natgillin/translations-raw huggingface dataset:
That Directive and that Regulation also provide the legal bases for the examination of applications for variations to the terms of marketing authorisations.
Navedeni direktiva in uredba zagotovita tudi pravno podlago za pregled vlog za spremembe pogojev dovoljenj za promet.
Directive 2009/53/EC of the European Parliament and of the Council has further harmonised the system for examination of applications for variations to cover also many medicinal products authorised under purely national procedures.
Z Direktivo 2009/53/ES Evropskega parlamenta in Sveta se je sistem za pregled vlog za spremembe še bolj harmoniziral in tako zajel tudi številna zdravila, ki so odobrena zgolj v skladu z nacionalnimi postopki.
That system, as laid down in Commission Regulation (EC) No 1234/2008, as amended following the adoption of Directive 2009/53/EC, should be maintained.
Ta sistem, naveden v Uredbi Komisije (ES) št. 1234/2008, kakor je bila spremenjena po sprejetju Direktive 2009/53/ES, bi bilo treba ohraniti.
It is appropriate, however, to consolidate that system by moving its core elements into Directive 2001/83/EC and Regulation (EC) No 726/2004, while maintaining in both acts a delegation of powers that allows the Commission to complement those core elements by laying down further necessary elements and to adapt the system for examination of applications for variations currently in force to technical and scientific progress.
Vseeno pa je primerno, da se navedeni sistem konsolidira s premaknitvijo njegovih ključnih elementov v Direktivo 2001/83/ES in Uredbo (ES) št. 726/2004 ter z ohranitvijo prenosa pooblastil v obeh aktih, ki Komisiji omogoča dopolnjevanje teh ključnih elementov z določitvijo nadaljnjih nujnih elementov in prilagajanje veljavnega sistema za pregled vlog za spremembe tehničnemu in znanstvenemu napredku.
As the provisions on variations in Directive 2001/83/EC should remain aligned to those in Regulation (EC) No 726/2004, it is appropriate to make the same changes in both those acts.
Določbe o spremembah v Direktivi 2001/83/ES bi morale biti še naprej skladne z določbami iz Uredbe (ES) št. 726/2004, zato je primerno vnesti enake spremembe v oba navedena akta.
The Agency should provide advice for the regulatory acceptance of innovative development methods in the context of research and development of medicinal products for human use and veterinary medicinal products.
Agencija bi morala zagotoviti svetovanje glede regulativnega sprejetja inovativnih razvojnih metod v okviru raziskav in razvoja zdravil za uporabo v humani medicini in zdravil za uporabo v veterinarski medicini.
Since 2015, the Agency, the European Food Safety Authority and the European Centre for Disease Prevention and Control have published Joint Interagency Antimicrobial Consumption and Resistance Analysis (JIACRA) Reports.
Agencija, Evropska agencija za varnost hrane in Evropski center za preprečevanje in obvladovanje bolezni že od leta 2015 izdajajo poročila o skupni medagencijski analizi protimikrobne uporabe in odpornosti (JIACRA).
It is appropriate that the Agency continue to contribute to periodic reporting on antimicrobial resistance at least every three years.
Primerno je, da Agencija še naprej prispeva k rednem poročanju o odpornosti mikrobov proti protimikrobnim snovem(v nadaljnjem besedilu: mikrobna odpornost) najmanj vsaka tri leta.
Considering the seriousness of the threat from antimicrobial resistance, it is desirable to increase the reporting frequency within the limits set by feasibility and data reliability.
Glede na resnost grožnje mikrobne odpornosti bi bilo treba povečati pogostost poročanja, v skladu z omejitvami, ki jih narekujeta izvedljivost in zanesljivost podatkov.
In order to ensure the enforcement of certain obligations relating to the marketing authorisation for medicinal products for human use granted in accordance with Regulation (EC) No 726/2004, the Commission should be able to impose financial penalties.
