natgillin/translations-raw huggingface dataset:
the categories of medicinal products to which paragraph 1 of this Article applies; and
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 87b za dopolnitev te uredbe z določitvijo:
the procedures and requirements for granting a marketing authorisation pursuant to this Article and for its renewal.’;
kategorij zdravil, za katere se uporablja odstavek 1 tega člena in
in Article 16, paragraph 4 is deleted;
postopkov in zahtev za izdajo dovoljenja za promet v skladu s tem členom in za njegovo podaljšanje.“;
the following Articles are inserted:
v členu 16 se odstavek 4 črta;
‘Article 16a
vstavita se naslednja člena:
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.
„Člen 16a
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.
Spremembe se razvrstijo v različne skupine, odvisno od ravni tveganja za javno zdravje ter morebitnega vpliva na kakovost, varnost in učinkovitost zadevnega zdravila.
The procedures for examination of applications for variations shall be proportionate to the risk and impact involved.
Te skupine zajemajo vse od sprememb pogojev za dovoljenje in promet z zdravilom, pri katerih je možnost vpliva na kakovost, varnost ali učinkovitost zdravila največja, do sprememb, ki na zdravilo nimajo nobenega vpliva ali pa je ta minimalen.
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.
Postopki za pregled vlog za spremembe so sorazmerni s povezanim tveganjem in vplivom.
The Commission is empowered to adopt delegated acts in accordance with Article 87b in order to supplement this Regulation by:
Ti postopki vključujejo tako postopke, ki omogočajo izvajanje šele po odobritvi na podlagi popolne znanstvene presoje, kot tudi postopke, ki omogočajo takojšnje izvajanje, imetniku dovoljenja za promet pa, da Agencijo obvesti naknadno.
specifying the categories in which variations shall be classified; and
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 87b za dopolnitev te uredbe z določitvijo:
establishing procedures for the examination of applications for variations to the terms of marketing authorisations.
določitvijo skupin, v katere se razvrščajo spremembe, in
Article 16b
določitvijo postopkov za pregled vlog za spremembe pogojev dovoljenj za promet z zdravilom.
A marketing authorisation may be transferred to a new marketing authorisation holder.
Člen 16b
Such a transfer shall not be considered to be a variation.
Dovoljenje za promet se lahko prenese na novega imetnika dovoljenja za promet.
The transfer shall be subject to prior approval by the Commission, following the submission of an application for the transfer to the Agency.
Tak prenos se ne šteje kot sprememba.
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.’;
Po predložitvi vloge za prenos Agenciji mora prenos predhodno odobriti Komisija.
Article 20 is amended as follows:
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 87b za dopolnitev te uredbe z določitvijo postopkov za pregled vlog, predloženih Agenciji, za prenos dovoljenja za promet.“;
paragraph 3 is replaced by the following:
člen 20 se spremeni:
At any stage of the procedure laid down in this Article, following appropriate consultation of the Agency, the Commission may take temporary measures.
odstavek 3 se nadomesti z naslednjim:
Those temporary measures shall be applied immediately.
Komisija lahko v kateri koli fazi postopka iz tega člena po ustreznem posvetovanju z Agencijo sprejme začasne ukrepe.
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.
Navedeni začasni ukrepi se začnejo takoj uporabljati.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 87(2) of this Regulation.
Komisija brez nepotrebnega odlašanja z izvedbenimi akti sprejme končno odločitev o ukrepih, ki jih je treba sprejeti v zvezi z zadevnim zdravilom.
The Commission may also, pursuant to Article 127a of Directive 2001/83/EC, adopt a decision addressed to the Member States.’;
Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 87(2) te uredbe.
paragraph 6 is replaced by the following:
Komisija lahko v skladu s členom 127a Direktive 2001/83/ES sprejme tudi odločitev, naslovljeno na države članice.“;
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.’;
odstavek 6 se nadomesti z naslednjim:
the following Article is inserted before Chapter 3:
Umik zdravila iz odstavka 4 lahko velja, dokler ni sprejeta končna odločitev v skladu z odstavkom 3.“;
‘Article 20a
pred poglavjem 3 se vstavi naslednji člen:
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.
„Člen 20a
The Commission shall adopt a decision to vary, suspend or revoke that marketing authorisation in accordance with the procedure set out in Article 10.’;
Kadar Agencija ugotovi, da imetnik dovoljenja za promet, izdanega v skladu s členom 14-a, ni izpolnil obveznosti iz dovoljenja za promet, o tem ustrezno obvesti Komisijo.
