natgillin/translations-raw huggingface dataset:
Te omejitve pripomorejo tudi k zmanjševanju možnosti, da bi ponarejevalci javnosti dobavljali ponarejena zdravila.
Such restriction help, among other things, to minimise the opportunities for counterfeiters to make counterfeit medicines available to the general public.
V interesu javnega zdravja in v skladu z načelom subsidiarnosti bi take omejitve morale ostati v veljavi.
In the interests of public health, and in accordance with the principles of subsidiary, such restrictions should be allowed to stay in place.
(2) Zaščitni elementi iz točke (o) člena 54 se ne smejo delno ali popolnoma odstraniti ali prekriti, razen če so zajamčene istovetnost, pristnost in sledljivost zdravil ter so izpolnjeni naslednji pogoji
(2) The safety features referred to in point (o) of Article 54 shall not be partly or fully removed or covered-up, unless the identification, authenticity and traceability of the medicinal products are guaranteed and the following conditions are fulfilled:
Člen 54 a – odstavek 2 – točka b a (novo)
Article 54a – paragraph 2 – point b a (new)
(ba) imetnik dovoljenja za proizvodnjo na zunanji embalaži jasno navede, če so bili prvotni zaščitni elementi deloma ali v celoti odstranjeni ali prekriti;
(ba) The manufacturing authorisation holder clearly indicates on the outer packaging when original safety features have been partly or fully removed or covered up;
Bolnike in druge udeležence v dobavni verigi je treba s pomočjo oznake na embalaži izrecno obvestiti, da je bil izvirni zaščitni element odstranjen ali nadomeščen.
Patients and others actors in the supply chain must be explicitly informed via a label on the pack where original safety features have been removed and replaced.
(b) število primerov ponaredkov v tretjih državah in Skupnosti ;
(b) the number of incidences of falsifications in third countries and within the Community ;
(b) število primerov ponaredkov po svetu, zlasti v Uniji;
(b) the number of incidences of falsifications worldwide, particularly within the Union ;
Razmere na področju spremljanja in nadzora, ki ga izvajajo pristojni organi tretjih država ter tamkajšnjih pravic intelektualne lastnine so precej drugačne kot v Evropi.
The situation in many third countries is quite different from the situation in Europe as regards monitoring and surveillance by the competent authorities and respect for intellectual property.
Člen 54 a – odstavek 4 – pododstavek 3 a (novo)
Article 54a – paragraph 4 – subparagraph 3 a (new)
Zaščitne elemente (z izjemo serijske številke) se uveljavi s pomočjo opredelitve ene ali več kategorij elementov, ki jih je treba uporabiti za določeno zdravilo ali kategorije zdravil.
The safety features (other than serialisation numbering) shall be imposed through the identification of one or more categories of feature that must be used for particular products or categories of product.
Odbor za farmacijo pri Komisiji določi kategorije, ki jih tvorijo zaščitni elementi, ki nudijo enakovredno učinkovitost, elemente iz iste kategorije pa se nato šteje za enakovredne za namene odstavka (2)(b) tega člena.
The Commission’s Pharmaceutical Committee shall define categories comprising safety features offering equivalent efficiency and effectiveness, and features from the same category shall then be considered equivalent for the purposes of paragraph (2)(b) of this Article.
Imetnik dovoljenja za proizvodnjo lahko po lastni presoji odloči, kateri element ali elemente bo uporabil znotraj neke kategorije, razen če Komisija določi razloge za uporabo določenega zaščitnega elementa .
Manufacturing authorisation holders shall have discretion as to which specific feature or features to use within a category, unless the Commission specifies reasons for requiring that a particular safety feature be used.
Države članice zagotovijo, da se spoštujeta lastništvo in zaupnost podatkov, ki izhajajo iz uporabe zaščitnih elementov, namenjenih potrditvi pristnosti zdravil.
