natgillin/translations-raw huggingface dataset:
(b) so v treh preteklih letih uspešno prestale poseben inšpekcijski pregled za aktivne farmacevtske učinkovine, ki ga je izvedel pristojni organ Unije ali organ države, s katero je sklenjen veljavni sporazum o vzajemnem priznavanju.
(b) they have, in the past three years, successfully passed an inspection specifically covering active pharmaceutical ingredients carried out by a competent Union authority or an authority of a country with which a mutual recognition agreement is in force.
Uspešno opravljen inšpekcijski pregled mora biti dokumentiran s potrdilom, ki ga izda pristojni organ in ki potrjuje skladnost s standardi dobre proizvodne prakse.
The passing of the inspection shall be documented by a certificate issued by a competent authority, attesting compliance with good manufacturing practice.
Pisno potrdilo, ki ga izda tretja država izvoza in potrjuje, da je obrat izdelal izvoženo aktivno učinkovino v skladu z dobro proizvodno prakso, zdaleč ni zadostno jamstvo.
Written confirmation from the exporting third country that good manufacturing practice has been complied with by the plant manufacturing the exported active substance is not a proper and sufficient guarantee.
Da bi zavarovali javno zdravje in ohranili konkurenčnost evropskih podjetij, morajo pristojni nacionalni organi izvajati inšpekcijske preglede teh proizvodnih obratov.
To ensure public health and safeguard the competitiveness of European firms, production sites need to be inspected by the competent national authorities.
Ta sistem bo ustrezno spodbudil tuje proizvajalce, da bodo svoje izvorne države spodbudili k skleniti sporazumov o vzajemnem priznavanju z Evropsko unijo.
This system will act as an incentive for foreign producers to ask their countries of origin to conclude mutual recognition agreements with the European Union.
Člen 47 – odstavek 2 a (novo)
Article 47 – paragraph 2 a (new)
Razviti je treba primerne in sorazmerne smernice za pomožne snovi in zdravilne učinkovine, saj se značilnosti njunih dobavnih verig zelo razlikujejo.
Appropriate and proportionate guidelines shall be developed for excipients and active substances as their supply chain characteristics are very different.
Predlaga se, da že obstoječe smernice služijo kot podlaga za nadzor za pomožne snovi in se okrepijo z ustreznimi dodatnimi zahtevami, kadar je to potrebno.
It is proposed that already exiting guidance form the basis of controls to be applied to excipients and augmented by additional appropriate requirements, when necessary.
Predlaga se pragmatični pristop, s katerim bi bile izpolnjene zahteve veljavne zakonodaje in bi se dograjevali že obstoječi učinkoviti sistemi.
This proposal would be a pragmatic approach which would fulfil the requirements of current legislation and build on effective systems already in place.
Člen 52 b – odstavek 1
Article 52b – paragraph 1
Ne glede na člen 2(1) in brez poseganja v naslov VII države članice zagotovijo, da se zdravila, ki niso namenjena za dajanje v promet, ne vnesejo v Skupnost, če se utemeljeno domneva, da imajo zdravila ponarejeno istovetnost, zgodovino ali vir.
Notwithstanding Article 2(1), and without prejudice to Title VII, Member States shall ensure that medicinal products not intended to be placed on the market are not introduced into the Community if there are reasons to believe that the products claim a falsified identity, history or source.
Ne glede na člen 2(1) in brez poseganja v naslov VII države članice zagotovijo, da se zdravila, ki niso namenjena za dajanje v promet, ne vnesejo v Skupnost in ne potujejo prek nje , če se utemeljeno domneva, da imajo zdravila ponarejeno istovetnost, zgodovino ali vir.
Notwithstanding Article 2(1), and without prejudice to Title VII, Member States shall ensure that medicinal products not intended to be placed on the market are not introduced into and do not transit through the Community if there are reasons to believe that the products claim a falsified identity, history or source.
Da se zagotovi varnost dobavne verige, morajo države članice nadzorovati tudi zdravila, ki potujejo prek EU, čeprav so ti proizvodi namenjeni tujemu trgu.
To ensure the safety of the supply chain, Member States need to monitor medicinal products in transit through the EU, even where the products concerned are intended for a foreign market.
o) zaščitni elementi, ki omogočajo preverjanje istovetnosti, pristnosti in sledljivosti zdravil, ki se izdajajo na recept, kot je opredeljeno v naslovu VI, razen radiofarmacevtskih izdelkov.
o) safety features making it possible to ascertain identification, authenticity and traceability of medicinal products , other than radiopharmaceuticals, subject to medical prescription as defined in Title VI.
