natgillin/translations-raw huggingface dataset:
Where this opinion of the Committee for Medicinal Products for Human Use differs from the recommendation of the Pharmacovigilance Risk Assessment Committee, the Committee for Medicinal Products for Human Use shall attach to its opinion a detailed explanation of the scientific grounds for the differences together with the recommendation.
Če se mnenje Odbora za zdravila za humano uporabo razlikuje od priporočila Odbora za ocenjevanje tveganja na področju farmakovigilance, Odbor za zdravila za humano uporabo svojemu mnenju priloži podrobno znanstveno razlago za razhajanja skupaj s priporočilom.
Where the opinion states that regulatory action concerning the marketing authorisation is necessary, the Commission shall adopt a decision to vary, suspend or revoke the marketing authorisation.
Kadar je v mnenju določeno, da je potreben regulativni ukrep glede dovoljenja za promet, Komisija sprejme odločbo o spremembi, začasnem preklicu ali ukinitvi dovoljenja za promet.
Article 10 of this Regulation shall apply to the adoption of that decision.
Člen 10 te uredbe se uporablja za sprejetje navedene odločbe.
Where the Commission adopts such a decision, it may also adopt a decision addressed to the Member States pursuant to Article 127a of Directive 2001/83/EC.
Kadar Komisija sprejme tako odločbo, lahko v skladu s členom 127a Direktive 2001/83/ES sprejme tudi odločbo, naslovljeno na države članice.
In the case of a single assessment of periodic safety update reports concerning more than one marketing authorisation in accordance with Article 107e(1) of Directive 2001/83/EC which includes at least one marketing authorisation granted in accordance with this Regulation, the procedure laid down in Articles 107e and 107g of that Directive shall apply.
Pri enotni oceni rednih posodobljenih poročil o varnosti zdravil za več kot eno dovoljenje za promet v skladu s členom 107e(1) Direktive 2001/83/ES, ki vključuje najmanj eno dovoljenje za promet, izdano v skladu s to uredbo, se uporablja postopek iz členov 107e in 107g navedene direktive.
The final recommendations, opinions and decisions referred to in paragraphs 3 to 5 of this Article shall be made public by means of the European medicines web-portal referred to in Article 26.
Končna priporočila, mnenja in odločitve iz odstavkov od 3 do 5 tega člena se objavijo prek evropskega spletnega portala o zdravilih iz člena 26.
Article 28a
Člen 28a
Regarding medicinal products for human use authorised in accordance with this Regulation, the Agency shall, in collaboration with the Member States, take the following measures:
Agencija v sodelovanju z državami članicami v zvezi z zdravili za humano uporabo, odobrenimi v skladu s to uredbo, sprejme naslednje ukrepe:
monitor the outcome of risk minimisation measures contained in risk management plans and of conditions referred to in points (c), (ca), (cb) and (cc) of Article 9(4) or in points (a) and (b) of Article 10a(1), and in Article 14(7) and (8);
spremljanje rezultatov ukrepov za zmanjšanje tveganj, vključenih v načrte obvladovanja tveganj, ter pogojev iz točk (c), (ca), (cb) in (cc) člena 9(4) ali točk (a) in (b) člena 10a(1) ter člena 14(7) in (8);
assess updates to the risk management system;
ocenjevanje posodobitve sistema obvladovanja tveganj;
monitor the data in the Eudravigilance database to determine whether there are new risks or whether risks have changed and whether those risks impact on the risk-benefit balance.
spremljanje podatkov v podatkovni bazi Eudravigilance, da se ugotovi, ali je prišlo do novih tveganj ali da so se tveganja spremenila in če ta vplivajo na razmerje med tveganjem in koristjo zdravila.
The Pharmacovigilance Risk Assessment Committee shall perform the initial analysis and prioritisation of signals of new risks or risks that have changed or changes to the risk-benefit balance.
Odbor za ocenjevanje tveganja na področju farmakovigilance opravi začetno analizo in prednostno razvrsti informacije o novih ali spremenjenih tveganjih ali spremembah razmerja med tveganjem in koristjo.
Where it considers that follow-up action may be necessary, the assessment of those signals and agreement on any subsequent action concerning the marketing authorisation shall be conducted in a timescale commensurate with the extent and seriousness of the issue.
Kadar meni, da so morda potrebni nadaljnji ukrepi, se ocena teh informacij in dogovor o kakršnih koli nadaljnjih ukrepih glede dovoljenja za promet izvedeta v časovnem okviru, ki je sorazmeren z obsegom in resnostjo zadeve.
