natgillin/translations-raw huggingface dataset:
Article 10 is amended as follows:
„Nadležna tijela država članica mogu, u skladu s Direktivom 2001/83/EZ, odobriti generički lijek na temelju odobrenog referentnog lijeka koji je odobrila Unija, pod sljedećim uvjetima:
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.
zahtjev za izdavanje odobrenja podnesen je u skladu s člankom 10.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 87(2).’;
Direktive 2001/83/EZ;”;
paragraph 5 is replaced by the following:
stavak 4. briše se;
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.
u članku 4. briše se stavak 3.;
in Article 10b, paragraph 1 is replaced by the following:
u članku 9. stavku 1. točka (d) zamjenjuje se sljedećim:
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).’;
odobrenje se treba izdati podložno uvjetima iz članka 14. stavka 8. i članka 14.-a.”;
Article 14 is amended as follows:
11. članak 10. mijenja se kako slijedi:
paragraph 1 is replaced by the following:
Komisija provedbenim aktima donosi konačnu odluku u roku od 15 dana nakon što dobije mišljenje Stalnog odbora za lijekove za humanu uporabu.
Without prejudice to paragraphs 4 and 5 of this Article and to Article 14-a, a marketing authorisation shall be valid for five years.’;
Ti se provedbeni akti donose u skladu s postupkom ispitivanja iz članka 87. stavka 2.”;
paragraph 7 is deleted.
stavak 5. zamjenjuje se sljedećim:
the following Article is inserted before Article 14a:
Komisija provedbenim aktima donosi detaljna pravila za provedbu stavka 4. kojima se određuju primjenjivi rokovi i postupci.
‘Article 14-a
u članku 10.b stavak 1. zamjenjuje se sljedećim:
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.
Komisija je ovlaštena za donošenje delegiranih akata u skladu s člankom 87.b radi dopune ove Uredbe utvrđivanjem situacija u kojima se mogu zahtijevati ispitivanja djelotvornosti nakon izdavanja odobrenja u skladu s člankom 9. stavkom 4. točkom (cc) i člankom 10.a stavkom 1. točkom (b).”;
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.
13. članak 14. mijenja se kako slijedi:
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.
stavak 1. zamjenjuje se sljedećim:
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.
Ne dovodeći u pitanje stavke 4. i 5. ovog članka i članak 14.-a, odobrenje za stavljanje u promet vrijedi pet godina.”;
Marketing authorisations granted pursuant to this Article shall be subject to specific obligations.
stavak 7. briše se;
Those specific obligations and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation.
ispred članka 14.a umeće se sljedeći članak:
Those specific obligations shall be reviewed annually by the Agency.
„Članak 14.-a
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.
U valjano opravdanim slučajevima, radi ispunjavanja nezadovoljenih medicinskih potreba pacijenata, odobrenje za stavljanje u promet za lijekove namijenjene liječenju, prevenciji ili medicinskoj dijagnozi ozbiljno iscrpljujućih ili po život opasnih bolesti može se izdati prije podnošenja sveobuhvatnih kliničkih podataka pod uvjetom da je korist od trenutačne dostupnosti dotičnog lijeka na tržištu veća od rizika povezanog s činjenicom da se još uvijek zahtijevaju dodatni podaci.
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.
U hitnim se situacijama odobrenje za stavljanje u promet takvih lijekova može izdati i u slučaju da nisu dostavljeni sveobuhvatni pretklinički ili farmaceutski podaci.
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.
Za potrebe ovog članka ‚nezadovoljene medicinske potrebe’ znači zdravstveno stanje za koje u Uniji ne postoji odobrena zadovoljavajuća metoda dijagnosticiranja, prevencije ili liječenja ili, čak i da takva metoda postoji, za koje će dotični lijek predstavljati značajnu terapijsku korist za pacijente pogođene tim stanjem.
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).
Odobrenja za stavljanje u promet mogu se izdati u skladu s ovim člankom samo ako je odnos rizika i koristi lijeka povoljan i ako će podnositelj zahtjeva vjerojatno moći dostaviti sveobuhvatne podatke.