(o) zaščitni elementi, ki omogočajo preverjanje istovetnosti, pristnosti in sledljivosti zdravil, ki se izdajajo na recept, kot je opredeljeno v naslovu VI, razen radiofarmacevtskih izdelkov in zdravil, ki zaradi posebnih značilnosti niso primerna za promet na debelo in v lekarnah, ter jih proizvajalec zato neposredno prodaja klinični ustanovi, v kateri se neposredno odmerijo bolniku; zaščitni elementi se lahko uporabljajo na podlagi analize za vsak primer posebej, tudi za zdravila, ki se izdajajo brez zdravniškega recepta, če kaže tveganje, povezano z proizvodom, na podlagi meril iz člena 54a(4) na utemeljeno domnevo, da bi proizvod utegnil biti ponarejen.
(o) safety features making it possible to ascertain identification, authenticity and traceability of medicinal products subject to medical prescription as defined in Title VI , other than radiopharmaceuticals and medicinal products which due to their specific characteristics are not suitable for distribution through a wholesaler and pharmacy and therefore are sold directly by the producer to a clinical establishment where they are directly administered to the patient; safety features may be applied, on the basis of a case-by-case analysis, to non-prescription medicinal products where the risk related to the product indicates, on the basis of the criteria set out in Article 54a(4), that there are reasonable grounds for considering that the product may be falsified.
Kar zadeva uporabo zaščitnih elementov, je treba upoštevati posebnosti proizvoda, da se preprečijo nesorazmerni stroški.
As far as implementation of safety features are concerned, the product's specific characteristics need to be taken into account so as not to generate disproportionately high costs.
Dosegli bi nasprotni učinek, če bi bili ti elementi obvezni za zdravila, ki jih proizvajalci prodajajo brez posrednikov direktno zdravstveni ustanovi, ki bolnikom ta zdravila daje (ustanove, ki zagotavljajo zdravljenje).
It would be counterproductive to impose safety features for medicines sold directly by producers, without any brokering, to clinical establishments at which they are directly administered to patient (facilities providing medical treatment).
Člen 54 – točka o – pododstavek 1 a (novo)
Article 54 – point o – subparagraph 1 a (new)
Ti zaščitni elementi se uporabljajo brez diskriminacije med načini prodaje.
These safety features shall be applied without discrimination among marketing channels.
Člen 54 – točka o a (novo)
Article 54 – point o a (new)
(8a) V členu 54 se doda naslednja točka (oa):
(8a) In Article 54, the following point (oa) is added:
„(oa) oznaka porekla (država, podjetje, proizvodni obrat), da se zagotovi sledljivost aktivne učinkovine.“
'(oa) with a view to ensuring the traceability of the active ingredient, details of the product's source (country, firm, production site).'
Člen 54 a – odstavek 2 – točka b
Article 54a – paragraph 2 – point b
(b) imetnik dovoljenja za proizvodnjo ravna skladno s točko (o) člena 54, tako da zaščitni element nadomesti z zaščitnim elementom, ki je enakovreden , kar zadeva možnost preverjanja istovetnosti, pristnosti in neprekinjene sledljivosti zdravila, pri tem pa ne odpre stične ovojnine, kakor je opredeljeno v členu 1(23);
(b) The manufacturing authorisation holder complies with point (o) of Article 54 by replacing the safety feature with a safety feature which is equivalent as regards the possibility to ascertain identification, authenticity and uninterrupted traceability of the medicinal product, and without opening the immediate packaging as defined in Article 1(23);
(b) imetnik dovoljenja za proizvodnjo ravna skladno s točko (o) člena 54, tako da zaščitne elemente nadomesti z zaščitnimi elementi , ki so enakovredni po kakovosti in količini, kar zadeva možnost preverjanja istovetnosti, pristnosti in neprekinjene sledljivosti zdravila, pri tem pa ne odpre stične ovojnine, kakor je opredeljeno v členu 1(23);
(b) The manufacturing authorisation holder complies with point (o) of Article 54 by replacing the safety features with safety features which are qualitatively and quantitatively equivalent as regards the possibility to ascertain identification, authenticity and uninterrupted traceability of the medicinal product, and without opening the immediate packaging as defined in Article 1(23);
Odpiranje zavitka zdravil zaradi prepakiranja je vedno občutljivo dejanje, saj je idealna priložnost za zamenjavo pristnih zdravil s ponarejenimi.