Da bi zagotovili izvrševanje nekaterih obveznosti v zvezi z dovoljenji za promet z zdravili za uporabo v humani medicini, ki se izdajajo v skladu z Uredbo (ES) št. 726/2004, bi morala Komisija imeti možnost, da naloži denarne kazni.
When assessing the responsibility for failures to comply with those obligations and imposing such penalties, it is important that means exist to address the fact that marketing authorisation holders could be part of a wider economic entity.
Pri ocenjevanju odgovornosti zaradi neizpolnjevanja obveznosti in izrekanju takih kazni je pomembno, da obstajajo načini, kako ravnati v primeru, da bi bili lahko imetniki dovoljenj za promet del širšega gospodarskega subjekta.
Otherwise, there is a clear and identifiable risk that the responsibility for a failure to comply with those obligations could be evaded, which might have an impact on the ability to impose effective, proportional and dissuasive penalties.
V nasprotnem primeru obstaja jasno in ugotovljeno tveganje, da se je mogoče odgovornosti zaradi neizpolnjevanja teh obveznosti izogniti, kar lahko vpliva na zmožnost izrekanja učinkovitih, sorazmernih in odvračilnih kazni.
Detailed rules concerning financial penalties for failure to comply with certain obligations laid down in Regulation (EC) No 726/2004 and in Regulation (EC) No 1901/2006 of the European Parliament and of the Council are specified in Commission Regulation (EC) No 658/2007.
Podrobna pravila glede denarnih kazni zaradi neizpolnjevanja nekaterih obveznosti iz Uredbe (ES) št. 726/2004 in Uredbe (ES) št. 1901/2006 Evropskega parlamenta in Sveta so določena v Uredbi Komisije (ES) št. 658/2007.
Those rules should be maintained, but it is appropriate to consolidate them by moving their core elements and the list specifying those obligations into Regulation (EC) No 726/2004, while maintaining a delegation of powers that allows the Commission to supplement Regulation (EC) No 726/2004 by laying down procedures for imposing such financial penalties.
Ta pravila bi bilo treba ohraniti, vendar jih je primerno konsolidirati, in sicer tako, da se v Uredbo (ES) št. 726/2004 vključijo njihovi ključni elementi in seznam, ki določa navedene obveznosti, ter se ohrani prenos pooblastil, ki Komisiji omogoča, da dopolni Uredbo (ES) št. 726/2004 s tem, da določi postopke za naložitev takih denarnih kazni.
Regulation (EC) No 1901/2006 should be amended to take into account that the specification of obligations in that Regulation that are subject to financial penalties is laid down in Regulation (EC) No 726/2004 together with the powers that allow the Commission to lay down procedures for imposing such financial penalties.
Uredbo (ES) št. 1901/2006 bi bilo treba spremeniti, da bi se upoštevalo, da so obveznosti iz navedene uredbe, za katere se uporabljajo denarne kazni, določene v Uredbi (ES) št. 726/2004 skupaj s pooblastili, ki Komisiji omogočajo, da določi postopke za naložitev takih denarnih kazni.
As a consequence of the entry into force of the Treaty of Lisbon, the powers conferred on the Commission under Regulation (EC) No 726/2004 should be aligned to Articles 290 and 291 of the Treaty on the Functioning of the European Union (TFEU).
Zaradi začetka veljavnosti Lizbonske pogodbe bi bilo treba pooblastila, ki so bila Komisiji podeljena na podlagi Uredbe (ES) št. 726/2004, uskladiti s členoma 290 in 291 Pogodbe o delovanju Evropske unije (PDEU).
In order to supplement or amend certain non-essential elements of Regulation (EC) No 726/2004, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of determining the situations in which post-authorisation efficacy studies may be required, specifying the categories of medicinal products to which a marketing authorisation subject to specific obligations could be granted and specifying the procedures and requirements for granting such a marketing authorisation and for its renewal, specifying the categories in which variations should be classified and establishing procedures for the examination of applications for variations to the terms of marketing authorisations, establishing procedures for the examination of applications for the transfer of marketing authorisations, laying down the procedure and rules for the imposition of fines or periodic penalty payments for a failure to comply with the obligations under Regulation (EC) No 726/2004 as well as the conditions and methods for their collection.
