natgillin/translations-raw huggingface dataset:
Pri uvedbi obveznih zaščitnih elementov za zdravila na recept je treba primerno upoštevati posebnosti nekaterih zdravil ali kategorij zdravil, kot so generična zdravila.
When introducing obligatory safety features for prescription medicinal products, due account should be taken of the particularities of certain products or categories of products, such as generic medicines.
To vključuje tveganje ponaredkov glede na njihovo ceno in razširjenost v preteklosti v Skupnosti in tujini ter posledice ponaredkov za javno zdravje glede na posebne značilnosti zadevnih zdravil ali resnost bolezni, katere zdravljenju so namenjena.
This includes the risk of falsifications in view of their price and past incidences in the Community and abroad, as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated.
(7) Zaradi upoštevanja novih profilov tveganj in hkratnega zagotavljanja delovanja notranjega trga za zdravila je treba na ravni Unije opredeliti zaščitne elemente, namenjene za zagotavljanje istovetnosti , potrditev pristnosti in sledljivost zdravil na recept.
(7) In order to take account of new risk profiles, while at the same time ensuring the functioning of the internal market for medicinal products, safety features designed to ensure the identification, authentication and traceability of prescription medicinal products should be established at Union level.
To vključuje tveganje ponaredkov glede na njihovo ceno in razširjenost v preteklosti v Unije in tujini ter posledice ponaredkov za javno zdravje glede na posebne značilnosti zadevnih zdravil ali resnost bolezni, katere zdravljenju so namenjena.
This includes the risk of falsifications in view of their price and past incidences in the Union and abroad, as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated.
Obstaja tudi tveganje ponaredkov zdravil brez recepta, vendar je primerno, da se najprej oceni učinek zaščitnih elementov za zdravila na recept, preden se sprejme odločitev, ali naj se ti razširijo na zdravila brez recepta.
However, it is appropriate to first assess the effect of the safety feature s for prescription medicinal products before taking a decision on whether to extend the safety features to non-prescription medicinal products.
Sporazumni predlog spremembe vključuje predloge sprememb 8 (Matias), 64 (Rossi), 65 (Liese), 66 (Ayuso), 67 (Tremopulos), 68 (Rapti), 69 (Bartolozzi), 70 (Antonescu, Niculescu), 71 (Chatzimarkakis), 72 (LindaMcAvan), 73 (Ulmer), 74 (Roth-Behrendt), 75 (Krahmer), 76 (Lukacijewska),77 (Skilakakis), 78 (Ulmer), 79 (Lukacijewska) in 83 (Parvanova).
This compromise covers amendments 8 (Matias), 64 (Rossi), 65 (Liese), 66 (Ayuso), 67 (Tremopoulos), 68 (Rapti), 69(Bartolozzi), 70(Antonescu,Niculescu), 71(Chatzimarkakis), 72(LindaMcAvan), 73(Ulmer), 74(Roth-Behrendt), 75(Krahmer), 76(Lukacijewska),77(Skylakakis), 78(Ulmer), 79(Lukacijewska), 83 (Parvanova)
(7a) Da bi zagotovili podobno in usklajeno raven varovanja javnega zdravja v vsej Evropski uniji ter preprečili izkrivljanje na notranjem trgu, je treba pojasniti pojem enakovrednih zaščitnih elementov.
(7a) In order to ensure a similar and harmonised level of protection of public health throughout the European Union and to avoid distortions in the internal market, a clarification of the notion of equivalent safety features should be provided for.
Sporazumni predlog spremembe vključuje predloge sprememb 9, 81 (Matias), 80 (Yannakoudakis), 82 (Ayuso).
This compromise amendment covers am 9 and 81(Matias), 80 (Yannakoudakis), 82 (Ayuso)
(7b) Uporaba tehnologij, s katerimi je mogoče potrditi pristnost in ugotoviti sledljivost zdravil na ravni individualnega odmerka (na primer kapsule, tablete ali tekočine v neposredni ovojnini, ki je ni možno odpreti brez vidnih poškodb), je tudi lahko v veliko pomoč pri boljšem spremljanju zdravil na trgu.
(7 b ) The use of technologies that allow the authentication and tracing of medicinal products at the level of individual dosage forms (e.g. the capsule, tablet or tamper-evident immediate packaging of liquids) can also be very valuable in terms of allowing better monitoring of products on the market.
Z uporabo tehnologij za potrjevanje pristnosti in ugotavljanje sledljivost zdravil na ravni individualnega odmerka, ki dopolnjujejo predlagane zaščitne elemente na ovojnini zdravil, bo mogoče hitro odkriti ponarejena zdravila, s tem pa dodatno zmanjšati zdravstvena in varnostna tveganja zaradi uporabe ponarejenih zdravil za bolnike.