Member States shall ensure that the ownership and confidentiality of the data resulting from the use of safety features intended to demonstrate the authenticity of pharmaceutical products are respected.
Zlasti informacije o distribucijskih kanalih ne smejo biti na razpolago v komercialne namene.
In particular, information concerning distribution channels shall not be made available for commercial use.
Člen 54 a – odstavek 4 – pododstavek 5 a (novo)
Article 54a – paragraph 4 – subparagraph 5 a (new)
Ukrepi iz tega odstavka primerno upoštevajo vsaj naslednje:
The measures referred to in this paragraph shall take due account of at least all of the following:
(a) Stroškovno učinkovitost sistema, da se zagotovi, da je vsak ukrep uporabljen na podlagi analize stroškov in koristi.
(a) The cost-effectiveness of the system, in order to ensure that any measure that is applied is based on a cost-benefit analysis.
(b) Stroški, povezani z ukrepi, se razdelijo sorazmerno med vse udeležence v dobavni verigi, pri tem pa se upošteva cena zadevnih zdravil.
(b) The costs relating to the measures shall be shared proportionately by all the actors in the supply chain and take the price of the medicinal product concerned into consideration.
(c) Neodvisnost sistema in zakonite interese pri varovanju podatkov poslovno zaupne narave, varovanje pravic industrijske in poslovne lastnine ter osebnih podatkov.
(c) The independence of the system and the legitimate interest in protecting information of a commercially confidential nature and the protection of industrial and commercial property rights and of personal data.
(4a) Odstavka 2 in 3 veljata tudi za imetnika dovoljenja za proizvodnjo, ki delno ali v celoti odstrani ali prekrije zaščitne elemente, ki jih izvirni proizvajalci zdravil, ki se izdajajo na recept, uporabljajo prostovoljno za namene iz odstavka 2 tega člena.
(4a) Paragraphs 2 and 3 shall also apply to a manufacturing authorisation holder who partly or fully removes or covers-up safety features that are applied on a voluntary basis to medicinal products that are subject to medical prescription by the original manufacturer for the purposes referred to in paragraph 2 of this Article.
(4b) Komisija v sodelovanju z Agencijo in oblastmi držav članic začne kampanjo obveščanja.
(4b) The Commission shall, in cooperation with the Agency and Member State authorities, launch an information campaign.
Kampanja poveča ozaveščenost potrošnikov o že obstoječih ukrepih za preverjanje, zaščitnih elementih (kot so hologrami in zaščitni pečati) na embalaži zdravil, ter o tveganju, povezanem z nakupom ponarejenih zdravil.
The campaign shall raise consumer awareness of the authentication measures already in place, of the safety features (such as holograms and safety seals) on the packaging of medicinal products, and of the risks involved in purchasing falsified medicinal products.
Zlasti je usmerjena na nepooblaščene spletne vire brez dovoljenja.
It shall focus in particular on unauthorised and unlicensed online sources.
Člen 85 c (novo)
Article 85 c (new)
Člen 85c
Article 85c
Komisija skupaj z državami članicami izdaja dovoljenja in vzpostavi evidenco pooblaščenih spletnih lekarn.
The Commission, together with the Member States, shall certify, and establish a register of accredited internet pharmacies.
Evidenca je dostopna prek javne podatkovne baze.
Such a register shall be accessible via a public database.
Komisija določi logotip Unije za potrjevanje kakovosti, ki se ga prikaže na spletnih straneh zakonitih spletnih lekarn.
The Commission shall establish a Union quality certification logo to be affixed on the webpages of the legitimate internet pharmacies.
Komisija zagotovi, da nobena od nepooblaščenih lekarn ne uporablja logotipa Unije ali trguje z zdravili na notranjem trgu.
The Commission shall ensure that none of the non-accredited pharmacies use the Union logo, or trade in medicinal products in the internal market.