Zaradi dopolnitve ali spremembe nekaterih nebistvenih elementov Uredbe (ES) št. 726/2004 bi bilo treba v skladu s členom 290 PDEU na Komisijo prenesti pooblastilo za sprejemanje aktov v zvezi z določanjem okoliščin, v katerih se lahko zahtevajo študije učinkovitosti po pridobitvi dovoljenja za promet, določitvijo kategorij zdravil, za katera bi se lahko dovoljenja za promet, za katera veljajo posebne obveznosti, izdala, določitvijo postopkov in zahtev za izdajo takega dovoljenja za promet in za njegovo podaljšanje, določitvijo skupin, v katere bi morale biti spremembe razvrščene, in postopkov za pregled vlog za spremembe pogojev dovoljenj za promet, določitvijo postopkov za pregled vlog za prenos dovoljenj za promet ter v zvezi z določitvijo postopka in pravil za naložitev glob ali periodičnih denarnih kazni za neizpolnitev obveznosti iz Uredbe (ES) št. 726/2004 ter pogojev in načinov izterjave.
In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Za zagotovitev enakopravnega sodelovanja pri pripravi delegiranih aktov Evropski parlament in Svet zlasti prejmeta vse dokumente sočasno s strokovnjaki iz držav članic, njuni strokovnjaki pa se lahko sistematično udeležujejo sestankov strokovnih skupin Komisije, ki zadevajo pripravo delegiranih aktov.
In order to ensure uniform conditions for the implementation of Regulation (EC) No 726/2004 in relation to marketing authorisations for medicinal products for human use, implementing powers should be conferred on the Commission.
Za zagotovitev enotnih pogojev izvajanja Uredbe (ES) št. 726/2004 v zvezi z dovoljenji za promet z zdravili za uporabo v humani medicini bi bilo treba na Komisijo prenesti izvedbena pooblastila.
It is appropriate, in order to provide for legal certainty, to clarify that Commission Regulation (EC) No 2141/96 remain in force and continue to apply unless and until repealed.
Za zagotovitev pravne varnosti je primerno, da se pojasni, da Uredba Komisije (ES) št. 2141/96 ostaja veljavna in se uporablja še naprej do njene morebitne razveljavitve.
For the same reason, it should be clarified that Regulations (EC) No 507/2006 and (EC) No 658/2007 remain in force and continue to apply unless and until repealed.
Iz istega razloga bi bilo treba pojasniti, da uredbi (ES) št. 507/2006 in št.
Regulations (EC) No 726/2004 and (EC) No 1901/2006 as well as Directive 2001/83/EC should therefore be amended accordingly,
(ES) št. 658/2007 ostajata veljavni in se uporabljata še naprej do njune morebitne razveljavitve.