The Commission is empowered to adopt delegated acts in accordance with Article 87b in order to supplement this Regulation by specifying:
Odobrenja za stavljanje u promet u skladu s ovim člankom podliježu posebnim obvezama.
the categories of medicinal products to which paragraph 1 of this Article applies; and
Te posebne obveze i, prema potrebi, rok za njihovo ispunjenje navode se u uvjetima odobrenja za stavljanje u promet.
the procedures and requirements for granting a marketing authorisation pursuant to this Article and for its renewal.’;
Te posebne obveze Agencija preispituje svake godine.
in Article 16, paragraph 4 is deleted;
U sklopu posebnih obveza iz stavka 4. od nositelja odobrenja za stavljanje u promet izdanog u skladu s ovim člankom zahtijeva se da dovrši ispitivanja koja su u tijeku, ili da provede nova ispitivanja, radi potvrđivanja da je odnos rizika i koristi povoljan.
the following Articles are inserted:
U sažetku opisa svojstava lijeka i uputi o lijeku jasno se navodi da je odobrenje za stavljanje u promet lijeka izdano u skladu s posebnim obvezama iz stavka 4.
‘Article 16a
Odstupajući od članka 14. stavka 1., odobrenje za stavljanje u promet izdano u skladu s ovim člankom vrijedi godinu dana i može se produžiti.
Variations shall be classified in different categories depending on the level of risk to public health and the potential impact on the quality, safety and efficacy of the medicinal product concerned.
Ako su ispunjene posebne obveze iz stavka 4. ovog članka, Komisija može, na zahtjev nositelja odobrenja za stavljanje u promet i nakon što dobije pozitivno mišljenje Agencije, izdati odobrenje za stavljanje u promet koje će vrijediti pet godina i koje će se moći obnoviti u skladu s člankom 14. stavcima 2. i 3.
Those categories shall range from changes to the terms of the marketing authorisation that have the highest potential impact on the quality, safety or efficacy of the medicinal product, to changes that have no or minimal impact thereon.
Komisija je ovlaštena za donošenje delegiranih akata u skladu s člankom 87.b radi dopune ove Uredbe navođenjem:
The procedures for examination of applications for variations shall be proportionate to the risk and impact involved.
kategorija lijekova na koje se primjenjuje stavak 1. ovog članka; i
Those procedures shall range from procedures that allow implementation only after approval based on a complete scientific assessment to procedures that allow immediate implementation and subsequent notification by the marketing authorisation holder to the Agency.
postupaka i zahtjeva za izdavanje odobrenja za stavljanje u promet u skladu s ovim člankom te za njegovu obnovu.”;
The Commission is empowered to adopt delegated acts in accordance with Article 87b in order to supplement this Regulation by:
u članku 16. briše se stavak 4.;
specifying the categories in which variations shall be classified; and
umeću se sljedeći članci:
establishing procedures for the examination of applications for variations to the terms of marketing authorisations.
„Članak 16.a
Article 16b
Izmjene se razvrstavaju u različite kategorije, ovisno o razini opasnosti za javno zdravlje te mogućem utjecaju na kakvoću, neškodljivost i djelotvornost dotičnog lijeka.
A marketing authorisation may be transferred to a new marketing authorisation holder.
Raspon tih kategorija je od promjena uvjeta odobrenja za stavljanje u promet koje imaju najveći mogući utjecaj na kakvoću, neškodljivost ili djelotvornost lijeka, do promjena koje imaju minimalni utjecaj na navedeno ili ga nemaju.
Such a transfer shall not be considered to be a variation.
Postupci za razmatranje zahtjeva za izmjene razmjerni su uključenom riziku i utjecaju.
The transfer shall be subject to prior approval by the Commission, following the submission of an application for the transfer to the Agency.
Ti postupci variraju od postupaka kojima se provedba dopušta tek nakon odobrenja temeljenog na potpunom znanstvenom ocjenjivanju do postupaka kojima se dopušta da se izmjene trenutačno provedu i da nositelj odobrenja za stavljanje u promet podatke naknadno dostavi Agenciji.
