natgillin/translations-raw huggingface dataset:
(b) jim je priloženo pisno potrdilo iz tretje države izvoza, da so standardi dobre proizvodne prakse, ki se uporabljajo za obrat, v katerem se izdeluje izvožena zdravilna učinkovina, vsaj enakovredni standardom, predpisanim v Uniji , ter da za obrat veljata reden strog in pregleden nadzor ter učinkovito izvrševanje dobre proizvodne prakse, vključno z večkratnimi in nenapovedanimi inšpekcijskimi pregledi , ki zagotavljata varovanje javnega zdravja na ravni, vsaj enakovredni tisti v Uniji, in da v primeru ugotovitve kršitev tretja država izvoznica o tem nemudoma obvesti Unijo .
(b) they are accompanied by a written confirmation from the exporting third country that the standards of good manufacturing practice s applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the Union , and that the plant is subject to regular strict and transparent control and efficient enforcement of good manufacturing practices including repeated and unannounced inspections, ensuring a protection of public health at least equivalent to that in the Union , and that in the event of findings relat ing to non-compliance, that information shall be supplied by the exporting third country to the Union without any delay.
Zaščita v tretjih državah mora biti vsaj enakovredna tisti v Skupnosti.
The protection in third countries should be at least equivalent to that in the Community.
V primeru kršitev mora tretja država izvoznica nemudoma obvestiti Skupnost.
In the event of non-compliance, this information should be immediately supplied by the exporting third country to the Community.
„ Načela dobre proizvodne prakse za zdravilne učinkovine, ki se uporabljajo kot vhodne snovi, iz točke (f) člena 46 in člena 46b se sprejmejo kot podrobne smernice .“
The principles of good manufacturing practice for active substances used as starting materials referred to in point (f) of Article 46 and in Article 46b shall be adopted in the form of detailed guidelines .’
„ Komisija z delegiranimi akti v skladu s členom 121a in pod pogoji iz členov 121b in 121c sprejme načela dobre proizvodne in distribucijske prakse za zdravilne učinkovine, ki se uporabljajo kot vhodne snovi in pomožne snovi, iz točke (f) člena 46 in člena 46b kot podrobna merila. “
The Commission shall adopt, by means of delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c, the principles of good manufacturing and distribution practices for active substances used as starting materials and excipients referred to in point (f) of Article 46 and in Article 46b in the form of detailed criteria.
Nadomešča predlog spremembe 26 iz osnutka poročila.
Replaces Amendment 26 of the draft report.
Člen 52 a
Article 52a
Proizvajalci in uvozniki zdravilnih učinkovin, ki se uporabljajo kot vhodne snovi, s sedežem v Skupnosti sporočijo svoj naslov pristojnemu organu države članice, v kateri imajo sedež.
Importers and manufacturers of active substances used as starting materials established in the Community shall notify their address to the competent authority of the Member State where they are established.
Proizvajalci , uvozniki in distributerji zdravilnih učinkovin, ki se uporabljajo kot vhodne snovi, s sedežem v Uniji sporočijo svoj naslov pristojnemu organu države članice, v kateri imajo sedež.
Importers , manufacturers and distributors of active substances used as starting materials established in the Union shall notify their address to the competent authority of the Member State where they are established.
Člen 52 b
Article 52b
(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 .
(1) 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 .
(1) Ne glede na člen 2(1) in brez poseganja v naslov VII države članice sprejmejo potrebne ukrepe, s katerimi preprečijo , da se zdravila, ki niso namenjena za dajanje v promet, vnesejo v Unijo in gredo preko nje , če se utemeljeno domneva, da so ta zdravila ponarejena .
(1) Notwithstanding Article 2(1), and without prejudice to Title VII, Member States shall take the necessary measures to prevent medicinal products not intended to be placed on the market from being introduced into and from transit ing through the Union if there are reasons to believe that the products are falsified.
(2) Komisija sprejme potrebne ukrepe za izvajanje odstavka 1.
(2) The Commission shall adopt the necessary measures for the implementation of paragraph 1.
Ti ukrepi, namenjeni spreminjanju 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).’
