natgillin/translations-raw huggingface dataset:
Države članice morajo zaradi uveljavljanja določb, ki se nanašajo na farmakovigilanco, zagotoviti, da za imetnika dovoljenja za promet , ki ne izpolnjuje obveznosti farmakovigilance, veljajo učinkovite, sorazmerne in odvračalne sankcije.
In order to enforce the provisions related to the pharmacovigilance, the Member States should ensure that effective, proportionate and dissuasive penalties are applied to marketing authorisation holders for non-compliance with pharmacovigilance obligations.
Države članice morajo zaradi uveljavljanja določb, ki se nanašajo na farmakovigilanco, zagotoviti, da za imetnika dovoljenja za promet , ki ne izpolnjuje obveznosti farmakovigilance, veljajo učinkovite, sorazmerne in odvračalne sankcije.
In order to enforce the provisions related to pharmacovigilance, the Member States should ensure that effective, proportionate and dissuasive penalties are applied to marketing authorisation holders for non-compliance with pharmacovigilance obligations.
Če pogoji iz dovoljenja za promet z zdravilom niso izpolnjeni v določenem roku, morajo biti nacionalni pristojni organi pooblaščeni za revizijo dodeljenega tovrstnega dovoljenja.
If the conditions included in the marketing authorisation are not fulfilled by the given deadline, the national competent authorities should have the power to review the marketing authoris ation granted .
Izkušnje kažejo, da podjetja v mnogih primerih, ko se je od njih zahtevalo, da izvedejo študije o varnosti zdravila po pridobitvi dovoljenja za promet, tega niso storila.
Experience shows that in many cases where companies were required to conduct post-authorisation safety studies they failed to do so.
V primeru zelo dobičkonosnih zdravil denarne kazni nimajo vedno odvračilnega učinka, zato bi morala zakonodaja državam članicam omogočiti tudi, da dovoljenje za promet z zdravilom začasno prekličejo ali ukinejo.
In the case of a highly profitable medicinal product, fines are not always dissuasive, and so the legislation should make clear that Member States also have the possibility of suspending or revoking the market authorisation.
(29a) Ta direktiva se uporablja brez poseganja v Direktivo 95/46/ES in Uredbo št. 45/2001/ES o varstvu posameznikov pri obdelavi osebnih podatkov v institucijah in organih Skupnosti ter o prostem pretoku tovrstnih podatkov.
(29a) This Directive should apply without prejudice to Directive 95/46/EC and Regulation 45/2001/EC on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data.
Varovanje javnega zdravja je bistveni družbeni interes, ki upravičuje obdelavo določljivih zdravstvenih podatkov, pod pogojem, da se obdelujejo samo po potrebi in udeležene strani to potrebo ocenijo na vsaki stopnji procesa farmakovigilance.
The purpose of safeguarding public health constitutes a substantial public interest which justifies the processing of identifiable health data as long as this is processed only when necessary and the parties involved assess th e necessity of processing such data at every stage of the pharmacovigilance process.
Člen 1 – odstavek 1 – točka a
Article 1 – point 1 – point a
Člen 1 – odstavek 11
Article 1 – paragraph 11
„(11) Neželen učinek: Neželen učinek zdravila je škodljiva in nenamerna reakcija.“
“(11) Adverse reaction: A response to a medicinal product which is noxious and unintended.”
„(11) Neželen učinek zdravila : Neželen učinek zdravila je škodljiva in nenamerna reakcija.“
“(11) Adverse drug reaction: A response to a medicinal product which is noxious and unintended.”
Izraz „neželen učinek“ je treba nadomestiti z natančnejšim izrazom „neželen učinek zdravila“, ki ga uporabljajo strokovnjaki in je mednarodno sprejet.
The term ‘adverse reaction’ should be replaced by the more precise term ‘adverse drug reaction’, which is used by experts and is internationally accepted.
Člen 11 – točka 3a in pododstavek 3
Article 11 - point 3a and subparagraph 3
(a) Vstavi se naslednja točka 3a:
(a) the following point 3a is inserted:
(a) Vstavita se naslednji točki 3a in 3b :
(a) the following point s 3a and 3b are inserted:
Za zdravila s seznama iz člena 23 Uredbe (ES) št. 726/2004 izjava, pred katero je črn simbol, o katerem se odloči na podlagi delegiranih aktov v skladu s členi 121a, 121b in 121c: „ Za to zdravilo se izvaja dodatno spremljanje varnosti.
