natgillin/translations-raw huggingface dataset:
The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 28 October 2010 in the format of the Commission review report for napropamide.
Osnutek poročila o oceni, dodatno poročilo in sklep Agencije so države članice in Komisija pregledale v okviru Stalnega odbora za prehranjevalno verigo in zdravje živali ter končno različico pripravile 28. oktobra 2010 v obliki poročila Komisije o pregledu glede napropamida.
The additional report by the rapporteur Member State and the new conclusion by the Authority concentrate on the concerns that lead to the non-inclusion.
Dodatno poročilo države članice poročevalke in nov sklep Agencije zadevata pomisleke, ki so povzročili nevključitev.
Those concerns were in particular the potential contamination of groundwater by the metabolite 2-(1-naphthyloxy)propionic acid, hereinafter ‘NOPA’, and the risk to mammals, fish-eating birds and aquatic organisms.
Navedeni pomisleki so zadevali zlasti možno onesnaženje podtalnice z metabolitom 2-(1-naftiloksi)propionska kislina (v nadaljnjem besedilu „NOPA“) in tveganje za sesalce, ptice, ki se hranijo z ribami, in vodne organizme.
The new data submitted by the applicant show the following.
Vlagatelj je medtem predložil nove podatke.
The metabolite NOPA is neither of toxicological nor of biological relevance.
V skladu z novimi podatki metabolit NOPA nima toksikološkega ali biološkega pomena.
Moreover, the risk to birds and mammals may be considered low, while for the risk for aquatic organisms acceptable uses were identified, on the basis of the additional data provided.
Poleg tega je tveganje za ptice in sesalce majhno, medtem ko so bile za vodne organizme na podlagi dodatnih podatkov določene sprejemljive uporabe.
Consequently, the additional data and information provided by the applicant permit to eliminate the specific concerns that led to the non-inclusion.
Zato se na podlagi dodatnih podatkov in informacij, ki jih je predložil vlagatelj, lahko izločijo posebni pomisleki, ki so povzročili nevključitev.
No other open scientific questions have arisen.
Drugih odprtih znanstvenih vprašanj ni bilo.
It has appeared from the various examinations made that plant protection products containing napropamide may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report.
Različne preiskave so pokazale, da se za fitofarmacevtska sredstva, ki vsebujejo napropamid, lahko pričakuje, da na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS, zlasti v zvezi z uporabami, ki so bile preučene in podrobno navedene v poročilu Komisije o pregledu.
It is therefore appropriate to include napropamide in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.
Zato je primerno vključiti napropamid v Prilogo I, da se v vseh državah članicah v skladu z določbami navedene direktive lahko registrirajo fitofarmacevtska sredstva, ki vsebujejo to aktivno snov.
Article 6(1) of Directive 91/414/EC provides that the inclusion of a substance in Annex I may be subject to conditions.
Člen 6(1) Direktive 91/414/EGS določa, da za vključitev snovi v Prilogo I lahko veljajo nekateri pogoji.
Therefore, it is appropriate to require that the applicant submits information on the aquatic risk for the photolysis metabolites and for NOPA, and information for the risk assessment of aquatic plants.
Zato je primerno zahtevati, da vlagatelj predloži informacije o tveganju za vodno okolje glede fotoliznih metabolitov in metabolita NOPA ter oceno tveganja za vodne rastline.
This Directive shall enter into force on 1 January 2011.
Ta direktiva začne veljati 1. januarja 2011.
OJ L 326, 4.12.2008, p. 35.
UL L 326, 4.12.2008, str. 35.
European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance napropamide.
Evropska agencija za varnost hrane; Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo napropamid.