The Agency and national competent authorities and the marketing authorisation holder shall inform each other in the event of new risks or risks that have changed or changes to the risk-benefit balance being detected.
V primeru odkritja novih ali spremenjenih tveganj ali sprememb razmerja med tveganjem in koristjo zdravila se Agencija, pristojni nacionalni organi in imetnik dovoljenja za promet o tem obvestijo.
For non-interventional post-authorisation safety studies concerning medicinal products for human use authorised in accordance with this Regulation which fulfil one of the requirements referred to in Articles 10 and 10a of this Regulation, the procedure provided for in paragraphs 3 to 7 of Article 107m, Articles 107n to 107p and Article 107q(1) of Directive 2001/83/EC shall apply.
Za neintervencijske študije varnosti po pridobitvi dovoljenja za promet z zdravili za humano uporabo, odobrenimi v skladu s to uredbo, ki izpolnjujejo eno od zahtev iz členov 10 in 10a te uredbe, se uporablja postopek iz člena 107m(3) do (7), členi 107n do 107p in člen 107q(1) Direktive 2001/83/ES.
Where, in accordance with the procedure referred to in paragraph 1 of this Article, the Pharmacovigilance Risk Assessment Committee issues recommendations for the variation, suspension or revocation of the marketing authorisation, the Committee on Medicinal Products for Human Use shall adopt an opinion taking into account the recommendation, and the Commission shall adopt a decision in accordance with Article 10.
Kadar Odbor za ocenjevanje tveganja na področju farmakovigilance v skladu s postopkom iz odstavka 1 tega člena izda priporočila za spremembo, začasni preklic ali ukinitev dovoljenja za promet, Odbor za zdravila za humano uporabo sprejme mnenje na podlagi priporočila, Komisija pa sprejme odločbo v skladu s členom 10.
Where the opinion of the Committee on Medicinal Products for Human Use differs from the recommendation of the Pharmacovigilance Risk Assessment Committee, the Committee on Medicinal Products for Human Use shall attach to its opinion a detailed explanation of the scientific grounds for the differences, together with the recommendation.
Če se mnenje Odbora za zdravila za humano uporabo razlikuje od priporočila Odbora za ocenjevanje tveganja na področju farmakovigilance, se mnenju Odbora za zdravila za humano uporabo priloži podrobna znanstvena razlaga razhajanj, skupaj s priporočilom.
The Agency shall collaborate with the World Health Organisation in matters of pharmacovigilance and shall take the necessary steps to submit to it, promptly, appropriate and adequate information regarding the measures taken in the Union which may have a bearing on public health protection in third countries.
Agencija v zadevah v zvezi s farmakovigilanco sodeluje s Svetovno zdravstveno organizacijo in sprejme potrebne ukrepe, da ji takoj pošlje ustrezne in zadostne informacije o ukrepih, sprejetih v Uniji, ki lahko vplivajo na varovanje javnega zdravja v tretjih državah.
The Agency shall make available promptly all suspected adverse reaction reports occurring in the Union to the World Health Organisation.
Agencija Svetovni zdravstveni organizaciji takoj zagotovi dostop do vseh poročil o domnevnih neželenih učinkih, ki so se pojavili v Uniji.
The Agency and the European Monitoring Centre for Drugs and Drug Addiction shall exchange information that they receive on the abuse of medicinal products including information related to illicit drugs.
Agencija in Evropski center za spremljanje drog in zasvojenosti z drogami si izmenjujeta prejete informacije o zlorabi zdravil, vključno z informacijami o prepovedanih drogah.
At the request of the Commission, the Agency shall participate in collaboration with the Member States in international harmonisation and standardisation of technical measures in relation to pharmacovigilance.
Na zahtevo Komisije Agencija v sodelovanju z državami članicami sodeluje pri mednarodnem usklajevanju in standardizaciji tehničnih ukrepov v zvezi z dejavnostjo farmakovigilance.
Article 28e
Člen 28e
The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems capable of achieving high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union.
Agencija in države članice sodelujejo pri nenehnem razvijanju sistemov farmakovigilance, ki lahko dosežejo visoke standarde varovanja javnega zdravja za vsa zdravila, ne glede na način pridobitve dovoljenja za promet, vključno z uporabo sodelovalnih pristopov, da se tako čim bolj poveča izraba virov, dostopnih v Uniji.
Article 28f
Člen 28f
The Agency shall perform regular independent audits of its pharmacovigilance tasks and report the results to its Management Board on a 2-yearly basis.