(2) Da bi določili potrebne ukrepe iz odstavka 1, Komisija z delegiranimi akti v skladu s členom 121a in pod pogoji iz členov 121b in 121c sprejme:
(2) In order to establish the necessary measures referred to in paragraph 1, the Commission shall adopt by means of delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c:
– merila, ki jih morajo nacionalni organi upoštevati, in preverjanja, ki jih morajo opraviti, ko ocenjujejo zdravilo, namenjeno za uvedbo v Uniji, kar zadeva njihovo istovetnost, zgodovino ali vir;
- t he criteria to be considered and the verifications to be made by the national authorities when assessing a medicinal product intended for introduction into the Union in terms of identity, history or source ;
– dokumentacijo, ki mora spremljati zdravilo, da bi olajšali izvrševanje, brez poseganja v veljavne zahteve glede dokumentacije v skladu s carinsko zakonodajo;
- t he documentation that is to accompany the medicinal product in order to facilitate enforcement, without prejudice to the applicable documentation requirements in accordance with customs legislation ;
– minimalen obseg sodelovanja ter mehanizme med carinskimi organi in pristojnimi organi za zdravila.
- t he minimum extent of cooperation and the mechanisms between customs authorities and competent authorities for medicinal products.
To vključuje vsaj koncepte obvladovanja tveganja in razloge za začetek inšpekcijskih pregledov.
This shall include at least risk management concepts and triggers for inspections.
S tem predlogom spremembe se stari postopek, tako imenovani postopek komitologije, uskladi z novim postopkom iz člena 290 Pogodbe o delovanju Evropske unije.
This amendment aligns the old so-called "comitology procedure" to the new procedure under Article 290 of the Treaty on the Functioning of the European Union.
Člen 52c
Article 52c
Komisija preuči možnosti za potrditev pristnosti na ravni individualnega odmerka kot metode za odkrivanje ponarejenih zdravil.
The Commission shall study the possibilities for the authentication of individual dosage forms, as a method of detecting falsified medicinal products.
Komisija lahko s preučevanjem možnosti za potrditev pristnosti na ravni individualnega odmerka izboljša ozaveščenost državljanov o najsodobnejših tehnikah, ki pomagajo preprečevati ponarejanje zdravil.
By studying the possibilities for the authentication of individual dosage forms, the Commission can raise the awareness of citizens on state-of-the-art techniques that help preventing pharmaceutical counterfeiting .
Člen 54 – točka o
Article 54 – point o
(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.
Odločitev, ali naj se zaščitni elementi razširijo na zdravila, ki se izdajajo brez recepta, temelji na oceni, ki jo opravi Komisija v skladu s členom 2(2a).
The decision on whether to extend the safety features to medicinal products not subject to medical prescription shall be based on a n assessment by the Commission in accordance with Article 2 ( 2a ) .
Sporazumni predlog spremembe vključuje predloge sprememb 201 (Chatzimarkakis), 202 (Perello Rodriguez), 203 (Rapti), 204 (Tremopulos, Rivasi), 205 (Bartolozzi), 206 (McAvan), 207 (Ulmer), 208 (Ayuso), 209 (Liese, Ulmer), 210 (Yannakoudakis), 211 (Grossetête, Ries), 212 (Chatzimarkakis, Leinen) in 213 (Ulmer).
This compromise amendment covers AM 201 (Chatzimarkakis), 202 (Perello Rodriguez), 203 (Rapti), 204 (Tremopoulos/Rivasi), 205 (Bartolozzi), 206 (McAvan), 207 (Ulmer), 208 (Ayuso), 209 (Liese/Ulmer), 210 (Yannakoudakis), 211 (Grossetête/Ries), 212 (Chatzimarkakis/Leinen), 213 (Ulmer)
Člen 54 a – odstavek 1 – uvodni del
Article 54a – paragraph 1 - introductory part
„Zaščitni elementi iz točke (o) člena 54 distributerjem na debelo , farmacevtom ali osebam z dovoljenjem ali pravico do izdajanja zdravil javnosti omogočajo, da izvajajo vse od naslednjega:
1.The safety features referred to in point (o) of Article 54 shall allow wholesale distributors or pharmacists or persons authorised or entitled to supply medicinal products to the public to perform all of the following:
Zaščitni elementi iz točke (o) člena 54 distributerjem na debelo ali farmacevtom in osebam z dovoljenjem ali pravico do izdajanja zdravil javnosti omogočajo, da izvajajo vse od naslednjega:
The safety features referred to in point (o) of Article 54 shall allow wholesale distributors or pharmacists and persons authorised or entitled to supply medicinal products to the public to perform all of the following:
Namen sprememb tega člena je olajšati njegovo uporabo ali pojasniti področje uporabe predlaganega besedila.
