priporočil ohranitev dovoljenja za promet z zdravili, ki vsebujejo etorikoksib v odmerku 90 mg, navedenih v Dodatku I mnenja, in spremembo ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila, kot je določeno v Dodatku III mnenja v skladu s členom 31(2) Direktive 2001/ 83/ ES, kakor je bila spremenjena.
As a consequence, the CHMP has recommended to maintain the Marketing Authorisation for all medicinal products containing 90 mg of etoricoxib referred to in Annex I of the Opinion and to amend the relevant sections of the summary of product characteristics and package leaflet, as set out in Annex III of the Opinion in accordance with Article 31 (2) of Directive 2001/ 83/ EC, as amended.
15 Prevajalska redakcija
RS
EMEA
Na podlagi vrednotenja dosegljivih podatkov in poročevalčevega poročila o oceni je CHMP menil, da razmerje med koristmi in tveganji zdravil, ki vsebujejo pimekrolimus, ostaja ugodno in je zato dne 23. marca 2006 sprejel mnenje, v katerem priporoča ohranitev dovoljenja za promet z dopolnitvami Povzetka glavnih značilnosti zdravila, označevanja in Navodil za uporabo za zdravila, ki vsebujejo pimekrolimus.
Based on evaluation of the available data and the Rapporteurs’ assessment reports, the CHMP considered that the benefit/ risk profile of pimecrolimus containing medicinal products remains favourable, and therefore adopted an opinion on 23 March 2006 recommending the maintenance of the Marketing Authorisations with amendments to the Summary of Product Characteristics, Labelling and Package Leaflet for pimecrolimus containing medicinal products.
16 Prevajalska redakcija
RS
EMEA
CVMP je predlagal ohranitev dovoljenj za promet z vsemi zdravili za uporabo v veterinarski medicini, ki vsebujejo toltrazuril in so namenjena za uporabo pri piščancih in puranih.
Therefore the Committee recommended maintaining the Marketing Authorisations for all veterinary medicinal products containing toltrazuril intended for use in chickens and turkeys.
17 Prevajalska redakcija
RS
EMEA
Vendar želi predlagatelj/ imetnik dovoljenja za promet za montelukast le ohranitev indikacije kot samostojnega zdravljenja za blago do zmerno perzistentno astmo pri otrocih, starih od 2 do 5 let.
However, the Applicant/ MAH only seeks to maintain the indication for montelukast as monotherapy in mild to moderate persistent asthma in children aged 2 years to 5 years.
18 Prevajalska redakcija
izobraževanje
CELEX: 31985R3716
ker je treba zato predvideti izdajanje ribiških dovoljenj s strani Komisije in sprejeti nekatere tehnične ukrepe za ohranitev virov, ki se uporabljajo brez vpliva na določbe Uredbe Sveta (EGS) št. 171/83 z dne 25. januarja 1983 o nekaterih tehničnih ukrepih za ohranitev ribolovnih virov [3], kakor je nazadnje spremenjena z Uredbo (EGS) št. 3625/84 [4];
Whereas it is therefore necessary to provide for the issue of fishing licences by the Commission and to adopt certain technical measures for the conservation of resources which shall apply without prejudice to the provisions of Council Regulation (EEC) No 171/83 of 25 January 1983 laying down certain technical measures for the conservation of fishery resources (3), as last amended by Regulation (EEC) No 3625/84 (4);
19 Prevajalska redakcija
RS
EMEA
CHMP je zato priporočil ohranitev dovoljenj za promet za vsa zdravila in podelitev dovoljenj za promet za vse vloge iz Dodatka I Mnenja, skladno s spremembami ustreznih poglavij Povzetka glavnih značilnosti zdravila in Navodila za uporabo, kot so navedene v Dodatku III Mnenja.
Therefore, the CHMP has recommended to maintain the Marketing Authorisations for all medicinal products and to grant Marketing Authorisations for all applications referred to in Annex I of the Opinion in accordance with the amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflet, set out in Annex III of the Opinion.
20 Prevajalska redakcija
izobraževanje
CELEX: 31985D0382
ker so po Direktivi 82/471/EGS države članice začasno pooblaščene za ohranitev nacionalnih dovoljenj, ki so jih pred uradnim obvestilom o tej direktivi podelile za uporabo beljakovinskih izdelkov, pridobljenih iz kvasovk rodu Candida, ki so gojene na n-alkanih;
Whereas under Directive 82/471/EEC the Member States are temporarily authorized to maintain the national authorizations which, prior to being notified of that Directive, they granted for the use of protein products obtained from Candida yeasts cultivated on n-alkanes;
21 Prevajalska redakcija
RS
EMEA
Posledično je CHMP priporočil ohranitev dovoljenj za promet za vsa zdravila iz Dodatka I k Mnenju ter spremembo ustreznih poglavij Povzetka glavnih značilnosti zdravila in Navodil za uporabo za sistemske formulacije piroksikama, kot je določeno v Dodatku III k Mnenju v skladu s členom 31(2) Direktive 2001/ 83/ ES, kot je bila spremenjena.
As a consequence, the CHMP has recommended to maintain the Marketing Authorisations for all medicinal products referred to in Annex I of the Opinion and to amend the relevant sections of the Summary of Product Characteristics and Package Leaflet of systemic formulations of piroxicam, as set out in Annex III of the Opinion in accordance with Article 31(2) of Directive 2001/ 83/ EC, as amended.
22 Prevajalska redakcija
RS
EMEA
Na podlagi ovrednotenja razpoložljivih podatkov in poročil o oceni, ki so jih podali poročevalci, je CHMP menil, da ostaja razmerje med koristmi in tveganji za zdravila, ki vsebujejo 150 mg bikalutamida, pozitivno ter je zato 24. maja 2007 sprejel mnenje, s katerim priporoča ohranitev ali podelitev, kot ustreza, dovoljenj za promet z zdravilom z dopolnitvami ustreznih poglavij Povzetka glavnih značilnosti zdravila, za zdravila, ki vsebujejo 150 mg bikalutamida.
Based on evaluation of the available data and the Rapporteurs’ assessment reports, the CHMP considered that the benefit/ risk profile of bicalutamide 150 mg-containing medicinal products remains favourable, and therefore adopted an opinion on 24 May 2007 recommending the maintenance or the granting, as appropriate, of the Marketing Authorisations with amendments to the relevant sections of the Summary of Product Characteristics, for bicalutamide 150 mg-containing medicinal products.
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1–22/22
ohranitev dovoljenja