Zaupanje potrošnikov v nakupe zdravil prek spletnih lekarn je treba okrepiti, distribucijo ponarejenih zdravil pa zmanjšati.
The consumers confidence in buying medication via the internet pharmacies needs to be strengthen, and distribution of falsified medication on the internet minimised.
Člen 85 d
Article 85d
Komisija in države članice sprejmejo delegirane akte, ki vsebujejo ukrepe za boljše ozaveščanje širše javnosti o tveganjih, povezanih z nakupom zdravil na spletu, ki lahko vključujejo:
The Commission and Member States shall adopt delegated acts containing measures to increase awareness among the general public of the risks related to purchasing medicinal products on the internet, which may include:
– opozorilo v iskalniku na vrhu spletne strani za primere iskanja zdravil na spletu;
- warnings appearing at the top of the internet page in search engines in the event of a search for medicinal products on the internet;
– kampanje obveščanja, v sodelovanju z državami članicami in organizacijami bolnikov in potrošnikov;
- information campaigns, in cooperation with the Member States and patients' and consumers' organisations;
– zlahka dostopen seznam pooblaščenih spletnih lekarn.
- providing an easily accessible list of accredited internet pharmacies;
(7) Če se pri inšpekcijskem pregledu iz odstavka 1 izkaže, da oseba ne ravna v skladu z načeli in smernicami dobre proizvodne prakse ali dobre distribucijske prakse iz zakonodaje Skupnosti, se ta informacija vnese v zbirko podatkov Skupnosti iz odstavka 6.
(7) If the outcome of the inspection as referred to in paragraph 1 is that the person does not comply with the principles and guidelines of good manufacturing practices or good distribution practices as provided for by Community legislation, the information shall be entered in the Community database referred to in paragraph 6.
Ta informacija navaja, katera načela, smernice in pravila so kršena.
Such information shall specify the principles, guidelines and rules not complied with.
Tudi o primerih, ko so bila ponarejena zdravila odkrita na trgu Unije, se poroča v to zbirko podatkov.
Cases where falsified medicines have been discovered on the Union market shall also be reported to this database.
Informacije, ki se vnesejo v zbirko podatkov Skupnosti, bi morale biti kar se da natančne.
The information which enters the Community database should be as specific as possible.
Države članice obvestijo Komisijo o teh predpisih najpozneje do [ vstaviti datum 18 mesecev po objavi] in jo nemudoma obvestijo o kakršni koli poznejši spremembi, ki vpliva nanje.
The Member States shall notify those provisions to the Commission by [ insert concrete date 18 months after publication] at the latest and shall notify it without delay of any subsequent amendment affecting them.
Kazni, ki se uporabljajo in so lahko kazenske sankcije, upoštevajo ogroženost javnega zdravja zaradi ponarejenih zdravil.
Applicable penalties, which may be criminal penalties, shall take into account the threat to public health presented by the falsification of medicinal products.
Predvidene kazni so usklajene , učinkovite, sorazmerne in odvračalne , ter med drugim obsegajo naslednje oblike ravnanja:
The penalties provided for shall be harmonised, effective, proportionate and dissuasive , and shall cover, inter alia, the following forms of behaviour:
(5) poskus izvedbe kateri koli od navedenih kršitev;
(5) attempting to commit any of the above-mentioned infringements.
Države članice obvestijo Komisijo o teh predpisih najpozneje do [18 mesecev po objavi] in jo nemudoma obvestijo o kakršni koli poznejši spremembi, ki vpliva nanje.
The Member States shall notify those provisions to the Commission by [18 months after the publication] at the latest and shall notify it without delay of any subsequent amendment affecting them.
Člen 118 b a (novo)
Article 118 b a (new)
Komisija za izmenjavo podatkov o sprejetih ukrepih za boj proti ponarejanju zdravil, vključno z veljavnimi sistemi kaznovanja, vzpostavi mrežo, ki bo povezovala Komisijo, Evropsko agencijo za vrednotenje zdravil in pristojne organe v državah članicah ter vključevala sodelovanje z organizacijami bolnikov in potrošnikov.