For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the statement, preceded by a black symbol which shall be decided on by means of delegated acts in accordance with Article s 121a, 121b and 121c : “This medicinal product is subject to additional safety monitoring.
Vse domnevne neželene učinke je treba sporočiti svojemu zdravniku, lekarnarju, zdravstvenemu delavcu ali <ime, spletni naslov, naslov in/ali telefonska številka nacionalnega pristojnega organa>.“
All suspected adverse reactions should be reported to your doctor, pharmacist, healthcare professional, or to name and web-address, postal address and / or telephone number of the national competent authority.”
(b) doda se naslednji pododstavek:
(b) the following subparagraph is added:
„ 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, ki niso navedena na seznamu iz člena 23 Uredbe (ES) št. 726/2004, je treba navesti izjavo: Vse domnevne neželene učinke je treba sporočiti svojemu zdravniku, lekarnarju, zdravstvenemu delavcu ali <ime, spletni naslov, naslov in/ali telefonska številka nacionalnega pristojnega organa>.“
For medicinal products not included in the list referred to in Article 23 of Regulation (EC) No 726/2004, the following statement should be included : “All suspected adverse reactions should be reported to your doctor, pharmacist, healthcare professional, or to name and web-address , postal address and/or telephone number of the national competent authority."
Člen 16c – odstavek 4 – pododstavek 2
Article 16c – paragraph 4 – subparagraph 2
V členu 16c(4) se pododstavek 2 nadomesti z naslednjim:
In Article 16c(4), subparagraph 2 is replaced by the following:
Odbor preuči, ali so druga merila za poenostavljeno registracijo, kakor je navedeno v členu 16a, v celoti izpolnjena.
The Committee shall consider whether the other criteria for a simplified registration as referred to in Article 16a are fully complied with.
Če Odbor meni, da je mogoče, pripravi rastlinsko monografijo Skupnosti, kakor je navedena v členu 16h(3), ki jo mora država članica upoštevati pri dokončni odločitvi.
If the Committee considers it possible, it shall establish a Community herbal monograph as referred to in Article 16h(3) which shall be complied with by the Member State when taking its final decision.
Postopek Skupnosti za pripravo monografij je učinkovit samo, če so države članice zavezane upoštevati monografije Skupnosti.
The Community procedure to establish monographs is only efficient if the Member States are obliged to follow the Community monographs.
Pristojni nacionalni organi nemudoma javno objavijo dovoljenje za promet skupaj s povzetkom glavnih značilnosti in pogoji, določenimi v skladu s členi 21a, 22 in 22a, skupaj z roki za izpolnitev pogojev, za vsako zdravilo, za katero so izdali dovoljenje za promet.
The national competent authorities shall make publicly available without delay the marketing authorisation together with the summary of the product characteristics and any conditions established in accordance with Articles 21a, 22 and 22a, together with any deadlines for their fulfilment, for each medicinal product which they have authorised.
Pristojni nacionalni organi nemudoma javno objavijo dovoljenje za promet skupaj z navodilom za uporabo, povzetkom glavnih značilnosti in pogoji, določenimi v skladu s členi 21a, 22 in 22a, skupaj z roki za izpolnitev pogojev, za vsako zdravilo, za katero so izdali dovoljenje za promet.
The national competent authorities shall make publicly available without delay the marketing authorisation together with the package leaflet, summary of the product characteristics and any conditions established in accordance with Articles 21a, 22 and 22a, together with any deadlines for their fulfilment, for each medicinal product which they have authorised.
Da bi širši javnosti zagotovili popolne in natančne informacije, je treba po pridobitvi dovoljenja za promet objaviti tudi navodilo za uporabo.
In the interest of providing complete and accurate information to the general public, the package leaflet should also be made public when marketing authorisation is granted.
Člen 21 – odstavek 4 – pododstavek 2
Article 21 – paragraph 4 – subparagraph 2
Pristojni nacionalni organi nemudoma javno objavijo poročilo o oceni skupaj z razlogi za svoje stališče, po izbrisu vseh podatkov poslovno zaupne narave.
