natgillin/translations-raw huggingface dataset:
Študije o varnosti zdravil po pridobitvi dovoljenja se ne smejo uporabljati za pridobitev dovoljenj za promet po znižani ceni brez zadostne ocene.
Post-authorisation safety studies must not be used to obtain marketing authorisations on the cheap, without sufficient evaluation.
Člen 1 – točka 1 – točka (d)
Article 1 – point 1 – point d
Člen 1 – točka 28b
Article 1 – point 28b
(28b) Sistem obvladovanja tveganja: Sklop farmakovigilančnih dejavnosti in posegov za opredelitev, ugotovitev značilnosti , preprečevanje ali zmanjševanje tveganj v zvezi z zdravilom, vključno z oceno učinkovitosti navedenih posegov.
(28b) Risk management system: a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including the assessment of the effectiveness of those interventions.
(28b) Sistem obvladovanja tveganja: sklop specifičnih farmakovigilančnih dejavnosti in posegov za količinsko določitev značilnosti ali preprečevanje predhodno in naknadno ugotovljenih tveganj v zvezi z zdravilom, vključno z oceno učinkovitosti navedenih posegov , ali za zgodnje odkrivanje novih tveganj .
(28b) Risk management system: a set of specific pharmacovigilance activities and interventions designed to quantify or prevent risks already detected, and risks identified subsequently, relating to a medicinal product, including the assessment of the effectiveness of those interventions , or to ensure early identification of new risks .
Vsa zdravila na evropskem trgu je treba temeljito nadzorovati s splošnim sistemom farmakovigilance, katerega učinkovitost mora biti okrepljena na evropski in nacionalni ravni.
All medicinal products available on the European market must be seriously monitored by the general pharmacovigilance system, which needs to be made more effective both at European and national levels.
Sistem obvladovanja tveganja mora omogočati, da se preprečijo tveganja, ki so že ugotovljena na podlagi te ocene.
A risk management system should make it possible to prevent risks already identified thanks to the pre-marketing authorisation assessment.
Člen 1 – točka 28c
Article 1 – point 28c
(28c) Sistem farmakovigilance: Sistem, ki ga uporabljajo imetniki dovoljenja za promet in države članice za izpolnjevanje nalog in odgovornosti, navedenih v naslovu IX , in katerega namen je spremljati odobrena zdravila in odkrivanje sprememb razmerja med tveganjem in koristmi zdravil.
(28c) Pharmacovigilance system: a system utilized by marketing authorisation holders and by Member States to fulfil the tasks and responsibilities listed in Title IX and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.
(28c) Sistem farmakovigilance: sistem, ki imetnikom dovoljenja za promet in državam članicam omogoča izpolnjevanje nalog in odgovornosti, navedenih v naslovu IX:
(28c) Pharmacovigilance system: a system allowing marketing authorisation holders and Member States, with a view to fulfilling the tasks and responsibilities listed in Title IX :
(a) zbiranje koristnih informacij za nadzor zdravil, zlasti glede njihovih neželenih učinkov na človeka, med drugim tudi pri nepravilni uporabi, zlorabi zdravil in napakah pri zdravilih, ter
(a) to collect information useful in the surveillance of medicinal products, with particular reference to adverse reactions in human beings, including misuse and abuse of medicinal products and medication errors; and
(b) znanstvena ocena teh informacij, da bi odkrili morebitne spremembe razmerja med tveganjem in koristmi odobrenih zdravil.
(b) to evaluate such information scientifically in order to detect any change to the risk-benefit balance of authorised medicinal products.
Farmakovigilanca je opazovalna znanstvena panoga, ki je v prvi vrsti namenjena bolnikom.
Pharmacovigilance is an observational scientific discipline first and foremost for the benefit of patients.
Njen namen ni nadzor varnosti zdravil (dvoumen izraz, ki zavaja zaradi pozitivne konotacije) – podatki o farmakovigilanci niso komercialni podatki, ki jih podjetja zbirajo v okviru poprodajnih storitev, temveč nadzor neželenih učinkov zdravil na človeka.