The amendments to this article are intended to facilitate its implementation or clarify the scope of the text proposed.
Pet let po začetku veljavnosti teh ukrepov je treba oceniti tudi njihovo učinkovitost.
It is also necessary, five years from the entry into force of these measures, to evaluate their effectiveness.
Poleg tega uporaba zaščitnih elementov ne sme biti omejena na ponarejanje zdravil.
Furthermore, the implementation of safety features should not be limited to the falsification of medicinal products.
Člen 54 a – odstavek 1 – točka a
Article 54a – paragraph 1 – point a
a) preverijo pristnost z ocenjevanjem očitnih, prikritih ali forenzičnih elementov na ovojnini ;
a) verify authenticity by assessing overt, covert or forensic devices;
(a) preverijo pristnost;
a) verify authenticity;
Člen 54 a – odstavek 1 – točka (b)
Article 54a – paragraph 1 – point b
(b) ugotovijo istovetnost posameznih zavitkov;
(b) identify individual packs;
(b) ugotovijo istovetnost posameznih zavitkov po enotnem standardu, ki velja za vso EU ;
(b) identify individual packs by a single EU-wide standard ;
Ker pa problem ponarejenih zdravil sega preko državnih meja, paleta različnih nacionalnih pravnih določb ni ustrezna za učinkovito varstvo bolnikov.
However, given that the problem of counterfeit medicines doesn’t stop at national borders a patchwork of different national legal provisions is not fit to effectively protect patients.
Zato morajo biti zaščitni elementi po vsej EU enaki.
Thus, the safety features must be the same throughout the entire EU.
Člen 54 a – odstavek 1 – točka c a (novo)
Article 54a - paragraph 1 - point c a (new)
(ca) ohranijo dodatne stroške čim nižje.
(c a ) keep the additional costs as low as possible.
Zaščitne elemente je treba uskladiti na podlagi jasnih meril.
Safety features need to be harmonised based on clear criteria.
Zagotavljati bi morali tudi, da pomožne snovi ne bodo ponarejene.
They should also ensure that the excipient is not falsified.
Poleg tega je treba dodatne stroške ohraniti čim nižje.
Furthermore the additional costs should be as low as possible.
Člen 54 a – odstavek 2 – uvodni del
Article 54a – paragraph 2 – introductory part
(2) Zaščitni elementi iz točke (o) člena 54 se ne smejo delno ali popolnoma odstraniti ali prekriti, razen če 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 following conditions are fulfilled:
(2) Zaščitni elementi iz točke (o) člena 54 se ne smejo delno ali popolnoma odstraniti ali prekriti, razen če so zajamčene istovetnost, pristnosti 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:
Zaščitni elementi naj bi zagotavljali istovetnost, pristnost in neprekinjeno sledljivosti zdravil od tovarne do potrošnika.
The safety features should guarantee the identification, authenticity and uninterrupted traceability of the medicinal product from the factory to the consumer.
Istovetnost, pristnost in sledljivost zdravil je treba zajamčiti v vseh okoliščinah.
The identification, authenticity and traceability of medicinal products must be guaranteed in all circumstances.
