natgillin/translations-raw huggingface dataset:
Members and alternates shall be chosen for their role and experience in the evaluation of medicinal products for human use as appropriate and shall represent the national competent authorities.
Namestniki zastopajo člane in volijo namesto njih ob njihovi odsotnosti ter so lahko tudi imenovani, da v skladu s členom 62 delujejo kot poročevalci.
The Committee for Medicinal Products for Human Use may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence.
Člani in namestniki so izbrani na podlagi svoje vloge in izkušenj pri vrednotenju zdravil za humano uporabo in zastopajo pristojne nacionalne organe.
Those members shall be appointed for a term of three years, which may be renewed, and shall not have alternates.
Odbor za zdravila za humano uporabo se lahko odloči za največ pet dodatnih članov, ki jih izbere na podlagi njihovih posebnih znanstvenih izkušenj in znanja.
With a view to the co-opting of such members, the Committee for Medicinal Products for Human Use shall identify the specific complementary scientific competence of the additional member or members.
Ti člani so imenovani za obdobje treh let, ki se lahko obnovi, in nimajo namestnikov.
Co-opted members shall be chosen among experts nominated by Member States or the Agency.’;
Pri izbiranju teh članov Odbor za zdravila za humano uporabo opredeli posebne dopolnilne znanstvene izkušnje in znanja dodatnega člana ali članov.
in paragraphs 3, 5 and 8, the words ‘each committee’ are replaced by the words ‘the Committee for Medicinal Products for Human Use’;
Kooptirani člani so izbrani med strokovnjaki, ki jih imenujejo države članice ali Agencija.“;
paragraph 4 is replaced by the following:
v odstavkih 3, 5 in 8 se besedi „vsak odbor“ nadomestita z besedami „Odbor za zdravila za humano uporabo“;
The Executive Director of the Agency or his or her representative and representatives of the Commission shall be entitled to attend all meetings of the committees referred to in Article 56(1), working parties and scientific advisory groups and all other meetings convened by the Agency or its committees.’;
odstavek 4 se nadomesti z naslednjim:
paragraphs 6 and 7 are replaced by the following:
Izvršni direktor Agencije ali njegov predstavnik in predstavniki Komisije imajo pravico biti navzoči pri vseh srečanjih odborov iz člena 56(1), delovnih skupin in znanstvenih svetovalnih skupin in vseh ostalih srečanjih, na katerih se sestajajo Agencija ali njen odbor.“;
Members of the Committee for Medicinal Products for Human Use and experts responsible for evaluating medicinal products shall rely on the scientific evaluation and resources available to national marketing authorisation bodies.
odstavka 6 in 7 se nadomestita z naslednjim:
Each competent national authority shall monitor the scientific level and independence of the evaluation carried out and facilitate the activities of nominated members of that Committee and experts.
Člani Odbora za zdravila za humano uporabo in strokovnjaki, ki so odgovorni za vrednotenje zdravil, se opirajo na znanstveno vrednotenje in vire, ki so na voljo nacionalnim organom za pridobitev dovoljenja za promet.
Member States shall refrain from giving those members and experts any instruction which is incompatible with their own individual tasks or with the tasks and responsibilities of the Agency.
Vsak pristojen nacionalni organ spremlja znanstveno raven in neodvisnost opravljenega vrednotenja ter olajša dejavnosti imenovanih članov tega odbora in strokovnjakov.
When preparing the opinion, the committees referred to in Article 56(1) shall use their best endeavours to reach a scientific consensus.
Države članice se vzdržijo, da bi tem članom in strokovnjakom dajale kakršna koli navodila, ki niso združljiva z njihovimi individualnimi nalogami ali nalogami ter odgovornostmi Agencije.
If such a consensus cannot be reached, the opinion shall consist of the position of the majority of members and divergent positions, with the grounds on which they are based.’;
Pri pripravi mnenja si odbori iz člena 56(1) kar najbolj prizadevajo, da bi dosegli znanstveno soglasje.
Article 62 is amended as follows:
Če takega soglasja ni mogoče doseči, je mnenje sestavljeno iz stališča večine članov in odstopajočih stališč z razlogi, na katerih temeljijo.“;
in paragraph 1, the third and fourth subparagraphs are replaced by the following:
člen 62 se spremeni:
‘When consulting the scientific advisory groups referred to in Article 56(2), the Committee shall forward to them the draft assessment report or reports drawn up by the rapporteur or the co-rapporteur.
v odstavku 1 se tretji in četrti pododstavek nadomestita z naslednjim:
The opinion issued by the scientific advisory group shall be forwarded to the chairman of the relevant committee in such a way as to ensure that the deadlines laid down in Article 6(3) are met.
