natgillin/translations-raw huggingface dataset:
Where the agreement reached by the Member States represented within the coordination group or the position of the majority of the Member States represented within the coordination group differs from the recommendation of the Pharmacovigilance Risk Assessment Committee, the coordination group shall attach to the agreement or majority position a detailed explanation of the scientific grounds for the differences together with the recommendation.
Če dogovor, ki so ga v skupini za usklajevanje dosegle zastopane države članice, ali stališče večine zastopanih držav članic v skupini za usklajevanje ni v skladu s priporočilom Odbora za ocenjevanje tveganja na področju farmakovigilance, skupina za usklajevanje temu dogovoru ali stališču večine skupaj s priporočilom priloži podrobno razlago znanstvenih utemeljitev za razhajanja.
Where the scope of the procedure, as determined in accordance with Article 107i(4), 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 recommendation of the Pharmacovigilance Risk Assessment Committee, consider the recommendation and adopt an opinion on the maintenance, variation, suspension, revocation or refusal of the renewal of the marketing authorisations concerned.
Kadar področje uporabe postopka, kakor je določeno v členu 107i(4), 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 priporočila Odbora za ocenjevanje tveganja na področju farmakovigilance preuči priporočilo in sprejme mnenje o ohranitvi, spremembi, začasnem preklicu, ukinitvi ali zavrnitvi podaljšanja zadevnega dovoljenja za promet z zdravilom.
Where an urgent adoption of the opinion is necessary, and on the basis of a proposal by its chairman, the Committee for Medicinal Products for Human Use may agree to a shorter deadline.
Odbor za zdravila za uporabo v humani medicini lahko, kjer je potrebno nujno sprejetje mnenja in na podlagi predloga svojega predsednika, doseže dogovor o krajšem roku.
Where the 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 mnenje Odbora za zdravila za uporabo v humani medicini ni skladno s priporočilom Odbora za ocenjevanje tveganja na področju farmakovigilance, Odbor za zdravila za uporabo v humani medicini svojemu mnenju skupaj s priporočilom priloži podrobno znanstveno razlago za razhajanja.
adopt a decision addressed to the Member States concerning the measures to be taken in respect of marketing authorisations that are granted by the Member States and that are subject to 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 so jih izdale države članice in ob upoštevanju postopka iz tega oddelka; ter
where the opinion is that regulatory action is necessary, adopt a decision to vary, suspend, revoke or refuse renewal of the marketing authorisations granted in accordance with Regulation (EC) No 726/2004 and subject to the procedure provided for in this section.
kadar obstaja mnenje, da je potreben ureditveni ukrep, sprejme odločitev o spremembi, začasnem preklicu, ukinitvi ali zavrnitvi podaljšanja dovoljenj za promet z zdravili, izdanih v skladu z Uredbo (ES) št. 726/2004, in ob upoštevanju postopka iz tega oddelka.
However, by way of derogation from Article 34(1) of this Directive, the procedure referred to in Article 121(2) thereof shall apply.
Vendar se z odstopanjem od člena 34(1) te direktive uporablja postopek iz člena 121(2).
However, by way of derogation from Article 10(2) of that Regulation, the procedure referred to in Article 87(2) thereof shall apply.
Vendar se z odstopanjem od člena 10(2) navedene uredbe uporablja postopek iz člena 87(2) navedene uredbe.
Publication of assessments
Objava ocen
Article 107l
Člen 107l
The Agency shall make public the final assessment conclusions, recommendations, opinions and decisions referred to in Articles 107b to 107k by means of the European medicines web-portal.
Agencija objavi sklepe, priporočila, mnenja in odločitve končnega ocenjevanja iz členov 107b do 107k na evropskem spletnem portalu o zdravilih.
Supervision of post-authorisation safety studies
Nadzor študij o varnosti zdravila po pridobitvi dovoljenja za promet
Article 107m
Člen 107m
This Chapter applies to non-interventional post-authorisation safety studies which are initiated, managed or financed by the marketing authorisation holder voluntarily or pursuant to obligations imposed in accordance with Articles 21a or 22a, and which involve the collection of safety data from patients or healthcare professionals.
To poglavje se uporablja za neintervencijske študije varnosti po pridobitvi dovoljenja za promet, ki jih prostovoljno ali na zahtevo v skladu s členom 21a ali 22a začne, upravlja ali financira imetnik dovoljenja za promet z zdravilom in ki vključujejo zbiranje varnostnih podatkov od bolnikov ali zdravstvenih delavcev.