The Commission is empowered to adopt delegated acts in accordance with Article 87b in order to supplement this Regulation by establishing procedures for the examination of applications to the Agency for the transfer of marketing authorisations.’;
Komisija je ovlaštena za donošenje delegiranih akata u skladu s člankom 87.b radi dopune ove Uredbe:
Article 20 is amended as follows:
navođenjem kategorija u koje se razvrstavaju izmjene; i
paragraph 3 is replaced by the following:
uspostavljanjem postupaka za razmatranje zahtjeva za izmjene uvjeta odobrenja za stavljanje u promet.
At any stage of the procedure laid down in this Article, following appropriate consultation of the Agency, the Commission may take temporary measures.
Članak 16.b
Those temporary measures shall be applied immediately.
Odobrenje za stavljanje u promet može se prenijeti na novog nositelja odobrenja za stavljanje u promet.
Without undue delay, the Commission shall, by means of implementing acts, adopt a final decision concerning the measures to be taken in respect of the medicinal product concerned.
Takav prijenos ne smatra se izmjenom.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 87(2) of this Regulation.
Prijenos podliježe prethodnom odobrenju Komisije, nakon što se Agenciji podnese zahtjev za prijenos.
The Commission may also, pursuant to Article 127a of Directive 2001/83/EC, adopt a decision addressed to the Member States.’;
Komisija je ovlaštena za donošenje delegiranih akata u skladu s člankom 87.b radi dopune ove Uredbe uspostavljanjem postupaka za razmatranje zahtjeva za prijenos odobrenja za stavljanje u promet koji se podnesu Agenciji.”;
paragraph 6 is replaced by the following:
17. članak 20. mijenja se kako slijedi:
The suspensive measures referred to in paragraph 4 may be maintained in force until such time as a final decision has been adopted in accordance with paragraph 3.’;
stavak 3. zamjenjuje se sljedećim:
the following Article is inserted before Chapter 3:
Nakon odgovarajućeg savjetovanja s Agencijom, Komisija može u bilo kojoj fazi postupka utvrđenog u ovom članku poduzeti privremene mjere.
‘Article 20a
Navedene privremene mjere odmah se primjenjuju.
Where the Agency concludes that a holder of a marketing authorisation granted pursuant to Article 14-a failed to comply with the obligations laid down in the marketing authorisation, the Agency shall inform the Commission accordingly.
Komisija bez neopravdane odgode provedbenim aktima donosi konačnu odluku o mjerama koje je potrebno poduzeti u pogledu dotičnog lijeka.
The Commission shall adopt a decision to vary, suspend or revoke that marketing authorisation in accordance with the procedure set out in Article 10.’;
Ti se provedbeni akti donose u skladu s postupkom ispitivanja iz članka 87. stavka 2. ove Uredbe.
Articles 30 to 54 are deleted;
Komisija može u skladu s člankom 127.a Direktive 2001/83/EZ donijeti i odluku upućenu državama članicama.”:
Article 55 is replaced by the following:
stavak 6. zamjenjuje se sljedećim:
‘Article 55
Mjere obustave iz stavka 4. mogu ostati na snazi do donošenja konačne odluke u skladu sa stavkom 3.”;
A European Medicines Agency is hereby established.
ispred poglavlja 3. umeće se sljedeći članak:
The Agency shall be responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products for human use and of veterinary medicinal products.’;
„Članak 20.a
Article 56 is amended as follows:
Ako Agencija zaključi da nositelj odobrenja za stavljanje u promet izdanog u skladu s člankom 14.-a nije poštovao obveze utvrđene u odobrenju za stavljanje u promet, Agencija o tome obavješćuje Komisiju.
in paragraph 1, point (b) is replaced by the following:
Komisija donosi odluku o izmjeni, obustavi ili opozivu tog odobrenja za stavljanje u promet u skladu s postupkom iz članka 10.”;
the Committee for Veterinary Medicinal Products set up pursuant to Article 139(1) of Regulation (EU) 2019/6;’;
članci od 30. do 54. brišu se;
in paragraph 2, the first subparagraph is replaced by the following:
20. članak 55. zamjenjuje se sljedećim:
The committees referred to in points (a), (aa), (c), (d), (da) and (e) of paragraph 1 of this Article may each establish standing and temporary working parties.