Agencija izvaja redne neodvisne preglede svojih nalog v zvezi s farmakovigilanco in o rezultatih vsaki dve leti poroča upravi.
The Commission shall make public a report on the performance of pharmacovigilance tasks by the Agency on 2 January 2014 at the latest and subsequently every 3 years thereafter.’;
Komisija objavi poročilo o izvajanju nalog Agencije v zvezi s farmakovigilanco najpozneje do 2. januarja 2014, nato pa vsaka tri leta.“;
Article 56(1) is amended as follows:
člen 56(1) se spremeni:
the Pharmacovigilance Risk Assessment Committee, which shall be responsible for providing recommendations to the Committee for Medicinal Products for Human Use and the coordination group on any question relating to pharmacovigilance activities in respect of medicinal products for human use and on risk management systems and it shall be responsible for monitoring the effectiveness of those risk management systems;’;
Odbor za ocenjevanje tveganja na področju farmakovigilance, odgovoren za pripravo poročil za Odbor za zdravila za humano uporabo in skupino za usklajevanje o vseh vprašanjih v zvezi z dejavnostjo farmakovigilance zdravil za humano uporabo, sistemi obvladovanja tveganj ter je odgovoren za spremljanje učinkovitosti teh sistemov obvladovanja tveganja;“;
a Secretariat, which shall provide technical, scientific and administrative support for the Committees and ensure appropriate coordination between them, and which shall provide technical and administrative support for the coordination group and ensure appropriate coordination between it and the Committees.’;
sekretariat, ki daje tehnično, znanstveno in upravno podporo odborom in zagotavlja njihovo medsebojno koordinacijo ter ki daje tehnično in upravno podporo skupini za usklajevanje in zagotavlja ustrezno koordinacijo med skupino za usklajevanje in odbori;“;
in paragraph 1, points (c) to (f) are replaced by the following:
točke od (c) do (f) odstavka 1 se nadomestijo z naslednjimi:
coordinating the monitoring of medicinal products for human use which have been authorised within the Union and providing advice on the measures necessary to ensure the safe and effective use of these medicinal products for human use, in particular by coordinating the evaluation and implementation of pharmacovigilance obligations and systems and the monitoring of such implementation;
koordiniranje spremljanja zdravil za humano uporabo, odobrenih v Uniji, in svetovanje o ukrepih, potrebnih za zagotovitev varne in učinkovite uporabe teh zdravil za humano uporabo, še zlasti s koordiniranjem vrednotenja in izvajanja obveznosti in sistemov s področja farmakovigilance ter spremljanjem tega izvajanja;
ensuring the collation and dissemination of information on suspected adverse reactions to medicinal products for human use authorised in the Union by means of a database permanently accessible to all Member States;
zagotavljanje zbiranja in razširjanja informacij o domnevnih neželenih učinkih zdravil za humano uporabo, odobrenih v Uniji, s podatkovno bazo, ki je stalno dostopna vsem državam članicam;
assisting Member States with the rapid communication of information on pharmacovigilance concerns to healthcare professionals and coordinating the safety announcements of the national competent authorities;
pomoč državam članicam tako, da informacije o pomislekih farmakovigilance takoj posreduje zdravstvenim delavcem in usklajuje varnostna sporočila pristojnih nacionalnih organov;
distributing appropriate information on pharmacovigilance concerns to the general public, in particular by setting up and maintaining a European medicines web-portal;’;
razširjanje ustreznih informacij o pomislekih farmakovigilance splošni javnosti, zlasti s postavitvijo in vodenjem evropskega spletnega portala o zdravilih;“;
in paragraph 2, the following subparagraph is inserted after the first subparagraph:
v odstavku 2 se za prvim pododstavkom vstavi naslednji pododstavek:
‘For the purposes of the database, the Agency shall set up and maintain a list of all medicinal products for human use authorised in the Union.
„Za namene podatkovne baze Agencija vzpostavi in vzdržuje seznam vseh zdravil za humano uporabo, odobrenih v Uniji.