This Chapter is without prejudice to national and Union requirements for ensuring the well-being and rights of participants in non-interventional post-authorisation safety studies.
To poglavje ne posega v nacionalne zahteve in zahteve Unije po zagotavljanju dobrega počutja in pravic udeležencev v neintervencijskih študijah varnosti po pridobitvi dovoljenja za promet.
The studies shall not be performed where the act of conducting the study promotes the use of a medicinal product.
Študije se ne izvedejo, kadar izvajanje študije spodbuja uporabo zdravila.
Payments to healthcare professionals for participating in non-interventional post-authorisation safety studies shall be restricted to the compensation for time and expenses incurred.
Plačila zdravstvenim delavcem za sodelovanje pri neintervencijskih študijah varnosti po pridobitvi dovoljenja za promet so omejena na nadomestilo za čas in nastale stroške.
The national competent authority may require the marketing authorisation holder to submit the protocol and the progress reports to the competent authorities of the Member States in which the study is conducted.
Pristojni nacionalni organ lahko od imetnika dovoljenja za promet z zdravilom zahteva, da pristojnim organom držav članic, v katerih se izvaja študija, predloži protokol in poročila o napredku.
The marketing authorisation holder shall send the final report to the competent authorities of the Member States in which the study was conducted within 12 months of the end of data collection.
Imetnik dovoljenja za promet z zdravilom pošlje končno poročilo pristojnim organom držav članic, v katerih se je izvajala študija, v 12 mesecih po koncu zbiranja podatkov.
While a study is being conducted, the marketing authorisation holder shall monitor the data generated and consider its implications for the risk-benefit balance of the medicinal product concerned.
Med izvajanjem študije imetnik dovoljenja za promet z zdravilom spremlja zbrane podatke in preuči njihove posledice za razmerje med tveganjem in koristjo zadevnega zdravila.
Any new information which might influence the evaluation of the risk-benefit balance of the medicinal product shall be communicated to the competent authorities of the Member State in which the medicinal product has been authorised in accordance with Article 23.
Vse nove informacije, ki bi lahko vplivale na oceno razmerja med tveganjem in koristjo zdravila, se sporočijo pristojnim organom držav članic, kjer je zdravilo odobreno v skladu s členom 23.
The obligation laid down in the second subparagraph is without prejudice to the information on the results of studies that the marketing authorisation holder shall make available by means of the periodic safety update reports as laid down in Article 107b.
Obveznost iz drugega pododstavka ne posega v informacije o rezultatih študij, ki jih imetnik dovoljenja za promet z zdravilom da na voljo z rednimi posodobljenimi poročili o varnosti zdravila, kot je določeno v členu 107b.
Articles 107n to 107q shall apply exclusively to studies referred to in paragraph 1 which are conducted pursuant to an obligation imposed in accordance with Articles 21a or 22a.
Členi 107n do 107q se uporabljajo izključno za študije iz odstavka 1, ki se izvedejo na podlagi obveznosti, naložene v skladu s členom 21a ali 22a.
Article 107n
Člen 107n
Before a study is conducted, the marketing authorisation holder shall submit a draft protocol to the Pharmacovigilance Risk Assessment Committee, except for studies to be conducted in only one Member State that requests the study according to Article 22a.
Pred izvedbo študije imetnik dovoljenja za promet z zdravilom predloži osnutek protokola Odboru za ocenjevanje tveganja na področju farmakovigilance, razen za študije, ki bodo izvedene samo v eni državi članici, ki študijo zahteva v skladu s členom 22a.
For such studies, the marketing authorisation holder shall submit a draft protocol to the national competent authority of the Member State in which the study is conducted.
Za takšne študije se od imetnika dovoljenja za promet z zdravilom zahteva, da osnutek protokola predloži pristojnemu nacionalnemu organu države članice, v kateri se izvaja študija.
