natgillin/translations-raw huggingface dataset:
It shall then inform the Commission and all the other Member States, giving the reasons for its decision.
Potem obvesti Komisijo in vse druge države članice, ter navede razloge za svojo odločitev.
The Commission shall consult the interested parties and the Member States and, where the national measures are justified, adopt necessary Community measures.
Komisija se posvetuje z zainteresiranimi stranmi in državami članicami ter, kjer so nacionalni ukrepi upravičeni, sprejme potrebne ukrepe Skupnosti.
On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 7(4).’;
V nujnih primerih lahko Komisija uporabi nujni postopek iz člena 7(4).“;
Where a Member State considers that:
Če država članica meni, da:
the list of devices in Annex II should be amended or extended; or
bi bilo treba spremeniti ali razširiti seznam pripomočkov v Prilogi II ali
the conformity of a device or category of devices should be established, by way of derogation from the provisions of Article 9, by applying one or more given procedures taken from amongst those referred to in Article 9,
bi bilo treba ugotoviti skladnost pripomočka ali družine pripomočkov z odstopanjem od določb člena 9 z uporabo enega ali več danih postopkov, izbranih izmed navedenih v členu 9,
it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures.
Komisiji predloži utemeljeno prošnjo in jo pozove, da sprejme potrebne ukrepe.
Where those measures concern matters referred to in point (a), designed to amend non-essential elements of this Directive, they shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).
Kadar se ti ukrepi nanašajo na zadeve iz točke (a), namenjene spreminjanju nebistvenih določb te direktive, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 7(3).
Where those measures concern matters referred to in point (b), they shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’.
Kadar se ti ukrepi nanašajo na zadeve iz točke (b), se sprejmejo v skladu z regulativnim postopkom iz člena 7(2).“.
Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity [4]
Direktiva 1999/5/ES Evropskega parlamenta in Sveta z dne 9. marca 1999 o radijski opremi in telekomunikacijski terminalski opremi ter medsebojnem priznavanju skladnosti te opreme [4]
As regards Directive 1999/5/EC, the Commission should be empowered in particular to adopt a decision specifying, for apparatus within certain equipment classes or apparatus of particular types, which of the additional requirements apply, to determine the date of application, including, where appropriate, a transitional period, of certain additional essential requirements to specific equipment classes or apparatus of particular types, and to decide on the form of the equipment class identifier to be affixed on specific types of radio equipment.
V zvezi z Direktivo 1999/5/ES bi bilo treba Komisiji zlasti podeliti pooblastila za sprejetje sklepa, s katerim določi, katere dodatne zahteve veljajo za določene razrede opreme ali aparate določenih tipov, za določitev datuma uporabe določenih dodatnih bistvenih zahtev za določene razrede opreme ali aparate določenih tipov, vključno s prehodnim obdobjem, če je to primerno, ter za določitev oblike razpoznavnega znaka razreda opreme, s katero se označijo posebni tipi radijske opreme.
Since those measures are of general scope and are designed to amend non-essential elements of Directive 1999/5/EC, inter alia, by supplementing it with new non-essential elements, they must 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 Direktive 1999/5/ES, med drugim z njenim dopolnjevanjem z novimi nebistvenimi določbami, jih je treba sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.
Accordingly, Directive 1999/5/EC is hereby amended as follows:
Zato se Direktiva 1999/5/ES spremeni:
Article 3(3) shall be replaced by the following:
člen 3(3) se nadomesti z naslednjim:
The Commission may decide that apparatus within certain equipment classes or apparatus of particular types shall be so constructed that:
Komisija lahko odloči, da morajo biti aparati v določenih razredih opreme ali aparati določenih tipov konstruirani tako, da:
it interworks via networks with other apparatus and that it can be connected to interfaces of the appropriate type throughout the Community; and/or that
prek omrežij medsebojno delujejo z drugimi aparati in da se lahko na celem območju Skupnosti priključijo na vmesnike ustreznega tipa in/ali
it does not harm the network or its functioning nor misuse network resources, thereby causing an unacceptable degradation of service; and/or that
ne škodijo omrežju ali njegovemu delovanju ter da ne zlorabljajo sredstev omrežja in s tem povzročijo nesprejemljivega poslabšanja storitev in/ali
it incorporates safeguards to ensure that the personal data and privacy of the user and of the subscriber are protected; and/or that
vsebujejo zaščitne naprave za zagotavljanje zaščite osebnih podatkov in zasebnosti uporabnikov in naročnikov in/ali
it supports certain features ensuring avoidance of fraud; and/or that
podpirajo določene funkcije, ki zagotavljajo izogibanje goljufijam, in/ali
it supports certain features ensuring access to emergency services; and/or that
podpirajo določene funkcije, ki zagotavljajo dostop do storitev za nujne primere, in/ali
it supports certain features in order to facilitate its use by users with a disability.
podpirajo določene funkcije, ki invalidom olajšujejo njihovo uporabo.
Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15a.’;
Ti ukrepi, namenjeni spreminjanju nebistvenih določb te direktive, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 15a.“;
In the case of shortcomings of harmonised standards with respect to the essential requirements, the Commission may, after consulting the committee and in accordance with the procedure laid down in Article 14, publish in the Official Journal of the European Union recommendations on the interpretation of harmonised standards or on the conditions under which compliance with those standards raises a presumption of conformity.
Če so usklajeni standardi glede bistvenih zahtev pomanjkljivi, lahko Komisija po posvetovanju z odborom in po postopku, ki ga določa člen 14, v Uradnem listu Evropske unije objavi priporočila za razlaganje usklajenih standardov ali pogoje, pod katerimi je skladnost s temi standardi osnova za domnevo o skladnosti.
After consultation of the committee and in accordance with the procedure laid down in Article 14, the Commission may withdraw harmonised standards by publication of a notice in the Official Journal of the European Union.’;
Po posvetovanju z odborom in po postopku, ki ga določa člen 14, lahko Komisija usklajene standarde umakne z objavo obvestila v Uradnem listu Evropske unije.“;
In taking a decision regarding the application of essential requirements under Article 3(3), the Commission shall determine the date of application of the requirements.
Pri odločanju o uporabi bistvenih zahtev iz člena 3(3) Komisija določi datum uporabe zahtev.
If it is determined that an equipment class needs to comply with particular essential requirements under Article 3(3), any apparatus of the equipment class in question which is first placed on the market before the date of application of the Commission’s determination can continue to be placed on the market for a reasonable period to be determined by the Commission.
Če se določi, da mora biti določeni razred opreme skladen s posebnimi bistvenimi zahtevami iz člena 3(3), se lahko vsak aparat iz obravnavanega razreda opreme, ki se prvič da na trg do datuma uporabe odločitve Komisije, razumen čas, ki ga določi Komisija, še naprej daje na trg.
The measures referred to in the first and second subparagraphs, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15a.’;
Ukrepi iz prvega in drugega pododstavka, namenjeni spreminjanju nebistvenih določb te direktive z njenim dopolnjevanjem, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 15a.“;
Where reference is made to this Article, 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 člen se uporabljata člen 5a(1) do (4) in člen 7 Sklepa 1999/468/ES, ob upoštevanju določb člena 8 Sklepa.“;
point 5 of Annex VII shall be replaced by the following:
v Prilogi VII se točka 5 nadomesti z naslednjim:
The equipment class identifier must take a form to be decided by the Commission.
Razpoznavni znak razreda opreme mora biti take oblike, kot jo določi Komisija.
Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15a.’.
Ti ukrepi, namenjeni spreminjanju nebistvenih določb te direktive z njenim dopolnjevanjem, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 15a.“.
Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products [5]
Uredba (ES) št. 141/2000 Evropskega parlamenta in Sveta z dne 16. decembra 1999 o zdravilih sirotah [5]
As regards Regulation (EC) No 141/2000, the Commission should be empowered in particular to adopt definitions of ‘similar medicinal product’ and ‘clinical superiority’.
V zvezi z Uredbo (ES) št. 141/2000 bi bilo treba Komisiji zlasti podeliti pooblastila za sprejetje opredelitev pojmov „podobno zdravilo“ in „klinična superiornost“.
Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 141/2000, inter alia, by supplementing it with new non-essential elements, they must 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 Uredbe (ES) št. 141/2002, med drugim z njenim dopolnjevanjem z novimi nebistvenimi določbami, jih je treba sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.
Accordingly, Regulation (EC) No 141/2000 is hereby amended as follows:
Zato se Uredba (ES) št. 141/2000 spremeni:
The Commission shall, in accordance with the regulatory procedure referred to in Article 10a(2), adopt the necessary provisions for implementing paragraph 1 of this Article in the form of an implementing Regulation.’;
Komisija v skladu z regulativnim postopkom iz člena 10a(2) sprejme potrebne določbe za izvajanje prvega odstavka tega člena v obliki izvedbene uredbe.“;
Article 5(8) shall be replaced by the following:
člen 5(8) se nadomesti z naslednjim:
The Agency shall forthwith forward the final opinion of the Committee to the Commission, which shall adopt a decision within 30 days of receipt of the opinion.
Agencija končno mnenje odbora takoj pošlje Komisiji in ta sprejme odločitev v 30 dneh od prejema mnenja.
Where, in exceptional circumstances, the draft decision is not in accordance with the opinion of the Committee, the decision shall be adopted in accordance with the regulatory procedure referred to in Article 10a(2).
