natgillin/translations-raw huggingface dataset:
In the case of a single assessment of periodic safety update reports that recommends any action concerning more than one marketing authorisation in accordance with Article 107e(1) which includes at least one marketing authorisation granted in accordance with the centralised procedure provided for in Chapter 1 of Title II of Regulation (EC) No 726/2004, the Committee for Medicinal Products for Human Use shall, within 30 days of receipt of the report of the Pharmacovigilance Risk Assessment Committee, consider the report and adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisations concerned, including a timetable for the implementation of the opinion.
V primeru enotne ocene rednih posodobljenih poročil o varnosti zdravila, ki priporočajo kakršne koli ukrepe, ki zadevajo več kot eno dovoljenje za promet z zdravilom v skladu s členom 107e(1), ki vključuje vsaj eno dovoljenje za promet z zdravilom, izdano v skladu s centraliziranim postopkom iz poglavja 1 naslova II Uredbe (ES) št. 726/2004, Odbor za zdravila za uporabo v humani medicini v 30 dneh po prejemu poročila Odbora za ocenjevanje tveganja na področju farmakovigilance preuči poročilo in sprejme mnenje o ohranitvi, spremembi, začasnem preklicu ali ukinitvi zadevnega dovoljenja za promet z zdravilom, vključno s časovnim razporedom za izvajanje mnenja.
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 to mnenje Odbora za zdravila za uporabo v humani medicini razlikuje od priporočila Odbora za ocenjevanje tveganja na področju farmakovigilance, Odbor za zdravila za uporabo v humani medicini svojemu mnenju priloži podrobno razlago znanstvenih utemeljitev za razhajanja skupaj s priporočilom.
On the basis of the opinion of the Committee for Medicinal Products for Human Use referred to in paragraph 3, the Commission shall:
Na podlagi mnenja Odbora za zdravila za uporabo v humani medicini iz odstavka 3 Komisija:
adopt a decision addressed to the Member States concerning the measures to be taken in respect of marketing authorisations granted by the Member States and concerned by the procedure provided for in this section; and
sprejme odločitev, naslovljeno na države članice, o ukrepih, ki jih je treba sprejeti glede dovoljenj za promet z zdravili, ki jih izdajo države članice in ki jih zadeva postopek na podlagi tega oddelka; ter
where the opinion states that regulatory action concerning the marketing authorisation is necessary, adopt a decision to vary, suspend or revoke the marketing authorisations granted in accordance with the centralised procedure provided for in Regulation (EC) No 726/2004 and concerned by the procedure provided for in this section.
kadar obstaja mnenje, da je potreben ureditveni ukrep o dovoljenju za promet z zdravilom, sprejme odločitev o spremembi, začasnem preklicu ali ukinitvi dovoljenj za promet z zdravili, izdanih v skladu s centraliziranim postopkom iz Uredbe (ES) št. 726/2004, in ki jih zadeva postopek na podlagi tega oddelka.
Articles 33 and 34 of this Directive shall apply to the adoption of the decision referred to in point (a) of the first subparagraph of this paragraph and to its implementation by the Member States.
Za sprejetje odločitve iz točke (a) prvega pododstavka tega odstavka in za izvajanje odločitve v državah članicah se uporabljata člena 33 in 34 te direktive.
Article 10 of Regulation (EC) No 726/2004 shall apply to the decision referred to in point (b) of the first subparagraph of this paragraph.
Za odločitev iz točke (b) prvega pododstavka tega odstavka se uporablja člen 10 Uredbe (ES) št. 726/2004.
Where the Commission adopts such decision, it may also adopt a decision addressed to the Member States pursuant to Article 127a of this Directive.
Kadar Komisija sprejme tako odločitev, lahko sprejme tudi odločitev, naslovljeno na države članice na podlagi člena 127a te direktive.
