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151–200/617
authorisation procedure
151 Končna redakcija
CELEX: 32004R0726
In the interest of public health, authorisation decisions under the centralised procedure should be taken on the basis of the objective scientific criteria of quality, safety and efficacy of the medicinal product concerned, to the exclusion of economic and other considerations.
V interesu javnega zdravja je treba odločitve o pridobitvi dovoljenja za promet po centraliziranem postopku sprejeti na podlagi objektivnih znanstvenih meril kakovosti, varnosti in učinkovitosti zadevnega zdravila, z izključevanjem ekonomskih in drugih premislekov.
152 Končna redakcija
CELEX: 41994D0017
This procedure provides the means to carry out immediate comprehensive checks to establish whether all the entry conditions are met by means of access to automated search data, checks carried out before authorisation to use the automated system was granted, and repeat controls.
Ta postopek omogoča takojšnje izvajanje celovitejših kontrol, s katerimi lahko takoj ugotovimo, ali so izpolnjeni vsi pogoji za vstop v državo, in sicer tako z računalniško podprtim dostopom do tiraličnih baz podatkov kot s preverjanjem pred izdanimi dovoljenji za uporabo in z izvajanjem ponovitvenih kontrol.
153 Končna redakcija
CELEX: 32004R0726
In order to meet, in particular, the legitimate expectations of patients and to take account of the increasingly rapid progress of science and therapies, accelerated assessment procedures should be set up, reserved for medicinal products of major therapeutic interest, and procedures for obtaining temporary authorisations subject to certain annually reviewable conditions.
Da bi zlasti izpolnili upravičena pričakovanja bolnikov in upoštevali vse hitrejši napredek znanosti in terapij, je treba vzpostaviti pospešene ocenjevalne postopke, rezervirane za zdravila večjega terapevtskega interesa, in postopke za pridobitev začasnih dovoljenj za promet, pogojenih z vsakoletnim preverjanjem nekaterih pogojev.
154 Končna redakcija
DRUGO
It may be decided, in accordance with the procedure laid down in Article 29, to limit the authorisations to particular species, to animals for slaughter, breeding or production, or to animals intended for particular purposes, and to apply all necessary health measures after importation.
V skladu s postopkom iz člena 29 se lahko odloči, da se omeji izdajo dovoljenj na določene vrste, živali za zakol, razplod ali rejo ali na živali, namenjene za določene namene, in da se vsi potrebni ukrepi za zdravstveno varstvo živali uporabijo po uvozu.
155 Končna redakcija
CELEX: 32004R0726
Only after a single scientific evaluation procedure addressing the quality, safety and efficacy of high-technology medicinal products has been conducted by the Agency, applying the highest possible standards, should marketing authorisation be granted by the Community, and this should be done by means of a rapid procedure ensuring close cooperation between the Commission and Member States.
Šele ko agencija izvede enoten znanstveni postopek vrednotenja glede kakovosti, varnosti in učinkovitosti visokotehnoloških zdravil in za to uporabi najvišje možne standarde, sme Skupnost izdati dovoljenje za promet in sicer s hitrim postopkom, ki zagotavlja tesno sodelovanje med Komisijo in državami članicami.
156 Končna redakcija
izobraževanje
CELEX: 32002R1605
If, for a given chapter, the authorisation of two or more provisional twelfths granted in the circumstances and under the procedures provided for in paragraph 3 is not sufficient to cover the expenditure necessary to avoid a break in continuity of the Communities' activity in the area covered by the chapter in question, authorisation may exceptionally be given to exceed the amount of the appropriations entered in the corresponding chapter of the budget of the preceding financial year.
Če za dani program odobritev dveh ali več začasnih dvanajstin v okoliščinah in po postopkih iz odstavka 3 ne zadostuje za pokrivanje izdatkov, potrebnih za preprečitev prekinitve kontinuitete delovanja Skupnosti na področju porabe, ki ga pokriva zadevni program, se lahko izjemoma dovoli prekoračitev sredstev, odobrenih za ustrezni program proračuna v preteklem proračunskem letu.