Opening a medicine pack for repackaging is always a delicate operation, because it provides the ideal opportunity to replace authentic medicines with falsified ones.
Zato morajo imeti osebe, ki ga izvajajo, ustrezno dovoljenje in jih je treba strogo nadzorovati.
This is why the person carrying out the operation must be duly authorised to do so and be subject to strict controls.
Ob prepakiranju zdravila je treba zagotoviti, da so zaščitni elementi, nameščeni na novi ovojnini, po obsegu in količini enakovredni tistim, ki jih je uporabil proizvajalec.
When a product is repackaged, it must be ensured that safety features that are qualitatively and quantitatively equivalent to those affixed by the producer are affixed to the new packaging.
Člen 54 a – odstavek 2 – točka b – pododstavek 1 a (novo)
Article 54 a – paragraph 2 – point b – subparagraph 1 a (new)
Zaščitni elementi se štejejo za enakovredne, kadar zagotavljajo enako raven učinkovitosti pri preverjanju istovetnosti, pristnosti, sledljivosti in nespreminjanja, pa tudi enake ravni tehnične zahtevnosti za podvajanje.
Safety features shall be considered equivalent when they offer the same level of efficacy for ascertaining identification, authentication, traceability and absence of tampering, as well as the same level of technical difficulty for duplication.
Ta točka se uporablja tudi za nov zaščitni element, kadar se z njim odstranjuje, nadomešča ali prekrije starega, razen kadar je prvotni zaščitni element prikrit in ga zato ni mogoče prepoznati.
When removing, replacing or covering the safety feature, this point should also be applicable to the new safety feature, unless the primary safety feature is a covert one and therefore cannot be recognised;
Ker prikritih zaščitnih elementov ni mogoče preverjati brez predhodnih podatkov, direktiva uvaja različne kategorije enakovrednih zaščitnih elementov v skladu s posebnimi merili, da se zagotovi, da bodo v postopku prepakiranja vzporedni trgovci res lahko uporabljali enakovredne zaščitne znake.
To ensure that parallel traders can indeed apply equivalent safety features during the process of re-packaging, this directive has to introduce the different categories of equivalent safety features according to specific criteria, recognising the fact covert safety features cannot be verified without prior information.
Člen 54 a – odstavek 2 – točka c a (novo)
Article 54a – paragraph 2 – point c a (new)
(ca) imetnik dovoljenja za proizvodnjo na zunanji ovojnini jasno navede, če so bili prvotni zaščitni elementi deloma ali v celoti odstranjeni ali prekriti;
(ca) The manufacturing authorisation holder clearly indicates on the outer packaging when original safety features have been partly or fully removed or covered up;
(3) Imetniki dovoljenja za proizvodnjo so v skladu z Direktivo Sveta 85/374/EGS odgovorni za škodo, povzročeno z zdravili, ki so ponarejena, kar zadeva njihovo istovetnost .
(3) Manufacturing authorisation holders shall be liable for damages in accordance with Council Directive 85/374/EEC caused by medicinal products which are falsified in terms of their identity.
(3) Imetniki dovoljenja za proizvodnjo iz odstavka 2 tega člena štejejo za proizvajalce v skladu z Direktivo Sveta 85/374/EGS.
(3) Manufacturing authorisation holders referred to in paragraph 2 of this Article shall be considered producers under Council Directive 85/374/EEC.
Za škodo, povzročeno z zdravili, ki so ponarejena, kar zadeva njihovo istovetnost, so odgovorni izvirnemu proizvajalcu, imetniku dovoljenja za promet z zdravili in potrošniku.
They shall be liable for damages caused by medicinal products which are falsified in terms of their identity to the original manufacturer, to the holder of the marketing authorisation and to consumers .
Potrebna je razjasnitev, da se zagotovi, da bodo imetniki dovoljenja za proizvodnjo, ki zdravila prepakirajo, dosledno odgovorni za svoje dejavnosti, tudi tam, kjer v dobavno verigo vstopijo ponarejena zdravila.
Clarification is required to ensure that manufacturing authorisation holders, which repackage products, will be strictly liable for all their activities, including where falsified medicines enter into the supply chain.
Člen 54 a – odstavek 4 – pododstavka 1 in 2
Article 54a – paragraph 4 – subparagraphs 1, 2
Komisija sprejme akte, ki vsebujejo potrebne ukrepe za izvajanje točke (o) člena 54 ter odstavkov (1) in (2) tega člena.