HAVE ADOPTED THIS REGULATION:
Uredbi (ES) št. 726/2004 in (ES) št. 1901/2006 ter Direktivo 2001/83/ES bi bilo zato treba ustrezno spremeniti –
Amendments to Regulation (EC) No 726/2004
Člen 1
Regulation (EC) No 726/2004 is amended as follows:
Spremembe Uredbe (ES) št. 726/2004
the title is replaced by the following:
Uredba (ES) št. 726/2004 se spremeni:
‘Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency’;
naslov se nadomesti z naslednjim:
the word ‘Community’ is replaced by the word ‘Union’ and any necessary grammatical changes are made;
„Uredba (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Unije za pridobitev dovoljenja za promet in nadzor zdravil za humano uporabo ter o ustanovitvi Evropske agencije za zdravila“;
the words ‘Community Register’ in Article 13(1) and (2) are replaced by the words ‘Union Register’;
beseda „Skupnost“ se nadomesti z besedo „Unija“ in temu ustrezno se besedilo slovnično prilagodi;
the words ‘Court of Justice of the European Communities’ are replaced by the words ‘Court of Justice of the European Union’;
besede „Register zdravil Skupnosti“ v členu 13(1) in (2) se nadomestijo z besedami „Register Unije“;
the words ‘Protocol on the Privileges and Immunities of the European Communities’ are replaced by the words ‘Protocol on the Privileges and Immunities of the European Union’;
besede „Sodišče Evropskih skupnosti“ se nadomestijo z besedami „Sodišče Evropske unije“;
in Article 1, the first paragraph is replaced by the following:
besede „Protokol o privilegijih in imunitetah Evropskih skupnosti“ se nadomestijo z besedami „Protokol o privilegijih in imunitetah Evropske unije“;
‘The purpose of this Regulation is to lay down Union procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human use and to establish a European Medicines Agency (“the Agency”) which shall carry out the tasks relating to medicinal products for human use and veterinary medicinal products that are laid down in this Regulation and other relevant Union legislation.’;
v členu 1 se prvi odstavek nadomesti z naslednjim:
in Article 2, the first paragraph is replaced by the following:
„Namen te uredbe je določiti postopke Unije za pridobitev dovoljenja za promet, nadzor in farmakovigilanco zdravil za humano uporabo ter ustanoviti Evropsko agencijo za zdravila (v nadaljnjem besedilu: Agencija), ki bo opravljala naloge glede zdravil za humano uporabo in veterinarskih zdravil, določene v tej uredbi in v drugi relevantni zakonodaji Unije.“;
‘The definitions laid down in Article 1 of Directive 2001/83/EC shall apply for the purposes of this Regulation.
v členu 2 se prvi odstavek nadomesti z naslednjim:
As a consequence, in this Regulation, the terms, “medicinal product” and “medicinal product for human use” mean a medicinal product as defined in point (2) of Article 1 of Directive 2001/83/EC.
„V tej uredbi se uporabljajo opredelitve iz člena 1 Direktive 2001/83/ES.
In addition, the following definitions shall apply for the purposes of this Regulation:
Zato v tej uredbi izraza ‚zdravilo‘ in ‚zdravilo za humano uporabo‘ pomenita zdravilo, kot je opredeljeno v točki 2 člena 1 Direktive 2001/83/ES.
“veterinary medicinal product” means a medicinal product as defined in point (1) of Article 4 of Regulation (EU) 2019/6 of the European Parliament and of the Council ;
V tej uredbi se poleg tega uporabljajo naslednje opredelitve:
“antimicrobial” means an antimicrobial as defined in point (12) of Article 4 of Regulation (EU) 2019/6.
‚veterinarsko zdravilo‘ pomeni zdravilo, kakor je opredeljeno v točki 1 člena 4 Uredbe (EU) 2019/6 Evropskega parlamenta in Sveta;
Article 3 is amended as follows:
‚protimikrobna snov‘ pomeni protimikrobno snov, kakor je opredeljena v točki 12 člena 4 Uredbe (EU) 2019/6.
