natgillin/translations-raw huggingface dataset:
Notwithstanding paragraph 4, for five years following the entry into force of Regulation (EC) No 1901/2006, the application for an extension of the duration of a certificate already granted shall be lodged not later than six months before the expiry of the certificate.’;
Ne glede na odstavek 4 se pet let po začetku veljavnosti Uredbe (ES) št. 1901/2006 prijava za podaljšanje veljavnosti že izdanega certifikata vloži najpozneje šest mesecev pred iztekom veljavnosti certifikata.“;
Article 8 shall be amended as follows:
člen 8 se spremeni, kakor sledi:
in paragraph 1, the following point shall be added:
v odstavku 1 se doda točka:
where the application for a certificate includes a request for an extension of the duration:
če prijava za certifikat vključuje tudi zahtevo za podaljšanje veljavnosti:
a copy of the statement indicating compliance with an agreed completed paediatric investigation plan as referred to in Article 36(1) of Regulation (EC) No 1901/2006;
kopijo izjave o skladnosti z dogovorjenim načrtom pediatričnih raziskav iz člena 36(1) Uredbe (ES) št. 1901/2006;
where necessary, in addition to the copy of the authorisations to place the product on the market as referred to in point (b), proof that it has authorisations to place the product on the market of all other Member States, as referred to in Article 36(3) of Regulation (EC) No 1901/2006.’;
če je to potrebno, poleg izvoda odobritve iz točke (b), da se da zdravilo na trg, dokazilo, da ima dovoljenje za dajanje zdravila v promet v vseh drugih državah članicah, kakor določa člen 36(3) Uredbe (ES) št. 1901/2006 .“;
the following paragraphs shall be inserted:
vstavita se odstavka:
Where an application for a certificate is pending, an application for an extended duration in accordance with Article 7(3) shall include the particulars referred to in paragraph 1(d) and a reference to the application for a certificate already filed.
Kadar je prijava za certifikat v postopku, prijava za podaljšanje veljavnosti certifikata v skladu s členom 7(3) vsebuje podatke iz odstavka 1(d) in sklic na prijavo za certifikat, ki je bila že vložena.
The application for an extension of the duration of a certificate already granted shall contain the particulars referred to in paragraph 1(d) and a copy of the certificate already granted.’;
Prijava za podaljšanje veljavnosti certifikata, ki je bil že izdan, vsebuje podatke iz odstavka 1(d) in kopijo certifikata, ki je bil že izdan.“;
Member States may provide that a fee is to be payable upon application for a certificate and upon application for the extension of the duration of a certificate.’;
Države članice lahko določijo plačilo pristojbine ob vložitvi prijave za izdajo certifikata in ob vložitvi prijave za podaljšanje veljavnosti certifikata.“;
Article 9 shall be amended as follows:
člen 9 se spremeni, kakor sledi:
in paragraph 1, the following subparagraph shall be added:
v odstavku 1 se doda pododstavek:
‘The application for an extension of the duration of a certificate shall be lodged with the competent authority of the Member State concerned.’;
„Prijava za podaljšanje veljavnosti že izdanega certifikata se vloži pri pristojnem organu zadevne države članice.“;
in paragraph 2, the following point shall be added:
v odstavku 2 se doda točka:
where applicable, an indication that the application includes an application for an extension of the duration.’;
kadar je potrebno, navedbo, da prijava vključuje prijavo za podaljšanje veljavnosti.“;
the following paragraph shall be added:
doda se odstavek:
Paragraph 2 shall apply to the notification of the application for an extension of the duration of a certificate already granted or where an application for a certificate is pending.
Odstavek 2 se uporablja za obvestilo o vložitvi prijave za podaljšanje veljavnosti že podeljenega certifikata ali če je prijava za certifikat v postopku.
The notification shall additionally contain an indication of the application for an extended duration of the certificate.’;
Obvestilo dodatno vsebuje navedbo o prijavi za podaljšanje veljavnosti certifikata.“;
in Article 10, the following paragraph shall be added:
v členu 10 se doda nov odstavek:
Paragraphs 1 to 4 shall apply mutatis mutandis to the application for an extension of the duration.’;
Odstavki 1 do 4 se smiselno uporabljajo za prijavo za podaljšanje veljavnosti.“;
in Article 11, the following paragraph shall be added:
v členu 11 se doda odstavek:
Paragraphs 1 and 2 shall apply to the notification of the fact that an extension of the duration of a certificate has been granted or of the fact that the application for an extension has been rejected.’;
Odstavka 1 in 2 se uporabljata za uradno obvestilo o tem, da je podaljšanje veljavnosti certifikata odobreno ali o tem, da je bila prijava za podaljšanje zavrnjena.“;
in Article 13, the following paragraph shall be added:
v členu 13 se doda odstavek:
The periods laid down in paragraphs 1 and 2 shall be extended by six months in the case where Article 36 of Regulation (EC) No 1901/2006 applies.