The use of technologies that allow the authentication and tracing of medicinal products at the level of individual dosage forms, as a complement to the safety features proposed for the packaging of medicinal products, will allow early detection of falsified products and in that way help to further reduce the health and safety risks that falsified products pose to patients.
(7c) Predlagane varnostne ukrepe in podatke, zbrane pri opredeljevanju, pooblaščanju in sledenju zdravilom, zlasti informacije o distribucijskih kanalih, je treba uporabiti v skladu z obstoječo zakonodajo Unije in nacionalno zakonodajo o varstvu podatkov.
(7 c ) The proposed safety measures and the data collected from identifying, authorising and tracing medicinal products , in particular information on distribution channels, should be used in accordance with existing Union and national legislation on data protection.
Treba je upoštevati zahteve o varstvu podatkov.
The data protection requirements must be met.
Zlasti informacije o distribucijskih kanalih zdravil bi lahko imetniki dovoljenj za promet uporabili v komercialne namene, zato do njih ne bi smeli imeti dostopa.
Particularly, information on the distribution channels of medicinal products could be of commercial use to marketing authorisation holders and should therefore not be made available to them.
(8) Vsak udeleženec dobavne verige, ki pakira zdravila, mora biti imetnik dovoljenja za proizvodnjo.
(8) Any actor in the supply chain who packages medicinal products has to be a holder of a manufacturing authorization.
Da bi bili zaščitni elementi učinkoviti, lahko imetnik dovoljenja za proizvodnjo odstrani, nadomesti ali prekrije te elemente samo pod strogimi pogoji.
In order for the safety features to be effective, the manufacturing authorization holder should only be permitted to remove, replace or cover these features under strict conditions.
(8) Vsak udeleženec dobavne verige, ki označuje ali pakira zdravila ali spreminja oznake ali ovojnino zdravil , mora biti imetnik dovoljenja za proizvodnjo.
(8) Any actor in the supply chain who labels or packages medicinal products or makes changes to the labelling or packaging of medicinal products has to be a holder of a manufacturing authorization.
Ti pogoji bi morali ustrezno ščititi pred vstopom ponarejenih zdravil v distribucijsko verigo in odražati strogo dolžnost skrbnosti teh imetnikov dovoljenja za proizvodnjo do izvirnega proizvajalca, imetnika dovoljenja za promet z zdravili in potrošnika zdravil.
Th ose strict conditions should provide adequate safeguards against falsified products entering the distribution chain and reflect a strict duty of care owed by those manufacturing authorisation holders to the original manufacturer and the marketing authorisation holder of the products and to consumers of the products.
Bolnike in druge udeležence v dobavni verigi je treba s pomočjo oznake na zavitku 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.
(9) Ti imetniki dovoljenja za proizvodnjo morajo biti dosledno odgovorni za škodo, ki jo bolnikom povzročijo zdravila, ki so jih dali v promet in so ponarejena, kar zadeva njihovo istovetnost.
(9) These manufacturing authorisation holders should be held strictly liable for damages to patients caused by products placed by them on the market which are falsified in relation to their identity.
(Ne zadeva slovenske različice.)
(9) These manufacturing authorisation holders must be held strictly liable for damages to patients caused by products placed by them on the market which are falsified in relation to their identity.
(Ne zadeva slovenske različice.)
Responsibility is the keystone of the protection arrangements.
(12) Ponarejene aktivne farmacevtske učinkovine pomenijo tveganje za aktivne farmacevtske učinkovine slabše kakovosti.
(12) Falsified active pharmaceutical ingredients pose the risk of sub-standard active pharmaceutical ingredients.
To tveganje je treba odpraviti.
This risk should be addressed.
Predvsem morajo proizvajalci zdravil sami ali prek organa, pooblaščenega za to, zagotoviti, da proizvajalec, ki jim dobavlja aktivne farmacevtske učinkovine, ravna v skladu z dobro proizvodno prakso.
In particular, manufacturers of medicinal products should ensure either by themselves of through a body accredited for that purpose that the supplying manufacturer of active pharmaceutical ingredients complies with good manufacturing practices.
To tveganje je treba odpraviti z združitvijo učinkovitega inšpekcijskega sistema in sistema za zagotavljanje sledljivosti aktivnih farmacevtskih učinkovin.
This risk should be addressed by combining an effective inspection system with a system ensuring the traceability of active pharmaceutical ingredients.
Predvsem morajo proizvajalci zdravil zagotoviti, da proizvajalec, ki jim dobavlja aktivne farmacevtske učinkovine, ravna v skladu z dobro proizvodno prakso.
In particular, manufacturers of medicinal products should ensure that the supplying manufacturer of active pharmaceutical ingredients complies with good manufacturing practices.
