natgillin/translations-raw huggingface dataset:
Not required for A to A VFR/day operations. For A to B VFR/day operations the requirement is applicable but the flight plan may be in a simplified form relevant to the kind of operations conducted. (cf.
Se ne zahteva za dnevne VFR operacije od A do A. Za dnevne VFR operacije od A do B se zahteva uporablja, vendar je lahko operativni načrt leta v poenostavljeni obliki, ki ustreza vrsti izvajanih operacij.
OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).’
UL L 184, 17.7.1999, str. 23“;
An operator shall ensure that, if designated areas of the fuselage suitable for break-in by rescue crews in emergency are marked on an aeroplane, such areas shall be marked as shown below. The colour of the markings shall be red or yellow, and if necessary they shall be outlined in white to contrast with the background.
Če ima letalo predele trupa, ki so primerni za vdor reševalnih ekip v letalo v sili, operator zagotovi, da se ti predeli označijo v skladu s spodaj navedenimi zahtevami: Oznake morajo biti rdeče ali rumene, po potrebi obrobljene z belo, da se ločijo od ozadja.
Particular emphasis must be placed on flight crew responsibilities during transition from non-visual conditions to visual conditions, and on the procedures to be used in deteriorating visibility or when failures occur. Special attention must be paid to the distribution of flight deck duties so as to ensure that the workload of the pilot making the decision to land or execute a missed approach enables him/her to devote himself/herself to supervision and the decision making process.
Poseben poudarek je treba nameniti odgovornosti letalske posadke med prehodom iz nevizualnih v vizualne pogoje ter postopkom ob poslabšanju vidljivosti ali ob pojavu okvare Posebno pozornost je treba nameniti delitvi dolžnosti članov posadke v pilotski kabini, da bi zagotovili takšno delovno obremenjenost pilota, ki sprejema odločitve za pristanek ali neuspeli prilet, ki mu omogoča, da se posveti nadzoru in procesu odločanja.
Special standard masses for the traffic load. In addition to standard masses for passengers and checked baggage, an operator can submit for approval to the Authority standard masses for other load items.
Posebne standardne mase za prometni tovor. operator lahko predloži Organu v odobritev poleg standardnih mas za potnike in prijavljeno prtljago tudi standardne mase za druge natovorjene predmete.
Computerised systems. Where mass and balance documentation is generated by a computerised mass and balance system, the operator must verify the integrity of the output data.
Računalniško podprti sistemi Če se dokumentacija o masi in ravnotežju pripravlja po računalniško podprtih sistemih za maso in ravnotežje, mora operator preveriti celovitost izhodnih podatkov.
familiarisation flying of at least 20 hours and 15 sectors. Familiarisation flights shall be conducted under the supervision of a suitably experienced cabin crew member on the aeroplane type to be operated.
Seznanitveni let prek najmanj 15 sektorjev, ki traja vsaj 20 ur. Seznanitveni leti se izvajajo pod nadzorom ustrezno izkušenega člana kabinskega osebja na tipu letala, predvidenem za uporabo.
An operator shall ensure that, unless the minimum flight crew is more than two, each cabin crew member is trained in the procedure for flight crew member incapacitation and shall operate the seat and harness mechanisms. Training in the use of flight crew members' oxygen system and use of the flight crew' check lists, where required by the operator's SOP's, shall be conducted by a practical demonstration
Operator zagotovi, da se vsak član kabinskega osebja usposobi za izvedbo postopka v primeru onesposobitve člana letalske posadke ter uporabo sedežnih mehanizmov in mehanizmov H-pasov, razen če znaša najmanjše število letalskega osebja več kot dva člana Usposabljanje za uporabo kisikovega sistema za člane letalske posadke in seznamov letalske posadke za preverjanje, če ga zahteva SOP operatorja, se izvede s praktičnim prikazom.
An operator shall ensure that the minimum rest provided as outlined above is increased periodically to a weekly rest period, being a 36-hour period including two local nights, such that there shall never be more than 168 hours between the end of one weekly rest period and the start of the next. As an exception to OPS 1.1095(1.9), the Authority may decide that the second of those local nights may start from 20:00 hours if the weekly rest period has a duration of at least 40 hours.