Signal detection
Zaznavanje znakov
Article 107h
Člen 107h
Regarding medicinal products authorised in accordance with this Directive, national competent authorities in collaboration with the Agency, shall take the following measures:
Glede zdravil, odobrenih v skladu s to direktivo, pristojni nacionalni organi v sodelovanju z Agencijo sprejmejo naslednje ukrepe:
monitor the outcome of risk minimisation measures contained in risk management plans and of the conditions referred to in Articles 21a, 22 or 22a;
spremljajo izid ukrepov za zmanjšanje tveganj iz načrtov za obvladovanje tveganj in pogojev iz členov 21a, 22 ali 22a;
assess updates to the risk management system;
ocenjujejo 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.
spremljajo podatke v podatkovni bazi Eudravigilance, da ugotovijo, ali je prišlo do novih tveganj ali da so se tveganja spremenila in če 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 opredeli prednostne znake o novih tveganjih ali o tveganjih, ki so se spremenila ali o spremembah razmerja med tveganjem in koristjo zdravil.
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 potrebni nadaljnji ukrepi, se ocena teh znakov in dogovor o vseh naknadnih ukrepih glede dovoljenja za promet z zdravilom 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 in pristojni nacionalni organi ter imetnik dovoljenja za promet z zdravilom o tem obvestijo.
Member States shall ensure that marketing authorisation holders inform the Agency and national competent authorities in the event of new risks or risks that have changed or when changes to the risk-benefit balance have been detected.
Države članice zagotovijo, da imetniki dovoljenj za promet z zdravili obvestijo Agencijo in pristojne nacionalne organe o odkritju novih ali spremenjenih tveganj ali spremembe razmerja med tveganjem in koristjo zdravila.
Urgent Union procedure
Nujni postopek Unije
Article 107i
Člen 107i
A Member State or the Commission, as appropriate, shall initiate the procedure provided for in this section, by informing the other Member States, the Agency and the Commission when urgent action is considered necessary, as a result of the evaluation of data resulting from pharmacovigilance activities, in any of the following cases:
Država članica ali Komisija, kot je ustrezno, začne postopek iz tega oddelka tako, da obvesti druge države članice, Agencijo in Komisijo, če je potrebno nujno ukrepanje zaradi izidov ocenjevanja podatkov, ki izhajajo iz dejavnosti farmakovigilance v vsakem od naslednjih primerov, ko:
it considers suspending or revoking a marketing authorisation;
obravnava možnost začasnega preklica ali ukinitve dovoljenja za promet z zdravilom;
it considers prohibiting the supply of a medicinal product;
obravnava možnost prepovedi dobav zdravila;
it considers refusing the renewal of a marketing authorisation;
obravnava možnost zavrnitve podaljšanja dovoljenja za promet;
it is informed by the marketing authorisation holder that, on the basis of safety concerns, he has interrupted the placing on the market of a medicinal product or has taken action to have a marketing authorisation withdrawn, or that he intends to do so;
jo imetnik dovoljenja za promet z zdravilom obvesti, da je zaradi varnostnih zadržkov prekinil dajanje zdravila na trg ali ukrepal za ukinitev dovoljenja za promet z zdravilom ali to namerava storiti;
it considers that a new contraindication, a reduction in the recommended dose, or a restriction to the indications is necessary.
obravnava možnost, da so potrebne nove kontraindikacije, zmanjšanje priporočenega odmerka ali omejitev indikacij.
The Agency shall verify whether the safety concern relates to medicinal products other than the one covered by the information, or whether it is common to all products belonging to the same range or therapeutic class.
Agencija preveri, če je varnostni zadržek povezan z drugimi zdravili, ki niso zajeta v obvestilu, ali če je skupen vsem izdelkom, ki pripadajo isti skupini ali terapevtski skupini.
Where the medicinal product involved is authorised in more than one Member State, the Agency shall without undue delay inform the initiator of the procedure of the outcome of this verification, and the procedures laid down in Articles 107j and 107k shall apply.
Če so zadevna zdravila odobrena v več kot eni državi članici, Agencija brez odlašanja obvesti začetnika postopka o ugotovitvah tega preverjanja, uporabijo pa se postopki iz členov 107j in 107k.
Otherwise, the safety concern shall be addressed by the Member State concerned.
Sicer se varnostni zadržek naslovi na zadevno državo članico.
The Agency or the Member State, as applicable, shall make information that the procedure has been initiated available to marketing authorisation holders.
Agencija ali država članica, kot je primerno, imetnike dovoljenj za promet z zdravili obvesti o tem, da se je postopek začel.
Without prejudice to the provisions of paragraph 1 of this Article, and Articles 107j and 107k, a Member State may, where urgent action is necessary to protect public health, suspend the marketing authorisation and prohibit the use of the medicinal product concerned on its territory until a definitive decision is adopted.