It is not designed to monitor the ‘safety of medicinal products’ (an ambiguous expression whose vocabulary is misleading because of its positive connotation): pharmacovigilance data are not commercial data collected by companies as part of their after-sales service.
Člen 1 – točka 1 – točka d a (novo)
Article 1 – point 1 – point d a (new)
Člen 1 – točke 32a, 32b in 32c (novo)
Article 1 – points 32 a, 32 b and 32 c (new)
(da) Dodajo se naslednje točke:
(da) The following points are inserted:
„(32a) Napaka pri zdravilu: nenamerno neizvedeno ali izvedeno dejanje v zvezi z zdravilom, ki lahko povzroči tveganje ali neželene učinke pri bolniku.
‘(32a) Medication error: a non-intentional omission or action relating to a medicinal product which can be the cause of a risk or of an adverse event for the patient.
To napako bi se glede na njeno naravo dalo preprečiti, saj kaže, kaj bi bilo treba storiti pri zdravljenju bolnika z zdravili, pa ni bilo storjeno.
A medication error is by definition preventable because it evidences what should have been done and what was not done during the patient’s medicinal therapy.
Napaka pri zdravilu lahko zadeva eno ali več etap, povezanih z zdravilom, kot so izbiranje v katalogu zdravil, predpisovanje, izdajanje, analiziranje receptov, farmacevtsko pripravljanje, shranjevanje, dobavljanje, upravljanje, informiranje in terapevtsko spremljanje, pa tudi vmesne člene, kot so prenašanje ali prepisovanje podatkov.
A medication error can concern one or more stages in the medicinal product’s cycle, such as formulary selection, prescription, dispensing, validation, preparation, storage, delivery, administration and therapeutic monitoring and information, but also its interfaces, such as communications and transcriptions.
(32b) Nepravilna uporaba: uporaba, ki ni v skladu s priporočili v povzetku glavnih značilnosti zdravila.
(32b) Misuse: use, of a medicinal product, that is not in compliance with the recommendations in the summary of the product characteristics.
(32c) Zdravstveno utemeljena uporaba zunaj indikacij: posebna uporaba, ki namenoma ni v skladu s priporočili povzetka glavnih značilnosti zdravila, navedenimi v poglavju „indikacije“, in temelji na podatkih iz ocene zdravila.“
(32c) Medically justified use not in accordance with indications: specific case of use deliberately not in compliance with the recommendations under the ‘indications’ section of the summary of the product characteristics but based on the assessment data.’
Člen 1 – točka 3 – točka (a)
Article 1 - point 3 - point a
Člen 11 – točka 3a
Article 11 – point 3a
„(3a) Povzetek osnovnih informacij, potrebnih za varno in učinkovito uporabo zdravila;“
“(3a) a summary of the essential information necessary to use the medicine safely and effectively;”
Člen 11 – pododstavek 3
Article 11 - subparagraph 3
„Za namene točke (3a) prvega pododstavka za zdravila s seznama iz člena 23 Uredbe (ES) št. 726/2004 povzetek vključuje izjavo: „To zdravilo se intenzivno spremlja. .
For the purposes of point (3a) of the first subparagraph, for medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the statement: “This medicinal product is under intensive monitoring.
Vse domnevne neželene učinke je treba sporočiti <ime in spletni naslov pristojnega nacionalnega organa.”
All suspected adverse reactions should be reported to name and web-address of the national competent authority.
Za zdravila s seznama iz člena 23 Uredbe (ES) št. 726/2004 povzetek vključuje :
For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the summary shall include the following :
(a) naslednjo izjavo: „To novoodobreno zdravilo se intenzivno spremlja , da bi izboljšali poznavanje njegovih neželenih učinkov .