Articles 30 to 54 are deleted;
Komisija sprejme odločbo o spremembi, začasnem preklicu ali ukinitvi tega dovoljenja za promet v skladu s postopkom iz člena 10.“;
Article 55 is replaced by the following:
členi 30 do 54 se črtajo;
‘Article 55
člen 55 se nadomesti z naslednjim:
A European Medicines Agency is hereby established.
„Člen 55
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.’;
S to uredbo se ustanovi Evropska agencija za zdravila.
Article 56 is amended as follows:
Agencija je odgovorna za koordiniranje obstoječih znanstvenih virov, ki so jih države članice dale na voljo zaradi vrednotenja, nadzora in farmakovigilance zdravil za humano uporabo in veterinarskih zdravil.“;
in paragraph 1, point (b) is replaced by the following:
člen 56 se spremeni:
the Committee for Veterinary Medicinal Products set up pursuant to Article 139(1) of Regulation (EU) 2019/6;’;
v odstavku 1 se točka (b) nadomesti z naslednjim:
in paragraph 2, the first subparagraph is replaced by the following:
Odbor za zdravila za uporabo v veterinarski medicini, ustanovljen v skladu s členom 139(1) Uredbe (EU) 2019/6;“;
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.
v odstavku 2 se prvi pododstavek nadomesti z naslednjim:
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.’;
Vsak od odborov iz točk (a), (aa), (c), (d), (da) in (e) odstavka 1 tega člena lahko ustanovi stalne in začasne delovne skupine.
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.
Odbor iz točke (a) odstavka 1 tega člena lahko ustanovi znanstvene svetovalne skupine v povezavi z vrednotenjem določenih vrst zdravil ali zdravljenj, na katere lahko prenese določene naloge, povezane s pripravo znanstvenih mnenj iz člena 5.“;
Those committees shall each establish a standing working party with the sole remit of providing scientific advice to undertakings.’;
Izvršni direktor v sodelovanju z Odborom za zdravila za humano uporabo in Odborom za zdravila za uporabo v veterinarski medicini določi upravne strukture in postopke, ki omogočajo razvoj svetovanja za podjetja, kot je navedeno v točki (n) člena 57(1), vključno s svetovanjem o uporabi novih metodologij in orodij pri raziskavah in razvoju, zlasti glede razvoja novih terapij.
in paragraph 4, the words ‘the Committee for Medicinal Products for Veterinary use’ are replaced by the words ‘the Committee for Veterinary Medicinal Products’;
Vsak od navedenih odborov ustanovi stalno delovno skupino, katere edina naloga je zagotoviti znanstveno svetovanje za podjetja.“;
Article 57 is amended as follows:
v odstavku 4 se besede „Odbor za zdravila za veterinarsko uporabo“ nadomestijo z besedami „Odbor za zdravila za uporabo v veterinarski medicini“;
paragraph 1 is amended as follows:
člen 57 se spremeni:
the introductory wording and points (a) to (f) are replaced by the following:
odstavek 1 se spremeni:
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.
uvodno besedilo in točke (a) do (f) se nadomestijo z naslednjim:
To that end, the Agency, acting particularly through its committees, shall carry out the following tasks:
Agencija državam članicam in institucijam Unije zagotovi najboljše možno znanstveno svetovanje o katerem koli vprašanju, ki je povezano z vrednotenjem kakovosti, varnosti in učinkovitosti zdravil za humano uporabo ali veterinarskih zdravil, ki se nanjo naslovi v skladu z zakonodajo Unije o zdravilih za humano uporabo ali veterinarskih zdravilih.
