natgillin/translations-raw huggingface dataset:
V primeru enotne ocene rednih poročil o varnosti zdravila, ki zadevajo več kot eno dovoljenje za promet v skladu s členom 107e(1), ki ne vključuje nobenega dovoljenja za promet, izdanega v skladu z Uredbo (ES) št. 726/2004, skupina za usklajevanje v 30 dneh po prejemu priporočila odbora za oceno tveganja na področju farmakovigilance sprejme mnenje o ohranitvi, spremembi, začasnem preklicu ali ukinitvi zadevnega dovoljenja za promet, vključno s časovnim razporedom za izvajanje mnenja.
In the case of a single assessment of periodic safety update reports concerning more than one marketing authorisation in accordance with Article 107e(1) which does not include any marketing authorisation granted in accordance with Regulation (EC) No 726/2004, the coordination group shall, within 30 days of receipt of the recommendation of the Pharmacovigilance Risk Assessment Committee, adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisations concerned, including a timetable for the implementation of the opinion.
Skupina za usklajevanje pred sprejetjem take odločitve zadevnemu imetniku dovoljenja za promet omogoči, da predloži pisna ali ustna pojasnila v predpisanem roku, ki ga je treba določiti.
Before adopting such a decision, the coordination group shall allow the marketing authorisation holders concerned to submit written or verbal explanations within the required time-limits, which must be specified.
To mnenje se nemudoma objavi skupaj z navedbo manjšinskih stališč.
The opinion shall be published immediately, indicating any minority views.
Mnenje odbora za oceno tveganja na področju farmakovigilance moralo imeti več veljave pri skupini za usklajevanje in Odboru za zdravila za uporabo v humani medicini, ki bi lahko zavrnila njegovo priporočilo samo, če bi odločitev utemeljila z znanstvenimi ugotovitvami in razlogi javnega zdravja.
The opinion of the PRAC should carry more weight with the coordination group and with the CHMP, who should only be able to overturn the PRAC's recommendation if they justify their decision on the grounds of science and public health.
Člen 107g – odstavek 2 – pododstavek 2
Article 107 g – paragraph 2 - subparagraph 2
Če mnenja ni mogoče sprejeti soglasno, se večinsko mnenje posreduje Komisiji, ki uporabi postopek iz členov 33 in 34.
If an opinion by consensus cannot be adopted, the majority opinion shall be forwarded to the Commission which shall apply the procedure laid down in Articles 33 and 34..
Lahko se uporabijo faze postopka iz člena 32(4).
The stages of the procedure described in Article 32(4) may be applied .
Dokončne odločitve je treba sprejemati redno po enakem poteku kot v drugih zakonskih postopkih ob upoštevanju nujnosti morebitnih vprašanj, ki jih je treba obravnavati.
The final decisions must be adopted in a consistent manner, following the same pattern as the other regulatory procedures, while bearing in mind the urgent nature of the issues that may need to be dealt with.
Člen 107g – odstavek 3
Article 107g - paragraph 3
V primeru enotne ocene rednih poročil o varnosti zdravila, ki zadevajo več kot eno dovoljenje za promet v skladu s členom 107e(1), ki vključuje vsaj eno dovoljenje za promet, izdano v skladu s postopkom iz Uredbe (ES) št. 726/2004, Odbor za zdravila za uporabo v humani medicini v 30 dneh po prejemu poročila Svetovalnega odbora za ocenjevanje tveganja farmakovigilance preuči poročilo in sprejme mnenje o ohranitvi, spremembi, začasnem preklicu ali ukinitvi zadevnega dovoljenja za promet.
In the case of a single assessment of periodic safety update reports concerning more than one marketing authorisation in accordance with Article 107e(1) which includes at least one marketing authorisation granted in accordance with the procedure 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 Advisory Committee, consider the report and adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisations concerned.
V primeru enotne ocene rednih poročil o varnosti zdravila, ki zadevajo več kot eno dovoljenje za promet v skladu s členom 107e(1), ki vključuje vsaj eno dovoljenje za promet, izdano v skladu s postopkom iz Uredbe (ES) št. 726/2004, Odbor za zdravila za uporabo v humani medicini v 30 dneh po prejemu priporočila odbora za oceno tveganja na področju farmakovigilance sprejme mnenje o ohranitvi, spremembi, začasnem preklicu ali ukinitvi zadevnega dovoljenja za promet.
In the case of a single assessment of periodic safety update reports concerning more than one marketing authorisation in accordance with Article 107e(1) which includes at least one marketing authorisation granted in accordance with the procedure 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, adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisations concerned.