The national competent authorities shall make publicly accessible without delay the assessment report, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature.
Utemeljitev se predloži ločeno za vsako indikacijo, za katero je pridobljeno dovoljenje za promet.
The justification shall be provided separately for each indication applied for.
Pristojni organi nemudoma javno objavijo končno poročilo o oceni zdravila skupaj z razlogi za svoje stališče, po izbrisu vseh podatkov poslovno zaupne narave.
The national competent authorities shall make publicly accessible without delay the final assessment report, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature.
Za boljše obveščanje javnosti je pomembno navesti, da mora biti na voljo končno poročilo.
To keep the public better informed, it is important to specify that the final report will be available for consultation.
Zaradi tehnične narave farmakovigilance so namreč potrebne številne zaporedne faze, preden se doseže končni rezultat.
The technical nature of pharmacovigilance requires many successive stages before a final outcome is reached.
Torej se zdi koristno javnosti dati na voljo ugotovitve in ne vmesne študije, ki jih je treba naknadno preverjati.
It therefore seems appropriate to make the findings publicly available and not the intermediate studies that require subsequent verification.
Namen tega mehanizma je, da se javnosti ne prestraši s še nedokončnimi ugibanji, ampak se jim informacije predstavi, ko so znanstveno potrjene.
The purpose of this approach is not to cause alarm among the general public about hypotheses that have not yet been proven but rather to provide the information once it has been scientifically approved.
Dovoljenje za promet se lahko izda, če je izpolnjen eden ali več naslednjih pogojev:
A marketing authorisation may be granted subject to one or more of the following conditions:
Poleg določb iz člena 19 se dovoljenje za promet lahko izda, če je izpolnjen eden ali več naslednjih pogojev:
In addition to the provisions laid down in Article 19, a marketing authorisation may be granted subject to one or more of the following conditions:
(1) izvedba nekaterih ukrepov za varno uporabo zdravila, vključenega v sistem upravljanja tveganja;
(1) to take certain measures for the safe use of the medicinal product contained in the risk management system;
(2) izvedba študije o varnosti zdravila po pridobitvi dovoljenja za promet;
(2) to conduct post-authorisation safety studies;
2) izvedba študije o varnosti zdravila po pridobitvi dovoljenja za promet ali študij varnosti in učinkovitosti po pridobitvi dovoljenja za promet, kjer ostajajo odprta vprašanja glede učinkovitosti proizvoda, ali ko bi znanstvena spoznanja glede razumevanju bolezni ali klinične metodologije bistveno spremenila prejšnje ocene učinkovitosti.
2) to conduct post-authorisation safety studies, or post - authorisation safety and efficacy studies where important questions relating to the efficacy of a product remain , or when scientific advances in the understanding of the disease or in the clinical methodology would significantly change previous efficacy evaluations.
V ta namen Komisija zagotovi smernice.
For this purpose, the Commission shall provide guidelines.
Poleg tega Komisija na podlagi podatkov, prejetih od Agencije in držav članic, pripravi poročilo, osredotočeno na pojem klinične učinkovitosti, študije in zahtevane podatke ter metodologije za njihovo oceno.
The Commission shall also, based on data received from the Agency and Member States, produce a report focusing on the concept of c linical e ffectiveness, on studies and data required and on methodologies for assessing it.
(3) izpolnjevanje zahtev o evidentiranju ali poročanju neželenih učinkov, ki so strožje od zahtev iz naslova IX;
(3) to comply with requirements on adverse reaction recording or reporting which are stricter than those referred to in Title IX;
(4) drugi pogoji ali omejitve glede varne in učinkovite uporabe zdravila.
(4) any other conditions or restrictions with regard to the safe and effective use of the medicinal product.
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 .
Dovoljenje za promet določa roke za izpolnitev pogojev.
The marketing authorisation shall lay down deadlines for the fulfilment of the conditions.
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.
T he competent authorities shall have the power and appropriate resources to immediately suspend or revoke the marketing authorisation in the event that the conditions included in the marketing authorisation are not fulfilled by the relevant deadline .