To this effect the following measures shall be taken:
V ta namen se sprejmejo naslednji ukrepi:
the Agency shall, by 2 July 2011 at the latest, make public a format for the electronic submission of information on medicinal products for human use;
Agencija najpozneje do 2. julija 2011 objavi obrazec za elektronsko pošiljanje informacij o zdravilih za humano uporabo;
marketing authorisation holders shall, by 2 July 2012 at the latest, electronically submit to the Agency information on all medicinal products for human use authorised or registered in the Union, using the format referred to in point (a);
imetniki dovoljenj za promet najpozneje do 2. julija 2012 Agenciji v elektronski obliki pošljejo informacije o vseh zdravilih za humano uporabo, odobrenih ali registriranih v Uniji, pri čemer uporabijo obrazec iz točke (a);
from the date set out in point (b), marketing authorisation holders shall inform the Agency of any new or varied marketing authorisations granted in the Union, using the format referred to in point (a).’;
od datuma iz točke (b) imetniki dovoljenj za promet obveščajo Agencijo o vseh novih ali spremenjenih dovoljenjih za promet, izdanih v Uniji, pri čemer uporabijo obrazec iz točke (a);“;
The Pharmacovigilance Risk Assessment Committee shall be composed of the following:
Odbor za ocenjevanje tveganja na področju farmakovigilance sestavlja:
one member and one alternate member appointed by each Member State, in accordance with paragraph 3 of this Article;
po en član in en namestnik člana, ki ju imenuje vsaka država članica v skladu z odstavkom 3 tega člena;
six members appointed by the Commission, with a view to ensuring that the relevant expertise is available within the Committee, including clinical pharmacology and pharmacoepidemiology, on the basis of a public call for expressions of interest;
šest članov, ki jih imenuje Komisija, da bi se odboru zagotovila ustrezna strokovnost, vključno s klinično farmakologijo in farmakoepidemiologijo, na podlagi javnega razpisa;
one member and one alternate member appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent healthcare professionals;
en član in en namestnik člana, ki ju na podlagi javnega razpisa imenuje Komisija po posvetovanju z Evropskim parlamentom, da bi ti predstavljali zdravstvene delavce;
one member and one alternate member appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent patient organisations.
en član in en namestnik člana, ki ju na podlagi javnega razpisa imenuje Komisija po posvetovanju z Evropskim parlamentom, da bi ti predstavljali organizacije bolnikov.
The alternate members shall represent and vote for the members in their absence.
Namestniki članov predstavljajo člane, kadar so ti odsotni in glasujejo v njihovem imenu.
The alternate members referred to in point (a) may be appointed to act as rapporteurs in accordance with Article 62.
Namestniki članov iz točke (a) se lahko imenujejo za poročevalce v skladu s členom 62.
A Member State may delegate its tasks in the Pharmacovigilance Risk Assessment Committee to another Member State.
Država članica lahko svoje naloge v Odboru za ocenjevanje tveganja na področju farmakovigilance prenese na drugo državo članico.
Each Member State may represent no more than one other Member State.
Vsaka država članica lahko zastopa največ eno dodatno državo članico.
The members and alternate members of the Pharmacovigilance Risk Assessment Committee shall be appointed on the basis of their relevant expertise in pharmacovigilance matters and risk assessment of medicinal products for human use, in order to guarantee the highest levels of specialist qualifications and a broad spectrum of relevant expertise.
Člani in namestniki članov Odbora za ocenjevanje tveganja na področju farmakovigilance so imenovani na podlagi njihovega ustreznega strokovnega znanja in izkušenj v zvezi s farmakovigilanco in ocenjevanjem tveganja zdravil za humano uporabo, in sicer tako, da se zagotovijo najvišje ravni specialističnih kvalifikacij in širok spekter ustrezne strokovnosti.
For this purpose, Member States shall liaise with the Management Board and the Commission in order to ensure that the final composition of the Committee covers the scientific areas relevant to its tasks.
V ta namen se države članice povežejo z upravo in Komisijo, da se zagotovi, da končna sestava odbora pokriva znanstvena področja, pomembna za njegove naloge.
The members and alternate members of the Pharmacovigilance Risk Assessment Committee shall be appointed for a term of 3 years, which may be prolonged once and thereafter renewed following the procedures referred to in paragraph 1.
Člani in namestniki članov Odbora za ocenjevanje tveganja na področju farmakovigilance so imenovani za obdobje treh let, ki se lahko enkrat obnovi in se nato podaljšuje v skladu s postopki iz odstavka 1.
The Committee shall elect its Chairman from among its members for a term of 3 years, which may be prolonged once.
Odbor izvoli predsednika med svojimi člani za obdobje treh let, ki se lahko enkrat obnovi.
Paragraphs 3, 4, 6, 7 and 8 of Article 61 shall apply to the Pharmacovigilance Risk Assessment Committee.
Za Odbor za ocenjevanje tveganja na področju farmakovigilance se uporablja člen 61(3), (4), (6), (7) in (8).