Če v izjemnih okoliščinah osnutek odločitve ni skladen z mnenjem odbora, se odločitev sprejme v skladu z regulativnim postopkom iz člena 10a(2).
The decision shall be notified to the sponsor and communicated to the Agency and to the competent authorities of the Member States.’;
Odločitev se uradno sporoči sponzorju, predloži se tudi Agenciji in pristojnim organom držav članic.“;
Article 8(4) shall be replaced by the following:
člen 8(4) se nadomesti z naslednjim:
The Commission shall adopt definitions of “similar medicinal product” and “clinical superiority” in the form of an implementing Regulation.
Komisija sprejme opredelitvi pojmov ‚podobno zdravilo‘ in ‚klinična superiornost‘ v obliki izvedbene uredbe.
Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10a(3).’;
Ti ukrepi, namenjeni spreminjanju nebistvenih določb te uredbe z njenim dopolnjevanjem, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 10a(3).“;
The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use, referred to in Article 121(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use.
Komisiji pomaga Stalni odbor za zdravila za ljudi iz člena 121(1) Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini.
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 [8]
Direktiva 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 [8]
As regards Directive 2001/20/EC, the Commission should be empowered in particular to adopt principles relating to good clinical practice and detailed rules in line with those principles, to lay down specific requirements and to adapt certain provisions.
V zvezi z Direktivo 2001/20/ES bi bilo treba Komisiji zlasti podeliti pooblastila za sprejetje načel v zvezi z dobro klinično prakso in podrobnih pravil, skladnih s temi načeli, za določitev posebnih zahtev in prilagoditev nekaterih določb.
Since those measures are of general scope and are designed to amend non-essential elements of Directive 2001/20/EC, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Ker sta ta ukrepa splošnega obsega in sta namenjena spreminjanju nebistvenih določb Direktive 2001/20/ES, med drugim z njenim dopolnjevanjem, ju je treba sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.
Accordingly, Directive 2001/20/EC is hereby amended as follows:
Direktiva 2001/20/ES se spremeni:
The Commission shall adopt the principles relating to good clinical practice and detailed rules in line with those principles and shall, if necessary, revise those principles and detailed rules to take account of technical and scientific progress.
Komisija sprejme načela glede dobre klinične prakse in podrobna pravila v skladu s temi načeli in po potrebi spremeni ta načela in pravila, da bi se upošteval tehnični in znanstveni napredek.
Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 21(3).
Ti ukrepi, namenjeni spreminjanju nebistvenih določb te direktive, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 21(3).
The principles and detailed rules shall be published by the Commission.’;
Komisija objavi načela in podrobna pravila.“;
Member States shall take all appropriate measures to ensure that the manufacture or importation of investigational medicinal products is subject to the holding of authorisation.
Države članice sprejmejo vse potrebne ukrepe, da bi zagotovile, da je pogoj za proizvodnjo ali uvoz zdravil v preskušanju, dovoljenje za promet.
The Commission shall lay down the minimum requirements which the applicant and, subsequently, the holder of the authorisation must meet in order to obtain the authorisation.
Da bi dovoljenje za promet dobil, mora vlagatelj in kasneje imetnik dovoljenja izpolniti osnovne zahteve, ki jih določi Komisija.
Those measures, designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 21(3).’;
Ti ukrepi, namenjeni spreminjanju nebistvenih določb te direktive z njenim dopolnjevanjem, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 21(3).“;
The Commission shall adapt this Directive to take account of scientific and technical progress.
Komisija prilagodi to direktivo zaradi upoštevanja znanstvenega in tehničnega napredka.
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products [10]
Direktiva 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini [10]
As regards Directive 2001/82/EC, the Commission should be empowered in particular to adapt certain provisions and annexes, and to lay down specific conditions of application.
V zvezi z Direktivo 2001/82/ES bi bilo treba Komisiji zlasti podeliti pooblastila za prilagoditev nekaterih določb in prilog ter za določitev posebnih pogojev za vloge.
Since those measures are of general scope and are designed to amend non-essential elements of Directive 2001/82/EC, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Ker sta ta ukrepa splošnega obsega in sta namenjena spreminjanju nebistvenih določb Direktive 2001/82/ES, med drugim z njenim dopolnjevanjem, ju je treba sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.
Accordingly, Directive 2001/82/EC is hereby amended as follows:
Zato se Direktiva 2001/82/ES spremeni:
By way of derogation from Article 11, the Commission shall establish a list of substances essential for the treatment of equidae and for which the withdrawal period shall be not less than six months according to the control mechanisms laid down in Decisions 93/623/EEC and 2000/68/EC.
Z odstopanjem od člena 11 Komisija sestavi seznam snovi, ki so bistvenega pomena za zdravljenje kopitarjev in za katere je karenca najmanj šest mesecev v skladu z nadzornimi mehanizmi iz odločb Komisije 93/623/EGS in 2000/68/ES.