Člen 22a – odstavek 1
Article 22a – paragraph 1
Po izdaji dovoljenja za promet lahko pristojni nacionalni organ od imetnika dovoljenja za promet zahteva izvedbo študije o varnosti zdravila po pridobitvi dovoljenja za promet, če ostajajo skrbi glede tveganj odobrenega zdravila.
After the granting of a marketing authorisation, the national competent authority may require a marketing authorisation holder to conduct a post-authorisation safety study if there are concerns about the risks of an authorised medicinal product.
Zahteva je pisna in vsebuje podrobno utemeljitev na podlagi znanstvenih argumentov ter cilje in časovni okvir za predložitev in izvedbo študije.
The requirement shall be made in writing, provide a detailed scientific justification and include the objectives and timeframe for submission and conduct of the study.
Zahteva za dodatno študijo o varnosti zdravila po pridobitvi dovoljenja za promet mora temeljiti na znanstvenih razlogih.
Requests for additional post-authorisation safety studies should be scientifically justified.
Predlog Komisije v zvezi s tem ni dovolj natančen.
The Commission’s proposal is not sufficiently clear on this point.
Člen 1 – točka 12 – točka (b)
Article 1 – point 12 – point b
Člen 24 – odstavek 3
Article 24– paragraph 3
Člen 59 – odstavek 1 – točka (aa) in pododstavka 2 in 3
Article 59 -paragraph 1– point aa and subparagraphs 2 and 3
(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;
(aa) za zdravila s seznama iz člena 23 Uredbe (ES) št. 726/2004 se vključi naslednja izjava, pred katero je črn simbol, o katerem se odloči na podlagi delegiranih aktov v skladu s členi 121a, 121b in 121c: „Za to zdravilo se izvaja dodatno spremljanje varnosti.
(aa) For medicinal products included on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following statement shall be included preceded by a black symbol which shall be decided on by means of delegated acts in accordance with Article s 121a, 121b and 121c : “This medicinal product is subject to additional safety monitoring.
Vse domnevne neželene učinke je treba sporočiti svojemu zdravniku, lekarnarju, zdravstvenemu delavcu ali <ime, spletni naslov, naslov in/ali telefonska številka nacionalnega pristojnega organa>.
All suspected adverse reactions should be reported to your doctor, pharmacist, healthcare professional, or to name and web-address, postal address and / or telephone number of the national competent authority .
(b) dodata se naslednji drugi in tretji pododstavek:
(b) the following second and third subparagraphs are added:
„Podatki iz točke (aa) prvega pododstavka se navedejo v okencu s črno obrobo.
The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border.
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 nacionalnega pristojnega organa>.“
All suspected adverse reactions should be reported to name and web-address of the national competent authority".
Za zdravila, ki niso navedena na seznamu iz člena 23 Uredbe (ES) št. 726/2004, se vključi naslednja izjava: „Vse domnevne neželene učinke je treba sporočiti svojemu zdravniku, lekarnarju, zdravstvenemu delavcu ali <ime, spletni naslov , naslov in/ali telefonska številka nacionalnega pristojnega organa>.“
For medicinal products not included in the list referred to in Article 23 of Regulation (EC) No 726/2004, the following statement should be included: “All suspected adverse reactions should be reported to your doctor, pharmacist, healthcare professional, or to name, web-address , postal address and/or telephone number of the national competent authority".
Člen 1 – točka 18 a (novo)
Article 1 - point 18 a (new)
Člen 59 – odstavek 3
Article 59 - paragraph 3
Člen 59(3) se spremeni:
Article 59(3) is amended as follows:
Komisija v 18 mesecih po začetku veljavnosti te direktive Evropskemu parlamentu in Svetu predloži poročilo o oceni, kako bi morala povzetek značilnosti zdravila in navodila za uporabo izpolniti potrebe bolnikov in zdravstvenih delavcev.
Within 18 months of the entry into force of this D irective, the Commission shall present to the European Parliament and the Council an assessment report on how the summary of product characteristics and the package leaflet should meet the needs of patients and healthcare professionals.
Komisija na tej podlagi izda predloge za izboljšanje berljivosti, oblike in vsebine teh dokumentov.
On the basis of this, the Commission shall issue proposals in order to improve the readability, layout and content of these documents.