Lahko se uporabijo faze postopka, ki so opisane v členu 9(2) Uredbe (ES) št. 726/2004.
The stages of the procedure described in Article 9(2) of Regulation (EC) No 726/2004 may be applied .
Odbor za zdravila za uporabo v humani medicini sprejme mnenje, ki se razlikuje od priporočila odbora za oceno tveganja na področju farmakovigilance, samo, če obstajajo za to trdni znanstveni dokazi in razlogi javnega zdravja.
The Committee for Medicinal Products for Human Use shall adopt an opinion which differs from the recommendation of the Pharmacovigilance Risk Assessment Committee, only if there exist strong scientific and public health grounds for do ing so.
Odbor za zdravila za uporabo v humani medicini te razloge pojasni v utemeljitvi, ki jo priloži k mnenju.
The Committee for Medicinal Products for Human Use shall explain these grounds in a justification to be annex ed to its opinion.
Gl. obrazložitev k odstavku 1 člena 107g.
see justification to Article 107g - paragraph 1.
Oddelek 2a (novo) se vstavi pred členom 107h
Section 2 a (new) to be inserted before Article 107h
Oddelek 2a
Section 2a
Zaznavanje opozoril
Signal Detection
Da ne bi prišlo do zmede, bi moral biti ta člen v posebnem, ustrezno naslovljenem oddelku.
To avoid confusion, this article should have its own, appropriately named section.
Oddelek 3 – naslov
Section 3 - heading
Postopek Skupnosti
Community procedure
Nujni postopek Unije
Urgent Union procedure
V tem oddelku je opisan postopek za takojšnjo razširitev informacij in usklajevanje, če država članica odkrije večjo težavo glede varnosti in ukrepa ali razmišlja o ukrepanju, da bi enostransko ukinila ali začasno preklicala dovoljenje za promet z zdravilom.
This section describes the procedure for immediate information sharing and coordination if one Member State uncovers a serious safety concern and acts - or considers acting - to unilaterally revoke or suspend a market authorisation.
Naslov predloga „Postopek Skupnosti“ ne odraža nujnosti tega postopka in povzroča zmedo glede centraliziranih in decentraliziranih postopkov za pridobitev dovoljenja za promet z zdravilom.
The proposed title, "Community procedure", does not reflect the urgency of the procedure and is confusing in the context of centralised and decentralised authorisation procedures for medicines.
Člen 107i – odstavek 1
Article 107 i – paragraph 1
Država članica sproži postopek na podlagi tega oddelka tako, da druge države članice, Agencijo in Komisijo obvesti, kadar:
A Member State shall initiate the procedure under this section, by informing the other Member States, the Agency and the Commission, in any of the following cases:
Država članica sproži postopek na podlagi tega oddelka tako, da druge države članice, Agencijo in Komisijo ter morebitne zadevne imetnike dovoljenj za promet obvesti, kadar:
A Member State shall initiate the procedure under this section, by informing the other Member States, the Agency, the Commission and the marketing authorisation holders potentially affected , in any of the following cases:
(a) razmišlja o začasnem preklicu ali ukinitvi dovoljenja za promet;
(a) it considers suspending or revoking of a marketing authorisation ;
(a) na podlagi ugotovitev vrednotenja podatkov o farmakovigilanci razmišlja o enem od naslednjih regulativnih ukrepov :
(a) it considers , in the light of the outcome of the assessment of pharmacovigilance data, one of the following regulatory measures:
– o začasnem preklicu ali ukinitvi dovoljenja za promet;
– suspending or revoking a marketing authorisation ;
(b) razmišlja o prepovedi izdajanja zdravila;
(b) it considers prohibiting the supply of a medicinal product;
– o prepovedi izdajanja zdravila;
– prohibiting the supply of a medicinal product;
(c) razmišlja o zavrnitvi podaljšanja dovoljenja za promet;
(c) it considers refusing the renewal of a marketing authorisation;
– o zavrnitvi podaljšanja dovoljenja za promet;
– refusing the renewal of a marketing authorisation;
(d) jo imetnik dovoljenja za promet obvesti, da je zaradi skrbi glede varnosti prekinil dajanje zdravila v promet ali ukinil dovoljenje za promet ali to namerava;
(d) 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 withdrawn a marketing authorisation, or that he intends to do so;
(b) jo imetnik dovoljenja za promet obvesti, da je zaradi skrbi glede varnosti prekinil dajanje zdravila v promet ali ukinil dovoljenje za promet ali to namerava;
(b) 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 withdrawn a marketing authorisation, or that he intends to do so;
(e) meni, da so potrebne nove kontraindikacije, zmanjšanje priporočenega odmerka ali omejitev indikacij;
(e) it considers that new contraindications, a reduction in the recommended dose, or a restriction to the indications is necessary;
(f) je izvedla inšpekcijski pregled farmakovigilance in ugotovila resne pomanjkljivosti.