157 Končna redakcija
delo in sociala
DRUGO: TRANS
(4) In the decision to initiate the procedure for the revocation of the authorisation, the Bank of Slovenia shall set the deadline, which may not be shorter than 15 days nor longer than 30 days counted from the day of the delivery of the decision to the subject of supervision, during which the subject of supervision may make statement regarding the grounds for the initiation of the procedure (hereinafter:
(3) V odločbi o začetku postopka za odvzem dovoljenja Banka Slovenije določi tudi rok, ki ne sme biti krajši od 15 dni in ne daljši od 30 dni šteto od dneva vročitve odločbe subjektu nadzora, v katerem se subjekt nadzora lahko izjavi o razlogih za začetek postopka (v nadaljevanju:
158 Končna redakcija
DRUGO
The purposes for which the authorities referred to in paragraph 1(b) may be given, the provisions relating to the marking of packages, and the quantities and the conditions under which Member States may grant such authorisation shall be determined in accordance with the procedure laid down in Article 21.
Nameni, za katere se lahko izdajo pooblastila iz odstavka 1(b), določbe, ki se nanašajo na označevanje pakiranj ter količine in pogoji, pod katerimi lahko države članice dodelijo takšna pooblastila, se določijo v skladu s postopkom iz člena 21.
159 Končna redakcija
finance
CELEX: 32002L0020
Member States shall ensure that all relevant information on rights, conditions, procedures, charges, fees and decisions concerning general authorisations and rights of use is published and kept up to date in an appropriate manner so as to provide easy access to that information for all interested parties.
Države èlanice zagotovijo, da se vse ustrezne informacije o pravicah, pogojih, postopkih, dajatvah, pristojbinah in odloèitvah glede podeljevanja splošnih odobritev in pravic uporabe objavijo in sproti dopolnjujejo na ustrezen naèin, s èimer se vsem zainteresiranim strankam zagotovi preprost dostop do teh informacij.
160 Končna redakcija
gospodarstvo
CELEX: 31998L0095
The purposes for which the authorisations referred to in paragraph 1(b) may be given, the provisions relating to the marking of packages, and the quantities and the conditions under which Member States may grant such authorisation shall be determined in accordance with the procedure laid down in Article 21.
Nameni, za katere se lahko izdajo pooblastila iz odstavka 1(b), določbe, ki se nanašajo na označevanje pakiranj ter količine in pogoji, pod katerimi lahko države članice dodelijo takšna pooblastila, se določijo v skladu s postopkom iz člena 21.
161 Končna redakcija
DRUGO
The purposes for which the authorisations referred to in paragraph 1(b) may be given, the provisions relating to the marking of packages, and the quantities and the conditions under which Member States may grant such authorisation, shall be determined in accordance with the procedure laid down in Article 20.
Nameni, za katere se lahko izdajo pooblastila iz odstavka 1(b), določbe, ki se nanašajo na označevanje pakiranj ter količine ter pogoji, pod katerimi lahko države članice dodelijo takšna pooblastila, se določijo v skladu s postopkom iz člena 20.
162 Končna redakcija
CELEX: 32004L0024
However, this simplified procedure should be used only where no marketing authorisation can be obtained pursuant to Directive 2001/83/EC, in particular because of a lack of sufficient scientific literature demonstrating a well-established medicinal use with recognised efficacy and an acceptable level of safety.
Vendar naj se ta poenostavljeni postopek uporablja samo, kadar na podlagi Direktive 2001/83/ES ni mogoče pridobiti dovoljenja za promet, ker ni zadovoljive znanstvene literature, ki bi dokazovala dobro uveljavljeno medicinsko uporabo s priznano učinkovitostjo in sprejemljivo ravnjo varnosti.
163 Končna redakcija
delo in sociala
DRUGO: TRANS
(1) The provisions of this section shall apply to the procedure for adopting decisions regarding the issue of authorisations or consents upon which the Bank of Slovenia adopts a decision, insofar as the law regulating individual procedures for the issue of an authorisation or consent does not stipulate otherwise.
(1) Določbe tega razdelka se uporabljajo v postopku odločanja o izdaji dovoljenj oziroma soglasij, o katerih odloča Banka Slovenije, kolikor zakon za posamezen postopek izdaje dovoljenja oziroma soglasja ne določa drugače.
164 Končna redakcija
DRUGO
The purposes for which the authorisations referred to in paragraph 1(b) may be given, the provisions relating to the marking of packages, and the quantities and the conditions under which Member States may grant such authorisation, shall be determined in accordance with the procedure referred to in Article 25(2).
Nameni, za katere se sme dati dovoljenja iz odstavka 1(b), določbe v zvezi z zaznamovanjem pakiranj ter količine in pogoji, pod katerimi države članice lahko podelijo tako dovoljenje, se določijo v skladu s postopkom iz člena 25(2).