Obdobja, določena v odstavkih 1 in 2, se podaljšajo za šest mesecev, kadar se uporablja člen 36 Uredbe (ES) št. 1901/2006.
In that case, the duration of the period laid down in paragraph 1 of this Article may be extended only once.’;
V tem primeru se obdobje, določeno v odstavku 1 tega člena, lahko podaljša samo enkrat.“;
the following Article shall be inserted:
vstavi se člen:
Revocation of an extension of the duration
Preklic podaljšanja veljavnosti
The extension of the duration may be revoked if it was granted contrary to the provisions of Article 36 of Regulation (EC) No 1901/2006.
Podaljšanje veljavnosti se lahko prekliče, če je bilo odobreno v nasprotju z določbami člena 36 Uredbe (ES) št. 1901/2006.
Any person may submit an application for revocation of the extension of the duration to the body responsible under national law for the revocation of the corresponding basic patent.’;
Katera koli oseba lahko organu, ki je po nacionalni zakonodaji odgovoren za preklic ustreznega osnovnega patenta, predloži prijavo za preklic podaljšanja veljavnosti.“;
Article 16 shall be amended as follows:
člen 16 se spremeni, kakor sledi:
the text of Article 16 becomes that Article's paragraph 1;
besedilo člena 16 postane odstavek 1 navedenega člena,
If the extension of the duration is revoked in accordance with Article 15a, notification thereof shall be published by the authority referred to in Article 9(1).’;
Če je podaljšanje veljavnosti preklicano v skladu s členom 15a, organ iz člena 9(1) o tem objavi uradno sporočilo.“;
Article 17 shall be replaced by the following:
člen 17 se nadomesti z:
The decisions of the authority referred to in Article 9(1) or of the bodies referred to in Articles 15(2) and 15a(2) taken under this Regulation shall be open to the same appeals as those provided for in national law against similar decisions taken in respect of national patents.’.
Proti odločitvam organov iz člena 9(1) ali organov iz členov 15(2) in 15a(2), ki so bili sprejete na podlagi te uredbe, se lahko vložijo enake pritožbe, kot jih predvideva nacionalna zakonodaja za podobne odločitve, sprejete v zvezi z nacionalnimi patenti.“.
In Article 11 of Directive 2001/20/EC, the following paragraph shall be added:
V členu 11 Direktive 2001/20/ES se doda odstavek:
By way of derogation from paragraph 1, the Agency shall make public part of the information on paediatric clinical trials entered in the European database in accordance with the provisions of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use.
Z odstopanjem od odstavka 1, Agencija objavi del podatkov o pediatričnih kliničnih preskušanjih, ki so vneseni v evropsko zbirko podatkov, v skladu z določbami Uredbe (ES) št. 1901/2006 Evropskega parlamenta in Sveta z dne 12. december 2006 o zdravilih za pediatrično uporabo.
In Article 6 of Directive 2001/83/EC, the first subparagraph of paragraph 1 shall be replaced by the following:
V členu 6 Direktive 2001/83/ES se besedilo prvega pododstavka odstavka 1 nadomesti z:
No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or unless an authorisation has been granted in accordance with Regulation (EC) No 726/2004, read in conjunction with Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use.
Zdravilo je lahko v državi članici v prometu samo na podlagi dovoljenja za promet z zdravilom, ki ga pristojni organi te države članice izdajo v skladu s to direktivo ali ga odobrijo v skladu z Uredbo (ES) št. 726/2004, v povezavi z Uredbo (ES) št. 1901/2006 Evropskega parlamenta in Sveta z dne 12. december 2006 o zdravilih za pediatrično uporabo.