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 zaščitni element nadomesti z zaščitnim elementom, ki je enakovreden, kar zadeva možnost preverjanja istovetnosti, pristnosti in nedotakljivosti zunanje ovojnine zdravila, pri tem pa ne spreminja stične ovojnine, kakor je opredeljeno v členu 1(23) , razen za namene iz člena 55 ;
(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 inviolability of the external packaging of the medicinal product, and without any changes to the immediate packaging as defined in Article 1(23) other than for the purposes set out in Article 55 ;
Člen 54 a – odstavek 2 – točka b – pododstavek 1 a (novo)
Article 54a – paragraph 2 – point b – subparagraph 1 a (new)
Zaščitni elementi so enakovredni, če so skladni z usklajenimi ukrepi iz člena 54a(4), kar zagotavlja, da so enako učinkoviti pri zagotavljanju istovetnosti, potrjevanju pristnosti in sledljivosti zdravila ter preprečevanju poseganja vanj in da jih je tehnično enako težko posnemati.
Safety features shall be considered equivalent where they comply with the harmonised measures provided for in Article 54a ( 4 ) , which shall ensure that they are equally efficient in identifying, authenticating, tracing and preventing tampering with medicinal products, and that they are equally technically difficult to duplicate.
Sporazumni predlog spremembe vključuje predloge sprememb 30 (Matias), 234 (Weisgerber, Ulmer), 235 (Merkies), 236 (Ayuso) in 277 (Chatzimarkakis).
This compromise amendment covers AM 30 (Matias), 234 (Weisgerber/Ulmer), 235 (Merkies), 236 (Ayuso), 277(Chatzimarkakis)
Člen 54 a – odstavek 2 – točka c
Article 54a - paragraph 2 – point c
(c) nadomestitev zaščitnega elementa je predmet nadzora pristojnega organa.
(c) The replacement of the safety feature is subject to supervision by the competent authority.
(c) Imetnik dovoljenja za proizvodnjo je odgovoren za vse dejavnosti iz odstavka 2.
(c) The manufacturing authorisation holder shall be responsible for all the activities involved in the acts described in p aragraph 2.
Da bi zagotovili optimalno varnost, ki si jo vsi želimo, se zdravilo ne sme spreminjati.
In the interests of ensuring the optimal safety standards desired by all, the medicinal product must not be manipulated.
Ko zdravilo zapakira imetnik dovoljenja za promet, mora to ostati nedotaknjeno, dokler ne pride do bolnika, kot to zahteva evropska strategija za varnost hrane.
Once the product has been packaged by the marketing authorisation holder, it must remain intact until it reaches the patient, in line with the current requirements of the European food safety strategy.
Vendar je treba v nekaterih primerih ohraniti možnost, da se izvirno zdravilo zapakira v drugo ovojnino, pri tem pa se ohranijo njegovi izvirni zaščitni elementi.
However, it should, in certain cases, still be possible to place the original product in another container while preserving intact the initial safety arrangements.
Člen 54 a – odstavek 2 – točka c a (novo)
Article 54a – paragraph 2 - point c a (new)
(ca) Zaščitni elementi iz točke (o) člena 54 se uporabljajo brez razlikovanja med distribucijskimi kanali.
(ca) The safety features referred to in point (o) of Article 54 shall be applied without discrimination between distribution channels.
Če se za zdravilo ugotovi, da potrebuje dodatne zaščitne elemente, je treba za preprečevanje nepotrebne zmede to zaščito uporabiti ne glede na distribucijski kanal.
If certain medicinal products have been identified to be in need of additional safety protection, this protection should be applied irrespective of its distribution channel as to avoid unnecessary confusion.
Člen 54 a – odstavek 3
Article 54a – paragraph 3
(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 .
Imetniki dovoljenja za proizvodnjo iz odstavka 2 štejejo za proizvajalce v skladu z Direktivo Sveta 85/374/EGS.
Manufacturing authorisation holders referred to in paragraph 2 shall be considered to be producers in accordance with Council Directive 85/374/EEC .
Odgovorni so za škodo, ki jo utrpijo izvirni proizvajalec, imetnik dovoljenja za promet in potrošniki ter izhaja iz sprememb, ki so jih opravili na zdravilu, ne glede na to, ali je zdravilo ponarejeno ali pristno.