Within 60 days of the submission of the draft protocol the national competent authority or the Pharmacovigilance Risk Assessment Committee, as appropriate, shall issue:
V 60 dneh po predložitvi osnutka protokola pristojni nacionalni organ ali Odbor za ocenjevanje tveganja na področju farmakovigilance izda:
a letter endorsing the draft protocol;
pismo o odobritvi osnutka protokola;
a letter of objection, which shall set out in detail the grounds for the objection, in any of the following cases:
pismo o ugovoru, ki temelji na podrobnih razlogih za ugovor, kadar:
it considers that the conduct of the study promotes the use of a medicinal product;
meni, da izvajanje študije spodbuja uporabo zdravila;
it considers that the design of the study does not fulfil the study objectives; or
meni, da zasnova študije ne izpolnjuje ciljev študije; ali
a letter notifying the marketing authorisation holder that the study is a clinical trial falling under the scope of Directive 2001/20/EC.
pismo, v katerem uradno obvešča imetnika dovoljenja za promet z zdravilom, da gre za klinično preskušanje, ki sodi v področje uporabe Direktive 2001/20/ES.
The study may commence only when the written endorsement from the national competent authority or the Pharmacovigilance Risk Assessment Committee, as appropriate, has been issued.
Študija se lahko začne samo s pisno odobritvijo pristojnega nacionalnega organa ali Odbora za ocenjevanje tveganja na področju farmakovigilance.
Where a letter of endorsement as referred to in paragraph 2(a) has been issued, the marketing authorisation holder shall forward the protocol to the competent authorities of the Member States in which the study is to be conducted and may thereafter commence the study according to the endorsed protocol.
Kadar je bilo izdano pismo o odobritvi iz točke (a) odstavka 2, imetnik dovoljenja za promet z zdravilom posreduje protokol pristojnim organom držav članic, v katerih je načrtovana izvedba študije, nato pa lahko začne izvajati študijo v skladu z odobrenim protokolom.
Article 107o
Člen 107o
After a study has been commenced, any substantial amendments to the protocol shall be submitted, before their implementation, to the national competent authority or to the Pharmacovigilance Risk Assessment Committee, as appropriate.
Po začetku študije se vsaka vsebinska sprememba protokola, preden se začne izvajati, predloži pristojnemu nacionalnemu organu ali Odboru za ocenjevanje tveganja na področju farmakovigilance.
The national competent authority or the Pharmacovigilance Risk Assessment Committee, as appropriate, shall assess the amendments and inform the marketing authorisation holder of its endorsement or objection.
Pristojni nacionalni organ ali Odbor za ocenjevanje tveganja na področju farmakovigilance oceni spremembe in obvesti imetnika dovoljenja za promet z zdravilom o svoji odobritvi ali ugovoru.
Where applicable, the marketing authorisation holder shall inform Member States in which the study is conducted.
Imetnik dovoljenja za promet z zdravilom, kadar je to primerno, obvesti države članice, kjer se študija izvaja.
Article 107p
Člen 107p
Upon completion of the study, a final study report shall be submitted to the national competent authority or the Pharmacovigilance Risk Assessment Committee within 12 months of the end of data collection unless a written waiver has been granted by the national competent authority or the Pharmacovigilance Risk Assessment Committee, as appropriate.
Po končani študiji se zaključna poročila o študiji predložijo pristojnemu nacionalnemu organu ali Odboru za ocenjevanje tveganja na področju farmakovigilance v 12 mesecih po koncu zbiranja podatkov, razen če se pristojni nacionalni organ ali Odbor za ocenjevanje tveganja na področju farmakovigilance temu pisno odpove.
The marketing authorisation holder shall evaluate whether the results of the study have an impact on the marketing authorisation and shall, if necessary, submit to the national competent authorities an application to vary the marketing authorisation.
Imetnik dovoljenja za promet z zdravilom oceni, ali rezultati študije vplivajo na dovoljenje za promet z zdravilom in kadar je potrebno, pristojnim nacionalnim organom predloži vlogo za spremembo dovoljenja za promet z zdravilom.
Together with the final study report, the marketing authorisation holder shall electronically submit an abstract of the study results to the national competent authority or the Pharmacovigilance Risk Assessment Committee.
Imetnik dovoljenja za promet z zdravilom skupaj z zaključnim poročilom o študiji pristojnemu nacionalnemu organu ali Odboru za ocenjevanje tveganja na področju farmakovigilance elektronsko predloži izvleček študije.
Article 107q
Člen 107q
Based on the results of the study and after consultation of the marketing authorisation holder, the Pharmacovigilance Risk Assessment Committee may make recommendations concerning the marketing authorisation, stating the reasons on which they are based.
Odbor za ocenjevanje tveganja na področju farmakovigilance na podlagi rezultatov študije in po posvetovanju z imetnikom dovoljenja za promet z zdravilom lahko izdela priporočilo glede dovoljenja za promet, v katerem navede razloge, na katerih to priporočilo temelji.