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;
V ta namen Agencija, ki deluje zlasti prek svojih odborov, izvaja naslednje naloge:
transmitting on request and making publicly available assessment reports, summaries of product characteristics, labels and package leaflets for the medicinal products for human use;
koordiniranje znanstvenega vrednotenja kakovosti, varnosti in učinkovitosti zdravil za humano uporabo in veterinarskih zdravil, za katere veljajo postopki pridobitve dovoljenja za promet v Uniji;
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;
posredovanje na zahtevo in omogočanje javnega dostopa do poročil o oceni zdravil za humano uporabo, povzetkov njihovih glavnih značilnosti, ovojnin in navodil za uporabo;
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;
usklajevanje spremljanja zdravil za humano uporabo in veterinarskih zdravil, odobrenih v Uniji, in svetovanje o ukrepih, potrebnih za zagotovitev varne in učinkovite uporabe teh zdravil, zlasti z usklajevanjem vrednotenja in izvajanja obveznosti in sistemov s področja farmakovigilance ter spremljanjem tega izvajanja;
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;
zagotavljanje zbiranja in razširjanja informacij o domnevnih neželenih učinkih zdravil za humano uporabo in veterinarskih zdravil, odobrenih v Uniji, s podatkovnimi bazami, ki so stalno dostopne vsem državam članicam;
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;’;
pomoč državam članicam tako, da informacije o pomislekih farmakovigilance v zvezi z zdravili za humano uporabo takoj posreduje zdravstvenim delavcem in usklajuje varnostna sporočila pristojnih nacionalnih organov;
points (g) and (h) are deleted;
razširjanje ustreznih informacij o pomislekih farmakovigilance v zvezi z zdravili za humano uporabo splošni javnosti, zlasti s postavitvijo in vodenjem evropskega spletnega portala o zdravilih;“;
points (i) to (t) are replaced by the following:
točki (g) in (h) se črtata;
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;
točke (i) do (t) se nadomestijo z naslednjim:
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;
pri zdravilih za humano uporabo in veterinarskih zdravilih koordiniranje preverjanja, kako se izpolnjujejo načela dobre proizvodne prakse, dobre laboratorijske prakse, dobre klinične prakse ter pri zdravilih za humano uporabo preverjanja, kako se izpolnjujejo obveznosti farmakovigilance;
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;
na zahtevo zagotavljanje tehnične in znanstvene podpore, da bi izboljšali sodelovanje med Unijo, njenimi državami članicami, mednarodnimi organizacijami in tretjimi državami pri znanstvenih in tehničnih vprašanjih, povezanih z vrednotenjem zdravil za humano uporabo in veterinarskih zdravil, še posebno v smislu razprav, organiziranih v okviru mednarodnih konferenc o harmonizaciji;
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;
vodenje stanja dovoljenj za promet z zdravili za humano uporabo in veterinarskih zdravil, ki so bila izdana v skladu s postopki Unije za pridobitev dovoljenja za promet;
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;
ustvarjanje podatkovne baze o zdravilih za humano uporabo, ki naj bo dostopna javnosti, zagotavljanje njenega posodabljanja in upravljanja neodvisno od farmacevtskih podjetij; podatkovna baza mora olajšati iskanje podatkov že odobrenih zdravil za navodila za uporabo; vključevati mora skupino podatkov o zdravilih za humano uporabo, odobrenih za zdravljenje otrok; informacije za splošno javnost se morajo oblikovati v primernem in razumljivem jeziku;
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;
pomoč Uniji in njenim državam članicam pri zagotavljanju informacij o zdravilih za humano uporabo in veterinarskih zdravilih, ki jih je ovrednotila Agencija, zdravstvenim delavcem in javnosti;
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;
svetovanje podjetjem o vodenju različnih preskusov in preskušanj, ki so potrebni, da bi dokazali kakovost, varnost in učinkovitost zdravil za humano uporabo in veterinarskih zdravil;
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;
preverjanje, ali se upoštevajo pogoji, določeni v zakonodaji Unije glede zdravil za humano uporabo in veterinarskih zdravil in v dovoljenjih za promet v primeru paralelne distribucije zdravil za humano uporabo in veterinarskih zdravil, odobrenih v skladu s to uredbo ali Uredbo (EU) 2019/6, kot je ustrezno;
with a view to the protection of public health, compiling scientific information concerning pathogenic agents which might be used in biological warfare, including the existence of vaccines and other medicinal products for human use and other veterinary medicinal products available to prevent or treat the effects of such agents;
priprava kakršnega koli znanstvenega mnenja, ki ga zahteva Komisija in zadeva vrednotenje zdravil za humano uporabo in veterinarskih zdravil ali vhodnih snovi, ki se uporabljajo v proizvodnji zdravil za humano uporabo in veterinarskih zdravil;