The Commission shall adopt acts containing the measures necessary for the implementation of point (o) of Article 54 and of paragraphs (1) and (2) of this Article.
Preden predloži dejanski predlog v skladu s členom 54, črka (o), Komisija oceni učinek na stroške in prednosti veljavnih sistemov proti ponarejanju ter se posvetuje z zainteresiranimi stranmi o izvedbi in uporabi oznake pristnosti.
Before formulating a specific proposal as provided for by Article 54(o), the Commission shall perform an impact assessment of the costs and benefits of the anti-counterfeiting systems currently in force and consult interested parties about the implementation and use of such authenticating seals.
Ti ukrepi , namenjeni za spreminjanje nebistvenih določb te direktive z njeno dopolnitvijo, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 121(2a) .
Those measures , designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 121(2a) .
Ti akti , namenjeni za spreminjanje nebistvenih določb 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 .
Obstaja vrsta tehnologij proti ponarejanju, kot so enodimenzionalna koda, podatkovna matrica, oznake, hologrami, radiofrekvenca (RFID) itd.
There are various options for anti-counterfeiting technologies, such as one-dimensional code, data matrices, seals, holograms, RFID, etc.
Preden se odloči za določeno oznako proti ponarejanju, bi Komisija morala oceniti vpliv ter vse razloge za in proti oznakam, ki so na tržišču, ter upoštevati dosedanje izkušnje in rezultate že zaključenih pilotnih projektov.
Before choosing a specific anti-counterfeiting seal, the Commission should perform an impact assessment in order to evaluate all the pros and cons of the seals available on the market and should take account of current experience and the results of the pilot projects which have been completed.
Člen 54 a – odstavek 4 – pododstavek 3 – točka e a (novo)
Article 54a – paragraph 4 – subparagraph 3 – point e a (new)
(ea) če se proizvod dobavlja neposredno (brez udeležbe tretjih strank, kot so distributerji na debelo, trgovci ali posredniki) v zdravstveno ustanovo, v kateri se zdravilo neposredno odmeri bolniku.
(ea) if the product is delivered directly, without the involvement of third parties, such as wholesale distributors, traders or brokers, to a healthcare setting in which the product is administered directly to the patient.
Člen 54 a – odstavek 4 – pododstavek 5
Article 54a – paragraph 4 – subparagraph 5
Pri ukrepih iz tega odstavka se primerno upoštevajo legitimni interesi glede varovanja poslovno zaupnih informacij ter varstvo pravic industrijske in poslovne lastnine.“
The measures referred to in this paragraph shall take due account of the legitimate interests to protect information of a commercially confidential nature and of the protection of industrial and commercial property rights.’
Države članice zagotovijo, da se spoštujeta lastnina in zasebnost podatkov, pridobljenih z uporabo tehnologije proti ponarejanju farmacevtskih proizvodov .
Member States shall ensure that the ownership and confidentiality of the data generated by using technology to combat counterfeiting of pharmaceutical products are respected. '
Pri uporabi oznak proti ponarejanju za preverjanje pristnosti zdravil se lahko pridobijo poslovno in osebno občutljivi podatki.
The use of anti-counterfeiting seals to check the authenticity of pharmaceuticals may generate data which might be commercially and personally sensitive.
Treba je spoštovati lastnino teh podatkov.
The ownership of such data should be respected.
Za podatke o osebni porabi zdravil bi se morali uporabljati zakonodaja o varstvu podatkov in etični kodeksi, ki veljajo na nacionalni ravni.
Data on personal consumption of pharmaceuticals should be subject to the relevant data protection legislation and codes of ethics in force at national level.
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.
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 purposes referred to in paragraph 2.
Od [vstaviti datum: 36 mesecev po objavi] dalje morajo biti vsa zdravila, ki se izdajajo na recept, razen radiofarmacevtskih izdelkov, od trenutka, ko je serija proizvedena v skladu s členom 51, označena s serijsko številko, ki nedvoumno določa istovetnost posameznega pakiranja.
As from [insert date: 36 months after publication] all medicinal products subject to medical prescription other than radiopharmaceuticals must, from the time of the batch release pursuant to Article 51, carry a serialisation number that identifies the individual package unequivocally.
Neprekinjen sistem preverjanja zdravil bi moral omogočati sistematski nadzor serijske številke na vsaki ovojnini ob izdaji zdravila, preden ga dobi bolnik.
An end-to-end product verification system should allow a systematic control of each pack's serial numbers at the point of dispensing before it reaches the patient.