Navodilo za uporabo odraža izsledke posvetovanj s ciljnimi skupinami bolnikov, da se zagotovi berljivost, jasnost in enostavna uporaba navodil.
The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use.
Člen 65 – točka (g)
Article 65 – point g
(g) „Povzetek osnovnih informacij, potrebnih za varno in učinkovito uporabo zdravila, predpisan v členu 11(3a) in členu 59(1)(aa).“
(g) the summary of the essential information necessary to use the medicine safely and effectively provided for in Article 11(3a) and Article 59(1)(aa).”
(g) postopek Unije, ki določa časovni potek postopka, jasno strukturo in opredeljene vloge za vse zainteresirane strani, tudi za izvajanje javnih predstavitev.
(g) the Union procedure for defining a procedural timeline, a clear structure and defined roles for all the stakeholders involved, including for the conduct of public hearings.
Treba je zavrniti predlagani povzetek osnovnih informacij o varni in učinkoviti uporabi zdravil, saj je pojem „osnovne informacije“ zavajajoč in bi utegnil biti napačno razumljen.
The proposed summary of essential information about the safe and effective use of medicines should be rejected since the concept of 'essential information' is misleading and might be misunderstood .
Treba je razviti smernice, da bi pojasnili postopke in časovni potek postopkov Skupnosti, tudi za javne obravnave.
Guidance should be developed to clarify the procedures and timelines for the community procedure, including public hearings .
Člen 1 – točka 20 a (novo)
Article 1 – point 20 a (new)
Člen 86 – odstavek 2
Article 86 – paragraph 2
Prva alinea člena 86(2) se spremeni:
The first indent of Article 86(2) is amended as follows:
„– označevanja in priloženega navodila za uporabo, kar urejajo določbe naslova V, in povzetka glavnih značilnosti zdravila, tudi če sta javnosti na voljo neodvisno od izdaje zdravila, v nespremenjeni obliki in brez dodatnega reklamnega gradiva ,“
“– the labelling and the accompanying package leaflets, which are subject to the provisions of Title V, and the summary of the product characteristics, insofar as they are made available to the public independently of the delivery of the medicinal product in unchanged wording and without additional promotional elements , ”
Vsaka država članica določi pristojni organ za opravljanje nalog farmakovigilance.
Each Member State shall designate a competent authority for the conduct of pharmacovigilance tasks
Vsaka država članica določi enega ali več pristojnih organov za opravljanje nalog farmakovigilance.
Each Member State shall designate one or more competent authorities for the conduct of pharmacovigilance tasks.
O tem, ali bodo imele enega ali več pristojnih organov, odgovornih za farmakovigilanco, bi morale odločati države članice.
It should be up to the Member States to have one or more competent authorities responsible for pharmacovigilance.
Države članice imajo lahko različne pristojne organe za različne farmacevtske izdelke.
Member States may have different competent authorities for different pharmaceutical products.
Člen 102 – odstavek 1 – točka 1
Article 102 - paragraph 1- point 1
(1) sprejmejo vse ustrezne ukrepe za spodbujanje zdravnikov, farmacevtov in drugih zdravstvenih delavcev, da nacionalnim pristojnim organom ali imetniku dovoljenja za promet poročajo o domnevnih neželenih učinkih;
(1) take all appropriate measures to encourage doctors, pharmacists and other health-care professionals to report suspected adverse reactions to the national competent authority or the marketing authorisation holder ;
(1) sprejmejo vse ustrezne ukrepe za spodbujanje bolnikov , zdravnikov, farmacevtov in drugih zdravstvenih delavcev, da nacionalnim pristojnim organom poročajo o domnevnih neželenih učinkih; ti ukrepi zajemajo usposabljanje za zdravstvene delavce in javne kampanje za bolnike.
(1) take all appropriate measures to encourage patients , doctors, pharmacists and other health-care professionals to report suspected adverse reactions to the national competent authority; these measures shall include training for health professionals and a public information campaign for patients.
Združenja bolnikov in potrošnikov je treba vključiti v obveščanje bolnikov ter v pripravljanje javnih informacijskih kampanj v sodelovanju z regulativnimi organi.
Patients’ and consumer organisations shall be involved in providing information to patients and in developing public information campaigns in cooperation with regulatory bodies.