Regulation (EC) No 726/2004 is hereby amended as follows:
Uredba (ES) št. 726/2004 se spremeni, kakor sledi:
Article 56(1) shall be replaced by the following:
člen 56(1) se nadomesti z:
The Agency shall comprise:
Agencijo sestavljajo:
the Committee for Medicinal Products for Human Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for human use;
Odbor za zdravila za uporabo v humani medicini, ki je odgovoren za pripravo mnenja Agencije o kakršnem koli vprašanju, ki se nanaša na vrednotenje zdravil za uporabo v humani medicini;
the Committee for Medicinal Products for Veterinary Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for veterinary use;
Odbor za zdravila za veterinarsko uporabo, ki je odgovoren za pripravo mnenja Agencije o kakršnem koli vprašanju, ki se nanaša na vrednotenje zdravil za uporabo v veterinarski medicini;
the Committee on Orphan Medicinal Products;
Odbor za zdravila sirote;
the Committee on Herbal Medicinal Products;
Odbor za zdravila rastlinskega izvora;
the Paediatric Committee;
Odbor za pediatrijo;
a Secretariat, which shall provide technical, scientific and administrative support for the committees and ensure appropriate coordination between them;
sekretariat, ki daje tehnično, znanstveno in upravno podporo odborom in zagotavlja njihovo ustrezno medsebojno koordinacijo;
an Executive Director, who shall exercise the responsibilities set out in Article 64;
izvršni direktor, ki izvršuje odgovornosti, določene v členu 64;
a Management Board, which shall exercise the responsibilities set out in Articles 65, 66 and 67.’;
uprava, ki izvršuje odgovornosti, določene v členih 65, 66 in 67.“;
in Article 57(1), the following point shall be added:
v členu 57(1) se doda točka:
taking decisions as referred to in Article 7(1) of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use.
sprejemanje odločitev iz člena 7(1) Uredbe (ES) št. 1901/2006 Evropskega parlamenta in Sveta z dne 12. december 2006 o zdravilih za pediatrično uporabo.
Decisions taken by the Agency under Regulation (EC) No 1901/2006 may form the subject of an action before the Court of Justice of the European Communities under the conditions laid down in Article 230 of the Treaty.’.
Sklepi Agencije v skladu z Uredbo (ES) št. 1901/2006 so lahko predmet tožbe pred Sodiščem Evropskih skupnosti pod pogoji, določenimi v členu 230 Pogodbe.“.
The requirement laid down in Article 7(1) shall not apply to valid applications pending at the time of entry into force of this Regulation.
Zahteva, določena v členu 7(1), se ne uporablja za popolne vloge, ki so ob začetku veljavnosti te uredbe že v postopku odločanja.
This Regulation shall enter into force on the thirtieth day following that of its publication in the Official Journal of the European Union.
Ta uredba začne veljati trideseti dan po objavi v Uradnem listu Evropske unije.
Article 7 shall apply from 26 July 2008.
Člen 7 se začne uporabljati 26. julija 2008.
Article 8 shall apply from 26 January 2009.
Člen 8 se začne uporabljati 26. januarja 2009.
Articles 30 and 31 shall apply from 26 July 2007.
Člena 30 in 31 se začneta uporabljati 26. julija 2007.
OJ C 267, 27.10.2005, p. 1.
UL C 267, 27.10.2005, str.1.
OJ L 182, 2.7.1992, p. 1.
UL L 182, 2.7.1992, str. 1.
OJ L 378, 27.12.2006, p. 1.’
UL L 378, 27.12.2006, str. 1.“
COMMISSION STATEMENT
IZJAVA KOMISIJE
In view of the risks of carcinogens, mutagens and substances toxic to reproduction, the Commission will request the Committee for Medicinal Products for Human Use of the European Medicines Agency to draw up an opinion on the use of these categories of substances as excipients of medicinal products for human use, on the basis of Articles 5(3) and 57(1)(p) of Regulation (EC) No 726/2004 of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
Komisija bo glede tveganj zaradi uporabe rakotvornih, mutagenih in strupenih snovi za razmnoževanje kot pomožnih snovi pri zdravilih za uporabo v humani medicini zaprosila za mnenje Odbor za zdravila za uporabo v humani medicini, ki je del Evropske agencije za zdravila, na podlagi členov 5(3) in 57(1)(p) Uredbe (ES) št. 726/2004 z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila.
The Commission will transmit the opinion of the Committee for Medicinal Products for Human Use to the European Parliament and the Council.
Komisija bo mnenje Odbora za zdravila za uporabo v humani medicini posredovala Evropskemu parlamentu in Svetu.
Within six months of the opinion of the Committee for Medicinal Products for Human Use, the Commission will inform the European Parliament and the Council of any necessary action it intends to take to follow-up on this opinion.
Najpozneje šest mesecev zatem, ko bo Odbor za zdravila za uporabo v humani medicini pripravil mnenje, bo Komisija obvestila Evropski parlament in Svet o vseh potrebnih ukrepih, ki naj bi se sprejeli na podlagi tega mnenja.