(a) a statement reading "This newly authorised medicinal product is under intensive monitoring in order to increase knowledge of its adverse reactions .
Vse domnevne neželene učinke je treba sporočiti <ime , spletni naslov , naslov in telefonska številka pristojnega nacionalnega organa> ali neposredno lekarni .“;
All suspected adverse reactions should be reported to name , web-address , postal address and telephone number of the national competent authority , or reported directly to the pharmacy";
(b) klicaj, obdan z rdečim trikotnikom.
(b) an exclamation mark surrounded by a red triangle.
Ta simbol je viden tudi na zunanji embalaži skupaj z navedbo, da je pred zaužitjem zdravila priporočljivo prebrati navodilo za uporabo.
This symbol shall also appear on the outer packaging, accompanied by an indication that it is advisable to read the package leaflet before taking the medicinal product .
Člen 1 – točka 7
Article 1 — point 7
Pristojni nacionalni organi pripravijo poročilo o oceni in pripombe na dokumentacijo v zvezi z rezultati farmacevtskih in predkliničnih preskusov ter kliničnih preskušanj ter sistema obvladovanja tveganja in sistema farmakovigilance zadevnega zdravila.
The national competent authorities shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical and pre-clinical tests, the clinical trials and the risk management system and the pharmacovigilance system of the medicinal product concerned.
Poročilo o oceni se dopolnjuje vedno, ko so na voljo novi podatki, ki so pomembni za vrednotenje kakovosti, varnosti ali učinkovitosti zadevnega zdravila.
The assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality, safety or efficacy of the medicinal product concerned.
Poročilo o oceni podrobno opisuje naravni potek bolezni in morebitno že obstoječe zdravljenje za to bolezen.
The assessment report shall detail the natural development of the disease and, where appropriate, the existing treatments for that disease.
Člen 1 – točka 8
Article 1 — point 8
Če obstaja zdravstvena potreba, ki ni izpolnjena, in če je razmerje med tveganjem in koristmi pozitivno, se lahko dovoljenje za promet izda, če je izpolnjen eden ali več naslednjih pogojev:
If the medicinal product responds to unmet medical needs and if its risk-benefit balance may be considered positive , a marketing authorisation may be granted subject to one or more of the following conditions:
Dovoljenje za promet določa roke za izpolnitev pogojev, kadar je to potrebno.
The marketing authorisation shall lay down deadlines for the fulfilment of the conditions where necessary.
Kadar pogoji iz dovoljenja za promet z zdravilom niso izpolnjeni v ustreznem roku, morajo imeti nacionalni pristojni organi pooblastila in ustrezna sredstva za takojšnji začasni preklic ali ukinitev tega dovoljenja.
The competent authorities shall have the power and appropriate resources to immediately suspend or revoke the marketing authorisation, where the conditions included in that marketing authorisation are not fulfilled by the relevant deadline.
Člen 23 – odstavek 4 – pododstavek 1
Article 23 – paragraph 4 – subparagraph 1
Zaradi stalnega ocenjevanja razmerja med tveganjem in koristmi lahko pristojni nacionalni organ od imetnika dovoljenja za promet kadar koli zahteva , da posreduje podatke, ki dokazujejo, da razmerje med tveganjem in koristmi ostaja ugodno .
In order that the risk-benefit balance may be continuously assessed, the national competent authority may at any time ask the holder of the marketing authorisation to forward data demonstrating that the risk-benefit balance remains favourable .
Zaradi stalnega ocenjevanja razmerja med tveganjem in koristmi lahko pristojni nacionalni organ od imetnika dovoljenja za promet in njegovega sistema farmakovigilance kadar koli zahteva, da posreduje podatke, ki so potrebni za ponovno oceno razmerja med tveganjem in koristmi.
In order that the risk-benefit balance may be continuously assessed, the national competent authority may at any time ask the holder of the marketing authorisation and its pharmacovigilance system to forward the data necessary for a reassessment of the risk-benefit balance.