The Commission shall establish a network between the Commission, the Agency and the competent authorities of the Member States and involve patients' and consumers' organisations in order to ensure the exchange of information on the measures taken to combat the falsification of medicinal products, including on the penalties systems in place.
Za pravilno razumevanje pojava ponarejenih zdravil, na primer dejavnikov, ki vodijo v nakup ponarejenih zdravil ter za učinkovit boj proti ponarejanju je treba vzpostaviti sodelovanje z organizacijami bolnikov.
In order to understand correctly the phenomenon of counterfeited medicinal products e.g. factors leading to purchase of counterfeited medicines, and act effectively to fight counterfeiting, it is essential to establish cooperation with Patients´ Organisations.
To lahko pomaga pri zbiranju podatkov o vedenju bolnikov, na primer o razlogih za nakup ponarejenih zdravil.
The latter can help in gathering important data on patients’ behaviour such as reasons of purchasing falsified medicines.
Člen 127 c (novo)
Article 127 c (new)
17a) Vstavi se naslednji člen:
17a) The following Article shall be inserted:
„Člen 127c
"Article 127c
Komisija do 30. junija 2012, nato pa vsaki dve leti, poroča Evropskemu parlamentu in Svetu o vplivu ukrepov iz te direktive in o potrebi po nadaljnji uskladitvi.
The Commission shall by 30 June 2012 and thereafter every two years report to the European Parliament and to the Council on the impact of the measures provided for by this Directive and the need for further harmonisation.
Komisija v ta namen oceni zlasti, ali je potrebna specifična uskladitev glede prodaje zdravil brez recepta in prodaje takih proizvodov prek spleta.
To that end, the Commission shall in particular assess whether specific harmonisation is needed with regard to ‘over-the-counter’ sales of medicinal products and sales of such products through the internet.
Poleg tega se ocenijo vhodne točke za ponarejena zdravila in nevarnosti zdravil brez recepta.
Furthermore, the market entry points of falsified medicinal products as well as the dangers of ‘over-the-counter’ medicinal products (OTCs) shall be evaluated.
Poročilo po potrebi vsebuje zakonodajne predloge.
Where appropriate, the report shall be accompanied by legislative proposals.
Po potrebi vsebuje predlog zakonodaje, ki bo v področje uporabe te direktive vključilo zdravila brez recepta.“
If necessary, it shall propose legislation designed to include OTCs in the scope of this Directive."
Potrošniki bi morali imeti možnost, da varno kupijo zdravila prek spleta in brez recepta.
Consumers should have the possibility to safely purchase medicinal products via the internet and 'over-the-counter'.
Poleg tega ni podanih veliko podatkov o tem, kje in kdaj ponarejena zdravila najverjetneje vstopijo v zakonito distribucijsko verigo.
Furthermore, little data is given regarding the question where and when falsified medicinal products are most likely to enter the legal distribution chain.
Člen 2 – odstavek 1 – pododstavek 3 – točka -a (novo)
Article 2 – paragraph 1 – subparagraph 3 – point -a (new)
(-a) predpise, potrebne za uskladitev s členom 1(9) te direktive, če se nanašajo na člen 54a(5) in člena 54a(2) in 54a(3), v obsegu iz člena 54a(5) 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(9) of this Directive in so far as it relates to Article 54a(5) and with Articles 54a(2) and 54a(3) to the extent they are referred to in Article 54a(5) of Directive 2001/83/EC as amended by this Directive from [insert date 6 months after publication of this Directive];
Tveganje za bolnike zaradi ponarejenih zdravil narašča, zato je treba sprejeti začasne ukrepe za okrepitev varnosti bolnikov, preden ta direktiva začne veljati.