165 Končna redakcija
CELEX: 32004L0028
By way of derogation from paragraphs 2 and 3, in the case of veterinary medicinal products which are covered by Directive 87/22/EEC, have benefited from the authorisation procedures under Articles 31 and 32 of this Directive or have been the subject of the procedures provided for in Articles 36, 37 and 38 of this Directive, the marketing authorisation holder shall additionally ensure that all suspected serious adverse reactions and human adverse reactions occurring in the Community are reported in such a way so as to be accessible to the reference Member State or a competent authority designated as reference Member State.
Z odstopanjem od odstavkov 2 in 3 mora imetnik dovoljenja za promet z zdravilom – v primeru zdravil za uporabo v veterinarski medicini iz Direktive 87/22/EGS, ki so pridobila dovoljenje za promet po postopkih iz členov 31 in 32 te direktive ter zdravil za uporabo v veterinarski medicini, ki so bila predmet postopkov iz členov 36, 37 in 38 te direktive – dodatno zagotoviti, da se o vseh domnevnih resnih neželenih škodljivih učinkih ter neželenih škodljivih učinkih pri ljudeh, do katerih prihaja znotraj Skupnosti, poroča v obliki, ki je dostopna referenčni državi članici ali pristojnemu organu države članice, ki je imenovan kot referenčna država članica.
166 Končna redakcija
DRUGO
The conditions under which Member States may grant the authorisations referred to in paragraph (b) above shall be determined in accordance with the procedure laid down in Article 40, particularly as regards the acquisition of data, the type of data, the storage and name of the variety and the labelling of packages.
Pogoji, pod katerimi lahko države članice dodelijo pooblastila iz odstavka (b), se določijo v skladu s postopkom iz člena 40, zlasti kar zadeva pridobivanje podatkov, vrsto podatkov, skladiščenje in ime sorte ter označevanje pakiranj.
167 Končna redakcija
gospodarstvo
CELEX: 31999R1493
The conditions and limits for the acidification and deacidification of fresh grapes, grape must, grape must in fermentation, new wine still in fermentation and wine, suitable for yielding quality wine psr, and the procedure for granting authorisations and derogations, shall be those laid down in point E of Annex V.
Pogoji in omejitve za dokisanje in razkisanje svežega grozdja, grozdnega mošta, delno prevretega grozdnega mošta, mladega delno prevretega vina in vina, primernega za pridobivanje kakovostnega vina pdpo, in postopek za izdajo dovoljenj in odstopov so določeni v točki E Priloge V.
168 Končna redakcija
DRUGO
The conditions under which Member States may grant the authorisations referred to in paragraph (b) above shall be determined in accordance with the procedure referred to in Article 46(2), particularly as regards the acquisition of data, the type of data, the storage and name of the variety and the labelling of packages.
Pogoji, pod katerimi lahko države članice podelijo dovoljenja iz odstavka (b) zgoraj, se določijo v skladu s postopkom iz člena 46(2), zlasti kar zadeva pridobivanje podatkov, tip podatkov, skladiščenje in ime sorte ter označevanje pakiranj.
169 Končna redakcija
CELEX: 32004R0726
In the light of the Commission's report on the experience gained, it has proved necessary to improve the operation of the authorisation procedures for the placing of medicinal products on the market in the Community and to amend certain administrative aspects of the European Agency for the Evaluation of Medicinal Products.
Na podlagi poročila Komisije o pridobljenih izkušnjah se je pokazalo, da je treba delovanje postopkov pridobivanja dovoljenj za dajanje zdravila v promet v Skupnosti izboljšati in spremeniti nekatere upravne vidike Evropske agencije za vrednotenje zdravil.
170 Končna redakcija
delo in sociala
DRUGO: TRANS
(1) The Bank of Slovenia and authorities responsible for the supervision of other financial organisations shall, upon request by an individual supervisory authority, send to the authority all the information concerning the bank or other financial organisation required in the procedure of carrying out tasks of supervising a financial organisation in the procedure in connection with the issue of authorisations or in adopting decisions on other specific matters.