That measure, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).’;
Ta ukrep, namenjen spreminjanju nebistvenih določb te direktive z njenim dopolnjevanjem, se sprejme v skladu z regulativnim postopkom s pregledom iz člena 89(2a).“;
in Article 11(2), the third subparagraph shall be replaced by the following:
v členu 11(2) se tretji pododstavek nadomesti z naslednjim:
‘However, the Commission may modify those specific withdrawal periods.
„Vendar Komisija lahko spremeni te karence.
Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).’;
Ti ukrepi, namenjeni spreminjanju nebistvenih določb te direktive, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 89(2a).“;
in Article 13(1), the fourth subparagraph shall be replaced by the following:
v členu 13(1) se četrti pododstavek nadomesti z naslednjim:
‘However, the 10-year period provided for in the second subparagraph shall be extended to 13 years in the case of veterinary medicinal products for fish or bees or other species designated by the Commission.
„Vendar se desetletno obdobje iz drugega pododstavka podaljša na 13 let v primeru zdravil za uporabo v veterinarski medicini za ribe ali čebele ali druge vrste, ki jih določi Komisija.
in Article 17(1), the second subparagraph shall be replaced by the following:
v členu 17(1) se drugi pododstavek nadomesti z naslednjim:
‘If it appears justified in the light of new scientific evidence, the Commission may adapt points (b) and (c) of the first subparagraph.
„Če je utemeljeno v smislu novih znanstvenih dokazov, lahko Komisija prilagodi točki (b) in (c) prvega pododstavka.
in Article 39(1), the third subparagraph shall be replaced by the following:
v členu 39(1) se tretji pododstavek nadomesti z naslednjim:
‘The Commission shall adopt those arrangements in the form of an implementing regulation.
„Komisija sprejme te dogovore v obliki izvedbene uredbe.
Article 50a(2) shall be replaced by the following:
člen 50a(2) se nadomesti z naslednjim:
The Commission shall adopt any amendments which may be necessary in order to adapt the provisions of paragraph 1 to take account of scientific and technical progress.
Komisija sprejme vse morebitne spremembe, potrebne za prilagoditev določb iz odstavka 1 zaradi upoštevanja znanstvenega in tehničnega napredka.
in Article 51, the first paragraph shall be replaced by the following:
v členu 51 se prvi odstavek nadomesti z naslednjim:
‘The principles and guidelines of good manufacturing practice for veterinary medicinal products referred to in Article 50(f) shall be adopted by the Commission in the form of a Directive addressed to the Member States.
„Načela in smernice dobre proizvodne prakse za zdravila za uporabo v veterinarski medicini iz točke (f) člena 50 sprejme Komisija v obliki direktive, naslovljene na države članice.
Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).’;
Ti ukrepi, namenjeni spreminjanju nebistvenih določb te direktive z njenim dopolnjevanjem, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 89(2a).“;
in Article 67, point (aa) shall be replaced by the following:
v členu 67 se točka (aa) nadomesti z naslednjim:
veterinary medicinal products for food-producing animals.
zdravila za uporabo v veterinarski medicini za živali za proizvodnjo hrane.
However, Member States may grant exemptions from this requirement according to criteria established by the Commission.
Vendar države članice lahko odobrijo izjeme od te zahteve glede na merila, ki jih določi Komisija.
The establishment of those criteria, being a measure designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).
Določitev navedenih meril, ki je ukrep, namenjen spreminjanju nebistvenih določb te direktive z njenim dopolnjevanjem, se sprejme v skladu z regulativnim postopkom s pregledom iz člena 89(2a).
Member States may continue to apply national provisions until either:
Države članice lahko še naprej uporabljajo državne predpise do:
the date of application of the decision adopted in accordance with the first subparagraph; or
datuma začetka veljavnosti sklepov, sprejetih v skladu s prvim pododstavkom, ali
1 January 2007, if no such decision has been adopted by 31 December 2006;’;
januarja 2007, če se noben tak sklep ne sprejme do 31. decembra 2006;“;
Article 68(3) shall be replaced by the following:
člen 68(3) se nadomesti z naslednjim:
The Commission shall adopt any amendments to the list of substances referred to in paragraph 1.
Komisija sprejme vsakršne spremembe seznama snovi iz odstavka 1.
Article 75(6) shall be replaced by the following:
člen 75(6) se nadomesti z naslednjim:
The Commission may amend paragraph 5 in the light of the experience gained from its operation.
Komisija lahko sprejme spremembe odstavka 5 ob upoštevanju izkušenj, pridobljenih med njegovim izvajanjem.
Article 79 shall be replaced by the following:
člen 79 se nadomesti z naslednjim:
‘Article 79
„Člen 79