„Ob posvetovanju z znanstvenimi svetovalnimi skupinami iz člena 56(2) jim odbor posreduje osnutek poročila ali poročil o oceni zdravila, ki ga sestavi poročevalec ali soporočevalec.
The substance of the opinion shall be included in the assessment report published pursuant to Article 13(3).’;
Mnenje, ki ga izda znanstvena svetovalna skupina, se posreduje predsedniku ustreznega odbora tako, da se zagotovi spoštovanje rokov iz člena 6(3).
Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products for human use and veterinary medicinal products who, taking into account Article 63(2), would be available to serve on working parties or scientific advisory groups of any of the committees referred to in Article 56(1), together with an indication of their qualifications and specific areas of expertise.
Vsebina mnenja je vključena v poročilo o oceni zdravila, ki je objavljeno v skladu s členom 13(3).“;
The Agency shall establish and maintain a list of accredited experts.
Države članice posredujejo Agenciji imena nacionalnih strokovnjakov z dokazanimi izkušnjami pri vrednotenju zdravil za humano uporabo in veterinarskih zdravil, ki bi bili ob upoštevanju člena 63(2) na voljo za delo v delovnih skupinah ali znanstvenih svetovalnih skupinah katerega koli odbora iz člena 56(1), skupaj z navedbo strokovnih usposobljenosti in posebnih strokovnih področij.
That list shall include the national experts referred to in the first subparagraph and any other experts appointed by the Agency or the Commission, and shall be updated.’;
Agencija pripravi in vodi seznam akreditiranih strokovnjakov.
Article 64 is amended as follows:
Tak seznam vključuje nacionalne strokovnjake iz prvega pododstavka in vse druge strokovnjake, ki jih neposredno določi Agencija ali Komisija, ter se posodablja.“;
The Executive Director shall be appointed by the Management Board, on a proposal from the Commission, for a period of five years on the basis of a list of candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and, as appropriate, by other means.
člen 64 se spremeni:
Before appointment, the candidate nominated by the Management Board shall be immediately invited to make a statement to the European Parliament and to answer any questions put by its Members.
Izvršnega direktorja imenuje upravni odbor na predlog Komisije za obdobje petih let na podlagi seznama kandidatov, ki jih predlaga Komisija po javnem razpisu, ki je bil objavljen v Uradnem listu Evropske unije in, kot je ustrezno, na drug način.
The mandate of the Executive Director may be renewed once by the Management Board, upon a proposal from the Commission.
Pred imenovanjem se kandidata, ki ga imenuje upravni odbor, nemudoma povabi, da poda izjavo Evropskemu parlamentu in odgovarja na morebitna vprašanja poslancev.
The Management Board may, upon a proposal from the Commission, remove the Executive Director from his or her post.’;
Upravni odbor lahko na predlog Komisije enkrat podaljša mandat izvršnega direktorja.
in paragraph 3, the second subparagraph is replaced by the following:
Upravni odbor lahko na predlog Komisije izvršnega direktorja razreši s položaja.“;
‘The draft report covering the activities of the Agency in the previous year shall include information about the number of applications evaluated by the Agency, the time taken for completion of the evaluation, and the medicinal products for human use and veterinary medicinal products authorised, rejected or withdrawn.’;
v odstavku 3 se drugi pododstavek nadomesti z naslednjim:
Article 66 is amended as follows:
„Osnutek poročila, ki zajema dejavnosti Agencije v preteklem letu, vključuje podatke o številu vlog, ovrednotenih v Agenciji, čas, potreben za ovrednotenje, in zdravila za humano uporabo in veterinarska zdravila, ki so odobrena, zavrnjena ali umaknjena.“;
point (a) is replaced by the following:
člen 66 se spremeni:
adopt an opinion on the rules of procedures of the Committee for Medicinal Products for Human Use (Article 61 of this Regulation) and the Committee for Veterinary Medicinal Products (Article 139 of Regulation (EU) 2019/6);’;
točka (a) se nadomesti z naslednjim:
point (j) is deleted;
sprejme mnenje o poslovnikih Odbora za zdravila za humano uporabo (člen 61 te uredbe) in Odbora za zdravila za uporabo v veterinarski medicini (člen 139 Uredbe (EU) 2019/6);“;
point (k) is replaced by following:
točka (j) se črta;
adopt rules to ensure the availability to the public of information concerning the authorisation or supervision of medicinal products for human use and of veterinary medicinal products (Article 80).’;
točka (k) se nadomesti z naslednjim:
in Article 67, paragraph 3 is replaced by the following:
sprejme pravila, ki zagotavljajo javnosti dostop do podatkov glede pridobitve dovoljenja za promet ali nadzora zdravil za humano uporabo in veterinarskih zdravil (člen 80).“;
The Agency’s revenue shall consist of:
v členu 67 se odstavek 3 nadomesti z naslednjim:
a contribution from the Union;
Prihodki Agencije so sestavljeni iz:
a contribution from third countries participating in the work of the Agency with which the Union has concluded international agreements for this purpose;
prispevka Unije;
fees paid by undertakings:
prispevka tretjih držav, ki sodelujejo pri delu Komisije in s katerimi je Unija sklenila mednarodne sporazume za ta namen;
for obtaining and maintaining Union marketing authorisations for medicinal products for human use and for veterinary medicinal products and for other services provided by the Agency, as provided for in this Regulation and in Regulation (EU) 2019/6; and
pristojbin, ki jih plačajo podjetja:
for services provided by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC;
za pridobitev in vzdrževanje dovoljenj za promet za zdravila za humano uporabo in veterinarska zdravila v Uniji ter za druge storitve, ki jih zagotavlja Agencija, kot je določeno v tej uredbi in Uredbi (EU) 2019/6 in
charges for other services provided by the Agency;
za storitve skupine za usklajevanje v zvezi z izpolnjevanjem nalog v skladu s členi 107c, 107e, 107g, 107k in 107q Direktive 2001/83/ES;
Union funding in the form of grants for participation in research and assistance projects, in accordance with the Agency’s financial rules referred to in Article 68(11) and with the provisions of the relevant instruments supporting the policies of the Union.
stroškov za druge storitve, ki jih zagotavlja Agencija;
The European Parliament and the Council (“the budgetary authority”) shall re-examine, when necessary, the level of the Union contribution, referred to in point (a) of the first subparagraph, on the basis of an evaluation of needs and by taking account of the level of fees referred to in point (c) of the first subparagraph.’;
sredstev Unije v obliki nepovratnih sredstev za sodelovanje pri raziskovalnih in podpornih projektih v skladu s finančnimi pravili Agencije iz člena 68(11) ter določbami ustreznih instrumentov, ki podpirajo politike Unije.
Article 68 is replaced by the following:
Evropski parlament in Svet (v nadaljnjem besedilu: proračunski organ) po potrebi ponovno pregledata raven prispevka Unije iz točke (a) prvega pododstavka na osnovi vrednotenja potreb in ob upoštevanju višine pristojbin iz točke (c) prvega pododstavka.“;
‘Article 68
člen 68 se nadomesti z naslednjim:
The Executive Director shall implement the budget of the Agency in accordance with Regulation (EU) 2018/1046 of the European Parliament and of the Council (“the Financial Regulation”).
„Člen 68
By 1 March of financial year n+1, the Agency’s accounting officer shall send the provisional accounts for year n to the Commission’s accounting officer and to the Court of Auditors.
Izvršni direktor izvaja proračun Agencije v skladu z Uredbo (EU) 2018/1046 Evropskega parlamenta in Sveta (v nadaljnjem besedilu: finančna uredba).
By 31 March of financial year n+1, the Executive Director shall send the report on the budgetary and financial management for year n to the European Parliament, to the Council, to the Commission and to the Court of Auditors.
Računovodja Agencije do 1. marca proračunskega leta n+1 računovodji Komisije in Računskemu sodišču pošlje začasni zaključni račun za leto n.
By 31 March of financial year n+1, the Commission’s accounting officer shall send the Agency’s provisional accounts for year n, consolidated with the Commission’s provisional accounts, to the Court of Auditors.
Izvršni direktor do 31. marca proračunskega leta n+1 Evropskemu parlamentu, Svetu, Komisiji in Računskemu sodišču pošlje poročilo o proračunskem in finančnem upravljanju za leto n.
On receipt of the Court of Auditors’ observations on the Agency’s provisional accounts pursuant to Article 246 of the Financial Regulation, the Agency’s accounting officer shall draw up the Agency’s final accounts and the Executive Director shall submit them to the Management Board for an opinion.
Do 31. marca proračunskega leta n+1 računovodja Komisije pošlje Računskemu sodišču začasni zaključni račun Agencije za leto n, konsolidiran z začasnim zaključnim računom Komisije.
The Management Board shall deliver an opinion on the Agency’s final accounts for year n.
Po prejemu pripomb Računskega sodišča v zvezi z začasnim zaključnim računom Agencije v skladu s členom 246 finančne uredbe, računovodja sestavi končni zaključni račun Agencije, izvršni direktor pa ga predloži upravnemu odboru, da ta izreče mnenje.