CAS No: 15299-99-7
Št. CAS: 15299-99-7
(Racemic mixture)
(racemna zmes)
Relevant impurity
pomembna nečistoča
Toluene: not more than 1,4 g/kg
toluen: največ 1,4 g/kg
1 January 2011
januar 2011
31 December 2020
december 2020
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on napropamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010, shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepi poročila o pregledu za napropamid ter zlasti dodatkov I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 28. oktobra 2010.
operator safety: conditions of use shall prescribe the use of adequate personal protective equipment, where necessary,
varnost izvajalca: v pogojih uporabe se po potrebi predpiše uporaba ustrezne osebne zaščitne opreme,
protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones,
zaščito vodnih organizmov: pogoji registracije po potrebi vključujejo ukrepe za zmanjšanje tveganja, kot so ustrezni varovalni pasovi,
consumer safety as regards the occurrence in groundwater of the metabolite 2-(1-naphthyloxy)propionic acid, hereinafter “NOPA”.
varnost potrošnikov, kar zadeva prisotnost metabolita 2-(1-naftiloksi)propionska kislina (v nadaljnjem besedilu ‚NOPA‘) v podtalnici.
The Member States concerned shall ensure that the applicant presents to the Commission, by 31 December 2012 at the latest, information confirming the surface water exposure assessment as regards the photolysis metabolites and the metabolite NOPA and information for the risk assessment of aquatic plants.’
Zadevne države članice zagotovijo, da vlagatelj Komisiji najpozneje do 31. decembra 2012 predloži informacije, ki potrjujejo oceno izpostavljenosti površinske vode glede fotoliznih metabolitov in metabolita NOPA, ter informacije za oceno tveganja za vodne rastline.“
It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 30 June 2009.
Navedeno poročilo je 30. junija 2009 predložila Evropski agenciji za varnost hrane (v nadaljnjem besedilu: Agencija) in Komisiji.
The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission.
Agencija je dodatno poročilo poslala v presojo drugim državam članicam in vlagatelju ter Komisiji posredovala prejete pripombe.
Directive 2010/84/EU of the European Parliament and of the Council
Direktiva 2010/84/EU Evropskega parlamenta in Sveta
amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
o spremembah Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini, glede farmakovigilance
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije, zlasti člena 114 in točke (c) člena 168(4) Pogodbe,
Acting in accordance with the ordinary legislative procedure [4],
v skladu z rednim zakonodajnim postopkom [4],
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [5] lays down harmonised rules for the authorisation, supervision and pharmacovigilance of medicinal products for human use within the Union.
Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [5] določa usklajena pravila za pridobitev dovoljenja za promet z zdravili, nadzor in farmakovigilanco zdravil za uporabo v humani medicini znotraj Unije.
Pharmacovigilance rules are necessary for the protection of public health in order to prevent, detect and assess adverse reactions to medicinal products placed on the Union market, as the full safety profile of medicinal products can only be known after they have been placed on the market.
Pravila o farmakovigilanci so potrebna za varovanje javnega zdravja, da se preprečijo, odkrijejo in ocenijo neželeni učinki zdravil, ki so v prometu v Uniji, saj je celotni varnostni profil zdravil lahko znan šele potem, ko so bila zdravila dana v promet.
In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products.
Glede na dosedanje izkušnje in potem, ko je Komisija ocenila sistem farmakovigilance v Uniji je postalo jasno, da je treba sprejeti ukrepe za izboljšanje izvajanja zakonodaje Unije o farmakovigilanci zdravil.
While the fundamental objective of the regulation of medicinal products is to safeguard public health, this aim should nevertheless be achieved by means that do not impede the free movement of safe medicinal products within the Union.
Ob upoštevanju dejstva, da je temeljni cilj predpisov o zdravilih varovanje javnega zdravja, bi moral biti ta cilj vseeno dosežen s sredstvi, ki ne ovirajo prostega pretoka varnih zdravil znotraj Unije.
It has emerged from the assessment of the Union system of pharmacovigilance that divergent actions by Member States in relation to safety issues pertaining to medicinal products are creating obstacles to the free movement of medicinal products.
Ocena sistema farmakovigilance v Uniji je pokazala, da različni ukrepi držav članic glede varnostnih vprašanj zdravil ustvarjajo ovire za prost pretok zdravil.
In order to prevent or eliminate those obstacles the existing pharmacovigilance provisions at Union level should be strengthened and rationalised.