They shall be liable for damage suffered by the original manufacturer, the holder of the marketing authorisation and consumers , resulting from changes that they have made to medicinal products , irrespective of whether the product is falsified or genuine .
Potrebno je pojasnilo, s katerim 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.
Kdor zdravila prepakira, je odgovoren za škodo, povzročeno zaradi vseh sprememb, ki jih je opravil na zdravilih, ne glede na to, ali so zdravila ponarejena ali pristna.
Repackagers should be liable for damages resulting from all changes that they make with respect to pharmaceutical products, irrespective of whether the product is falsified or genuine.
Člen 54 a – odstavek 4 – pododstavek 1
Article 54a – paragraph 4 – subparagraph 1
Komisija sprejme potrebne ukrepe za izvajanje točke (o) člena 54 ter odstavkov (1) in (2) tega člena.
The Commission shall adopt the measures necessary for the implementation of point (o) of Article 54 and of paragraphs (1) and (2) of this Article.
Komisija z delegiranimi akti v skladu s členom 121a in pod pogoji iz členov 121b in 121c sprejme potrebne ukrepe za izvajanje točke (o) člena 54 ter odstavkov (1) in (2) tega člena.
The Commission shall adopt , by means of delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c, the measures necessary for the implementation of point (o) of Article 54 and of paragraphs (1) and (2) of this Article.
Preden se v skladu s točko (o) člena 54 predlagajo posebni ukrepi in da bi izbrali možnost, ki najbolj ustreza potrebam državljanov, Komisija opravi javno oceno učinka na stroške in koristi obstoječih zaščitnih elementov ter se posvetuje s stranmi, udeleženimi pri izvajanju in uporabi teh zaščitnih elementov, da bi ugotovila učinkovitost posebnih ukrepov glede na obstoječe nacionalne ureditve.
Before specific measures are proposed in accordance with point (o) of Article 54, and in order to choose the option that best matches citizens' needs, the Commission shall carry out a public impact assessment of the costs and benefits of existing safety features, as well as a consultation with the parties involved in the implementation and use of such safety features, so as to demonstrate the effectiveness of the specific measures compared with existing national arrangements.
Člen 54 a – odstavek 4 – pododstavek 2
Article 54a – paragraph 4 – subparagraph 2
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).
Člen 54 a – odstavek 4 – pododstavek 3 – uvodni del
Article 54a – paragraph 4 – subparagraph 3 – introductory part
Komisija pri sprejemanju teh ukrepov upošteva tveganje, povezano z zdravili ali kategorijami zdravil, in vsaj vse od naslednjega:
When adopting those measures, the Commission shall consider the risk related to products or categories of products and at least all of the following:
Komisija pri sprejemanju teh ukrepov upošteva tveganje, povezano z zdravili na recept , in vsaj vse od naslednjega:
When adopting those measures, the Commission shall consider the risk related to prescription products or categories of products and at least all of the following:
Ocena na podlagi tveganja v predlogu Komisije bo povečala varnost bolnikov in pomagala usmeriti preprečevanje ponarejanja točno na tista zdravila, ki jih to zadeva.
The risk-based assessment in the Commission proposal will enhance patient safety and will help to focus the fight against counterfeiting on precisely those medicines that are affected.
Bistveno je torej zagotoviti, da so zaobjeta vsa zdravila in da se določijo ustrezna merila.
Therefore, guaranteeing that all medicines are included and the correct criteria are well established is essential.
Poleg tega morajo uporabljena merila zagotoviti, da se natančno določijo pravi vzroki ponarejanja in onemogoči manevrski prostor ponarejevalcem, da bi razvijali nove pobude.
Moreover, the criteria employed must guarantee that the true drivers of counterfeiting will be pinpointed and deny room for counterfeiters to develop new initiatives.
Cena in primeri v preteklosti v EU so najustreznejše merilo.
Price and past incidents within the EU represent the most appropriate criteria.
Člen 54 a – odstavek 4 – pododstavek 3 – točka a a (novo)
Article 54a – paragraph 4 – subparagraph 3 – point a a (new)
(aa) zapletenost dobavne verige;
(aa) the complexity of the supply chain;