Given the growing risks to patients from counterfeit medicines, the introduction of interim measures to strengthen patient safety before entry into force are urgently required.
Začasni ukrepi naj bi določali tudi, da imetniki dovoljenj za proizvodnjo (vključno s tistimi, ki zdravila ponovno pakirajo), ki odstranijo ali prekrijejo zaščitne elemente, ki jih je prostovoljno nanesel izdelovalec, nadomestijo zaščitne elemente z enakovrednimi vidnimi zaščitnimi elementi in da so odgovorni, če zaradi njihovih dejanj ponarejena zdravila vstopijo v dobavno verigo.
Interim 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.
Člen 2 – odstavek 1 – pododstavek 3 – točka b
Article 2 – paragraph 1 – subparagraph 3 – point b
(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 48 mesecev po objavi].
(b) the provisions necessary to comply with Article 1(6) and (8) from [insert concrete date 48 months after publication].
Člen 2 – odstavek 1 – pododstavek 3 – točka b a (novo)
Article 2 – paragraph 1 – subparagraph 3 – point b a (new)
(ba) predpise, potrebne za uskladitev s členom 1(9) te direktive, razen če se nanašajo na člen 54a(5) in člena 54a(2) in 54a(3), v obsegu iz člena 54a(5) Direktive 2001/83/ES, kakor je spremenjena s to direktivo, [vstaviti datum 48 mesecev po objavi];
(ba) the provisions necessary to comply with Article 1(9) of this Directive except in so far as it relates to Article 54a(5) and with Articles 54a(2) and 54a(3) to the extent they are referred to in Article 54a(5) of Directive 2001/83/EC as amended by this Directive from [insert date 48 months after publication of this Directive].
Tveganje za bolnike zaradi ponarejenih zdravil narašča, zato je treba sprejeti začasne ukrepe za okrepitev varnosti bolniko,v preden ta direktiva začne veljati.
Given the growing risks to patients from counterfeit medicines, the introduction of interim measures to strengthen patient safety before entry into force are urgently required.
o skupnem stališču Sveta z namenom sprejetja uredbe Evropskega parlamenta in Sveta o določitvi obveznosti gospodarskih subjektov, ki dajejo na trg les in lesne proizvode
on the Council position at first reading for adopting a regulation of the European Parliament and of the Council laying down the obligations of operators who place timber and timber products on the market
(Postopek soodločanja: druga obravnava)
(Ordinary legislative procedure: second reading)
– ob upoštevanju stališča Sveta v prvi obravnavi (05885/4/2010 – C7‑0053/2010 ),
– having regard to the Council position at first reading (05885/4/2010 – C7‑0053/2010 ),
– ob upoštevanju členov 251(2) in 175(1) Pogodbe ES, v skladu s katerima je Komisija poslala predlog Parlamentu ( C6-0373/2008 ),
– having regard to Article 251(2) and Article 175(1) of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C6-0373/2008 ),
– ob upoštevanju sporočila Komisije Evropskemu parlamentu in Svetu „Posledice začetka veljavnosti Lizbonske pogodbe za še nedokončane medinstitucionalne postopke odločanja“ ( KOM(2009)0665 ),
– having regard to the Commission Communication to the European Parliament and the Council entitled "Consequences of the entry into force of the Treaty of Lisbon for ongoing interinstitutional decision-making procedures" ( COM(2009)0665 ),
– ob upoštevanju členov 294(7) in 192(1) Pogodbe o delovanju Evropske unije,
– having regard to Article 294(7) and Article 192(1) of the Treaty on the Functioning of the European Union,
Sprejeta besedila, 22.4.2009, P6_TA(2009)0225 . ,
Texts adopted, 22.4.2009, P6_TA(2009)0225 . ,
– ob upoštevanju mnenja Evropskega ekonomsko-socialnega odbora
– having regard to the opinion of the Economic and Social Committee
– ob upoštevanju priporočila za drugo obravnavo Odbora za okolje, javno zdravje in varnost hrane ( A7‑0149/2010 ),
– having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Food Safety ( A7‑0149/2010 ),
(1a) Gozdno okolje je skupna dediščina človeštva, ki jo je treba varovati, ohranjati in, kjer je izvedljivo, obnavljati, končni cilj tega pa je ohranjanje biotske raznovrstnosti in funkcij ekosistemov, varovanje podnebnega sistema ter varstvo pravic domorodnih ljudstev in skupnosti, odvisnih od gozda.