Člen 1 – točka 14 – točka (a)
Article 1 – point 14 – point a
Ustanovi se skupina za usklajevanje za naslednje namene :
A coordination group shall be set up for the following purposes :
Ustanovita se dve usklajevalni skupini :
Two coordination groups shall be set up :
(a) usklajevalna skupina za medsebojno priznavanje in decentralizirane postopke je odgovorna za naslednje naloge:
(a) A coordination group for mutual recognition and decentralised procedures shall be responsible for the following tasks:
(a) preučevanje vseh vprašanj, povezanih s pridobitvijo dovoljenj za promet z zdravilom v dveh ali več državah članicah v skladu s postopki, določenimi v Poglavju 4;
(a) the examination of any question relating to a marketing authorisation of a medicinal product in two or more Member States in accordance with the procedures laid down in Chapter 4;
(i) preučevanje vseh vprašanj, povezanih s pridobitvijo dovoljenj za promet z zdravilom v dveh ali več državah članicah v skladu s postopki, določenimi v Poglavju 4;
(i) the examination of any question relating to a marketing authorisation of a medicinal product in two or more Member States in accordance with the procedures laid down in Chapter 4;
(b) preučevanje vseh vprašanj, povezanih s farmakovigilanco zdravil, ki jih odobrijo države članice, v skladu s členi 107c, 107e, 107g, 107l in 107r;
(b) the examination of questions related to the pharmacovigilance of medicinal products authorised by the Member States, in accordance with Articles 107c, 107e, 107g, 107l and 107r;
(c) preučevanje vseh vprašanj, povezanih s spremembami pogojev dovoljenj za promet, ki jih izdajo države članice, v skladu s členom 35(1).
(c) the examination of questions related to the variations to the terms of marketing authorisations granted by the Member States, in accordance with Article 35(1).
(ii) preučevanje vseh vprašanj, povezanih s spremembami pogojev dovoljenj za promet, ki jih izdajo države članice, v skladu s členom 35(1) , razen vprašanj, povezanih s farmakovigilanco .
(ii) the examination of questions related to the variations to the terms of marketing authorisations granted by the Member States, in accordance with Article 35(1) , with the exception of all questions relating to pharmacovigilance .
Usklajevalni skupini za medsebojno priznavanje in decentralizirane postopke pri izvajanju nalog pomaga Odbor za zdravila za uporabo v humani medicini iz člena 5(1) Uredbe (ES) št. 726/2004.
For the fulfilment of its tasks, the coordination group for mutual recognition and decentralised procedures shall be assisted by the Committee for Medicinal Products for Human Use referred to in Article 5(1) of Regulation (EC) No 726/2004.
(b) Usklajevalna skupina za oceno tveganja na področju farmakovigilance je odgovorna za naslednje naloge:
(b) A coordination group for pharmacovigilance risk assessment shall be responsible for the following tasks:
(i) preučevanje vseh vprašanj, povezanih s farmakovigilanco zdravil, ki jih odobrijo države članice, v skladu s členi 107c, 107e, 107g, 107l in 107r;
i) the examination of questions related to the pharmacovigilance of medicinal products authorised by the Member States, in accordance with Articles 107c, 107e, 107g, 107l and 107r;
(ii) preučevanje vseh vprašanj glede farmakovigilance, povezanih s spremembami pogojev dovoljenj za promet, ki jih izdajo države članice, v skladu s členom 35(1).
ii) the examination of questions related to the variations to the terms of marketing authorisations granted by the Member States, in accordance with Article 35(1), for all questions relating to pharmacovigilance.
Agencija zagotovi sekretariat za to skupino za usklajevanje.
The Agency shall provide the secretariat of this coordination group.