(1) Banka Slovenije in organi, ki so pristojni za nadzor drugih finančnih organizacij, morajo na zahtevo posameznega nadzornega organa posredovati temu organu vse podatke glede banke oziroma druge finančne organizacije, ki jih potrebuje v postopku opravljanja nalog nadzora nad finančno organizacijo, v postopku v zvezi z izdajo dovoljenj oziroma pri odločanju o drugih posamičnih zadevah.
171 Končna redakcija
delo in sociala
DRUGO: TRANS
2. if it concludes on the basis of the evidence under the second paragraph of Article 214 of the present law that it has not been proved that the subject of supervision committed the act or that there existed the circumstances because of which it had issued the decision regarding the initiation of the procedure for the revocation of the authorisation.
2. če na podlagi dokazov iz drugega odstavka 214. člena tega zakona zaključi, da ni dokazano, da je subjekt nadzora storil dejanje, oziroma da so podane okoliščine, zaradi katerih je izdala odločbo o začetku postopka za odvzem dovoljenja.
172 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.
173 Končna redakcija
CELEX: 32004R0726
Article 71 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(4) provides that, within six years of the entry into force of the Regulation, the Commission is to publish a general report on the experience acquired as a result of the operation of the procedures laid down in the Regulation.
Člen 71 Uredbe Sveta (EGS) št. 2309/93 z dne 22. julija 1993, ki določa postopke Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za ljudi in za uporabo v veterini ter ustanavlja Evropsko agencijo za vrednotenje zdravil, predpisuje, da je v šestih letih po začetku veljavnosti uredbe Komisija dolžna objaviti splošno poročilo o izkušnjah, pridobljenih kot rezultat uporabe postopkov iz te uredbe.
174 Končna redakcija
CELEX: 32004L0028
In the case referred to in paragraph 4, the Member States that have approved the assessment report, summary of product characteristics, labelling and package leaflet of the reference Member State may, on request by the applicant, grant a marketing authorisation for the veterinary medicinal product without waiting for the outcome of the procedure laid down in Article 36.
V primeru iz odstavka 4 države članice – ki so potrdile poročilo o oceni, povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo referenčne države članice – lahko na zahtevo predlagatelja izdajo dovoljenje za promet s tem zdravilom, ne da bi čakale na izide postopka iz člena 36.
175 Končna redakcija
CELEX: 32004R0726
A number of provisions need to be introduced to put in place stringent and efficient pharmacovigilance procedures, to allow the competent authority to take provisional emergency measures, including the introduction of amendments to the marketing authorisation and, finally, to permit a reassessment to be made at any time of the risk-benefit balance of a medicinal product.
Uvesti je treba številne določbe za stroge in učinkovite postopke farmakovigilance, da pristojni organ lahko sprejme začasne izredne ukrepe, vključno z uvedbo sprememb v dovoljenje za promet in nazadnje, da v vsakem trenutku dovoli ponovno oceno razmerja med tveganjem in koristmi zdravila.
176 Končna redakcija
CELEX: 32004R0726
Moreover, with a view to ensuring the effective harmonisation of administrative decisions taken by Member States with regard to medicinal products presented in accordance with decentralised authorisation procedures, it is necessary to endow the Community with the means to resolve disagreements between Member States concerning the quality, safety and efficacy of medicinal products.
Da pa bi zagotovili učinkovito uskladitev upravnih odločitev držav članic glede zdravil, predstavljenih v skladu z decentraliziranimi postopki pridobivanja dovoljenja za promet, je treba Skupnosti dodeliti sredstva za reševanje nesoglasij med državami članicami glede kakovosti, varnosti in učinkovitosti zdravil.
177 Končna redakcija
CELEX: 32004L0027
In order to increase availability of medicinal products, in particular on smaller markets, it should, in cases where an applicant does not apply for an authorisation for a medicinal product in the context of the mutual-recognition procedure in a given Member State, be possible for that Member State, for justified public health reasons, to authorise the placing on the market of the medicinal product.
Zaradi večje dostopnosti zdravil, predvsem na manjših trgih, je treba v primerih, kadar predlagatelj ne vloži vloge za pridobitev dovoljenja za promet z zdravilom v okviru postopka z medsebojnim priznavanjem v zadevni državi članici, tej državi članici omogočiti, da iz utemeljenih razlogov javnega zdravja dovoli dajanje tega zdravila v promet.
178 Končna redakcija
CELEX: 32004L0039
Without prejudice to the procedures for the withdrawal of authorisation or to the right of Member States to impose criminal sanctions, Member States shall ensure, in conformity with their national law, that the appropriate administrative measures can be taken or administrative sanctions be imposed against the persons responsible where the provisions adopted in the implementation of this Directive have not been complied with.