„Članak 55.
The committee referred to in point (a) of paragraph 1 of this Article may establish scientific advisory groups in connection with the evaluation of specific types of medicinal products or treatments, to which it may delegate certain tasks associated with drawing up the scientific opinions referred to in Article 5.’;
Osniva se Europska agencija za lijekove.
The Executive Director, in consultation with the Committee for Medicinal Products for Human Use and the Committee for Veterinary Medicinal Products, shall set up the administrative structures and procedures allowing the development of advice for undertakings, as referred to in point (n) of Article 57(1), including advice on the use of novel methodologies and tools in research and development, particularly regarding the development of new therapies.
Agencija je nadležna za koordinaciju postojećih znanstvenih izvora koje su joj države članice stavile na raspolaganje radi ocjenjivanja, nadzora i farmakovigilancije lijekova za humanu uporabu i veterinarsko-medicinskih proizvoda.”;
Those committees shall each establish a standing working party with the sole remit of providing scientific advice to undertakings.’;
21. članak 56. mijenja se kako slijedi:
in paragraph 4, the words ‘the Committee for Medicinal Products for Veterinary use’ are replaced by the words ‘the Committee for Veterinary Medicinal Products’;
u stavku 1. točka (b) zamjenjuje se sljedećim:
Article 57 is amended as follows:
Odbor za veterinarsko-medicinske proizvode osnovan u skladu s člankom 139. stavkom 1.
paragraph 1 is amended as follows:
Uredbe (EU) 2019/6;”;
the introductory wording and points (a) to (f) are replaced by the following:
u stavku 2. prvi podstavak zamjenjuje se sljedećim:
The Agency shall provide the Member States and the institutions of the Union with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human use or veterinary medicinal products which is referred to it in accordance with the Union legislation relating to medicinal products for human use or veterinary medicinal products.
Svaki od odbora iz stavka 1. točaka (a), (aa), (c), (d), (da) i (e) ovog članka može osnivati stalne i privremene radne skupine.
To that end, the Agency, acting particularly through its committees, shall carry out the following tasks:
Odbor iz stavka 1. točke (a) ovog članka može osnivati znanstveno-savjetodavne skupine u vezi s ocjenjivanjem određenih vrsta lijekova ili liječenja te im može delegirati određene zadaće povezane sa sastavljanjem znanstvenih mišljenja iz članka 5.”;
coordinating the scientific evaluation of the quality, safety and efficacy of medicinal products for human use and of veterinary medicinal products which are subject to Union marketing authorisation procedures;
Izvršni direktor, uz savjetovanje s Odborom za lijekove za humanu uporabu i s Odborom za veterinarsko-medicinske proizvode, uspostavlja upravne strukture i postupke koji omogućuju razvoj savjetovanja za poduzeća, kako je navedeno u članku 57. stavku 1. točki (n), uključujući savjetovanje o uporabi novih metodologija i alata u istraživanju i razvoju, posebno u pogledu razvoja novih terapija.
transmitting on request and making publicly available assessment reports, summaries of product characteristics, labels and package leaflets for the medicinal products for human use;
Svaki od tih odbora osniva stalnu radnu skupinu čija je jedina zadaća pružati znanstvene savjete poduzećima.”;
coordinating the monitoring of medicinal products for human use and of veterinary medicinal products which have been authorised in the Union and providing advice on the measures necessary to ensure the safe and effective use of those products, in particular by coordinating the evaluation and implementation of pharmacovigilance obligations and systems and the monitoring of such implementation;
(Ne odnosi se na hrvatsku verziju.)