Da se preprečijo in odpravijo te ovire, bi bilo treba obstoječe določbe farmakovigilance na ravni Unije izboljšati in racionalizirati.
For the sake of clarity, the definition of the term ‘adverse reaction’ should be amended to ensure that it covers noxious and unintended effects resulting not only from the authorised use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorisation, including the misuse and abuse of the medicinal product.
Zaradi jasnosti bi bilo treba opredelitev izraza „neželeni učinek“ spremeniti, da se zagotovi, da ne zajema samo škodljivih in nenamernih učinkov, ki izhajajo iz dovoljene uporabe zdravila v običajnih odmerkih, ampak tudi napak pri zdravljenju in uporabe zunaj okvira pogojev dovoljenja za promet z zdravilom, vključno z nepravilno uporabo in zlorabo zdravil.
The suspicion of an adverse drug reaction, meaning that there is at least a reasonable possibility of there being a causal relationship between a medicinal product and an adverse event, should be sufficient reason for reporting.
Sum neželenega učinka zdravila, kar pomeni, da je vzročna povezava med zdravilom in neželenim dogodkom vsaj razumno mogoča, bi moral zadostovati za poročanje.
Therefore, the term ‘suspected adverse reaction’ should be used when referring to reporting obligations.
Zato bi se moral izraz „domnevni neželeni učinek“ uporabljati, ko se govori o obveznostih poročanja.
Without prejudice to the existing Union and national provisions and practices on medical confidentiality, Member States should ensure that reporting and processing of personal data related to suspected adverse reactions, including those associated with medication errors is carried out on a confidential basis.
Brez poseganja v obstoječe določbe Unije in nacionalne določbe ter prakso glede zdravniške molčečnosti bi morale države članice zagotoviti zaupnost pri poročanju in obdelavi osebnih podatkov, ki se nanašajo na domnevne resne neželene učinke, tudi tistih, povezanih z napakami pri zdravljenju.
This should not affect Member States’ obligations regarding the mutual exchange of information on pharmacovigilance issues or their obligation to make available to the public important information on pharmacovigilance concerns.
To pa ne bi smelo vplivati na obveznost vzajemne izmenjave informacij na področju farmakovigilance med državami članicami ali objave pomembnih informacij v zvezi s farmakovigilanco.
Furthermore, the principle of confidentiality should not affect the obligations of the persons concerned to provide information under criminal law.
Poleg tega načelo zaupnosti ne bi smelo vplivati na obveznosti zadevnih oseb, da posredujejo informacije v skladu s kazenskim pravom.
The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem.
Onesnaževanje voda in tal s farmacevtskimi ostanki je vse večji okoljski problem.
Member States should consider measures to monitor and evaluate the risk of environmental effects of such medicinal products, including those which may have an impact on public health.
Države članice bi morale sprejeti ukrepe za spremljanje in ocenjevanje tveganja vpliva teh zdravil na okolje, tudi tistih, ki lahko vplivajo na javno zdravje.
The Commission should, based, inter alia, on data received from the European Medicines Agency, the European Environment Agency and Member States, produce a report on the scale of the problem, along with an assessment on whether amendments to Union legislation on medicinal products or other relevant Union legislation are required.
Komisija bi morala tudi na podlagi podatkov, prejetih od Evropske agencije za zdravila, Evropske agencije za okolje in držav članic pripraviti poročilo o razsežnosti problema, obenem pa oceniti, ali so potrebne spremembe zakonodaje Unije o zdravilih ali druge zadevne zakonodaje.
The marketing authorisation holder should establish a pharmacovigilance system to ensure the monitoring and supervision of one or more of its authorised medicinal products, recorded in a pharmacovigilance system master file which should be permanently available for inspection.
Imetnik dovoljenja za promet z zdravilom bi moral vzpostaviti sistem farmakovigilance, s katerim zagotovi spremljanje in nadzor enega ali več svojih zdravil, ki so pridobila dovoljenje za promet, opisanem v glavni dosjeju o sistemu farmakovigilance, ki bi moral biti stalno dostopen za pregled.
The competent authorities should undertake to supervise those pharmacovigilance systems.
Navedene sisteme bi morali nadzirati pristojni organi.
Applications for marketing authorisations should therefore be accompanied by a brief description of the corresponding pharmacovigilance system, which should include a reference to the location where the pharmacovigilance system master file for the medicinal product concerned is kept and available for inspection by the competent authorities.
Vlogi za dovoljenje za promet z zdravilom bi zato bilo treba priložiti kratek opis zadevnega sistema farmakovigilance, ki bi moral vključevati napotilo na mesto, kjer se hrani glavni dosje o sistemu farmakovigilance za zadevno zdravilo, ki je stalno dostopna za pregled pristojnih organov.
Marketing authorisation holders should plan pharmacovigilance measures for each individual medicinal product in the context of a risk management system.
Imetniki dovoljenja za promet z zdravilom bi morali farmakovigilančne ukrepe za vsako zdravilo načrtovati v okviru sistema obvladovanja tveganj.
The measures should be proportionate to the identified risks, the potential risks, and the need for additional information on the medicinal product.
Ukrepi bi morali biti sorazmerni z ugotovljenimi tveganji, možnimi tveganji in potrebo po dodatnih informacijah o zdravilu.
It should also be ensured that any key measures included in a risk management system are made conditions of the marketing authorisation.
Treba bi bilo tudi zagotoviti, da so morebitni ključni ukrepi iz sistema obvladovanja tveganj vključeni kot pogoji za dovoljenje za promet z zdravilom.
It is necessary from a public health perspective to complement the data available at the time of authorisation with additional data about the safety and, in certain cases, the efficacy of authorised medicinal products.
Z vidika javnega zdravja je treba podatke, ki so na voljo ob izdaji dovoljenja za promet z zdravilom, dopolniti z dodatnimi podatki o varnosti in v nekaterih primerih tudi o učinkovitosti zdravil, ki so pridobila dovoljenje za promet.
Competent authorities should therefore be empowered to impose on the marketing authorisation holder the obligation to conduct post-authorisation studies on safety and on efficacy.
Pristojni organi bi morali torej imeti pooblastilo, da imetniku dovoljenja za promet z zdravilom naložijo obveznost, da opravi študije o varnosti in učinkovitosti zdravila po pridobitvi dovoljenja.
It should be possible to impose that obligation at the time of the granting of the marketing authorisation or later, and it should be a condition of the marketing authorisation.
Obstajati bi morala možnost, da se ta obveznosti naloži v času izdaje dovoljenja za promet z zdravilom ali pozneje, in da bi bila pogoj za dovoljenje za promet z zdravilom.
Such studies may be aimed at collecting data to enable the assessment of the safety or efficacy of medicinal products in everyday medical practice.
Cilj teh dodatnih študij je lahko zbiranje podatkov, ki bi omogočili oceno varnosti ali učinkovitosti zdravil v vsakodnevni medicinski praksi.
It is essential that a strengthened system of pharmacovigilance not lead to the premature granting of marketing authorisations.
Pomembno je, da krepitev sistema farmakovigilance ne povzroči prezgodnje odobritve dovoljenja za promet z zdravilom.
However, some medicinal products are authorised subject to additional monitoring.
Vendar so nekatera zdravila odobrena pod pogojem dodatnega spremljanja.
This includes all medicinal products with a new active substance and biological medicinal products, including biosimilars, which are priorities for pharmacovigilance.
To vključuje vsa zdravila z novimi zdravilnimi učinkovinami in biološka zdravila, tudi biološko podobna zdravila, za katere so farmakovigilančne dejavnosti prednostne.
Competent authorities may also require additional monitoring for specific medicinal products that are subject to the obligation to conduct a post-authorisation safety study or to conditions or restrictions with regard to the safe and effective use of the medicinal product.
Pristojni organi lahko tudi zahtevajo, da se dodatno spremljajo določena zdravila, za katera velja obveznost izvedbe študije o varnosti zdravila po pridobitvi dovoljenja za promet, ali pogoji ali omejitve glede varnosti in učinkovite uporabe zdravila.
Medicinal products subject to additional monitoring should be identified as such by a black symbol and an appropriate standardised explanatory sentence in the summary of product characteristics and in the package leaflet.
Zdravila, ki se dodatno spremljajo, bi bilo treba označiti s črnim simbolom in ustrezno kratko standardizirano obrazložitvijo v povzetku glavnih značilnosti zdravila in navodilu za uporabo.
A publicly available list of medicinal products subject to additional monitoring should be kept up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency [6] (hereinafter referred to as the ‘Agency’).
Evropska agencija za zdravila, ustanovljena z Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila [6] (v nadaljnjem besedilu: „Agencija“), bi morala posodabljati javno dostopen seznam zdravil, ki se dodatno spremljajo.
The Commission should, in collaboration with the Agency and national competent authorities and following consultations with organisations representing patients, consumers, doctors and pharmacists, social health insurers, and other interested parties, present to the European Parliament and the Council an assessment report regarding the readability of the summaries of product characteristics and the package leaflets and their value to the healthcare professionals and the general public.
Komisija bi morala v sodelovanju z Agencijo in pristojnimi nacionalnimi organi po posvetovanju z združenji bolnikov, potrošnikov, zdravnikov in farmacevtov, organizacijami socialnega in zdravstvenega zavarovanja ter drugimi zainteresiranimi stranmi Evropskemu parlamentu in Svetu predstaviti poročilo o oceni berljivosti povzetkov značilnosti zdravila in navodil za uporabo ter njihove pomembnosti za zdravstvene delavce in splošno javnost.
Following an analysis of that data, the Commission should, if appropriate, make proposals to improve the layout and content of the summaries of product characteristics and of the package leaflets to ensure that they represent a valuable source of information for healthcare professionals and the general public respectively.
Po analizi teh podatkov bi morala Komisija, če je to ustrezno, predstaviti predloge za izboljšanje oblike in vsebine povzetka značilnosti zdravila in navodil za uporabo, da bi zagotovila, da bodo dragocen vir informacij za zdravstvene strokovnjake oziroma splošno javnost.
Experience has shown that the responsibilities of marketing authorisation holders with regard to pharmacovigilance of authorised medicinal products should be clarified.
Izkušnje so pokazale, da bi bilo treba pojasniti odgovornosti imetnikov dovoljenj za promet glede farmakovigilance za zdravila, ki so pridobila dovoljenje za promet.
The marketing authorisation holder should be responsible for continuously monitoring the safety of its medicinal products, for informing the authorities of any changes that might impact on the marketing authorisation, and for ensuring that the product information is kept up to date.
Imetnik dovoljenja za promet bi moral biti odgovoren za nenehno spremljanje varnosti svojih zdravil, za obveščanje organov o vseh spremembah, ki bi lahko vplivale na dovoljenje za promet z zdravilom, ter za zagotovitev, da so informacije o zdravilu posodobljene.
As medicinal products could be used outside the terms of the marketing authorisation, the marketing authorisation holder’s responsibilities should include providing all available information, including the results of clinical trials or other studies, as well as reporting any use of the medicinal product which is outside the terms of the marketing authorisation.
Ker se zdravila lahko uporabljajo izven pogojev dovoljenja za promet z zdravilom, bi morale odgovornosti imetnika dovoljenja za promet z zdravilom vključevati zagotavljanje vseh razpoložljivih informacij, vključno z rezultati kliničnih preskušanj ali drugih študij, ter poročanje o uporabi zdravila izven pogojev dovoljenja za promet z zdravilom.
It is also appropriate to ensure that all relevant information collected on the safety of the medicinal product is taken into account when the marketing authorisation is being renewed.
Prav tako je primerno zagotoviti, da se pri podaljšanju dovoljenja za promet upoštevajo vse pomembne informacije o varnosti zdravila.