coordinating the supervision of the quality of medicinal products for human use and of veterinary medicinal products placed on the market by requesting testing of compliance with their authorised specifications by an Official Medicines Control Laboratory or by a laboratory that a Member State has designated for that purpose;
z ozirom na varovanje javnega zdravja, zbiranje znanstvenih podatkov glede patogenih povzročiteljev, ki bi se lahko uporabili v biološkem bojevanju, vključno s prisotnostjo cepiv in drugih zdravil za humano uporabo in drugih veterinarskih zdravil, ki so na voljo za preprečevanje ali zdravljenje učinkov teh povzročiteljev;
forwarding annually to the budgetary authority any information relevant to the outcome of the evaluation procedures for medicinal products for human use and veterinary medicinal products;
koordiniranje nadzora kakovosti zdravil za humano uporabo in veterinarskih zdravil, danih v promet, z zahtevo za preskušanje skladnosti z odobrenimi specifikacijami, ki ga opravi uradni kontrolni laboratorij za analizno preskušanje zdravil ali pa laboratorij, ki ga je država članica imenovala v ta namen;
taking decisions as referred to in Article 7(1) of Regulation (EC) No 1901/2006 of the European Parliament and of the Council;
letno pošiljanje vsakršnih podatkov, ki so pomembni za izid postopkov vrednotenja zdravil za humano uporabo in veterinarskih zdravil, proračunskemu organu;
the following point is added:
sprejemanje odločitev iz člena 7(1) Uredbe (ES) št. 1901/2006 Evropskega parlamenta in Sveta;
contributing to the joint reporting with the European Food Safety Authority and European Centre for Disease Prevention and Control on the sales and use of antimicrobials in human and veterinary medicine as well as on the situation as regards antimicrobial resistance in the Union based on contributions received by Member States, taking into account the reporting requirements and periodicity in Article 57 of Regulation (EU) 2019/6.
doda se naslednja točka:
Such joint reporting shall be carried out at least every three years.’;
prispevanje k skupnemu poročanju z Evropsko agencijo za varnost hrane in Evropskim centrom za preprečevanje in obvladovanje bolezni o prodaji in uporabi protimikrobnih snovi v humani in veterinarski medicini ter o razmerah na področju mikrobne odpornosti v Uniji na podlagi prispevkov držav članic, pri čemer se upoštevajo zahteve za poročanje in periodičnost iz člena 57 Uredbe (EU) 2019/6.
The database provided for in point (l) of paragraph 1 of this Article shall include the summaries of product characteristics, the package leaflet and the information shown on the labelling.
Tako skupno poročanje se izvaja najmanj vsaka tri leta.“;
That database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC.
Podatkovna baza iz točke (l) odstavka 1 tega člena vključuje povzetke glavnih značilnosti zdravil, navodila za uporabo zdravila in podatke, prikazane na ovojnini.
The database shall subsequently be extended to include any medicinal product for human use authorised in the Union.’;
Ta podatkovna baza se pripravlja postopoma, prednost imajo zdravila, odobrena na podlagi te uredbe, in tista, ki so odobrena na podlagi poglavja 4 naslova III Direktive 2001/83/ES.
in Article 59, paragraph 4 is replaced by the following:
Podatkovna se bo širila, da bo vključevala vsa zdravila za humano uporabo z dovoljenjem za promet v Uniji.“;
Unless otherwise provided for in this Regulation, Regulation (EU) 2019/6 or Directive 2001/83/EC, where there is a fundamental conflict over scientific points and the body concerned is a body in a Member State, the Agency and the national body concerned shall work together either to resolve the conflict or to prepare a joint document clarifying the scientific points of conflict.
v členu 59 se odstavek 4 nadomesti z naslednjim:
Such joint document shall be published immediately after its adoption.’;
V primeru temeljnega nasprotja glede znanstvenih vprašanj in če gre pri zadevnem organu za organ v državi članici, skušata Agencija in zadevni nacionalni organ skupaj rešiti nasprotja ali pa pripravita skupen dokument, v katerem pojasnita sporna znanstvena vprašanja, če ni drugače določeno v tej uredbi, Uredbi (EU) 2019/6 ali Direktivi 2001/83/ES.
Article 61 is amended as follows:
Tak skupen dokument se objavi takoj po sprejetju.“;
paragraphs 1 and 2 are replaced by the following:
člen 61 se spremeni:
Each Member State shall, after consultation of the Management Board, appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Medicinal Products for Human Use.
odstavka 1 in 2 se nadomestita z naslednjim:
The alternates shall represent and vote for the members in their absence and may also be appointed to act as rapporteurs in accordance with Article 62.
Vsaka država članica po posvetovanju z upravnim odborom imenuje enega člana in enega namestnika v Odbor za zdravila za humano uporabo, in sicer z možnostjo podaljšanja za obdobje treh let.