paragraph 2 is replaced by the following:
člen 3 se spremeni:
Any medicinal product not appearing in Annex I may be granted a marketing authorisation by the Union in accordance with this Regulation, if:
odstavek 2 se nadomesti z naslednjim:
the medicinal product contains an active substance which, on 20 May 2004, was not authorised in the Union; or
Kateremu koli zdravilu, ki ni navedeno v Prilogi I, sme Unija izdati dovoljenje za promet v skladu s to uredbo, če:
the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with this Regulation is in the interest of patients' health at Union level.’;
zdravilo vsebuje zdravilno učinkovino, ki 20. maja 2004 ni imela dovoljenja za promet v Uniji ali
in paragraph 3, the introductory wording and point (a) are replaced by the following:
predlagatelj dokaže, da zdravilo predstavlja pomembno terapevtsko, znanstveno ali tehnično inovacijo ali da je izdaja dovoljenja za promet v skladu s to uredbo v interesu zdravja bolnikov na ravni Unije.“;
‘A generic medicinal product of a reference medicinal product authorised by the Union may be authorised by the competent authorities of the Member States in accordance with Directive 2001/83/EC under the following conditions:
uvodno besedilo in točka (a) odstavka 3 se nadomestita z naslednjim:
the application for authorisation is submitted in accordance with Article 10 of Directive 2001/83/EC;’;
„Generično zdravilo referenčnega zdravila, ki ga je odobrila Unija, lahko odobrijo pristojni organi držav članic v skladu z Direktivo 2001/83/ES pod naslednjimi pogoji:
paragraph 4 is deleted;
je vloga za pridobitev dovoljenja za promet vložena v skladu s členom 10 Direktive 2001/83/ES;“;
in Article 4, paragraph 3 is deleted;
odstavek 4 se črta;
in Article 9(1), point (d) is replaced by the following:
v členu 4 se odstavek 3 črta;
the authorisation needs to be granted subject to the conditions provided for in Article 14(8) and Article 14-a.’;
v členu 9(1) se točka (d) nadomesti z naslednjim:
Article 10 is amended as follows:
je dovoljenje za promet treba izdati ob upoštevanju pogojev, predvidenih v členu 14(8) in členu 14-a.“;
The Commission shall, by means of implementing acts, take a final decision within 15 days after obtaining the opinion of the Standing Committee on Medicinal Products for Human Use.
člen 10 se spremeni:
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 87(2).’;
Komisija z izvedbenimi akti sprejme končno odločitev v 15 dneh po pridobitvi mnenja Stalnega odbora za zdravila za humano uporabo.
paragraph 5 is replaced by the following:
Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 87(2).“;
The Commission shall, by means of implementing acts, adopt detailed rules for the implementation of paragraph 4 which specify the applicable time limits and procedures.
odstavek 5 se nadomesti z naslednjim:
in Article 10b, paragraph 1 is replaced by the following:
Komisija z izvedbenimi akti sprejme podrobna pravila za izvajanje odstavka 4, ki določajo veljavne roke in postopke.
The Commission is empowered to adopt delegated acts in accordance with Article 87b, in order to supplement this Regulation by determining the situations in which post-authorisation efficacy studies may be required under point (cc) of Article 9(4) and point (b) of Article 10a(1).’;
v členu 10b se odstavek 1 nadomesti z naslednjim:
Article 14 is amended as follows:
Na Komisijo se prenese pooblastilo, da v skladu s členom 87b sprejme delegirane akte za dopolnitev te uredbe z določitvijo okoliščin, v katerih se lahko zahtevajo študije učinkovitosti po pridobitvi dovoljenja za promet na podlagi točke (cc) člena 9(4) in točke (b) člena 10a(1).“;
paragraph 1 is replaced by the following:
člen 14 se spremeni
Without prejudice to paragraphs 4 and 5 of this Article and to Article 14-a, a marketing authorisation shall be valid for five years.’;
odstavek 1 se nadomesti z naslednjim:
paragraph 7 is deleted.
Brez poseganja v odstavka 4 in 5 tega člena in v člen 14-a je dovoljenje za promet veljavno pet let.“;
the following Article is inserted before Article 14a:
odstavek 7 se črta;
‘Article 14-a
pred člen 14a se vstavi naslednji člen:
In duly justified cases, to meet unmet medical needs of patients, a marketing authorisation may, for medicinal products intended for the treatment, prevention or medical diagnosis of seriously debilitating or life-threatening diseases, be granted prior to the submission of comprehensive clinical data provided that the benefit of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required.
„Člen 14-a
In emergency situations, a marketing authorisation for such medicinal products may be granted also where comprehensive pre-clinical or pharmaceutical data have not been supplied.