(f) it has conducted a pharmacovigilance inspection and found serious deficiencies.
(c) je izvedla inšpekcijski pregled farmakovigilance in ugotovila resne pomanjkljivosti.
(c) it has conducted a pharmacovigilance inspection and found serious deficiencies.
Imetnik dovoljenja za promet z zdravilom mora imeti možnost, da je zelo zgodaj obveščen o začetku tega postopka, da lahko zbere dokaze in informacije, potrebne za hitro izvedbo tega postopka.
The marketing authorisation holder must be able to be informed very quickly once the procedure has been initiated so that he can assemble the evidence and information needed for the swift conduct of the procedure.
Ker primere, ko sta potrebna revizija ali omejitev dovoljenja za promet z zdravilom, ureja člen 31 Direktive 2001/83/ES, je treba preprečiti vsakršno zmedo in birokratske formalnosti, ki bi nastale zaradi dvojnega postopka.
Since cases requiring a review or restriction of a marketing authorisation are covered by Article 31 of Directive 2001/81/EC, any confusion and red tape created by having dual procedures must be avoided.
Člen 107k – odstavek 1 – pododstavek 1
Article 107k – paragraph 1 – subparagraph 1
Po informacijah iz člena 107i(1) Agencija javno objavi sprožitev postopka na evropskem spletnem portalu o varnosti zdravil .
Following the information referred to in Article 107i(1), the Agency shall publicly announce the initiation of the procedure by means of the European medicines safety web-portal.
Po informacijah iz člena 107i(1) Agencija obvesti zadevne imetnike dovoljenja za promet in javno objavi sprožitev postopka na evropskem spletnem portalu o zdravilih .
Following the information referred to in Article 107i(1), the Agency shall notify the concerned marketing authorisation holders and publicly announce the initiation of the procedure by means of the European medicines web-portal.
Člen 107k – odstavek 2 – pododstavek 1
Article 107 k – paragraph 2 – subparagraph 1
Svetovalni odbor za ocenjevanje tveganja farmakovigilance oceni zadevo, ki je bila predložena.
The Pharmacovigilance Risk Assessment Advisory Committee shall assess the matter which has been submitted.
Za namene navedene ocene lahko izvede javno obravnavo.
For the purposes of that assessment, it may hold a public hearing.
Odbor za oceno tveganja na področju farmakovigilance oceni zadevo, ki je bila predložena.
The Pharmacovigilance Risk Assessment Committee shall assess the matter which has been submitted.
Za namene navedene ocene lahko izvede javno obravnavo , če so na podlagi znanstvenih podatkov izpolnjena objektivna merila, ob upoštevanju učinkovitosti in koristi zadevnega proizvoda ter prejšnjih ocen razmerja med tveganjem in koristmi, ki jih je opravil odbor za zdravila za uporabo v humani medicini ali skupina za usklajevanje v skladu s postopkom izdaje dovoljenja za promet z zdravilom, kakor je določen v členu 107l, v katerem mora sodelovati poročevalec odbora za zdravila za uporabo v humani medicini za zadevni proizvod ali poročevalec skupine za usklajevanje.
For the purposes of that assessment, it may hold a public hearing, if objective criteria are met on the basis of scientific data, taking account of the effectiveness and benefits of the product concerned and of earlier risk/benefit assessments conducted by the Committee for Medicinal Products for Human Use or the coordination group in accordance with the procedure for granting marketing authorisations laid down in Article 107l, which must involve the rapporteur of the Committee for Medicinal Products for Human Use on the product in question, or the rapporteur of the coordination group.
Agencija v posvetovanju z zainteresiranimi stranmi pripravi smernice o izvedbi in poteku javnih obravnav.
The Agency, in consultation with the parties concerned, shall draw up guidelines on the organisation and conduct of public hearings.
Javna obravnava, ki jo izvede ta odbor, je primerno orodje, če je izvedbo te obravnave mogoče pravilno opredeliti ob upoštevanju ne samo tveganja, ampak tudi koristi zadevnega(-ih) proizvoda(-ov), da bi bile razprave verodostojne in objektivne.