Opinion of the European Parliament of 7 September 2005 (OJ C 193 E, 17.8.2006, p. 225), Council Common Position of 10 March 2006 (OJ C 132 E, 7.6.2006, p. 1) and Position of the European Parliament of 1 June 2006 (not yet published in the Official Journal).
Mnenje Evropskega parlamenta z dne 7. septembra 2005 (UL C 193 E, 17.8.2006, str. 225), Skupno stališče Sveta z dne 10. marca 2006 (UL C 132 E, 7.6.2006, str. 1) in Stališče Evropskega parlamenta z dne 1. junija 2006 (še ni objavljeno v Uradnem listu).
Council Decision of 23 October 2006.
Sklep Sveta z dne 23. oktobra 2006.
Regulation (EC) No 1902/2006 of the European Parliament and of the Council
Uredba (ES) ŠT.1902/2006 Evropskega parlamenta in Sveta
amending Regulation 1901/2006 on medicinal products for paediatric use
o spremembah Uredbe 1901/2006 o zdravilih za pediatrično uporabo
Having regard to the Treaty establishing the European Community, in particular Article 95 thereof,
ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti in zlasti člena 95 Pogodbe,
The measures necessary for the implementation of Regulation (EC) No 1901/2006 [2] 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 Uredbe (ES) št. 1901/2006 [2], 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 define further the grounds for granting a deferral for the initiation or completion of some or all of the measures in the paediatric investigation plan and to specify the maximum amounts as well as the conditions and methods for collection of the financial penalties for infringement of the provisions of Regulation (EC) No 1901/2006 or the implementing measures adopted pursuant to it.
Zlasti bi bilo treba pooblastiti Komisijo, da podrobno opredeli razloge za odlog začetka ali končanja nekaterih ali vseh ukrepov iz načrta pediatričnih preiskav ter določi najvišje zneske kot tudi pogoje in načine pobiranja denarne kazni za kršitve določb Uredbe (ES) št. 1901/2006 ali izvedbenih ukrepov, sprejetih v skladu z njo.
Since these measures are of general scope and are designed to supplement Regulation (EC) No 1901/2006 by the addition of new non-essential elements, these measures should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Te ukrepe splošnega obsega, ki so namenjeni dopolnitvi Uredbe (ES) št. 1901/2006 tako da se dodajo nove nebistvene določbe, bi bilo treba sprejeti v skladu z regulativnim postopkom s pregledom, predvidenim v členu 5a Sklepa 1999/468/ES.
It is necessary to amend Regulation (EC) No 1901/2006 accordingly,
Uredbo (ES) št. 1901/2006 je zato treba ustrezno spremeniti —
Regulation (EC) No 1901/2006 is hereby amended as follows:
Uredba (ES) št. 1901/2006 se spremeni, kakor sledi:
in Article 20, paragraph 2 shall be replaced by the following:
v členu 20 se odstavek 2 nadomesti z naslednjim:
On the basis of the experience acquired as a result of the operation of this Article, the Commission may adopt provisions, in accordance with the regulatory procedure with scrutiny referred to in Article 51(2), amending or supplementing non-essential elements of this Regulation to define further the grounds for granting a deferral.’;
Komisija lahko za podrobno opredelitev razlogov za odlog, na podlagi izkušenj pridobljenih pri izvajanju tega člena, sprejme določbe, v skladu z regulativnim postopkom s pregledom iz člena 51(2) o spremembah ali dopolnitvah nebistvenih določb te uredbe.“;
in Article 49, paragraph 3 shall be replaced by the following:
v členu 49 se odstavek 3 nadomesti z naslednjim:
Measures amending or supplementing non-essential elements of this Regulation concerning the maximum amounts as well as the conditions and methods for collection of those penalties shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 51(2).’;
Ukrepi, ki spreminjajo ali dopolnjujejo nebistvene določbe te uredbe, se glede najvišjih zneskov kot tudi pogojev in načinov za pobiranje teh kazni sprejmejo v skladu regulativnim postopkom s pregledom iz člena 51(2).“;
in Article 51, paragraph 2 shall be replaced by the following:
v členu 51 se odstavek 2 nadomesti z naslednjim:
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 člen 5a(1) do (4) in člen 7 Sklepa 1999/468/ES, ob upoštevanju določb člena 8 Sklepa.“.
This Regulation is binding in its entirety and directly applicable in all Member States.
Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.
Opinion of the European Parliament of 14 December 2006 (not yet published in the Official Journal) and Council Decision of 19 December 2006.