Brez poseganja v določbe odstavka 1 tega člena in členov 107j in 107k lahko država članica, če je potrebno nujno ukrepanje za zavarovanje javnega zdravja, začasno prekliče dovoljenje za promet z zdravilom in prepove uporabo zadevnega zdravila na svojem ozemlju do sprejetja dokončne odločitve.
It shall inform the Commission, the Agency and the other Member States no later than the following working day of the reasons for its action.
O razlogih za svoje ukrepe obvesti Komisijo, Agencijo in ostale države članice najpozneje naslednji delovni dan.
At any stage of the procedure laid down in Articles 107j to 107k, the Commission may request Member States in which the medicinal product is authorised to take temporary measures immediately.
V kateri koli fazi postopka iz členov 107j in 107k lahko Komisija zahteva, da države članice, v katerih je zdravilo odobreno, takoj sprejmejo začasne ukrepe.
Where the scope of the procedure, as determined in accordance with paragraph 1, includes medicinal products authorised in accordance with Regulation (EC) No 726/2004, the Commission may, at any stage of the procedure initiated under this section, take temporary measures immediately in relation to those marketing authorisations.
Kadar področje uporabe postopka, kakor je določeno v skladu z odstavkom 1, vključuje zdravila, odobrena v skladu z Uredbo (ES) št. 726/2004, lahko Komisija v kateri koli fazi postopka, sproženega na podlagi tega oddelka, takoj sprejme začasne ukrepe v zvezi z navedenimi dovoljenji za promet z zdravilom.
The information referred to in this Article may relate to individual medicinal products or to a range of medicinal products or a therapeutic class.
Obvestila iz tega člena se lahko nanašajo na eno zdravilo ali na skupino zdravil ali terapevtsko skupino.
If the Agency identifies that the safety concern relates to more medicinal products than those which are covered by the information or that it is common to all medicinal products belonging to the same range or therapeutic class, it shall extend the scope of the procedure accordingly.
Če Agencija ugotovi, da se varnostni zadržek nanaša na več zdravil, kot jih zajema obvestilo, ali na vsa zdravila, ki sodijo v navedeno skupino ali terapevtsko skupino, ustrezno razširi področje uporabe postopka.
Where the scope of the procedure initiated under this Article concerns a range of medicinal products or therapeutic class, medicinal products authorised in accordance with Regulation (EC) No 726/2004 which belong to that range or class shall also be included in the procedure.
Kadar področje uporabe postopka, sproženega na podlagi tega člena, zadeva skupino zdravil ali terapevtsko skupino, so zdravila, odobrena v skladu z Uredbo (ES) št. 726/2004, ki sodijo v navedeno skupino ali terapevtsko skupino, tudi vključena v postopek.
At the time of the information referred to in paragraph 1, the Member State shall make available to the Agency all relevant scientific information that it has at its disposal and any assessment by the Member State.
V času obvestila iz odstavka 1 država članica Agenciji da na voljo vse zadevne znanstvene informacije, ki jih ima na voljo, ter vse ocene države članice.
Article 107j
Člen 107j
Following receipt of the information referred to in Article 107i(1), the Agency shall publicly announce the initiation of the procedure by means of the European medicines web-portal.
Po tem ko je prejela obvestilo iz člena 107i(1) Agencija objavi začetek postopka na evropskem spletnem portalu o zdravilih.
In parallel, Member States may publicly announce the initiation on their national medicines web-portals.
Istočasno lahko države članice obvestijo javnost o sprožitvi postopka na svojih nacionalnih spletnih portalih o zdravilih.
The announcement shall specify the matter submitted to the Agency in accordance with Article 107i, and the medicinal products and, where applicable, the active substances concerned.
V objavi se navedejo zadeva, predložena v skladu s členom 107i, zadevna zdravila, in kadar je primerno, zadevne zdravilne učinkovine.
It shall contain information on the right of the marketing authorisation holders, healthcare professionals and the public to submit to the Agency information relevant to the procedure and it shall state how such information may be submitted.
Objava vsebuje informacije o pravici imetnikov dovoljenj za promet z zdravili, zdravstvenih delavcev in javnosti, da Agenciji predložijo informacije, pomembne za postopek, ter možne načine predložitve teh informacij.
The Pharmacovigilance Risk Assessment Committee shall assess the matter which has been submitted to the Agency in accordance with Article 107i.