The mandate of the Pharmacovigilance Risk Assessment Committee shall cover all aspects of the risk management of the use of medicinal products for human use including the detection, assessment, minimisation and communication relating to the risk of adverse reactions, having due regard to the therapeutic effect of the medicinal product for human use, the design and evaluation of post-authorisation safety studies and pharmacovigilance audit.’;
Pristojnosti Odbora za ocenjevanje tveganja na področju farmakovigilance vključujejo vse vidike obvladovanja tveganj pri uporabi zdravil, vključno z odkrivanjem, ocenjevanjem, zmanjševanjem in sporočanjem tveganj povezanih z neželenimi učinki zdravil ob upoštevanju terapevtskih učinkov zdravila, pripravo in oceno varnostnih študij po pridobitvi dovoljenja za promet in presojo farmakovigilance.“;
Article 62 is amended as follows:
člen 62 se spremeni:
‘Where, in accordance with this Regulation, any of the Committees referred to in Article 56(1) is required to evaluate a medicinal product for human use, it shall appoint one of its members to act as rapporteur, taking into account existing expertise in the Member State.
„Kadar se v skladu s to uredbo od katerega koli odbora iz člena 56(1) zahteva, da ovrednoti zdravilo za humano uporabo, odbor imenuje enega od svojih članov za poročevalca ob upoštevanju obstoječega strokovnega znanja v državi članici.
The Committee concerned may appoint a second member to act as co-rapporteur.
Zadevni odbor lahko imenuje še enega člana za so-poročevalca.
A rapporteur appointed for this purpose by the Pharmacovigilance Risk Assessment Committee shall closely collaborate with the rapporteur appointed by the Committee for Medicinal Products for Human Use or the Reference Member State for the medicinal product for human use concerned.’;
Poročevalec, ki ga za ta namen imenuje Odbor za ocenjevanje tveganja na področju farmakovigilance, tesno sodeluje s poročevalcem, ki ga imenuje Odbor za zdravila za humano uporabo ali referenčna država članica za zadevno zdravilo za humano uporabo.“;
‘If there is a request for re-examination of one of its opinions where this possibility is provided for in Union law, the Committee concerned shall appoint a different rapporteur and, where necessary, a different co-rapporteur from those appointed for the initial opinion.
„Če obstaja zahteva za ponoven pregled enega od mnenj, kadar je ta možnost predvidena v zakonodaji Unije, zadevni odbor določi drugega poročevalca in po potrebi drugega so-poročevalca, kot sta bila imenovana za prvotno mnenje.
The re-examination procedure may deal only with the points of the opinion initially identified by the applicant and may be based only on the scientific data available when the Committee adopted the initial opinion.
Postopek ponovnega pregleda lahko obravnava le posamezne dele mnenja, ki jih je na začetku opredelil predlagatelj, in lahko temelji le na znanstvenih podatkih, ki so bili na voljo, ko je odbor sprejel prvotno mnenje.
The applicant may request that the Committee consult a scientific advisory group in connection with the re-examination.’;
Predlagatelj lahko zahteva, da se odbor v zvezi s ponovnim pregledom posvetuje z znanstveno svetovalno skupino.“;
‘Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products for human use 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.’;
„Države članice posredujejo Agenciji imena nacionalnih strokovnjakov z dokazanimi izkušnjami pri vrednotenju zdravil za humano uporabo, 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 kvalifikacij in posebnih strokovnih področij.“;
‘The first and second subparagraphs shall also apply to the work of rapporteurs in 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.’;
„Prvi in drugi pododstavek se uporabljata tudi za delo poročevalcev v skupini za usklajevanje v zvezi z izpolnjevanjem njenih nalog v skladu s členom 107c, 107e, 107g, 107k in 107q Direktive 2001/83/ES.“;
Article 64(2) is amended as follows:
člen 64(2) se spremeni:
for managing all the Agency resources necessary for conducting the activities of the Committees referred to in Article 56(1), including making available appropriate scientific and technical support to those Committees, and for making available appropriate technical support to the coordination group;’;
upravljanje vseh sredstev Agencije, potrebnih za opravljanje dejavnosti odborov, navedenih v členu 56(1), vključno z zagotavljanjem primerne znanstvene in tehnične podpore navedenim odborom, ter za zagotavljanje ustrezne tehnične podpore skupini za usklajevanje;“;
for ensuring appropriate coordination between the Committees referred to in Article 56(1) and, where necessary, between the Committees and the coordination group;’;
zagotavljanje primerne koordinacije med odbori, navedenimi v členu 56(1), in po potrebi med odbori in skupino za usklajevanje;“;