Mnenje Evropskega parlamenta z dne 14. decembra 2006 (še ni bilo objavljeno v Uradnem listu) in Sklep Sveta z dne 19. decembra 2006.
Regulation (EC) No 1905/2006 of the European Parliament and of the Council
Uredba (ES) št. 1905/2006 Evropskega parlamenta in Sveta
establishing a financing instrument for development cooperation
o vzpostavitvi instrumenta za financiranje razvojnega sodelovanja
A new framework for planning and delivering assistance is proposed in order to make the Community's external assistance more effective.
Da bi izboljšali učinkovitost zunanje pomoči Skupnosti, je bil predlagan nov okvir, ki ureja načrtovanje in zagotavljanje pomoči.
Council Regulation (EC) No 1085/2006 [2] establishes an Instrument for Pre Accession (IPA) for Community assistance to candidate and potential candidate countries.
Uredba Sveta (ES) št. 1085/2006 [2] vzpostavlja Instrument za predpristopno pomoč za pomoč Skupnosti državam kandidatkam in potencialnim državam kandidatkam.
Regulation (EC) No 1638/2006 [3] lays down general provisions establishing a European Neighbourhood and Partnership Instrument (ENPI).
Uredba (ES) št. 1638/2006 [3] vzpostavlja splošne določbe o ustanovitvi Evropskega instrumenta sosedstva in partnerstva (ENPI).
Council Regulation (EC) No 1934/2006 [4] establishes a financing instrument for cooperation with industrialised and other high-income countries and territories.
Uredba Sveta (ES) št. 1905/2006 [4] vzpostavlja instrument za financiranje sodelovanja z industrializiranimi državami in ozemlji ter drugimi državami in ozemlji z visokim dohodkom.
Regulation (EC) No 1717/2006 [5] establishes an instrument for stability.
Uredba (ES) št. 1717/2006 [5] vzpostavlja instrument za stabilnost.
Regulation (EC) No …/2007 [6] establishes an instrument for nuclear safety cooperation.
Uredba (ES) št. 1905/2006 [6] vzpostavlja instrument za sodelovanje na področju jedrske varnosti.
Regulation (EC) No 1889/2006 [7] establishes a financing instrument for the promotion of democracy and human rights worldwide.
Uredba (ES) št. 1905/2006 [7] vzpostavlja instrument financiranja za spodbujanje demokracije in človekovih pravic po svetu.
Council Regulation (EC) No 1257/96 [8] concerns humanitarian aid.
Uredba Sveta (ES) št. 1257/96 [8] zadeva humanitarno pomoč.
This Regulation establishes a financing instrument for development cooperation providing direct support for the Community's development cooperation policy.
Ta uredba vzpostavlja instrument za financiranje razvojnega sodelovanja, ki zagotavlja neposredno pomoč politiki Skupnosti na področju razvojnega sodelovanja.
The Community pursues a development cooperation policy aimed at achieving the objectives of poverty reduction, sustainable economic and social development and the smooth and gradual integration of developing countries into the world economy.
Skupnost izvaja politiko razvojnega sodelovanja, ki je namenjena uresničitvi ciljev zmanjševanja revščine, trajnostnega gospodarskega in socialnega razvoja ter skladnega in postopnega vključevanja držav v razvoju v svetovno gospodarstvo.
The Community pursues a cooperation policy that fosters cooperation, partnerships and joint undertakings between economic players in the Community and partner countries and regions, and promotes dialogue between political, economic and social partners in relevant sectors.
Skupnost izvaja politiko sodelovanja, ki pospešuje sodelovanje, oblikovanje partnerstev in skupnih podjetij med udeleženci iz gospodarstva v Skupnosti ter partnerskih državah in regijah ter spodbuja dialog med političnimi, gospodarskimi in socialnimi partnerji v ustreznih sektorjih.
The Community's development cooperation policy and international action are guided by the Millennium Development Goals (MDGs), such as the eradication of extreme poverty and hunger, adopted by the United Nations General Assembly on 8 September 2000, and the main development objectives and principles approved by the Community and its Member States in the context of the United Nations (UN) and other competent international organisations in the field of development cooperation.
Razvojni cilji tisočletja, na primer izkoreninjenje skrajne revščine in lakote, kakor jih je Generalna skupščina Združenih narodov sprejela 8. septembra 2000, in glavni razvojni cilji in načela, ki so jih Skupnost in njene države članice odobrile v okviru Združenih narodov (ZN) in drugih pristojnih mednarodnih organizacij na področju razvojnega sodelovanja, vodijo politiko razvojnega sodelovanja in mednarodno dejavnost Skupnosti.