Skupini za usklajevanje pri izvajanju nalog farmakovigilance pomaga Svetovalni odbor za ocenjevanje tveganja farmakovigilance iz člena 56(1)(aa) Uredbe (ES) št. 726/2004.“
For the fulfilment of its pharmacovigilance tasks, the coordination group shall be assisted by the Pharmacovigilance Risk Assessment Advisory Committee referred to in Article 56(1)(aa) of Regulation (EC) No 726/2004.
Usklajevalni skupini za oceno tveganja na področju farmakovigilance pri izvajanju nalog farmakovigilance pomaga evropski odbor za farmakovigilanco iz člena 56(1)(aa) Uredbe (ES) št. 726/2004.
For the fulfilment of its pharmacovigilance tasks, the coordination group for pharmacovigilance risk assessment shall be assisted by the European Pharmacovigilance Committee referred to in Article 56(1)(aa) of Regulation (EC) No 726/2004.
Sekretariat za ti skupini zagotavlja Agencija.
The Agency shall provide the secretariat for these coordination groups.
Člen 27 – odstavek 1 – pododstavek 3
Article 27 – paragraph 1 – subparagraph 3
Skupini za usklajevanje pri izvajanju nalog farmakovigilance pomaga odbor za farmakovigilanco iz člena 56(1)(aa) Uredbe (ES) št. 726/2004.
For the fulfilment of its pharmacovigilance tasks, the coordination group shall be assisted by the Pharmacovigilance Committee referred to in Article 56(1)(aa) of Regulation (EC) No 726/2004.
Člen 1 – točka 14 – točka (b)
Article 1 – point 14 – point b
Člen 27 – odstavek 2 – pododstavka 2 in 3
Article 27 – paragraph 2 - subparagraphs 2 and 3
„Člani skupine za usklajevanje in strokovnjaki se pri izvajanju svojih nalog opirajo na znanstvene in ureditvene vire, ki so na voljo nacionalnim organom za izdajo dovoljenja za promet.
Members of the coordination group and experts shall, for the fulfilment of their tasks, rely on the scientific and regulatory resources available to national marketing authorisation bodies.
Vsak pristojen nacionalni organ spremlja raven strokovnosti opravljenega vrednotenja ter olajša dejavnosti imenovanih članov skupine za usklajevanje in strokovnjakov.
Each national competent authority shall monitor the level of expertise of the evaluations carried out and facilitate the activities of nominated coordination group members and experts.
Člani usklajevalnih skupin in strokovnjaki se pri izvajanju svojih nalog opirajo na znanstvene in ureditvene vire, ki so na voljo nacionalnim organom , pristojnim za izdajo dovoljenja za promet oziroma za farmakovigilanco .
Members of the coordination groups and experts shall, for the fulfilment of their tasks, rely on the scientific and regulatory resources available to the national bodies responsible for, respectively, issuing marketing authorisations and pharmacovigilance .
Vsak pristojni nacionalni organ spremlja raven strokovnosti opravljenega vrednotenja ter olajša dejavnosti imenovanih članov usklajevalne skupine in strokovnjakov.
Each national competent authority shall monitor the level of expertise of the evaluations carried out and facilitate the activities of nominated coordination group members and experts.
Za skupino za usklajevanje se glede preglednosti in neodvisnosti članov uporablja člen 63 Uredbe (ES) št. 726/2004.“
Article 63 of Regulation (EC) No 726/2004 shall apply to the coordination group as regards the transparency and independence of its members.
Za usklajevalni skupini se glede preglednosti in neodvisnosti članov , tako od Agencije kot od imetnikov dovoljenja za promet, uporablja člen 63 Uredbe (ES) št. 726/2004.
Article 63 of Regulation (EC) No 726/2004 shall apply to the coordination groups as regards the transparency and independence of their members from both the Agency and marketing authorisation holders .
Član ene usklajevalne skupine hkrati ne sme biti član druge usklajevalne skupine.
A member of one coordination group may not simultaneously be a member of the other coordination group.
Člani usklajevalne skupine za oceno tveganja na področju farmakovigilance so neodvisni od nacionalnih organov za izdajo dovoljenj za promet.
