natgillin/translations-raw huggingface dataset:
Predvsem je pomembno jasno in enopomensko opredeliti, kaj je predmet predloga – torej „ponarejeno zdravilo“, pa tudi vse udeležence v distribucijski verigi, kot so trgovci in posredniki, ki morajo biti pooblaščeni za izvajanje dejavnosti in spoštovati sistem dobre prakse enako kot proizvajalci in distributerji.
First, it is important to have clear and unambiguous definitions of both the subject of the proposal – namely, falsified medicinal products – and all those involved in the distribution chain, such as traders and brokers, who must operate on the basis of authorisations and be required to comply with good practice in the same way as producers and distributors.
To mora veljati tudi za vzporedne trgovce, ki morajo upoštevati jasne obveznosti in biti strogo nadzorovani.
This must also apply to parallel traders, who must be the subject of clear obligations and stringent checks.
Poleg tega je nujno okrepiti in posplošiti nadzor nad proizvodnimi obrati, ki izvažajo farmacevtske surovine, tudi aktivne učinkovine, da bi dobili zagotovilo o skladnosti z dobro proizvodno prakso, hkrati pa z učinkovitim sistemom sledljivosti zagotovili javno zdravje.
Furthermore, more stringent, systematic inspections need to be carried out at the plants at which pharmaceutical starting materials, including active ingredients, are produced for export, in order to ensure compliance with good manufacturing practice, while public health needs to be protected by means of an effective traceability system.
Če se po eni strani z odobravanjem sprejme predlog o uvedbi sistema o vzajemnem priznavanju s tistimi državami izvoznicami, ki zagotavljajo kakovost proizvodnje, primerljivo z EU, pa je po drugi pomembno spremeniti predlog Komisije, da bi zagotovili, da se bo prvi inšpekcijski pregled na kraju samem opravil pred uvrstitvijo države na seznam, ne pa najpozneje v treh letih po tem.
While the proposal to establish a mutual recognition system with exporting countries that can guarantee production quality standards equivalent to those in the EU is to be welcomed, the Commission proposal needs to be amended to ensure that the first on-site inspection takes place prior to a country's inclusion on the list and not within three years of that inclusion.
Na ta način se bo mogoče dejansko prepričati o jamstvih teh držav, preden dobijo dovoljenje za vstop proizvodov na evropski trg.
This will make it possible to ascertain the reliability of the guarantees provided by the third country before it is authorised to place products on the Community market.
Jamstvo, ki se zahteva od proizvajalcev, delujočih v državi, s katero Evropa ni sklenila prej navedenega sporazuma, ni zadostno.
The guarantees required of producers not from a country with which the EU has signed a mutual recognition agreement are not demanding enough.
Tem proizvajalcem se namreč dovoli izvoz v Evropo, če jim je tretja država izvoznica izdala pisno potrdilo o kakovosti proizvodnje.
Such producers are authorised to export to the EU if the exporting third country provides written confirmation of production quality standards.
Očitno je, da se s takim postopkom ne pridobi nikakršnega dejanskega jamstva, temveč bo tretje države le odvračal od tega, da bi sklenile sporazum o vzajemnem priznavanju z EU.
This procedure clearly fails to provide a proper and sufficient guarantee and, furthermore, will not encourage third countries to conclude mutual recognition agreements with the EU.
Pomembno je obravnavati tudi druga vprašanja, na primer spletno prodajo in možnost, da se predpišejo obvezni zaščitni elementi tudi za zdravila brez zdravniškega recepta, če obstaja utemeljena domneva, da bi ta utegnila biti ponarejena.
Other issues also need to be addressed, such as Internet sales and the possibility of affixing safety features to over-the-counter medicines, where there is good reason to believe that they may be falsified.
Nazadnje se zdi obdobje za začetek veljavnosti direktive predolgo glede na to, da v predlogu niso predvideni obvezni in splošni inšpekcijski pregledi proizvodnih obratov.
Finally, given that the proposal fails to provide for systematic mandatory inspection of production facilities, the time frames for the entry into force of the directive's provisions are excessively long.
ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti in zlasti člena 95 Pogodbe,
Having regard to the Treaty establishing the European Community , and in particular Article 95 thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije, zlasti členov 114 in 168 Pogodbe,
Having regard to the Treaty on the Functioning of the European Union , and in particular Articles 114 and 168 thereof,
Cilj direktive ni zgolj vzpostaviti delovanje notranjega trga za zdravila, temveč tudi zagotoviti visoko raven varovanja javnega zdravja v Evropski uniji.
The aim of this Directive is not only to establish the functioning of the internal market for medicinal products but to ensure as well a high level of protection of public health in the EU.
(3a) Izkušnje kažejo, da prodaja zdravil prek spleta potrošnikom ne omogoča, da bi z zadostno gotovostjo ugotovili, ali so kupili zdravila prek zakonite dobavne verige ali ne in ali so varna.
(3a) Experience shows that, when medicinal products are purchased on the Internet, the consumer cannot be sufficiently sure that the products purchased have been sourced through the legal supply chain and are thus safe.
Komisija mora v sodelovanju z Agencijo in organi držav članic preučiti ta pojav in po potrebi predstaviti zakonodajni predlog za varovanje javnega zdravja evropskih državljanov.
The Commission should, in cooperation with the Agency and Member State authorities, analyse Internet sales and, where appropriate, submit a legislative proposal seeking to protect the health of European citizens.
Naglo širjenje ponudbe ponarejenih zdravil prek spleta povzroča veliko zaskrbljenost.
The increasingly wide availability of medicinal products on the Internet is a matter of considerable concern.
Ker pa ni bila izvedena študija, ki bi omogočila jasen pregled nad tem pojavom, bi lahko širitev tega predloga, da bi zajel tudi to področje, imel nasprotni učinek od željenega.
However, until a study is carried out with a view to providing a clear picture of the situation, it would be counter-productive to extend the proposal's scope to cover Internet sales.
Zato je primerno pozvati različne institucionalne subjekte, naj preučijo to problematiko in po potrebi prestavijo zakonodajni predlog, ki bo omogočil, da se v celoti spoprimemo s tem izzivom.
The various institutional stakeholders therefore need to analyse Internet sales and, where appropriate, submit a legislative proposal that will properly address this problem.
(4a) Namen te direktive je preprečiti vstop ponarejenih zdravil v zakonito farmacevtsko verigo in ne posega v pravice intelektualne in industrijske lastnine.
(4a) This Directive seeks to prevent falsified medicinal products from entering the legal supply chain and should be without prejudice to intellectual and industrial property legislation.
Vstop ponarejenih zdravil v zakonito farmacevtsko mrežo ni samo velik vir nevarnosti za javno zdravje, temveč tudi zelo zaskrbljujoč dejavnik za ta evropski industrijski sektor ter zlasti za mala in srednja podjetja v njem.
The entry of falsified medicinal products into the legal supply chain not only poses a major threat to public health but is also a matter of serious concern to Europe's pharmaceutical sector, in particular the SMEs working within it.
Zato je nujno, da se zaščitijo intelektualne in industrijske pravice, da bi zagotovili nadaljnje obsežne naložbe v raziskave in razvoj evropske industrije zdravil.
Intellectual and industrial property rights therefore need to be safeguarded in order to ensure that the European pharmaceutical industry is able to continue to invest heavily in research and development.
(4b) Komisija in države članice morajo podpreti novi osnutek konvencije Sveta Evrope o ponarejanju zdravil in podobnih kaznivih dejanjih, ki ogrožajo javno zdravje, ki bo predvidoma na voljo v podpis v letu 2010.
(4b) The new draft Convention of the Council of Europe on counterfeiting of medicinal products and similar crimes involving threats to public health, which is expected to be open for signature in 2010, should be supported by the Commission and the Member States.
Potreben je mednarodni pravni instrument v obliki konvencije, ki bo uvedel novo zakonodajo, vključno z novimi kaznivimi dejanji farmacevtske kriminalitete, vzpostavil posebne kazni za ponarejanje zdravil in zmanjševanje njihove kakovosti ter določil pravila, ki bodo urejala pristojnosti in žrtvam farmacevtske kriminalitete omogočala upoštevanje njihovih interesov.
An international legal instrument is needed, in the form of a convention, designed to introduce new legislation including a new offence relating to pharmaceutical crime, to establish specific penalties for counterfeiting and impairing the quality of medicines and lay down rules governing jurisdiction allowing the interests of victims of pharmaceutical crime to be taken into account.
(4c) Znatna količina zdravil, kupljenih prek interneta, se prodaja na spletnih straneh, ki ne razkrijejo svojega dejanskega fizičnega naslova.
(4c) A considerable number of medicines purchased over the internet come from sites that conceal their actual physical address.
Zato je treba razlikovati med zakonitimi lekarnami, ki prodajajo po pošti, ali spletnimi lekarnami, in nezakonito dobavno verigo preko nenadzorovanih nakupov na internetu.
Therefore, a distinction should be made between legitimate mail-order or internet pharmacies and the illegal supply chain through non-controlled internet purchasing.
Države članice morajo zagotoviti, da pristojni organi stalno nadzorujejo spletne strani za prodajo zdravil.
Member States should ensure that the internet sale of medicinal products is continuously monitored by designated bodies.
Ker je v nekaterih državah članicah prodaja prek interneta del zakonite dobavne verige, jo je treba upoštevati.
Since some Member States recognise internet sales as part of the legal supply chain, internet sales have to be taken into account.
Mednarodna skupina za boj proti ponarejanju zdravil pri Svetovni zdravstveni organizaciji ocenjuje, da so zdravila, kupljena na nezakonitih spletnih straneh, ki skrivajo svoj fizični naslov, ponarejena v več kot polovici primerov.
The International Medical Products Anti-Counterfeiting Taskforce (IMPACT) of the World Health Organisation estimated that medicines purchased over the internet from illegal sites that conceal their physical address are falsified in over 50% of cases.
Tega torej ne smemo prezreti in mora biti vključeno v direktivo.
This situation should therefore not be ignored and should be part of the directive.
(4d) Evropske državljane je treba seznaniti z nevarnostjo, ki jo za njihovo zdravje pomenijo izdelki, naročeni na nenadzorovanih spletnih straneh ali v nezakonitih dobavnih verigah.
(4d) European citizens should be made aware of the danger to their health from ordering products from non-controlled internet websites or from the illegal supply chain.
Komisija mora skupaj z državami članicami in v sodelovanju z organizacijami bolnikov in potrošniškimi organizacijami sprejeti ukrepe za večjo osveščenost javnosti o tveganjih, povezanih z nakupom zdravil prek interneta.
The Commission together with the Member States and in cooperation with patients' and consumers' organisations should adopt measures to increase awareness among the general public of the risks related to purchasing medicinal products on the internet.
Kampanje osveščanja javnosti morajo državljane seznaniti, ali so njihove spletne lekarne uradno registrirane in pod nadzorom javnih organov.
Public awareness campaigns should inform citizens whether their internet pharmacy is officially registered and controlled by public authorities.
Boljša osveščenost je ključna prvina boja proti dobavi ponarejenih zdravil prek interneta.
Awareness raising is a crucial element in fighting the supply of falsified medicinal products through internet sales.
Pobude za zagotavljanje informacij so ključne, saj se osveščen in poučen potrošnik lahko izogne ponarejenim zdravilom.
Information initiatives are crucial because a conscious and knowledgeable consumer is able to avoid falsified medicines.
Zaradi izkušenj, ki jih imajo organizacije bolnikov in potrošniške organizacije, lahko v skupnostih, ki jih dobro poznajo, podajajo ustrezne, natančne in dostopne informacije.
Patients and consumers' organisations have the experience to provide relevant, accurate and accessible information for the communities that they know well.
(4e) Koristno je uvesti opredelitev pojma „ponarejeno zdravilo“, da bi se ta zdravila razločevala od zakonitih zdravil v nepooblaščeni prodaji.
(4e) It is useful to introduce a definition of the concept of ‘falsified medicinal product’ in order to distinguish such products from legal but unauthorised medicinal products.
Poleg tega ne gre zamenjevati zdravil z dovoljenjem za promet ali drugače zakonitih zdravil, ki imajo kakovostne napake, ter zdravil, ki zaradi proizvodnih napak ali nadaljnjega ravnanja ne ustrezajo zahtevam dobre proizvodne ali distribucijske prakse, s ponarejenimi zdravili.
Furthermore, authorised or otherwise legitimate products with quality defects and medicinal products that due to mistakes in the manufacturing or subsequent handling do not comply with the requirement of Good Manufacturing Practices or Good Distribution Practices should not be confused with falsified medicines.
Zanje morajo veljati sorazmerna pravila, da se z vsemi izvedljivimi sredstvi izključi možnost, da bi zdravila, ki so ponarejena, kar zadeva njihovo istovetnost, zgodovino ali vir odobrenega zdravila, vstopila v zakonito dobavno verigo v Skupnosti.
They should be submitted to proportionate rules in order to exclude, by all practical means, the possibility that medicinal products which are falsified in relation to their identity, history or source to enter the legal supply chain in the Community.
Treba je uvesti jasno in enopomensko opredelitev zanje, opredeliti njihovo pristojnost, poleg tega pa morajo zanje veljati sorazmerna pravila, da se z vsemi izvedljivimi sredstvi izključi možnost, da bi zdravila, ki so ponarejena, kar zadeva njihovo istovetnost, zgodovino ali vir odobrenega zdravila, vstopila v zakonito dobavno verigo v Skupnosti.
They should be clearly and unambiguously defined, as should their responsibilities, and should be submitted to proportionate rules in order to exclude, by all practical means, the possibility that medicinal products which are falsified in relation to their identity, history or source to enter the legal supply chain in the Community.
Zlasti morajo imeti ti udeleženci veljavno licenco za svojo poslovno dejavnost, ki jo morajo izvajati v skladu z dobro prakso, ki jo je opredelila Komisija v sodelovanju z Agencijo in organi držav članic, enako kot velja za proizvajalce in distributerje zdravil.
In particular, such persons should have a valid licence for their business activities, which should be conducted in accordance with the good practice laid down by the Commission, in cooperation with the Agency and the Member State authorities, by analogy with that applying to producers and distributors of medicinal products.
Da bi zagotovili varnost farmacevtskih proizvodov, je treba upoštevati vse udeležence, ki delajo v sektorju, na samo distributerjev na debelo.
To ensure the safety of pharmaceutical products, due account needs to be taken of all those working in the sector and not just wholesale distributors.
(7) Zaradi upoštevanja novih profilov tveganj in hkratnega zagotavljanja delovanja notranjega trga za zdravila je treba na ravni Skupnosti opredeliti zaščitne elemente, namenjene za zagotavljanje istovetnosti, potrditev pristnosti in sledljivost zdravil.
(7) In order to take account of new risk profiles, while at the same time ensuring the functioning of the internal market for medicinal products, safety features designed to ensure the identification, authentication and traceability of medicinal products should be established at Community level.
Pri uvedbi obveznih zaščitnih elementov za zdravila na recept je treba primerno upoštevati posebnosti nekaterih zdravil ali kategorij zdravil, kot so generična zdravila, zdravila brez zdravniškega recepta in zdravila, ki jih prodajo brez posredovanja direktno ustanovam, kjer jih dajejo bolnikom .
When introducing obligatory safety features for medicinal products, due account should be taken of the particularities of certain products or categories of products, such as generic medicines , over-the-counter medicines and medicines sold directly by producers, without any brokering, to establishments at which they are provided to patients .
Treba je razviti učinkovit sistem za zagotavljanje istovetnosti, potrjevanje pristnosti in sledljivost zdravil na podlagi ocene tveganja, predvidene v členu 54a(4).
An effective system for identifying, authenticating and tracing medicinal products on the basis of the risk assessment provided for in Article 54a(4) needs to be developed.
Ob določanju zaščitnih elementov je treba upoštevati posebne značilnosti zdravila, da ne bi povzročili nesorazmerno visokih stroškov.
When the safety features are laid down, the product's specific characteristics need to be taken into account so as not to generate disproportionately high costs.
Če bi bili ti elementi obvezni za proizvode, ki jih proizvajalci brez posrednikov direktno prodajajo zdravstveni ustanovi, ki bolnikom ta zdravila daje, bi lahko dosegli nasprotni učinek.
For example, it would be counter-productive to impose safety features for medicines sold directly by producers, without any brokering, to healthcare facilities at which they are provided to patients.
(7a) Državam članicam bi bilo treba prepustiti, da v sodelovanju z zainteresiranimi stranmi posebne vidike potrjevanja pristnosti zdravil obravnavajo tako, kot menijo, da je najbolje za njihov trg zdravil, ob upoštevanju zaščitnih elementov, določenih v skladu s to direktivo.
(7a) Member States, in cooperation with stakeholders, should be permitted to regulate the particular aspects of authentication of medicines in the way which they consider most appropriate for their market in medicinal products, taking account of the safety features established in accordance with this Directive.
Pomembno je zagotoviti pristnost zdravil, ki se izdajo na recept, in zdravil brez recepta.
It is important to ensure the authenticity both of prescription medicines and of non-prescription medicines.
(7b) Tehnologije, ki omogočajo identifikacijo in sledljivost posameznih količin farmacevtskih proizvodov, so lahko sredstvo za učinkovitejši boj proti ponarejanju zdravil, zato jih morajo institucije, ki so zadolžene za varovanje javnega zdravja v Evropi, natančno preučiti.
(7b) Technologies which make it possible to identify and trace pharmaceuticals at the individual dose level may be a means of combating counterfeiting of medicinal products more effectively and deserve careful analysis by the institutions responsible for safeguarding public health in Europe .
Treba je upoštevati vse tehnologije, ki so na voljo v boju proti temu pojavu, škodljivemu za zdravje evropskih državljanov.
It is important to take account of all the available technologies for combating this phenomenon, which is damaging to the health of Europe's citizens.
(7c) Da bi se bolniki pravočasno zaščitili pred tveganjem, ki ga povzročajo ponarejena zdravila, mora imetnik dovoljenja za proizvodnjo, ki delno ali v celoti odstrani ali prekrije prostovoljno uporabljene zaščitne elemente, slednje nadomestiti z enakovrednimi zaščitnimi elementi, ki morajo zagotavljati istovetnost ter potrjevati pristnost in sledljivost zdravil na recept, takoj ko začne veljati ta direktiva.
(7c) In order to provide patients with timely protection from the risks arising from falsified medicinal products, a manufacturing authorisation holder who partly or fully removes or covers-up safety features that are applied on a voluntary basis should be required to replace such safety features with equivalent safety features designed to ensure the identification, authentication and traceability of prescription medicinal products as soon as this Directive enters into force.
Tudi ko bo direktiva začela veljati, se najbrž še nekaj let ne bodo uporabljali kakšni konkretni ukrepi.
Even after the Directive comes into force, it is unlikely that any concrete measures will actually be in place for some years.
V slednjih bi moralo biti med drugim zahtevano, da mora imetnik dovoljenja za proizvodnjo (tudi tisti, ki izdelke prepakira), ki odstrani ali prekrije zaščitne elemente, ki jih je prostovoljno namestil tvorec, te elemente nadomestiti z enako očitnimi zaščitnimi elementi, ter da je dosledno odgovoren v primeru vstopa ponarejenih zdravil v dobavno verigo zaradi njegovega ravnanja.
These measures should require inter alia that manufacturing authorization holders, (including repackagers) who remove or cover up overt safety features applied on a voluntary basis by the originator, replace them with equivalent overt safety features, and be held strictly liable in the case of counterfeits entering the supply chain as a result of their actions.
(8) Vsak udeleženec dobavne verige, ki pakira zdravila, mora biti imetnik dovoljenja za proizvodnjo.
(8) Any actor in the supply chain who packages medicinal products has to be a holder of a manufacturing authorization .
(8) Vsak udeleženec dobavne verige, ki označuje ali pakira zdravila ali spreminja oznake ali ovojnino zdravil , mora biti imetnik dovoljenja za proizvodnjo.
(8) Any actor in the supply chain who labels or packages medicinal products or inserts changes to the labelling or packaging of medicinal products has to be a holder of a manufacturing authorization.
Da bi bili zaščitni elementi učinkoviti, lahko imetnik dovoljenja za proizvodnjo odstrani, nadomesti ali prekrije te elemente samo pod strogimi pogoji.
In order for the safety features to be effective, the manufacturing authorisation holder should only be permitted to remove, replace or cover these features under strict conditions.
Strogi pogoji bi morali ustrezno ščititi pred vstopom ponarejenih zdravil v distribucijsko verigo in odražati strogo dolžnost skrbnosti teh imetnikov dovoljenja za proizvodnjo do izvirnega proizvajalca, imetnika dovoljenja za promet z zdravili in potrošnika zdravil.
The strict conditions should provide adequate safeguards against falsified products entering the distribution chain and also reflect a strict duty of care of those manufacturing authorisation holders towards the original manufacturer and the marketing authorisation holder of the products and to consumers of the products.
(11a) Evropski državljani morajo biti pozorni na tveganja, povezana z naročanjem zdravil pri nezakonitih dobaviteljih.
(11a) European citizens should have their attention drawn to the risks which arise when medicinal products are ordered from illegal suppliers.
Zlasti bi bilo treba spodbujati ukrepe za obveščanje javnosti v državah članicah in po Evropi.
In particular, public information measures should be promoted in the Member States and throughout Europe .
Komisija in države članice bi morale sprejeti ukrepe za večjo ozaveščenost javnosti o tveganjih, povezanih z nakupom zdravil na internetu.
The Commission and Member States should adopt measures to increase awareness among the general public of the risks related to purchasing medicinal products on the Internet.
To tveganje je treba odpraviti z združitvijo učinkovitega inšpekcijskega sistema in sistema za zagotavljanje sledljivosti aktivnih farmacevtskih učinkovin.
This risk should be addressed by combining an effective inspection system with a system ensuring the traceability of active pharmaceutical ingredients .
Predvsem morajo proizvajalci zdravil sami zagotoviti, da proizvajalec, ki jim dobavlja aktivne farmacevtske učinkovine, ravna v skladu z dobro proizvodno prakso.
In particular, manufacturers of medicinal products should themselves ensure that the supplying manufacturer of active pharmaceutical ingredients complies with good manufacturing practices.