(1a) The forest environment is a common heritage of humankind that must be protected, preserved and, where practicable, restored with the ultimate aim of maintaining biodiversity and ecosystem functions, protecting the climate system, and safeguarding the rights of indigenous peoples and forest-dependent communities.
Znova se vlaga besedilo Evropskega parlamenta iz prve obravnave.
Restoring EP first reading.
V mnogostranskih sporazumih o okolju, kot sta konvencija o biološki raznovrstnosti in okvirna konvencija Združenih narodov o spremembi podnebja, sta biotska raznovrstnost in podnebje obravnavana kot skupna dediščina človeštva.
In multilateral environmental agreements, such as the Convention on Biological Diversity and the United Nations Framework Convention on Climate Change, biodiversity and climate are referred to as common heritages of human kind.
V mednarodnem pravu je s tem vzpostavljena posebna odgovornost za zagotavljanje njune zaščite.
In international law, this establishes a special responsibility to provide for their protection.
Predlog spremembe Evropskega parlamenta št. 5 iz prve obravnave.
EP first reading amendment 5.
(2) Zaradi vedno večjega povpraševanja po lesu in lesnih proizvodih po svetu ter institucionalnih in upravnih pomanjkljivosti v gozdarskem sektorju v številnih državah, ki pridobivajo les, nezakonita sečnja in z njo povezano trgovanje zbujata vse večjo skrb.
(2) Due to the growing demand for timber and timber products worldwide in combination with the institutional and governance deficiencies that are present in the forest sector in a number of timber-producing countries illegal logging and the associated trade have become matters of ever greater concern.
(2) Zaradi institucionalnih in upravnih pomanjkljivosti v gozdarskem sektorju v številnih državah, ki pridobivajo les, nezakonita sečnja in z njo povezano trgovanje zbujata vse večjo skrb.
(2) Due to the institutional and governance deficiencies that are present in the forest sector in a number of timber-producing countries illegal logging and the associated trade have become matters of ever greater concern.
Upravljanje se že priznava za pomembno vprašanje, ki je povezano z nezakonito sečnjo.
Governance is a major issue related to illegal logging already recognised as such.
(2a) Les, ki se proizvaja trajnostno, veže toplogredne pline in je eden najbolj okolju prijaznih materialov, kar jih obstaja.
(2a) Timber produced in a sustainable way binds greenhouse gases and is one of the most environmentally friendly materials that exists.
Zaradi vedno večjega povpraševanja po vsem svetu bi bilo treba spodbujati trajnostno proizvodnjo lesa, tako v Uniji kot zunaj nje.
In view of the growing demand worldwide, sustainable production of timber should be encouraged, both within and outside the Union .
Za gozdove pomeni veliko grožnjo, saj povečuje njihovo krčenje, to pa povzroča približno 20 % emisij CO 2 , ogroža biotsko raznovrstnost in trajnostno upravljanje gozdov ter razvoj pa tudi gospodarsko preživetje subjektov, ki ravnajo v skladu z veljavno zakonodajo.
It poses a significant threat to forests as it contributes to the process of deforestation, which is responsible for about 20 % of CO 2 emissions, threatens biodiversity, and undermines sustainable forest management and development including the commercial viability of operators acting in accordance with applicable legislation.
Poleg tega ima tudi družbene, politične in gospodarske posledice .
In addition, it also has social, political and economic implications.