The recommendations shall mention the divergent positions and the grounds on which they are based.
V priporočilu se navedejo različna stališča, vključno z njihovimi utemeljitvami.
When recommendations for the variation, suspension or revocation of the marketing authorisation are made for a medicinal product authorised by the Member States pursuant to this Directive, the Member States represented within the coordination group shall agree a position on the matter taking into account the recommendation referred to in paragraph 1 and including a timetable for the implementation of the agreed position.
V primeru priporočil za spremembo, začasni preklic ali ukinitev dovoljenja za promet za zdravilo, ki ga odobrijo države članice na podlagi te direktive, države članice zastopane v skupini za usklajevanje sprejmejo stališče o zadevi ob upoštevanju priporočila iz odstavka 1, vključno s časovnim razporedom za izvajanje sprejetega stališča.
The Member States shall adopt necessary measures to vary, suspend or revoke the marketing authorisation concerned in accordance with the implementation timetable determined in the agreement.
Države članice sprejmejo ustrezne ukrepe, da spremenijo, začasno prekličejo ali ukinejo zadevno dovoljenje za promet z zdravilom v skladu s časovnim razporedom za izvajanje, določenim v dogovoru.
The agreement shall be made public on the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004.
Dogovor se objavi na evropskem spletnem portalu o zdravilih, vzpostavljenem v skladu s členom 26 Uredbe (ES) št. 726/2004.
If an agreement by consensus cannot be reached, the position of the majority of the Member States represented within the coordination group shall be forwarded to the Commission, which shall apply the procedure laid down in Articles 33 and 34.
Če dogovora ni mogoče doseči soglasno, se stališče večine zastopanih držav članic v okviru skupine za usklajevanje posreduje Komisiji, ki uporabi postopek, določen v členih 33 in 34.
Where the agreement reached by the Member States represented within the coordination group or the position of the majority of Member States differs from the recommendation of the Pharmacovigilance Risk Assessment Committee, the coordination group shall attach to the agreement or majority position a detailed explanation of the scientific grounds for the differences together with the recommendation.
Če dogovor, ki so ga v skupini za usklajevanje dosegle zastopane države članice, ali stališče večine držav članic ni v skladu s priporočilom Odbora za ocenjevanje tveganja na področju farmakovigilance, skupina za usklajevanje temu dogovoru ali stališču večine skupaj s priporočilom priloži podrobno razlago znanstvenih utemeljitev za razhajanja.
Implementation, Delegation and Guidance
Izvajanje, prenos pooblastil in smernice
In order to harmonise the performance of the pharmacovigilance activities provided for in this Directive, the Commission shall adopt implementing measures in the following areas for which pharmacovigilance activities are provided for in Article 8(3), and in Articles 101, 104, 104a, 107, 107a, 107b, 107h, 107n and 107p:
Da bi uskladili opravljanje dejavnosti na področju farmakovigilance iz te direktive, Komisija sprejme izvedbene ukrepe na naslednjih področjih za katera so predvidene dejavnosti farmakovigilance, ki so določena v členih 8(3) in členih 101, 104, 104a, 107, 107a, 107b, 107h, 107n in 107p:
the content and maintenance of the pharmacovigilance system master file kept by the marketing authorisation holder;
vsebina in vzdrževanje glavnega dosjeja o sistemu farmakovigilance, ki ga opravlja imetnik dovoljenja za promet z zdravilom;
the minimum requirements for the quality system for the performance of pharmacovigilance activities by the national competent authorities and the marketing authorisation holder;
minimalne zahteve za sistem kakovosti za izvajanje dejavnosti na področju farmakovigilance s strani pristojnih nacionalnih organov in imetnikov dovoljenj za promet z zdravili;
the use of internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities;
uporaba mednarodno dogovorjene terminologije, oblik in standardov za izvajanje dejavnosti farmakovigilance;
the minimum requirements for the monitoring of data in the Eudravigilance database to determine whether there are new risks or whether risks have changed;
minimalne zahteve za spremljanje podatkov v podatkovni bazi Eudravigilance, da se ugotovi, ali je prišlo do novih tveganj ali da so se tveganja spremenila;
the format and content of the electronic transmission of suspected adverse reactions by Member States and the marketing authorisation holder;
oblika in vsebina elektronskega prenosa obvestil o domnevnih neželenih učinkih s strani držav članic in imetnikov dovoljenj za promet z zdravili;
the format and content of electronic periodic safety update reports and risk management plans;
oblika in vsebina elektronskih rednih posodobljenih poročil o varnosti zdravila in načrtov za obvladovanje tveganj;
the format of protocols, abstracts and final study reports for the post-authorisation safety studies.
oblika protokolov, izvlečkov in zaključnih poročil za študije o varnosti zdravila po pridobitvi dovoljenja za promet.