Brez poseganja v postopke za odvzem dovoljenja ali v pravico držav članic, da naložijo kazenske sankcije, države članice v skladu s svojim nacionalnim pravnim redom zagotovijo, da se lahko proti odgovornim osebam sprejmejo ustrezni administrativni ukrepi ali se jim naložijo administrativne sankcije, če se določbe, sprejete pri izvajanju te direktive, ne izpolnjujejo.
179 Končna redakcija
CELEX: 32004L0027
By way of derogation from paragraphs 2, 3 and 4, in the case of medicinal products which are covered by Directive 87/22/EEC or which have qualified for the procedures laid down in Articles 28 and 29 of this Directive or which have been the subject of the procedures under Articles 32, 33 and 34 of this Directive, the marketing authorisation holder shall also ensure that all suspected serious adverse reactions occurring in the Community are reported in such a way as to be accessible to the reference Member State or to any competent authority acting as reference Member State.
Z odstopanjem od odstavkov 2, 3 in 4, če gre za zdravila, ki jih obravnava Direktiva 87/22/EGS, ali za zdravila, ki so pridobila dovoljenja za promet po postopkih iz členov 28 in 29 te direktive, ali za zdravila, ki so bila predmet postopkov iz členov 32, 33 in 34 te direktive, imetnik dovoljenja za promet z zdravilom dodatno zagotovi, da se o vseh domnevnih resnih neželenih učinkih, ki se pojavljajo v Skupnosti, poroča tako, da so informacije dostopne referenčni državi članici ali vsakemu pristojnemu organu, ki opravlja vlogo referenčne države članice.
180 Končna redakcija
CELEX: 32004R0726
Furthermore, in order to create greater legal certainty it is necessary to define the responsibilities regarding the transparency rules for the Agency's work, to set certain conditions for the marketing of medicinal products authorised by the Community, to confer on the Agency powers to monitor the distribution of medicinal products authorised by the Community and to specify the sanctions and the procedures for implementing them in the event of failure to observe the provisions of this Regulation and the conditions contained in the authorisations granted under the procedures it establishes.
Da bi poleg tega dosegli večjo pravno varnost, je treba opredeliti odgovornosti glede pravil transparentnosti pri delu agencije, postaviti nekatere pogoje za trženje zdravil, ki jih odobri Skupnost, pooblastiti agencijo za spremljanje distribucije zdravil, ki jih odobri Skupnost, navesti kazni in postopke za njihovo izvajanje, če se ne upoštevajo določbe te uredbe, ter pogoje, vsebovane v izdanih dovoljenjih za promet po postopkih, ki jih vzpostavlja.
181 Končna redakcija
CELEX: 32004L0039
In the circumstances referred to in the first subparagraph, the Commission may decide, in accordance with the procedure referred to in Article 64(2), at any time and in addition to the initiation of negotiations, that the competent authorities of the Member States must limit or suspend their decisions regarding requests pending or future requests for authorisation and the acquisition of holdings by direct or indirect parent undertakings governed by the law of the third country in question.
V okoliščinah iz prvega pododstavka se lahko Komisija kadar koli in poleg uvedbe pogajanj v skladu s postopkom iz člena 64(2) odloči, da morajo pristojni organi držav članic omejiti ali zadržati svoje odločitve v zvezi s tekočimi ali prihodnjimi zahtevki za izdajo dovoljenja in pridobitvijo deležev s strani neposrednih ali posrednih matičnih podjetij, za katere velja zakonodaja zadevne tretje države.
182 Končna redakcija
CELEX: 32004L0017
To forestall the proliferation of specific arrangements applicable to certain sectors only, the current special arrangements created by Article 3 of Directive 93/38/EEC and Article 12 of Directive 94/22/EC of the European Parliament and of the Council of 30 May 1994 on the conditions for granting and using authorisations for the prospection, exploration and production of hydrocarbons(13) governing entities exploiting a geographical area for the purpose of exploring for or extracting oil, gas, coal or other solid fuels should be replaced by the general procedure allowing for exemption of sectors directly exposed to competition.