ensuring the collation and dissemination of information on suspected adverse reactions to medicinal products for human use and to veterinary medicinal products authorised in the Union by means of databases that are permanently accessible to all Member States;
22. članak 57. mijenja se kako slijedi:
assisting Member States with the rapid communication of information on pharmacovigilance concerns relating to medicinal products for human use to healthcare professionals and coordinating the safety announcements of the national competent authorities;
stavak 1. mijenja se kako slijedi:
distributing appropriate information on pharmacovigilance concerns relating to medicinal products for human use to the general public, in particular by setting up and maintaining a European medicines web-portal;’;
i. uvodni dio i točke od (a) do (f) zamjenjuju se sljedećim:
points (g) and (h) are deleted;
Agencija državama članicama i institucijama Unije pruža najbolje moguće znanstvene savjete o svim pitanjima koja su joj upućena, a odnose se na ocjenjivanje kakvoće, neškodljivosti i djelotvornosti lijekova za humanu uporabu ili veterinarsko-medicinskih proizvoda, u skladu sa zakonodavstvom Unije o lijekovima za humanu uporabu ili veterinarsko-medicinskim proizvodima.
points (i) to (t) are replaced by the following:
U tu svrhu Agencija, posebno djelujući putem svojih odbora, izvršava sljedeće zadaće:
coordinating, as regards medicinal products for human use and veterinary medicinal products, the verification of compliance with the principles of good manufacturing practice, good laboratory practice, good clinical practice and, as regards medicinal products for human use, the verification of compliance with pharmacovigilance obligations;
koordiniranje znanstvenog ocjenjivanja kakvoće, neškodljivosti i djelotvornosti lijekova za humanu uporabu i veterinarsko-medicinskih proizvoda na koje se primjenjuju postupci Unije za izdavanje odobrenja za stavljanje u promet;
upon request, providing technical and scientific support in order to improve cooperation between the Union, its Member States, international organisations and third countries on scientific and technical issues relating to the evaluation of medicinal products for human use and of veterinary medicinal products, in particular in the context of discussions organised in the framework of international conferences on harmonisation;
dostavljanje na zahtjev i javno objavljivanje izvješća o procjeni, sažetaka opisa svojstava lijeka, označivanja i uputa o lijekovima za te lijekove za humanu uporabu;
recording the status of marketing authorisations for medicinal products for human use and for veterinary medicinal products granted in accordance with Union marketing authorisation procedures;
koordiniranje nadzora lijekova za humanu uporabu i veterinarsko-medicinskih proizvoda koji su odobreni u Uniji te pružanje savjeta o mjerama potrebnima za osiguranje neškodljive i djelotvorne uporabe tih lijekova odnosno proizvoda, posebno putem koordinacije ocjenjivanja i provedbe obveza i sustava farmakovigilancije te praćenja te provedbe;
creating a database on medicinal products for human use, to be accessible to the general public, and ensuring that it is updated, and managed independently of pharmaceutical companies; the database is to facilitate the search for information already authorised for package leaflets; it is to include a section on medicinal products for human use authorised for the treatment of children; the information provided to the general public is to be worded in an appropriate and comprehensible manner;
osiguravanje uspoređivanja i širenja informacija o sumnjama na nuspojave lijekova za humanu uporabu i veterinarsko-medicinskih proizvoda koji su odobreni u Uniji, putem baza podataka koje su stalno dostupne svim državama članicama;
assisting the Union and its Member States in the provision of information to health-care professionals and the general public about medicinal products for human use and about veterinary medicinal products evaluated by the Agency;
pružanje pomoći državama članicama u brzom prosljeđivanju podataka zdravstvenim djelatnicima o pitanjima farmakovigilancije u vezi s lijekovima za humanu uporabu i koordiniranje sigurnosnih obavijesti nacionalnih nadležnih tijela;
advising undertakings on the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products for human use and of veterinary medicinal products;
distribuiranje odgovarajućih podataka široj javnosti o pitanjima farmakovigilancije u vezi s lijekovima za humanu uporabu, posebno uspostavom i održavanjem europskog internetskog portala za lijekove;”;
checking that the conditions laid down in Union legislation on medicinal products for human use and on veterinary medicinal products and in the marketing authorisations are met in the case of parallel distribution of medicinal products for human use and on veterinary medicinal products authorised in accordance with this Regulation or, as applicable, Regulation (EU) 2019/6;
točke (g) i (h) brišu se;
drawing up, at the Commission’s request, any other scientific opinion concerning the evaluation of medicinal products for human use and of veterinary medicinal products or the starting materials used in the manufacture of medicinal products for human use and of veterinary medicinal products;
točke od (i) do (t) zamjenjuju se sljedećim: