natgillin/translations-raw huggingface dataset:
Glede na veliko nevarnost za javno zdravje in za medsebojno zaupanje med bolniki, farmacevti in proizvajalci se morajo določbe te direktive začeti izvajati zelo hitro.
Given the major threat posed both to public health and the bond of trust between patients, pharmacists and producers, the provisions of this Directive need to be implemented extremely rapidly.
Člen 118 c (novo)
Article 118c a (new)
Člen 118ca
Article 118ca
Komisija in države članice tesno sodelujejo s Svetom Evrope pri vzpostavitvi evropske konvencije o odpravi ponarejanja zdravil in trgovanja s ponarejenimi zdravili.
The Commission and the Member States shall cooperate closely with the Council of Europe on the establishment of a European Convention on the suppression of the falsification of medicinal products and trafficking in falsified medicines.
Konvencija mora zajemati civilne in kazenskopravne vidike ponarejanja zdravil in trgovanja z njimi.
The Convention covers the civil and criminal law aspects of falsification and trafficking of falsified medicinal products.
1) Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje [vstaviti datum 18 mesecev po objavi].
1) Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [insert concrete date 18 months after publication] at the latest.
1) Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje [vstaviti datum 6 mesecev po objavi].
1) Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [insert concrete date 6 months after publication] at the latest.
Te predpise začnejo uporabljati [vstaviti datum 6 mesecev po objavi + en dan].
They shall apply those provisions from [insert concrete date 6 months after publication + one day].
(a) predpise, potrebne za uskladitev s členom 1(4), če se nanašajo na člena 46b(2)(b) in 46b(3) Direktive 2001/83/ES, kakor je spremenjena s to direktivo, [vstaviti datum 6 mesecev po objavi];
(a) the provisions necessary to comply with Article 1(4) in so far as it relates to Articles 46b(2)(b) and 46b(3) of Directive 2001/83/EC as amended by this Directive from [insert concrete date 6 months after publication];
(b) predpise, potrebne za uskladitev s členom 1(6), (8) in (9) [vstaviti datum 48 mesecev po objavi].
(b) the provisions necessary to comply with Article 1(6),(8) and (9) from [insert concrete date 48 months after publication] .
(b) predpise, potrebne za uskladitev s členom 1(6), in (8) [vstaviti datum 12 mesecev po objavi].
(b) the provisions necessary to comply with Article 1(6) and (8) from [insert concrete date 12 months after publication] ;
(c) predpise, potrebne za uskladitev s členom 1(9), kadar se nanaša na člen 54a(5) ter člen 54a(2) in (3), če sta povezana s členom 54a(5) Direktive 2001/83/ES, kakor je spremenjena s to direktivo z dne [vstaviti datum 6 mesecev po objavi];
(c) the provisions necessary to comply with Article 1(9) in so far as it relates to Article 54a(5) and Articles 54a(2) and 54a(3) to the extent they are referred to 54a(5) of Directive 2001/83/EC as amended by this Directive from [insert concrete date 6 months after publication];
(d) predpise, potrebne za uskladitev s členom 1(9), razen kadar se nanaša na člen 54a(5) ter člena 54a(2) in (3), če sta povezana s členom 54a(5) Direktive 2001/83/ES, kakor je spremenjena s to direktivo z dne [vstaviti datum 48 mesecev po objavi].
(d) the provisions necessary to comply with Article 1(9) except in so far as it relates to Article 54a(5) and Articles 54a(2) and 54a(3) to the extent they are referred to 54a(5) of Directive 2001/83/EC as amended by this Directive from [insert concrete date 48 months after publication].
Do …[vstaviti datum: 12 mesecev po objavi] Komisija v sodelovanju z Agencijo in organi držav članic izdela kakovostno in količinsko študijo o internetni prodaji ponarejenih zdravil v Evropi in po potrebi predstaviti zakonodajni predlog za varovanje javnega zdravja evropskih državljanov.
By ... [insert date: 12 months after publication ], t he Commission shall, in cooperation with the Agency and the Member State authorities, produce a qualitative and quantitative study of Internet sales of falsified medicinal products in Europe and, where appropriate, submit a legislative proposal seeking to protect the health of European citizens.
Da bi zavarovali javno zdravje in pred sprejetjem morebitnih zakonodajnih ukrepov, je treba zbrati količinske in kvalitativne podatke o razširjenosti tega pojava v Evropi.
With a view to protecting public health and before taking any legislative action, data need to be collected on the scale and seriousness of the problem in Europe.
Lara Comi, António Fernando Correia De Campos, Ilda Figueiredo, Andrzej Grzyb, Jolanta Emilia Hibner, Oriol Junqueras Vies, Ivailo Kalfin, Marian-Jean Marinescu, Vladko Todorov Panajotov (Vladko Todorov Panayotov), Frédérique Ries, Silvia-Adriana Ţicău, Hermann Winkler
Lara Comi, António Fernando Correia De Campos, Ilda Figueiredo, Andrzej Grzyb, Jolanta Emilia Hibner, Oriol Junqueras Vies, Ivailo Kalfin, Marian-Jean Marinescu, Vladko Todorov Panayotov, Frédérique Ries, Silvia-Adriana Ţicău, Hermann Winkler
V Evropski uniji se je povečalo število zdravil, ki so ponarejena, kar zadeva njihovo istovetnost, zgodovino ali vir.
There is an increase in the European Union of medicinal products which are falsified in relation to their identity, history or source.
Ponarejena zdravila lahko vsebujejo sestavine slabše kakovosti ali ponarejene sestavine, ne vsebujejo sestavin ali pa vsebujejo napačne odmerke sestavin, vključno z zdravilnimi učinkovinami.
Falsified medicinal products may contain sub-standard or falsified ingredients, no ingredients or ingredients in the wrong dosage, including active ingredients.
Zelo ogrožajo evropske bolnike in evropsko industrijo, javnost in oblikovalci politike pa so zelo zaskrbljeni zaradi nenehnega povečevanja količine teh zdravil, odkritih v Evropski uniji v zadnjem letu.
They pose a major threat to European patients and European industry, and there are strong concerns in the public and amongst policy makers about the steady increase of these products detected in the European Union in the last year.
Komisija želi vzpostaviti učinkovito zakonodajno podlago za boj proti ponarejenim zdravilom na notranjem trgu Evropske unije, tako da bo uvedla boljše zaščitne elemente in sisteme iskanja in sledenja embalaže zdravil, poenostavila postopke, povečala preglednost in obveščanje, izboljšala zbiranje podatkov in postopke ocenjevanja, povečala sodelovanje zainteresiranih strani ter opredelila najboljšo prakso.
The Commission wishes to establish an effective legislative basis for the fight against falsified medicinal products on the internal market of the European Union by introducing better safety features and track and trace systems of medicinal packaging, simplifying procedures, enhanced transparency and communication, better data collection and evaluation procedures, more involvement of stakeholders and the establishment of best practices.
Čeprav pripravljavka mnenja odobrava predlog, meni, da ga je mogoče izboljšati, predvsem kar zadeva vprašanja varstva potrošnikov.
Though your rapporteur for opinion welcomes the proposal, she is of the view that there is room for further improvement, mainly with regard to consumer protection issues .
Zato v nadaljevanju predlaga spremembe v skladu z naslednjimi smernicami:
She therefore proposes amendments along the following lines:
· Zaradi zakonske pravne varnosti in jasnosti bi morala biti opredelitev pojma „ponarejeno zdravilo“ v besedilu direktive jasno osredotočena na varstvo potrošnikov.
· For reasons of legal certainty and clarity, there should be a definition of the term 'falsified medicinal product' in the text of the Directive with a clear focus on consumer protection.
· Ker se ocenjuje, da večina ponarejenih zdravil vstopi na notranji trg s spletno prodajo, se zdi, da omejena usmerjenost na zakonito dobavno verigo ne zadostuje.
· As it is estimated that the majority of falsified medicines enters the internal market via internet sales, the limited focus on the legal supply chain seems to be insufficient.
Zato poročevalka poziva Komisijo, naj vsaki dve leti poroča Evropskemu parlamentu in Svetu o vplivu ukrepov iz te direktive in o tem, ali je potrebna nadaljnja uskladitev, zlasti kar zadeva prodajo zdravil na spletu in brez recepta.
Therefore, the rapporteur calls on the Commission to report to the European Parliament and to the Council every two years on the impact of the measures established by this Directive as well as the need for further harmonisation, in particular regarding sales of medicinal products through the internet and 'over-the-counter' sales of such products.
· Potrošnike zdravil bi bilo treba z javnimi kampanjami obveščanja ozavestiti o novih zaščitnih elementih za zdravila in nevarnostih nakupa zdravil na nepooblaščenih spletnih mestih.
· Via public information campaigns, consumers of medicinal products should be made aware of the new safety features for medicines and the dangers of purchasing medicinal products from unlicensed internet sites.
· Informacije, ki se vnašajo v zbirko podatkov Skupnosti, bi morale biti kar se da natančne.
· The information entering in the Community database should be as specific as possible.
Poleg tega bi morala zbirka podatkov vsebovati primere ponarejenih zdravil, ki so bila odkrita na trgu Unije.
Furthermore, the database should contain cases of falsified medicinal products which have been discovered on the Union market.
· Obdelava podatkov na več stopnjah postopka iskanja in sledenja bi morala potekati v skladu z obstoječo zakonodajo Skupnosti in nacionalno zakonodajo o varstvu podatkov ter ne bi smela biti na voljo za komercialne namene.
· The processing of data during several stages of the track and trace process should take place in accordance with existing Community and national legislation on data protection and should not be available for any commercial purpose.
· Ponarejanje zdravil je hudo kaznivo dejanje organiziranega kriminala, ki ogroža človeška življenja.
· The falsification of medicinal products is a severe organised criminal activity which endangers human lives.
Zato bi se moralo to odražati na sankcijah za ponarejanje.
Therefore, sanctions against falsification should reflect this.
Pomembno je okrepiti določbe o sankcijah v direktivi, pri tem pa upoštevati načelo subsidiarnosti.
Without violating the principle of subsidiarity, it is important to strengthen the provisions on sanctions in the Directive.
· Nazadnje, z Lizbonsko pogodbo, ki je začela veljati 1. decembra 2009, se postopek komitologije ne uporablja več.
· Finally, with the Lisbon Treaty, which entered into force on 1 December 2009, the comitology procedure is obsolete.
Zato je treba določbe direktive v zvezi s komitologijo nadomestiti z določbami v zvezi z enim od novih postopkov, ki so predvideni v Pogodbi o delovanju Evropske unije (člen 290 ali 291 PDEU).
Therefore, Directive provisions as regards comitology have to be replaced by provisions with reference to one of the new procedures foreseen in the Treaty on the Functioning of the European Union (Art.290 or 291 TFEU).
Pristojni Odbor za okolje, javno zdravje in varnost hrane se poziva, da pojasni to vprašanje.
The responsible Committee on the Environment, Public Health and Food Safety is asked to clarify this issue.
(3a) Izkušnje kažejo, da pri nakupu zdravila prek spleta potrošnik ne more vedno preveriti pristnosti vira.
(3a) Experience shows that, when consumers purchase medicinal products on the internet, they cannot always verify the authenticity of the source.
Komisija naj z Agencijo in državami članicami začne usklajene kampanje za ozaveščanje potrošnikov o tveganju, povezanem z nabavo zdravil prek nepooblaščenih spletnih mest.
The Commission, in coordination with the Agency and the Member States , should launch campaigns to raise awareness among consumers of the risks they run in obtaining medicines over the internet from unlicensed sites.
Komisija naj vsaki dve leti poroča Evropskemu parlamentu in Svetu o učinkih ukrepov iz te direktive in ali je potrebna nadaljnja uskladitev, pri tem pa naj nameni pozornost zlasti prodaji zdravil na spletu, pri čemer odločitev, ali se dovoli prodaja zdravil prek spleta, sprejeme vsaka posamezna država članica.
Furthermore, the Commission should report every two years to the European Parliament and to the Council on the impact of the measures provided for in this Directive and the need for further harmonisation, with particular regard to the sale of medicines on the internet, whereby the decision on whether or not to authorise the sale of medicines on the internet rests with each Member State .
Večina ponarejenih proizvodov vstopi na trg prek nezakonitih spletnih mest.
The majority of falsified products enter the market via illegal online sites.
Potrošnikom bi moralo biti omogočeno, da zdravila varno nabavijo prek spleta, pri čemer vsaka država članica dovoli prodajo zdravil na spletu v skladu z načelom subsidiarnosti, ob upoštevanju skladnosti z vso ustrezno evropsko zakonodajo.
Consumers should have the possibility to safely obtain medicinal products via the internet, whereby it will be for each Member State to authorise the sale of medicines on the internet in accordance with the subsidiarity principle, subject to compliance with all the relevant European legislation.
(3b ) Po sprejetju te direktive naj Komisija v sodelovanju z Agencijo in organi držav članic začne kampanjo obveščanja in ozaveščanja potrošnikov o tveganjih, ki jih prinaša nakup ponarejenih zdravil, pri čemer se osredotoči zlasti na ukrepe za preverjanje in zaščitne elemente na ovojnini zdravil ali drugje (kot so hologrami in zaščitni pečati).
(3b ) After the adoption of this Directive, t he Commission should, in cooperation with the Agency and Member State authorities, launch campaigns informing and raising awareness among consumers of the risk involved in purchasing falsified medicinal products, focusing in particular on the authentication measures and safety features (such as holograms and safety seals) shown on the packaging of medicinal products or elsewhere.
(3c) Komisija mora v dveh leti po sprejetju te direktive predložiti obširno oceno razmer na področju prodaje zdravil brez recepta, pri tem pa se osredini na vprašanje, ali gre zdravila brez recepta vključiti v področje uporabe te direktive in na kakšen način.
(3c) Within two years after the date of adoption of this Directive, the Commission should submit a comprehensive evaluation of the situation regarding 'over-the-counter' medicinal products (OTCs), focusing on the question of whether and in what form OTCs should be included in the scope of this Directive.
Za odločitev, ali naj se zdravila, ki so na prodaj brez recepta, vključijo v področje uporabe te direktive, je potrebna dodatna ocena nevarnosti, povezane z njimi.
Further evaluation is needed of the possible dangers of OTCs in order to decide whether they should be included in the scope of this Directive.
(4a) Državljane Unije je treba seznaniti z nevarnostjo, ki jo za njihovo zdravje predstavljajo izdelki, naročeni na nenadzorovanih spletnih straneh ali v nezakonitih dobavnih verigah.
(4a) Citizens of the Union should be made aware of the danger to their health of 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 potrošnikov sprejeti ukrepe za večjo ozaveščenost širše javnosti o tveganjih, povezanih z nakupom zdravil prek spleta.
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 involved in purchasing medicinal products via the internet.
Za vse udeležene 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.
All actors should be subject 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 might enter the legal supply chain in the Community.
Za zagotavljanje istovetnosti, pristnosti in neprekinjene sledljivosti zdravil od tovarne do potrošnika bi morala za vse udeležene v distribucijski verigi veljati enaka pravila, zahteve in odgovornost.
All actors in the distribution chain should be subject to the same rules, level of requirements and responsibility in order to ensure the identification, authenticity and uninterrupted traceability of medicinal products from the factory to the consumer.
Zaščitne elemente (z izjemo serijske številke) je treba razdeliti po kategorijah na podlagi enakovrednosti, na splošno pa naj imetniki dovoljenja za proizvodnjo sprejmejo poseben element ali več elementov za uporabo v določeni kategoriji.
Safety features (other than serialisation numbering) should be grouped in categories based on equivalence and, in general, manufacturing authorization holders should adopt a specific feature or features to use within a particular category.
Zaščitni elementi se štejejo za enakovredne, če zagotavljajo enako raven zaščite pri preverjanju pristnosti, nespreminjanja in, kjer je to primerno, istovetnosti, pa tudi enako raven tehnične zahtevnosti za podvajanje izvirnega zaščitnega elementa.
Safety features should be considered equivalent when they ensure the same level of protection in terms of ascertaining authenticity, absence of tampering and, where relevant, identification, and present the same level of technical difficulty of duplication.
Zaradi zagotavljanja enake ravni varovanja je treba opredeliti obseg enakovrednih zaščitnih elementov, namenjenih zagotavljanju istovetnosti, pristnosti in sledljivosti zdravil na recept, če so bili odstranjeni.
In order to ensure the same level of protection it is necessary to clarify the scope of equivalent safety features designed to ensure the identification, authentication and traceability of prescription medicinal products when they are removed.
Razdeliti jih je treba po kategorijah glede na njihovo zapletenost, pri odstranjevanju (ali prekrivanju) pa jih je treba nadomestiti s podobnimi elementi, ki nudijo enakovredno raven varovanja in zapletenosti.
They should be grouped according to complexity and the removal (or covering up) of these features will require replacement with a similar feature providing an equivalent level of protection and complexity.
(7a) Predlagane varnostne ukrepe in podatke, zbrane pri opredeljevanju, pooblaščanju in sledenju zdravilom, je treba uporabiti v skladu z obstoječo zakonodajo Unije in nacionalno zakonodajo o varstvu podatkov.
(7a) The proposed safety measures and the data collected from identifying, authorising and tracing medicinal products should be used in accordance with existing Union and national legislation on data protection.
Še posebej to velja za informacije o distribucijskih kanalih.
This includes in particular information on distribution channels.
(18a) Države članice naj sodelujejo tudi z Europolom na področju pravosodnega in policijskega sodelovanja, kar bo med drugim pripomoglo k okrepitvi uporabe sedanjih omejitev nezakonite dobave zdravil na spletu.
(18a) Member States should cooperate with Europol in the fields of justice and police cooperation, inter alia, in order to strengthen the application of existing restrictions regarding the illegal supply of medicinal products on the internet.
Sodelovanje med državami članicami, vključno z izmenjavo zgledov najboljše prakse in tehnološkega znanja, je pomembno za reševanje vprašanja nezakonite dobave zdravil prek spleta.
Cooperation between Member States, including exchanges of best practices and technological know-how, is important in order to address the illegal supply of medicinal products via the internet.
Tako sodelovanje pa naj vključuje tudi Europol, saj si je pridobil znatne tehnične izkušnje na področju boja proti kibernetski kriminaliteti v Evropski uniji.
Such cooperation should, however, also include Europol which has acquired significant technical expertise in sectors relating to combating cybercrime at EU level.
-1) V členu 1 se za točko 5 vstavi naslednja točka 5a:
-1) In Article 1, the following point 5a is inserted after point 5:
Vsako zdravilo, ki je bilo naklepno ali namerno ponarejeno, kar zadeva:
Any medicinal product that has been intentionally or deliberately falsified in relation to its:
(a) istovetnost, vključno z ovojnino, oznako, ime in sestavo sestavin, vključno s pomožnimi snovmi, ter zdravilne učinkovine in njihove odmerke; in/ali
(a) identity, including its packaging, labelling, name and composition in terms of both ingredients, including excipients and active ingredients, and the dosage thereof; and/or
(b) izvor, vključno s proizvajalcem, državo proizvodnje, državo izvora in imetnikom dovoljenja za promet z zdravili; in/ali
(b) source, including the manufacturer, the country of manufacture, the country of origin and the marketing authorisation holder; and/or
(c) zgodovino, vključno z evidencami in dokumenti, ki omogočajo ugotavljanje istovetnosti distribucijske verige.
(c) history, including the registers and documents enabling the distribution chain to be identified.
Kršitve patentov ali spore o njih je treba razlikovati od ponarejanja ali ponaredkov zdravil.
Infringements or disputes concerning patents must be distinguished from counterfeiting or falsification of medicinal products.
Zdravila (tako generična kot z blagovno znamko), ki nimajo dovoljenja za promet v določeni državi, imajo pa ga za promet v drugih, se ne štejejo za ponarejene.
Medicinal products (whether generic or branded) that are not authorised for marketing in a given country but are authorised elsewhere shall not be considered falsified.
Serije slabše kakovosti, z napakami v kakovosti ali ki niso skladne z dobro proizvodno in distribucijsko prakso zakonitih zdravil se ne štejejo za ponarejene.
Sub-standard batches or quality defects or non-compliance with Good Manufacturing Practices/Good Distribution Practices (GMP/GDP) in legitimate medicinal products shall not be considered falsified.
Komisija je pooblaščena za sprejemanje delegiranih aktov za posodobitev te opredelitve na podlagi tehničnega in znanstvenega napredka in/ali mednarodnih sporazumov.
The Commission shall be empowered to adopt delegated acts updating this definition on the basis of technical and scientific progress and/or international agreements.
Navedeni akti, katerih namen je sprememba nebistvenih elementov te direktive z njeno dopolnitvijo, se sprejmejo v skladu s postopkom iz člena 290 Pogodbe o delovanju Evropske unije.“
Those acts, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the procedure referred to in Article 290 of the Treaty on the Functioning of the European Union. "
Zaradi pravne varnostni in jasnosti je treba uvesti opredelitev „ponarejenega zdravila“ v besedilo direktive.
For reasons of legal certainty and clarity a definition of 'falsified medicinal product' should be introduced into the text of the Directive.
2a) V členu 2 se za odstavkom 3 vstavi naslednji odstavek 3a:
2a) In Article 2, the following paragraph 3a is inserted after paragraph 3:
Nobena določba te direktive ne vpliva na pravico držav članic, da omejijo ali prepovejo prodajo zdravil na recept prek spleta.“
Nothing in this Directive shall affect the right of Member States to restrict or prohibit the sale of prescription medicines via the internet."
V veliki večini držav članic je prodaja zdravil na recept prek spleta trenutno omejena.
The vast majority of Member States currently restrict the sale of prescription medicines through the internet.