Those measures shall take account of the work on international harmonisation carried out in the area of pharmacovigilance and shall, where necessary, be revised to take account of technical and scientific progress.
V navedenih ukrepih se upošteva delo mednarodnega usklajevanja, opravljeno na področju farmakovigilance in se po potrebi spremenijo, da se upošteva tehnični in znanstveni napredek.
Those measures shall be adopted in accordance with the regulatory procedure referred to in Article 121(2).
Ti ukrepi se sprejmejo v skladu s postopkom iz člena 121(2).
Article 108a
Člen 108a
In order to facilitate the performance of pharmacovigilance activities within the Union, the Agency shall, in cooperation with competent authorities and other interested parties, draw up:
Za spodbujanje dejavnosti na področju farmakovigilance v Uniji, Agencija v sodelovanju s pristojnimi organi in drugimi zainteresiranimi stranmi oblikuje:
guidance on good pharmacovigilance practices for both competent authorities and marketing authorisation holders;
smernice o dobri praksi na področju farmakovigilance za pristojne organe in imetnike dovoljenj za promet z zdravili;
scientific guidance on post-authorisation efficacy studies.
znanstvene smernice o študijah učinkovitosti po pridobitvi dovoljenja za promet z zdravilom.
Article 108b
Člen 108b
The Commission shall make public a report on the performance of pharmacovigilance tasks by the Member States on 21 July 2015 at the latest and then every 3 years thereafter.’.
Komisija objavi poročilo o tem, kako države članice izvajajo naloge farmakovigilance najpozneje 21. julija 2015 in nato vsaka tri leta.“;
Article 111 is amended as follows:
člen 111 se spremeni:
‘The competent authority of the Member State concerned shall, in cooperation with the Agency, ensure that the legal requirements governing medicinal products are complied with, by means of inspections, if necessary unannounced, and, where appropriate, by asking an Official Medicines Control Laboratory or a laboratory designated for that purpose to carry out tests on samples.
„Pristojni organ zadevne države članice v sodelovanju z Agencijo z inšpekcijskimi pregledi, če je potrebno nenapovedanimi, ter s prošnjo za testiranje vzorcev, naslovljeno na Uradni kontrolni laboratorij za preskušanje zdravil ali laboratorij, pooblaščen za ta namen, zagotovi, da se pravne zahteve, ki urejajo področje zdravil, izpolnjujejo.
This cooperation shall consist in sharing information with the Agency on both inspections that are planned and that have been conducted.
To sodelovanje sestavlja izmenjava informacij z Agencijo o načrtovanih in izvedenih inšpekcijskih pregledih.
Member States and the Agency shall cooperate in the coordination of inspections in third countries.’;
Države članice in Agencija sodelujejo pri usklajevanju inšpekcijskih pregledov v tretjih državah.“;
in the fifth subparagraph, point (d) is replaced by the following:
v petem pododstavku se točka (d) nadomesti z naslednjim:
inspect the premises, records, documents and pharmacovigilance system master file of the marketing authorisation holder or any firms employed by the marketing authorisation holder to perform the activities described in Title IX.’;
pregled prostorov, evidenc, dokumentov in glavnega dosjeja o sistemu farmakovigilance imetnika dovoljenja za promet z zdravilom ali vseh podjetij, ki jih imetnik dovoljenja z promet z zdravilom uporablja za izvajanje dejavnosti, opisanih v naslovu IX.“;
After every inspection referred to in paragraph 1, the competent authority shall report on whether the inspected entity complies with the principles and guidelines of good manufacturing practice and good distribution practices referred to in Articles 47 and 84, or whether the marketing authorisation holder complies with the requirements laid down in Title IX.
Po vsakem inšpekcijskem pregledu iz odstavka 1 pristojni organ poroča, ali pregledan subjekt ravna po načelih in smernicah dobre proizvodne prakse in dobre distribucijske prakse iz členov 47 in 84 in ali imetnik dovoljenja za promet z zdravilom izpolnjuje zahteve, določene v naslovu IX.