Operator zagotovi, da se najkrajši čas počitka v skladu s prej navedenim redno podaljša na tedenski čas počitka, ki znaša 36 ur in vključuje dve krajevni noči, tako da ni med koncem enega tedenskega počitka in začetkom naslednjega nikoli več kot 168 ur. Kot izjemo od OPS 1.1095, točka 1.9, lahko Organ določi, da se druga od obeh krajevnih noči začne ob 20:00, če tedenski počitek traja vsaj 40 ur.
Regulation (EC) No 1900/2006 of the European Parliament and of the Council
Uredba (ES) št. 1900/2006 Evropskega parlamenta in Sveta
Annex III to Regulation (EEC) No 3922/91 [2] provides for common technical requirements and administrative procedures applicable to commercial transportation by aeroplanes.
Priloga III k Uredbi (EGS) št. 3922/91 [2] določa skupne tehnične predpise in upravne postopke, ki se uporabljajo za komercialni prevoz z zrakoplovi.
Those harmonised requirements and procedures apply to all aeroplanes used by Community operators whether registered in a Member State or in a third country.
Ti usklajeni predpisi in postopki se uporabljajo za vse zrakoplove, ki jih uporabljajo izvajalci Skupnosti, ki so registrirani v državi članici ali v tretji državi.
The measures necessary for the implementation of Regulation (EEC) No 3922/91 should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [3].
Ukrepe, potrebne za izvajanje Direktive (EGS) št. 3922/91, bi bilo treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [3].
In particular, the Commission should be empowered to establish the conditions under which, as provided for in Regulation (EEC) No 3922/91, the common technical requirements and administrative procedures set out in Annex III thereof may be amended or supplemented, or a Member State exempted from applying them.
Zlasti bi bilo treba podeliti Komisiji pooblastila za določitev pogojev, pod katerimi bi se lahko, kakor je določeno v Uredbi (EGS) št. 3922/91, spremenili ali dopolnili tehnični predpisi in upravni postopki iz Priloge III navedene uredbe, ali bi bila lahko država članica upravičena, da jih ne uporablja.
Since those measures are of general scope and are designed to amend non-essential elements of that Regulation, or to supplement it by the addition of new non-essential elements, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Ker so ti ukrepi splošnega obsega in so namenjeni spreminjanju nebistvenih določb navedene uredbe ali dopolnitvi navedene uredbe z dodajanjem novih nebistvenih določb, bi jih bilo treba sprejeti po regulativnem postopku s pregledom iz člena 5a Sklepa 1999/468/ES.
When, on imperative grounds of urgency regarding the maintenance of a sufficient level of aviation safety, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to use the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of certain measures.
Kadar v nujnih primerih zaradi ohranjanja zadostne ravni varnosti zračnega prometa ni mogoče upoštevati običajnih rokov za regulativni postopek s pregledom, bi bilo treba Komisiji omogočiti uporabo nujnega postopka iz člena 5a(6) Sklepa št. 1999/468/ES za sprejetje nekaterih ukrepov.
Regulation (EEC) No 3922/1991 should therefore be amended accordingly,
Uredbo (EGS) št. 3922/91 bi bilo zato treba spremeniti —
The fourth subparagraph of paragraph 3 shall be replaced by the following:
četrti pododstavek odstavka 3 se nadomesti z naslednjim:
‘In such a case, the Commission shall notify its decision to all Member States, which shall be entitled to apply that measure.
„V takem primeru Komisija uradno obvesti o svoji odločitvi vse države članice, ki so upravičene do uporabe navedenega ukrepa.
The relevant provisions of Annex III may also be amended in accordance with Article 11, so as to reflect that measure.’;
Ustrezne določbe iz Priloge III se tudi lahko spremenijo v skladu s členom 11, tako da odražajo navedeni ukrep.“.
The fourth subparagraph of paragraph 4 shall be replaced by the following:
četrti pododstavek odstavka 4 se nadomesti z naslednjim:
Article 11 shall be amended as follows:
Člen 11 se spremeni:
Paragraph 1 shall be replaced by the following:
odstavek 1 se nadomesti z naslednjim:
The measures, designed to amend non-essential elements of this Regulation by supplementing it, which are necessitated by scientific and technical progress and which amend the common technical requirements and administrative procedures listed in Annex III, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3).