The holding of public hearings by the Committee is a relevant tool provided that they are conducted properly and take account not just of the risks but also of the benefits of the product(s) concerned, so that discussions on the subject are credible and objective.
Predvsem je treba ohraniti bolnikovo dobro počutje in oceniti tveganja z vidika koristi zdravila ob upoštevanju vseh razpoložljivih informacij.
The main aim is to protect the patient’s wellbeing and to compare the risks and benefits of a medicinal product in the light of all the information provided.
Člen 107k – odstavek 3 – uvodni del
Article 107 k – paragraph 3 – introductory part
V 60 dneh po predložitvi informacij Svetovalni odbor za ocenjevanje tveganja farmakovigilance pripravi priporočilo, v katerem navede razloge, na katerih to priporočilo temelji.
Within 60 days of the information submitted, the Pharmacovigilance Risk Assessment Advisory Committee shall make a recommendation, stating the reasons on which it is based.
Priporočilo je eno od ali kombinacija naslednjega:
The recommendation shall be any or a combination of the following:
V 60 dneh po predložitvi informacij Svetovalni odbor za oceno tveganja na področju farmakovigilance tudi ob upoštevanju koristi zdravila, kakor jih je ocenil odbor za zdravila za uporabo v humani medicini ali skupina za usklajevanje v skladu s postopkom izdaje dovoljenja za promet z zdravilom, kakor je določen v členu 107l, pripravi priporočilo, v katerem navede razloge, na katerih to priporočilo temelji.
Within 60 days of the information submitted, the Pharmacovigilance Risk Assessment Advisory Committee shall make a recommendation, stating the reasons on which it is based, and taking account of the benefits of the medicinal product as assessed by the Committee for Medicinal Products for Human Use or the coordination group in accordance with the procedure for granting marketing authorisations laid down in Article 107l.
Člen 107l – odstavek 1
Article 107 l - paragraph 1
Kadar področje uporabe postopka iz člena 107i(2) ne vključuje nobenega dovoljenja za promet, izdanega v skladu s postopkom iz Uredbe (ES) št. 726/2004, skupina za usklajevanje v 30 dneh po priporočilu Svetovalnega odbora za ocenjevanje tveganja farmakovigilance preuči priporočilo in sprejme mnenje o ohranitvi, spremembi, začasnem preklicu, ukinitvi ali zavrnitvi podaljšanja zadevnega dovoljenja za promet, vključno s časovnim razporedom za izvajanje mnenja .
Where the scope of the procedure, as determined in accordance with Article 107i(2), does not include any marketing authorisation granted in accordance with the procedure of Regulation (EC) No 726/2004, the coordination group shall, within 30 days of the recommendation of the Pharmacovigilance Risk Assessment Advisory Committee, consider the recommendation and adopt an opinion on the maintenance, variation, suspension, revocation or refusal of the renewal of the marketing authorisations concerned, including a timetable for the implementation of the opinion.
Kadar področje uporabe postopka iz člena 107i(2) ne vključuje nobenega dovoljenja za promet, izdanega v skladu s postopkom iz Uredbe (ES) št. 726/2004, skupina za usklajevanje ukrepa v skladu s členom 107g(1).
Where the scope of the procedure, as determined in accordance with Article 107i(2), does not include any marketing authorisation granted in accordance with the procedure of Regulation (EC) No 726/2004, the coordination group shall act in accordance with Article 107g(1).
Načelo, da morata Odbor za zdravila za uporabo v humani medicini in skupina za usklajevanje utemeljiti, zakaj je njuno mnenje drugačno od priporočila odbora za oceno tveganja na področju farmakovigilance, bi moralo veljati tudi a ocene, izvedene po nujnem postopku Unije.
The principle that the CHMP and the coordination group should have to justify why their opinion differs from the recommendation of the PRAC should also apply to assessments carried out under the Urgent Community Procedure.
Člen 107l – odstavek 3
Article 107 l - paragraph 3
Kadar področje uporabe postopka, kakor je določeno v členu 107i(2), vključuje vsaj eno dovoljenje za promet, izdano v skladu s postopkom iz Uredbe (ES) št. 726/2004, Odbor za zdravila za uporabo v humani medicini v 30 dneh po priporočilu Svetovalnega odbora za ocenjevanje tveganja farmakovigilance preuči priporočilo in sprejme mnenje o ohranitvi, spremembi, začasnem preklicu, ukinitvi ali zavrnitvi podaljšanja zadevnega dovoljenja za promet .