V ustrezno utemeljenih primerih se zaradi zadovoljevanja neizpolnjenih zdravstvenih potreb bolnikov lahko dovoljenje za promet za zdravila, namenjena za zdravljenje, preprečevanje ali diagnozo resno izčrpavajočih ali življenjsko nevarnih bolezni, izda pred predložitvijo celovitih kliničnih podatkov, če korist takojšnje razpoložljivosti zadevnega zdravila na trgu odtehta tveganje, ki izhaja iz dejstva, da so potrebni še dodatni podatki.
For the purposes of this Article, “unmet medical needs” means a condition for which there exists no satisfactory method of diagnosis, prevention or treatment authorised in the Union or, even if such a method exists, in relation to which the medicinal product concerned will be of major therapeutic advantage to those affected.
V izrednih razmerah se lahko dovoljenje za promet za taka zdravila izda tudi kadar niso bili predloženi popolni predklinični ali farmacevtski podatki.
Marketing authorisations may be granted pursuant to this Article only if the risk-benefit balance of the medicinal product is favourable and the applicant is likely to be able to provide comprehensive data.
Za namene tega člena ‚nezadovoljene zdravstvene potrebe‘ pomeni zdravstveno stanje, za katero v Uniji ni odobrena nobena zadovoljiva metoda diagnoze, preprečevanja ali zdravljenja, in tudi če taka metoda obstaja, bo zadevno zdravilo za prizadete pomenilo znatno terapevtsko prednost.
Marketing authorisations granted pursuant to this Article shall be subject to specific obligations.
Dovoljenja za promet se v skladu s tem členom lahko izdajo le, če je razmerje med tveganjem in koristjo ugodno in če je verjetno, da bo predlagatelj zmožen zagotoviti popolne podatke.
Those specific obligations and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation.
Pri dovoljenjih za promet, ki se izdajo v skladu s tem členom, je treba upoštevati posebne obveznosti.
Those specific obligations shall be reviewed annually by the Agency.
Te posebne obveznosti in po potrebi roki za njihovo izpolnitev morajo biti navedeni v pogojih za dovoljenje za promet.
As part of the specific obligations referred to in paragraph 4, the holder of a marketing authorisation granted pursuant to this Article shall be required to complete ongoing studies, or to conduct new studies, with a view to confirming that the risk-benefit balance is favourable.
Te obveznosti vsako leto pregleda Agencija.
The summary of product characteristics and the package leaflet shall clearly mention that the marketing authorisation for the medicinal product has been granted subject to specific obligations as referred to in paragraph 4.
Kot del posebnih obveznosti iz odstavka 4 bo moral imetnik dovoljenja za promet, izdanega v skladu s tem členom, dokončati študije, ki potekajo, ali izvesti nove ter z njimi potrditi, da je razmerje med tveganji in koristmi ugodno.
By way of derogation from Article 14(1), a marketing authorisation granted pursuant to this Article shall be valid for one year, on a renewable basis.
V povzetku glavnih značilnosti zdravila in navodilu za uporabo je jasno navedeno, da je dovoljenje za promet z zdravilom izdano v skladu z posebnimi obveznostmi iz odstavka 4.
When the specific obligations referred to in paragraph 4 of this Article have been fulfilled, the Commission may, following an application by the marketing authorisation holder, and after receiving a favourable opinion from the Agency, grant a marketing authorisation valid for five years and renewable pursuant to Article 14(2) and (3).
Z odstopanjem od člena 14(1) dovoljenje za promet, odobreno v skladu s tem členom, velja eno leto in je obnovljivo.
The Commission is empowered to adopt delegated acts in accordance with Article 87b in order to supplement this Regulation by specifying:
Ko so posebne obveznosti iz odstavka 4 tega člena izpolnjene, lahko Komisija na podlagi vloge imenika dovoljenja za promet in po prejetju ugodnega mnenja Agencije, izda dovoljenje za promet z veljavnostjo petih let in obnovljivo v skladu s členom 14(2) in (3).