Ukrepi za spremembo nebistvenih določb te uredbe z dopolnitvijo le-te, ki so nujni zaradi znanstvenega in tehničnega napredka in ki spreminjajo skupne tehnične predpise in upravne postopke, ki jih navaja Priloga III, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 12(3).
On imperative grounds of urgency, the Commission may follow the urgency procedure referred to in Article 12(4).’;
V nujnih primerih Komisija lahko uporabi nujni postopek iz člena 12(4).“;
In paragraph 2, the words ‘in Article 12’ shall be replaced by ‘in Article 12(3)’;
v odstavku 2 se „člen 12“ nadomesti s „členom 12(3)“;
The Commission shall be assisted by the Air Safety Committee (hereinafter referred to as “the Committee”).
Komisiji pomaga Odbor za varnost zračnega prometa (v nadaljevanju ‚odbor‘).
Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Pri sklicevanju na ta odstavek se uporabljata člena 5a(1) do (4) in člen 7 Sklepa 1999/468/ES, ob upoštevanju določb člena 8 Sklepa.
Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’.
Pri sklicevanju na ta odstavek se uporabljata člen 5a(1), (2), (4) in (6) ter člen 7 Sklepa 1999/468/ES, ob upoštevanju določb člena 8 Sklepa.“.
Done at Brussels, 20 December 2006
V Bruslju, 20. decembra 2006
Opinion of the European Parliament of 30 November 2006 (not yet published in the Official Journal) and Council Decision of 19 December 2006.
Mnenje Evropskega parlamenta z dne 30. novembra 2006 (še ni objavljeno v Uradnem listu) in Sklep Sveta z dne 19. decembra 2006.
Regulation as last amended by Regulation (EC) No 1899/2006 of the European Parliament and of the Council. (See page 1 of this Official Journal).
Uredba, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1899/2006 Evropskega parlamenta in Sveta (glej stran 1 tega Uradnega lista).
Regulation (EC) No 1901/2006 of the European Parliament and of the Council
Uredba (ES) št. 1901/2006 Evropskega parlamenta in Sveta
on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
o zdravilih za pediatrično uporabo in spremembah Uredbe (EGS) št. 1768/92, Direktive 2001/20/ES, Direktive 2001/83/ES in Uredbe (ES) št. 726/2004
Before a medicinal product for human use is placed on the market in one or more Member States, it generally has to have undergone extensive studies, including pre-clinical tests and clinical trials, to ensure that it is safe, of high quality and effective for use in the target population.
Preden je zdravilo za uporabo v humani medicini dano v promet v eni ali več državah članicah, mora biti načeloma predmet obširnih študij, vključno s pred-kliničnimi preskusi in kliničnimi preskušanji, s čimer se zagotovi, da je varno, visoko kakovostno in učinkovito za uporabo pri ciljni populaciji.
Such studies may not have been undertaken for use in the paediatric population and many of the medicinal products currently used to treat the paediatric population have not been studied or authorised for such use.
Takšne študije morda niso bile izvedene za uporabo pri pediatrični populaciji in mnogo zdravil, ki se trenutno uporablja za zdravljenje pediatrične populacije, ni bilo predmet študij ali odobrenih za takšno uporabo.
Market forces alone have proven insufficient to stimulate adequate research into, and the development and authorisation of, medicinal products for the paediatric population.
Izkazalo se je, da tržni dejavniki sami ne morejo zadostno spodbujati ustreznih raziskav, razvoja in odobritev zdravil za pediatrično populacijo.
Problems resulting from the absence of suitably adapted medicinal products for the paediatric population include inadequate dosage information which leads to increased risks of adverse reactions including death, ineffective treatment through under-dosage, non-availability to the paediatric population of therapeutic advances, suitable formulations and routes of administration, as well as use of magistral or officinal formulations to treat the paediatric population which may be of poor quality.
Med težave, ki jih povzroča pomanjkanje ustrezno prilagojenih zdravil za pediatrično populacijo, sodijo nezadostni podatki o odmerjanju, ki vodijo k večjim tveganjem neželenih učinkov, tudi smrti, neučinkovitost zdravljenja zaradi premajhnega odmerjanja, terapevtski napredki, ustrezni pripravki in poti uporabe zdravila niso na voljo pediatrični populaciji, magistralni pripravki ali galenski izdelki za zdravljenje pediatrične populacije pa so lahko slabe kakovosti.