Odbor za ocenjevanje tveganja na področju farmakovigilance oceni zadevo, ki je bila predložena Agenciji v skladu s členom 107i.
The rapporteur shall closely collaborate with the rapporteur appointed by the Committee for Medicinal Products for Human Use and the Reference Member State for the medicinal products concerned.
Poročevalec tesno sodeluje s poročevalcem, ki ga imenujeta Odbor za zdravila za uporabo v humani medicini in referenčna država članica za zadevna zdravila.
For the purposes of that assessment, the marketing authorisation holder may submit comments in writing.
Za namene navedene ocene lahko imetniki dovoljenja za promet z zdravilom pisno podajo svoje pripombe.
Where the urgency of the matter permits, the Pharmacovigilance Risk Assessment Committee may hold public hearings, where it considers that this is appropriate on justified grounds particularly with regard to the extent and seriousness of the safety concern.
Če nujnost zadeve to dovoljuje, Odbor za ocenjevanje tveganja na področju farmakovigilance lahko opravi javno obravnavo, in če to šteje za primerno na podlagi utemeljenih razlogov, zlasti kar zadeva obseg in resnost varnostnega zadržka.
The hearings shall be held in accordance with the modalities specified by the Agency and shall be announced by means of the European medicines web-portal.
Obravnave se opravijo na način, ki ga natančno določi Agencija, in se objavijo na evropskem spletnem portalu o zdravilih.
The announcement shall specify the modalities of participation.
V obvestilu se natančno določijo načini sodelovanja.
In the public hearing, due regard shall be given to the therapeutic effect of the medicinal product.
Na javni obravnavi se ustrezno pozornost nameni terapevtskim učinkom zdravila.
The Agency shall, in consultation with the parties concerned, draw up Rules of Procedure on the organisation and conduct of public hearings, in accordance with Article 78 of Regulation (EC) No 726/2004.
Agencija, po posvetovanju z zainteresiranimi stranmi, določi poslovnik, ki se uporablja za organizacijo in izvedbo javnih obravnav, v skladu s členom 78 Uredbe (ES) št. 726/2004.
Where a marketing authorisation holder or another person intending to submit information has confidential data relevant to the subject matter of the procedure, he may request permission to present that data to the Pharmacovigilance Risk Assessment Committee in a non-public hearing.
Kadar ima imetnik dovoljenja za promet ali druga oseba, ki namerava predložiti informacije, zaupne podatke, pomembne za vsebino postopka, lahko zahteva, da te podatke predstavi Odboru za ocenjevanje tveganja na področju farmakovigilance na obravnavi, ki ni javna.
Within 60 days of the information being submitted, the Pharmacovigilance Risk Assessment Committee shall make a recommendation, stating the reasons on which it is based, having due regard to the therapeutic effect of the medicinal product.
V 60 dneh po predložitvi informacij Odbor za ocenjevanje tveganja na področju farmakovigilance pripravi priporočilo, v katerem navede razloge, na katerih to priporočilo temelji, ob upoštevanju terapevtskih učinkov zdravila.
The recommendation shall mention the divergent positions and the grounds on which they are based.
V priporočilu se navedejo različna stališča, vključno z njihovimi utemeljitvami.
In the case of urgency, and on the basis of a proposal by its chairman, the Pharmacovigilance Risk Assessment Committee may agree to a shorter deadline.
Odbor za ocenjevanje tveganja na področju farmakovigilance lahko v izrednih razmerah in na predlog svojega predsednika doseže dogovor o krajšem roku.
The recommendation shall include any or a combination of the following conclusions:
Priporočilo vsebuje enega ali kombinacijo naslednjih sklepov:
no further evaluation or action is required at Union level;
na ravni Unije se ne zahteva nobeno nadaljnje ocenjevanje ali ukrepanje;
the marketing authorisation holder should conduct further evaluation of data together with the follow-up of the results of that evaluation;
imetnik dovoljenja za promet bi moral opraviti nadaljnje ocenjevanje podatkov skupaj z nadaljnjim spremljanjem rezultatov navedenega ocenjevanja;
the marketing authorisation holder should sponsor a post-authorisation safety study together with the follow up evaluation of the results of that study;
imetnik dovoljenja za promet bi moral financirati študijo o varnosti zdravila po pridobitvi dovoljenja za promet skupaj z nadaljnjo oceno rezultatov navedene študije;
the Member States or marketing authorisation holder should implement risk minimisation measures;
države članice ali imetnik dovoljenja za promet z zdravilom bi moral izvesti ukrepe za zmanjšanje tveganj;
the marketing authorisation should be suspended, revoked or not renewed;
dovoljenje za promet z zdravilom bi bilo treba začasno preklicati, ukiniti ali ga ne podaljšati;
the marketing authorisation should be varied.
dovoljenje za promet z zdravilom bi bilo treba spremeniti.