The Agency’s accounting officer shall, by 1 July of financial year n+1, send the final accounts, together with the Management Board’s opinion, to the European Parliament, to the Council, to the Court of Auditors and to the Commission’s accounting officer.
Upravni odbor izda mnenje o končnem zaključnem računu Agencije za leto n.
The final accounts for year n shall be published in the Official Journal of the European Union by 15 November of financial year n+1.
Računovodja Agencije do 1. julija proračunskega leta n+1 Evropskemu parlamentu, Svetu, Računskemu sodišču in računovodji Komisije pošlje končni zaključni račun skupaj z mnenjem upravnega odbora.
The Executive Director shall send to the Court of Auditors a reply to its observations by 30 September of financial year n+1.
Končni zaključni račun za leto n se objavi v Uradnem listu Evropske unije do 15. novembra proračunskega leta n+1.
The Executive Director shall also send that reply to the Management Board.
Izvršni direktor pošlje Računskemu sodišču odgovor na njegove pripombe do 30. septembra proračunskega leta n+1.
The Executive Director shall submit to the European Parliament, at the latter’s request, any information required for the smooth application of the discharge procedure for the financial year concerned, as laid down in Article 261(3) of the Financial Regulation.
Izvršni direktor ta odgovor pošlje tudi upravnemu odboru.
The European Parliament, upon a recommendation from the Council, shall, before 15 May of financial year n+2, give a discharge to the Executive Director in respect of the implementation of the budget for year n.
Izvršni direktor predloži Evropskemu parlamentu na zahtevo slednjega vse podatke, potrebne za čim lažjo uporabo postopka razrešnice za zadevno finančno leto, kakor je določeno v členu 261(3) finančne uredbe.
The financial rules applicable to the Agency shall be adopted by the Management Board after the Commission has been consulted.
Evropski parlament na priporočilo Sveta pred 15. majem proračunskega leta n+2 podeli izvršnemu direktorju razrešnico v zvezi z izvajanjem proračuna za leto n.
They shall not depart from Commission Delegated Regulation (EU) No 1271/2013 unless specifically required for the Agency’s operation and with the Commission’s prior consent.
Upravni odbor po posvetovanju s Komisijo sprejme finančna pravila, ki se uporabljajo za Agencijo.
Article 70 is deleted;
Ta ne odstopajo od Delegirane uredbe Komisije (EU) št. 1271/2013, razen če se to posebej zahteva za delovanje Agencije in ob predhodni privolitvi Komisije.
in Article 75, the first paragraph is replaced by the following:
člen 70 se črta;
‘The staff of the Agency shall be subject to the Staff Regulations of Officials of the European Union and the Conditions of Employment of Other Servants of the European Union.
v členu 75 se prvi odstavek nadomesti z naslednjim:
In respect of its staff, the Agency shall exercise the powers which have been devolved to the appointing authority.’;
„Osebje Agencije mora upoštevati Kadrovske predpise za uradnike Evropske unije in Pogoje za zaposlitev drugih uslužbencev Evropske unije.
Article 77 is replaced by the following:
Agencija v zvezi s svojim osebjem izvaja pooblastila, prenesena na organ, odgovoren za imenovanja.“;
‘Article 77
člen 77 se nadomesti z naslednjim:
The Commission may, in agreement with the Management Board and the relevant committee, invite representatives of international organisations with an interest in the harmonisation of technical requirements applicable to medicinal products for human use and to veterinary medicinal products to participate as observers in the work of the Agency.
„Člen 77
The conditions for participation shall be determined in advance by the Commission.’;
Komisija lahko v dogovoru z upravnim odborom in ustreznim odborom povabi predstavnike mednarodnih organizacij z interesom za harmonizacijo tehničnih zahtev za zdravila za humano uporabo in veterinarska zdravila, da pri delu Agencije sodelujejo kot opazovalci.
in Article 78, paragraph 2 is replaced by following:
Pogoje za sodelovanje predhodno določi Komisija.“;
The committees referred to in Article 56(1) of this Regulation and any working parties and scientific advisory groups established in accordance with that Article or Article 139(3) of Regulation (EU) 2019/6 shall in general matters establish contacts, on an advisory basis, with parties concerned with the use of medicinal products for human use and of veterinary medicinal products, in particular patient organisations and healthcare professionals’ associations.
v členu 78 se odstavek 2 nadomesti z naslednjim:
Rapporteurs appointed by those committees may, on an advisory basis, establish contacts with representatives of patient organisations and healthcare professionals’ associations relevant to the indication of the medicinal product for human use or veterinary medicinal product concerned.’;
Odbori iz člena 56(1) te uredbe in katera koli delovna skupina ter znanstvene svetovalne skupine, ustanovljene v skladu z navedenim členom ali členom 139(3) Uredbe (EU) 2019/6, v splošnih zadevah vzpostavijo stike svetovalne narave s strankami, ki jih zadeva uporaba zdravil za humano uporabo in veterinarskih zdravil, zlasti z organizacijami bolnikov in združenji zdravstvenih delavcev.