This Regulation aims to facilitate the development and accessibility of medicinal products for use in the paediatric population, to ensure that medicinal products used to treat the paediatric population are subject to ethical research of high quality and are appropriately authorised for use in the paediatric population, and to improve the information available on the use of medicinal products in the various paediatric populations.
Namen te uredbe je omogočiti razvoj in dostopnost zdravil za uporabo pri pediatrični populaciji, zagotoviti, da so zdravila za zdravljenje pediatrične populacije predmet visoko kakovostnih, etičnih raziskav in da so primerno odobrena za uporabo pri pediatrični populaciji, ter izboljšati razpoložljive informacije o uporabi zdravil pri različnih pediatričnih populacijah.
These objectives should be achieved without subjecting the paediatric population to unnecessary clinical trials and without delaying the authorisation of medicinal products for other age populations.
Ti cilji bi morali biti doseženi na takšen način, da pediatrična populacija ni podvržena nepotrebnim kliničnim preskušanjem, in brez zamujanja pri odobritvah zdravil za populacije drugih starosti.
While taking into account the fact that the regulation of medicinal products must be fundamentally aimed at safeguarding public health, this aim must be achieved by means that do not impede the free movement of safe medicinal products within the Community.
Ob upoštevanju dejstva, da mora biti temeljni cilj urejanja predpisov o zdravilih varovanje javnega zdravja, mora biti ta cilj dosežen s sredstvi, ki ne ovirajo prostega pretoka varnih zdravil znotraj Skupnosti.
The differences between the national legislative, regulatory and administrative provisions on medicinal products tend to hinder intra-Community trade and therefore directly affect the operation of the internal market.
Razlike v nacionalnih zakonskih in drugih predpisih o zdravilih lahko ovirajo trgovino znotraj Skupnosti in tako neposredno vplivajo na delovanje notranjega trga.
Any action to promote the development and authorisation of medicinal products for paediatric use is therefore justified with a view to preventing or eliminating these obstacles.
Vsak ukrep za podporo razvoju in odobritvam zdravil za pediatrično uporabo je torej utemeljen za preprečevanje in odpravljanje teh ovir.
Article 95 of the Treaty is therefore the proper legal basis.
Člen 95 Pogodbe je torej primerna pravna podlaga.
The establishment of a system of both obligations and rewards and incentives has proved necessary to achieve these objectives.
Uvedba sistema, ki obsega tako obveznosti kot tudi nagrade in spodbude, se je pri doseganju teh ciljev pokazala za nujno.
The precise nature of these obligations and rewards and incentives should take account of the status of the particular medicinal product concerned.
Natančna narava obveznosti ter nagrad in spodbud bi morala upoštevati status posameznega zdravila.
This Regulation should apply to all the medicinal products required for paediatric use and therefore its scope should cover products under development and yet-to-be authorised, authorised products covered by intellectual property rights and authorised products no longer covered by intellectual property rights.
Ta uredba bi se morala uporabljati za vsa zdravila, ki jih potrebuje pediatrična populacija, zato bi moralo njeno področje uporabe obsegati izdelke v razvoju, ki jih je treba še odobriti, odobrene izdelke, ki so predmet varstva pravic intelektualne lastnine, in odobrene izdelke, ki niso več predmet varstva pravic intelektualne lastnine.
Any concerns about conducting trials in the paediatric population should be balanced by the ethical concerns about giving medicinal products to a population in which they have not been appropriately tested.
Vse pomisleke glede izvajanja preskušanj pri pediatrični populaciji bi bilo treba uravnotežiti z etičnimi pomisleki, ki zadevajo dajanje zdravil populaciji, v okviru katere niso bila ustrezno preskušena.
Public health threats from the use of untested medicinal products in the paediatric population can be safely addressed through the study of medicinal products for the paediatric population, which should be carefully controlled and monitored through the specific requirements for the protection of the paediatric population who take part in clinical trials in the Community laid down in Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use [3].
Ogroženost javnega zdravja zaradi uporabe nepreizkušenih zdravil pri pediatrični populaciji se lahko varno opredeli s študijami o zdravilih za pediatrično populacijo, ki bi jih bilo treba skrbno nadzorovati in spremljati na podlagi posebnih zahtev za varstvo pediatrične populacije, ki so del kliničnih preskušanj v Skupnosti, določenih v Direktivi 2001/20/ES Evropskega parlamenta in Sveta z dne 4. aprila 2001 o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi [3].