Za preprečitev širitve uporabe posebnih ureditev samo za določene sektorje, je treba trenutne posebne ureditve na podlagi člena 3 Direktive 93/38/EGS in člena 12 Direktive 94/22/ES Evropskega parlamenta in Sveta z dne 30. maja 1994 o pogojih za izdajo in uporabo dovoljenj za iskanje, raziskovanje in izkoriščanje ogljikovodikov [13], ki določa naročnike, ki geografsko razmejena območja izkoriščajo za odkrivanje in pridobivanje nafte, plina, premoga ali drugega trdnega goriva, nadomestiti s splošnim postopkom, ki dovoljuje izjeme za sektorje, ki so neposredno izpostavljeni konkurenci.
183 Pravna redakcija
finance
CELEX: 32003R2065
An authorisation procedure should therefore be established at Community level.
Postopek odobritve je torej treba uvesti na ravni Skupnosti.
184 Pravna redakcija
gospodarstvo
CELEX: 32003R1831
Since the objectives of the said Regulation are different from those of this Regulation, feed additives should undergo an authorisation procedure in addition to the authorisation procedure provided for by that Regulation before they are placed on the market.
Ker se cilji navedene uredbe razlikujejo od ciljev te uredbe, bi morali krmni dodatki, preden se dajo na trg, prestati postopek izdaje dovoljenja poleg postopka izdaje dovoljenja, predvidenega z navedeno uredbo.
185 Pravna redakcija
gospodarstvo
CELEX: 32003R1831
(16) It is also necessary to provide for a simplified authorisation procedure for those additives which have successfully undergone the authorisation procedure for food use provided for in Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption. fn
(16) Predvideti bi bilo treba tudi poenostavljeni postopek za izdajo dovoljenja za tiste dodatke, ki so uspešno prestali postopek za izdajo dovoljenja za uporabo v hrani, predviden v Direktivi Sveta 89/107/EGS z dne 21. decembra 1988 o približevanju zakonodaj držav članic o živilskih dodatkih, dovoljenih za uporabo v hrani, namenjeni za prehrano ljudi fn.
186 Pravna redakcija
DRUGO
the feasibility of various options to improve further the consistency and efficiency of this framework, including a centralised Community authorisation procedure and the arrangements for the final decision making by the Commission;
izvedljivosti različnih možnosti za nadaljnje izboljšanje skladnosti in učinkovitosti tega okvira, vključno s centraliziranim postopkom Skupnosti za odobritve in ureditvijo za končno odločanje Komisije;
187 Pravna redakcija
DRUGO
It is necessary to establish a Community authorisation procedure for the placing on the market of GMOs, as or in products, where the intended use of the product involves the deliberate release of the organism(s) into the environment.
Treba je vzpostaviti postopek Skupnosti za odobritev dajanja GSO v promet kot proizvodov ali v proizvodih, kjer predvidena uporaba proizvoda vključuje namerno sproščanje organizma(-ov) v okolje.
188 Pravna redakcija
DRUGO
simplified procedure, the authorisation of which foresees the use of seals.
v poenostavljenem postopku, odobritev katerega predvideva uporabo carinskih oznak.
189 Pravna redakcija
finance
CELEX: 32003R2065
(14) Since many smoke flavourings are already on the market in the Member States, provision should be made to ensure that the transition to a Community authorisation procedure is smooth and does not disturb the existing smoke flavourings market.
(14) Glede na to, da so mnoge arome dima že na tržišču držav članic, je treba zagotoviti, da bo prehod na postopek odobritve v Skupnosti gladek in ne bo povzročal motenj na obstoječem tržišču arom dima.
190 Pravna redakcija
DRUGO
provision should therefore be made for an authorisation procedure to be introduced for a full and clearly defined three-year period and for the scope of this measure to be made subject to strict conditions so that it remains verifiable and limited;
zato je treba določiti postopek odobritve, ki se uvede za celotno in jasno opredeljeno obdobje treh let, ter za obseg tega ukrepa določiti stroge pogoje, da bi ostal preverljiv in omejen.
191 Pravna redakcija
regionalni razvoj
CELEX: 32003D1229
In particular, the necessary authorisation procedures shall be completed rapidly.
Zlasti je treba hitro zaključiti potrebne postopke izdaje dovoljenj.
192 Pravna redakcija
promet
CELEX: 22002A0430(03)
international carriage of passengers, by coach and bus, and authorisation procedures
mednarodni avtobusni prevoz potnikov in postopki za izdajo dovoljenj
Prevodi: en > sl
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authorisation procedure