The members of the coordination group for pharmacovigilance risk assessment shall be hierarchically independent of the national marketing authorisation bodies.
Člen 1 – točka 18 – točka (a)
Article 1 – point 18 – point a
Člen 59 – odstavek 1 – točka aa
Article 59 – paragraph 1 – point aa
(a) vstavi se naslednja točka (aa):
(a) the following point (aa) is inserted:
„(aa) Povzetek osnovnih informacij, potrebnih za varno in učinkovito uporabo zdravila;“
“(aa) a summary of the essential information necessary to use the medicine safely and effectively;”
Člen 1 – točka 18 – točka (a a) (novo)
Article 1 – point 18 – point a a (new)
Člen 59 – odstavek 1 – točka h a (novo)
Article 59 – paragraph 1 – point h a (new)
(aa) Vstavi se naslednja točka (ha):
(aa) the following point (ha) is inserted:
„(ha) odstranljiv del navodila, ki ga bolnik lahko odtrga, vsebuje pa naslednjo izjavo: „Vse domnevne neželene učinke je treba sporočiti svojemu zdravniku, farmacevtu ali <ime, spletni naslov, naslov in/ali telefonska številka ter številka telefaksa nacionalnega pristojnega organa>.“;“
“(ha) a detachable portion of the leaflet that the patient can tear off, including the following statement: “Suspected adverse reactions should be reported to your doctor, pharmacist, or to name, web-address, postal address and/or telephone and fax number of the national competent authority;”
Člen 59 – odstavek 1 – pododstavka 2 in 3
Article 59 – paragraph 1 – subparagraphs 2 and 3
Vsako novo ali spremenjeno besedilo se za obdobje enega leta navede s krepkim tiskom, pred katerim je naslednji simbol in besedilo „Novi podatki“.
Any new or amended text shall for a period of 1-year be presented in bold text and preceded by the following symbol and text "New information" .
Za zdravila s seznama iz člena 23 Uredbe (ES) št. 726/2004 se vključi naslednja dodatna izjava: „To zdravilo se intenzivno spremlja.
For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included “This medicinal product is under intensive monitoring.
Vse domnevne neželene učinke je treba sporočiti <ime in spletni naslov pristojnega nacionalnega organa.”
All suspected adverse reactions should be reported to name and web-address of the national competent authority".
Za zdravila s seznama iz člena 23 Uredbe (ES) št. 726/2004 se vključi naslednja dodatna izjava: „ Po pridobitvi dovoljenja za promet za to zdravilo se spremlja njegova varnost .
For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included “This medicinal product is subject to post-authorisation safety monitoring.
Vse domnevne neželene učinke je treba sporočiti <ime in spletni naslov nacionalnega pristojnega organa > .“
All suspected adverse reactions should be reported to name and web-address of the national competent authority".
Informacije v navodilih za uporabo se pogosto posodabljajo večkrat letno (povprečno dva- do trikrat), zato bi označevanje novih informacij s krepkim tiskom in posebnim simbolom morda lahko pacientom dalo napačen vtis, da so te informacije pomembnejše, s tem pa bi navodila zbegala uporabnike.
As the information in package leaflets are often updated several times per year (2/3 times on average) highlighting the new information in bold and with a special symbol runs the risk of giving patients a wrong impression that this information is the more important information as well as provide a confusing leaflet.
Člen 59 – odstavek 1 – pododstavek 3
Article 59 – paragraph 1 – subparagraph 3
Za zdravila s seznama iz člena 23 Uredbe (ES) št. 726/2004 se vključijo naslednji dodatni elementi :
For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional elements shall be included :
(a) izjava: „To novoodobreno zdravilo se intenzivno spremlja , da bi izboljšali poznavanje njegovih neželenih učinkov .
(a) a statement reading “This newly authorised medicinal product is under intensive monitoring in order to increase knowledge of its adverse reactions .