It is appropriate to create a scientific committee, the Paediatric Committee, within the European Medicines Agency, hereinafter ‘the Agency’, with expertise and competence in the development and assessment of all aspects of medicinal products to treat paediatric populations.
V okviru Evropske agencije za zdravila (v nadaljnjem besedilu „Agencija“) se ustanovi znanstveni odbor, Odbor za pediatrijo, s strokovnim znanjem in pristojnostjo glede razvoja in presoje vseh vidikov zdravil za zdravljenje pediatrične populacije.
The rules on scientific committees of the Agency, as laid down in Regulation (EC) No 726/2004 [4], should apply to the Paediatric Committee.
Za Odbor za pediatrijo naj veljajo določbe, ki veljajo za znanstveni odbor Agencije, kakor so navedene v Uredbi (ES) št. 726/2004 [4].
Members of the Paediatric Committee should therefore not have financial or other interests in the pharmaceutical industry which could affect their impartiality, should undertake to act in the public interest and in an independent manner, and should make an annual declaration of their financial interests.
Člani Odbora za pediatrijo zato ne morejo imeti finančnih ali drugih interesov v farmacevtski industriji, ki bi lahko vplivali na njihovo nepristranskost, pa naj delujejo v javnem interesu ali neodvisno, ter bi morali podati letno izjavo o svojih finančnih interesih.
The Paediatric Committee should be primarily responsible for the scientific assessment and agreement of paediatric investigation plans and for the system of waivers and deferrals thereof; it should also be central to various support measures contained in this Regulation.
Odbor za pediatrijo bi moral biti v prvi vrsti odgovoren za znanstveno presojo in izdajo soglasij z načrti pediatričnih raziskav ter za sistem opustitev in odlogov, poleg tega pa bi moral imeti odločujoč vpliv pri različnih podpornih ukrepih iz te uredbe.
In its work, the Paediatric Committee should consider the potential significant therapeutic benefits for the paediatric patients involved in the studies or the paediatric population at large including the need to avoid unnecessary studies.
Odbor za pediatrijo bi moral pri svojem delu upoštevati morebitne pomembne terapevtske koristi študij za pediatrične bolnike, vključene v študije, ali za širšo pediatrično populacijo, vključno s potrebo po izogibanju nepotrebnim študijam.
The Paediatric Committee should follow existing Community requirements, including Directive 2001/20/EC, as well as International Conference on Harmonisation (ICH) guideline E11 on the development of medicinal products for the paediatric population, and it should avoid any delay in the authorisation of medicinal products for other populations deriving from the requirements for studies in the paediatric population.
Odbor za pediatrijo naj upošteva obstoječe zahteve Skupnosti, vključno z Direktivo 2001/20/ES in smernico E11 Mednarodne konference o harmonizaciji (ICH), glede razvoja zdravil za pediatrično populacijo, in naj se izogiba zamudam pri odobritvah zdravil za druge populacije, ki nastanejo kot posledica zahtev za študije na pediatrični populaciji.
Procedures should be established for the Agency to agree and modify a paediatric investigation plan, which is the document upon which the development and authorisation of medicinal products for the paediatric population should be based.
Za Agencijo bi bilo treba oblikovati postopke za izdajo soglasij z načrtom pediatričnih raziskav in za spremembe načrtov pediatričnih raziskav, torej dokumenta, na katerem bi morala temeljiti razvoj in odobritev zdravil za pediatrično populacijo.
The paediatric investigation plan should include details of the timing and the measures proposed to demonstrate the quality, safety and efficacy of the medicinal product in the paediatric population.
Načrt pediatričnih raziskav bi moral vključevati podrobnosti glede časovnega poteka in predlaganih ukrepov za dokazovanje kakovosti, varnosti in učinkovitosti zdravil pri pediatrični populaciji.
Since the paediatric population is in fact composed of a number of population subsets, the paediatric investigation plan should specify which population subsets need to be studied, by what means and by when.
Ker je pediatrična populacija v bistvu sestavljena iz številnih delov populacij, bi bilo treba v načrtu pediatričnih raziskav natančno določiti, katere dele populacije je treba raziskati, na kakšen način in kdaj.