For the purposes of point (d) of the first subparagraph, the recommendation shall specify the risk minimisation measures recommended and any conditions or restrictions to which the marketing authorisation should be made subject.
Za namene točke (d) prvega pododstavka priporočilo določa priporočene ukrepe za zmanjšanje tveganj ter pogoje ali omejitve, ki veljajo za dovoljenje za promet z zdravilom.
Where, in the cases referred to in point (f) of the first subparagraph, it is recommended to change or add information in the summary of product characteristics or the labelling or package leaflet, the recommendation shall suggest the wording of such changed or added information and where in the summary of the product characteristics, labelling or package leaflet such wording should be placed.
Kadar je v primerih iz točke (f) prvega pododstavka priporočeno, da se v povzetku glavnih značilnosti zdravila, označevanju ali navodilu za uporabo spremenijo ali dodajo informacije, priporočilo predlaga besedilo takih spremenjenih ali dodanih informacij in kje v povzetku glavnih značilnosti zdravila, označevanju ali navodilu za uporabo naj bo to besedilo.
Article 107k
Člen 107k
Where the scope of the procedure, as determined in accordance with Article 107i(4), does not include any marketing authorisation granted in accordance with the centralised procedure provided for in Chapter 1 of Title II of Regulation (EC) No 726/2004, the coordination group shall, within 30 days of receipt of the recommendation of the Pharmacovigilance Risk Assessment Committee, consider the recommendation and reach a position on the maintenance, variation, suspension, revocation or refusal of the renewal of the marketing authorisation concerned, including a timetable for the implementation of the agreed position.
Kadar področje uporabe postopka, kakor je določeno v skladu s členom 107i(4) ne vključuje nobenega dovoljenja za promet z zdravilom, izdanega v skladu s centraliziranim postopkom iz poglavja 1 naslova II Uredbe (ES) št. 726/2004, skupina za usklajevanje v 30 dneh po prejemu priporočila Odbora za ocenjevanje tveganja na področju farmakovigilance preuči priporočilo in doseže dogovor o stališču o ohranitvi, spremembi, začasnem preklicu, ukinitvi ali zavrnitvi podaljšanja zadevnega dovoljenja za promet z zdravilom, vključno s časovnim razporedom za izvajanje dogovorjenega stališča.
Where an urgent adoption of the position is necessary, and on the basis of a proposal by its chairman, the coordination group may agree to a shorter deadline.
Skupina za usklajevanje lahko, kjer je potrebno nujno sprejetje stališča in na podlagi predloga svojega predsednika, doseže dogovor o krajšem roku.
The Member States shall adopt necessary measures to maintain, vary, suspend, revoke or refuse renewal of the marketing authorisation concerned in accordance with the implementation timetable determined in the agreement.
Države članice sprejmejo ustrezne ukrepe, da ohranijo, spremenijo, začasno prekličejo, ukinejo ali zavrnejo podaljšanje zadevnega dovoljenja za promet z zdravilom v skladu s časovnim razporedom za izvajanje, določenim v dogovoru.
In the event that a variation is agreed upon, the marketing authorisation holder shall submit to the national competent authorities an appropriate application for a variation, including an updated summary of product characteristics and package leaflet within the determined timetable for implementation.
V primeru dogovora o spremembi, imetnik dovoljenja za promet z zdravilom pristojnemu nacionalnemu organu predloži ustrezno vlogo za spremembo, vključno s posodobljenim povzetkom glavnih značilnosti zdravila in navodilom za uporabo v časovnem roku določenem za uveljavitev.
However, by way of derogation from Article 34(1), the procedure referred to in Article 121(2) shall apply.
Vendar se z odstopanjem od člena 34(1) uporablja postopek iz člena 121(2).