Naslov VII – postavka
Title VII - heading
„Promet na debelo in trgovanje z zdravili“.
‘Wholesale distribution and trading of medicinal products’;
„Promet na debelo , posredovanje in trgovanje z zdravili“.
‘Wholesale distribution , brokering and trading of medicinal products’;
Da bi zagotovili varnost farmacevtskih proizvodov, je treba upoštevati vse udeležence, ki delajo v sektorju, na samo distributerje na debelo in trgovce z zdravili.
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 and traders.
Člen 77 – odstavek 4
Article 77 – paragraph 4
Države članice pošljejo Komisiji izvod dovoljenja iz odstavka 1.
The Member States shall forward to the Agency a copy of the authorization referred to in paragraph 1.
Agencija te informacije vnese v zbirko podatkov Skupnosti iz člena 111(6).
The Agency shall enter that information in the Community database referred to in Article 111(6).
Države članice zagotovijo na zahtevo Komisije ali katere koli države članice vse ustrezne informacije o posameznih dovoljenjih, ki so jih izdale v skladu z odstavkom 1.“
At the request of the Commission or any Member State, Member States shall supply all appropriate information concerning the individual authorization which they have granted under paragraph 1.'
Države članice zagotovijo na zahtevo Komisije ali katere koli države članice v razumnem roku vse ustrezne informacije o posameznih dovoljenjih, ki so jih izdale v skladu z odstavkom 1.“
At the request of the Commission or any Member State, Member States shall supply , within a reasonable period of time, all appropriate information concerning the individual authorization which they have granted under paragraph 1.'
(12a) V členu 77 se odstavek 6 nadomesti z naslednjim besedilom:
(12a) In Article 77, paragraph 6 is replaced by the following:
Država članica, ki je izdala dovoljenje iz odstavka 1, dovoljenje začasno prekliče ali ukine po tem, ko je obvestila imetnika dovoljenja , če niso več izpolnjeni pogoji dovoljenja ali če dovoljenje ni bilo uporabljeno več kot tri leta, razen v primerih, ko dovoljenje ni bilo uporabljeno zaradi razumno potrebnega časa za uskladitev z obveznostmi iz te direktive, in o tem takoj obvesti ostale države članice in Komisijo.“
The Member State which granted the authorisation referred to in paragraph 1 shall suspend or revoke that authorisation , after having notified the holder thereof, if the conditions of authorisation cease to be met or if the authorisation has not been used for more than three years, except in cases where the authorisation was not used on account of the time reasonably necessary to comply with the obligations under this Directive, and shall forthwith inform the other Member States and the Commission thereof .'
(12b) Vstavi se naslednji člen 79a:
(12b) The following Article 79a is inserted:
„Člen 79a
'Article 79a
Komisija v sodelovanju z Agencijo in organi držav članic določi pravila in merila za pridobitev dovoljenja za trgovanje z zdravili in posredovanje zdravil.
The Commission shall, in cooperation with the Agency and Member State authorities, lay down rules and criteria for obtaining medicinal product trading and brokering licences.
Vlagatelj mora izpolnjevati vsaj naslednje minimalne pogoje:
Applicants shall, as a minimum requirement:
(a) imeti stalni naslov in posredovati podatke, ki zagotavljajo, da se jasno in enopomensko ugotovi istovetnost njegovega uradnega sedeža trgovskega ali posredniškega podjetja;
(a) have a permanent address and supply details enabling their official trading or brokering offices to be clearly and unambiguously identified;
(b) se obvezati, da bo zagotovil izvajanje svoje dejavnosti samo z osebami ali organizacijami, ki izpolnjujejo pogoje iz člena 80.“
(b) undertake to ensure that their business is conducted solely with persons or bodies meeting the requirements set out in Article 80.'
Člen 1 – točka 13 – točka (–a) (novo)
Article 1 – point 13 – point -a (new)
Člen 80 – uvodni del
Article 80 – introductory part
(-a) uvodni del se nadomesti z naslednjim:
(-a) The introductory part is replaced by the following:
„Imetniki dovoljenja za promet, imetniki dovoljenja za trgovanje in imetniki dovoljenja za posredovanje zdravil morajo izpolnjevati vsaj naslednje pogoje:“
' Holders of the distribution authorisation , holders of the trading authorisation and holders of the brokering authorisation for medicinal products must fulfil the following minimum requirements: '
Člen 1 – točka 13 – točka (a)
Article 1 – point 13 – point a
Člen 80 – točka (e)
Article 80 – point e