Where the scope of the procedure, as determined in accordance with Article 107i(2), includes at least one marketing authorisation granted in accordance with the procedure of Regulation (EC) No 726/2004, the Committee for Medicinal Products for Human Use shall, within 30 days of the recommendation of the Pharmacovigilance Risk Assessment Advisory 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 iz člena 107i(2) vključuje vsaj eno dovoljenje za promet, izdano v skladu s postopkom iz Uredbe (ES) št. 726/2004, Odbor za zdravila za uporabo v humani medicini ukrepa v skladu s členom 107g(3).
Where the scope of the procedure, as determined in accordance with Article 107i(2), includes at least one marketing authorisation granted in accordance with the procedure of Regulation (EC) No 726/2004, the Committee for Medicinal Products for Human Use shall act in accordance with Article 107g(3).
Gl. obrazložitev k odstavku 1 člena 107l.
see justification to Article 107l - paragraph 1.
Člen 107m
Article 107 m
Agencija javno objavi priporočila, mnenja in odločbe iz členov 107b do 107l na evropskem spletnem portalu o varnosti zdravil .
The Agency shall make public the recommendations, opinions and decisions referred to in Articles 107b to 107l by means of the European medicines safety web-portal.
Agencija javno objavi končne ugotovitve ( priporočila, mnenja in končne odločbe ) iz členov 107b do 107l na evropskem spletnem portalu o zdravilih .
The Agency shall make public the final conclusions (recommendations, opinions and final decisions) referred to in Articles 107b to 107l by means of the European medicines web-portal.
Informacija, ki se objavi na tem spletnem portalu, mora biti popolna, vendar ne zapletena.
The information to be published on this web-portal must be comprehensive but not complex.
Člen 107n – odstavek 1
Article 107 n – paragraph 1
Člen 108 – uvodni stavek
Article 108 - introductory sentence
Komisija po posvetovanju z Agencijo, državami članicami in zainteresiranimi stranmi sprejme in objavi smernice za dobro farmakovigilančno prakso za zdravila, odobrena v skladu s členom 6(1), na naslednjih področjih :
Following consultation with the Agency ,Member States and interested parties , the Commission shall adopt and make public guidelines on good pharmacovigilance practice for medicinal products authorised in accordance with Article 6(1)in the following areas:
Po ustreznih posvetovanjih Komisija z delegiranimi akti v skladu s členom 121a in pod pogoji iz členov 121b in 121c sprejme in objavi smernice za dobro farmakovigilančno prakso za zdravila, odobrena v skladu s členom 6(1), na naslednjih področjih:
Following appropriate consultations , the Commission shall adopt , by means of delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c , and make public , guidelines on good pharmacovigilance practice for medicinal products authorised in accordance with Article 6(1) in the following areas:
Člen 108 – odstavek 1 – točka 5
Article 108 – paragraph 1 – point 5
(5) oblika elektronskega poročanja o neželenih učinkih s strani državi članic in imetnikov dovoljenja za promet;
(5) the format of electronic reporting of adverse reactions by Member states and marketing authorization holders;
(5) oblika elektronskega poročanja o neželenih učinkih s strani državi članic in imetnikov dovoljenja za promet, vključno s predstavitvijo zbranih informacij .
(5) the format of electronic reporting of adverse reactions by Member states and marketing authorization holders , including the presentation of the collected information.
Zbrane informacije morajo razlikovati med neželenimi učinki zaradi prevelikega odmerjanja, nepravilne uporabe, zlorabe zdravil, napak pri zdravilih ter neželenimi učinki, ki se pojavijo med študijami zdravil ali po poklicni izpostavljenosti;
The collected information must distinguish adverse reactions due to overdose, misuse, abuse, medication errors, and adverse reactions occurring in the course of studies with the medicinal product or after occupational exposure ;
Da bi bilo mogoče zagotoviti ustrezno oceno in nadaljnje ukrepanje, morajo biti pristojni organi sposobni razlikovati med različnimi neželenimi učinki, saj bo to pripeljalo do drugačnega nadaljnjega ukrepanja (dodatna opozorila, kontraindikacije, odvzem dovoljenja za promet itd. …).
To enable an appropriate assessment and follow up, competent authorities must be able to distinguish between the different adverse reactions because it will lead to a different follow-up (additional warnings, contra-indications, suspension of marketing authorisation etc…).
Člen 108 – odstavek 2a (novo)
Article 108 – paragraph 2a (new)