Article 79 is deleted;
Poročevalci, ki so jih imenovali ti odbori, lahko v okviru svetovanja vzpostavijo stike s predstavniki organizacij bolnikov in združenj zdravstvenih delavcev, ki ustrezajo indikacijam zadevnega zdravila za humano uporabo ali veterinarskega zdravila.“;
in Article 80, the first paragraph is replaced by the following:
člen 79 se črta;
‘To ensure an appropriate level of transparency, the Management Board shall, on the basis of a proposal by the Executive Director and in agreement with the Commission, adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the authorisation or supervision of medicinal products for human use and of veterinary medicinal products which is not of a confidential nature.’;
v členu 80 se prvi odstavek nadomesti z naslednjim:
in Article 82, paragraph 3 is replaced by the following:
„Da bi zagotovili primerno raven transparentnosti, upravni odbor na podlagi predloga izvršnega direktorja in v dogovoru s Komisijo sprejme pravila, da zagotovi javnosti dostop do uredbenih, znanstvenih ali tehničnih podatkov, ki niso zaupne narave in se navezujejo na pridobitev dovoljenja za promet ali nadzor zdravil za humano rabo in veterinarskih zdravil.“;
Without prejudice to the unique Union nature of the content of the documents referred to in points (a) to (d) of Article 9(4), this Regulation shall not prohibit the use of two or more commercial designs for a given medicinal product for human use covered by a single marketing authorisation.’;
v členu 82 se odstavek 3 nadomesti z naslednjim:
In Article 84, paragraph 3 is deleted;
Brez poseganja v edinstveno naravo vsebine dokumentov Unije iz točk (a) do (d) člena 9(4) ta uredba ne prepoveduje uporabe dveh ali več trgovskih modelov za dano zdravilo za humano uporabo, zajeto v enem dovoljenju za promet.“;
the following Article is inserted:
v členu 84 se odstavek 3 črta;
‘Article 84a
vstavi se naslednji člen:
The Commission may impose financial penalties in the form of fines or periodic penalty payments on the holders of marketing authorisations granted under this Regulation if they fail to comply with any of the obligations laid down in Annex II in connection with the marketing authorisations.
„Člen 84a
The Commission may, insofar as specifically provided for in the delegated acts referred to in point (b) of paragraph 10, impose the financial penalties referred to in paragraph 1 also on a legal entity or legal entities other than the marketing authorisation holder provided that such entities form part of the same economic entity as the marketing authorisation holder and that such other legal entities:
Komisija lahko naloži denarne kazni v obliki glob ali periodičnih denarnih kazni imetnikom dovoljenj za promet, ki so izdana po tej uredbi, če ne izpolnjujejo katere od obveznosti, določenih v Prilogi II v zvezi z dovoljenji za promet.
exerted a decisive influence over the marketing authorisation holder; or
Komisija lahko, če je to posebej določeno v delegiranih aktih iz točke (b) odstavka 10, naloži denarne kazni iz odstavka 1 tudi pravnemu subjektu ali pravnim subjektom, ki niso imetniki dovoljenja za promet, če so ti del istega gospodarskega subjekta kot imetnik dovoljenja za promet in če so ti drugi pravni subjekti:
were involved in, or could have addressed, such failure to comply with the obligation by the marketing authorisation holder.
odločilno vplivali na imetnika dovoljenja za promet ali
Where the Agency or a competent authority of a Member State is of the opinion that a marketing authorisation holder has failed to comply with any of the obligations, as referred to in paragraph 1, it may request the Commission to investigate whether to impose financial penalties pursuant to that paragraph.
sodelovali pri neizpolnjevanju obveznosti, ki jo je zakrivil imetnik dovoljenja za promet, oziroma bi to lahko preprečili.
In determining whether to impose a financial penalty and in determining its appropriate amount, the Commission shall be guided by the principles of effectiveness, proportionality and dissuasiveness and take into consideration, where relevant, the seriousness and the effects of the failure to comply with the obligations.
Kadar Agencija ali pristojni organ države članice meni, da imetnik dovoljenja za promet ni izpolnil katere od obveznosti iz odstavka 1, lahko zaprosi Komisijo, da preuči, ali je treba v skladu z navedenim odstavkom naložiti denarne kazni.