Za zagotovitev ustreznega varovanja javnega zdravja morajo pristojni organi v državah članicah pregledovati proizvodne obrate v sodelovanju z Evropsko agencijo za zdravila.
To ensure that public health is properly protected, the competent authorities of the Member States should inspect production sites, in cooperation with the European Medicines Agency.
V primerih, ko je več različnih zasebnih akreditiranih organov, bi se pojavila negotovost glede učinkovitosti inšpekcijskih pregledov in zmeda glede tega, kdo je odgovoren za zagotavljanje točnosti ugotovitev inšpekcijskih pregledov, poleg tega bi bil tudi dvoumen odnos med podjetji, v katerih poteka inšpekcijski pregled, in inšpekcijskimi organi, zaradi česar bi obstajala nevarnost korupcije.
In cases where there were a number of different accredited private bodies, there would be uncertainty about the effectiveness of inspections and confusion as to who was responsible for ensuring the accuracy of inspection findings, and the ambiguous relationship between firms being inspected and the bodies inspecting them could give rise to a risk of corruption.
(13) Proizvodnja aktivnih farmacevtskih učinkovin mora biti skladna z dobro proizvodno prakso ne glede na to, ali se te učinkovine proizvajajo v Skupnosti ali uvažajo.
(13) The manufacture of active pharmaceutical ingredients should be subject to good manufacturing practices irrespective of whether those ingredients were manufactured in the Community or imported.
V zvezi s proizvodnjo aktivnih farmacevtskih učinkovin v tretjih državah je treba zagotoviti, da pravila za proizvodnjo aktivnih farmacevtskih učinkovin, namenjenih izvozu v Skupnost, vključno z inšpekcijskimi pregledi in izvrševanjem, določajo raven varovanja javnega zdravja, enakovredno ravni, ki jo določa zakonodaja Skupnosti .
With regard to the manufacture of active pharmaceutical ingredients in third countries, it should be ensured that the rules for the manufacture of active pharmaceutical ingredients intended for export to the Community, including inspection and enforcement, provide for a level of protection of public health equivalent to that provided for by Community legislation .
(13) Za zagotovitev ustreznega varovanja javnega zdravja mora biti proizvodnja aktivnih farmacevtskih učinkovin skladna z dobro proizvodno prakso in s podatki, navedenimi ali priloženimi v vlogi za dovoljenje za promet, ne glede na to, ali se te učinkovine proizvajajo v Uniji ali uvažajo.
(13) In order to ensure sufficient protection of public health the manufacture of active pharmaceutical ingredients should be subject to good manufacturing practices and should comply with the information submitted within, or accompanying , the m arketing a uthorisation a pplication , irrespective of whether those ingredients were manufactured in the Union or imported.
Certainty as to the source and quality of active pharmaceutical ingredients is of essential importance.
Certainty as to the source and quality of active pharmaceutical ingredients is of essential importance.
To ensure compliance with good manufacturing practice, thorough inspections of production facilities need to be carried out on a regular basis.The inclusion of excipients within the scope is relevant provided that excipients are addressed separately from active pharmaceutical ingredients and that specific requirements will apply which are different from those applicable to active pharmaceutical ingredients.
To ensure compliance with good manufacturing practice, thorough inspections of production facilities need to be carried out on a regular basis.The inclusion of excipients within the scope is relevant provided that excipients are addressed separately from active pharmaceutical ingredients and that specific requirements will apply which are different from those applicable to active pharmaceutical ingredients.
The Manufacturing Authorisation Holder holds responsibility for ensuring that the quality of excipients is fit for purpose and this provision is already embedded in EU Good Manufacturing Practices (GMP) for medicinal products for human use
The Manufacturing Authorisation Holder holds responsibility for ensuring that the quality of excipients is fit for purpose and this provision is already embedded in EU Good Manufacturing Practices (GMP) for medicinal products for human use
Directive 2003/94 of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational products for human use, OJ L 262, p.22-26 .
Directive 2003/94 of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational products for human use, OJ L 262, p.22-26 .
(13a) Aktivne farmacevtske učinkovine, proizvedene v obratih v tretjih državah, je treba ne le inšpekcijsko pregledovati zaradi kršenja pravil, temveč je treba pri njih opravljati tudi analize tveganj in ciljno usmerjene inšpekcijske preglede na podlagi obveščevalnih podatkov ter preiskave.
(13a) Active pharmaceutical ingredients manufactured in plants based in third countries should be subject not only to inspections carried out on the grounds of non-compliance but also to risk analysis and intelligence-based targeted inspections and searches.
Nadomešča predlog spremembe 12 iz poročila.
Replaces amendment 12 of the report.
(13b) Kjer dobra proizvodna praksa za pomožne snovi ali enakovredni sistemi že obstajajo in so dobro urejeni, se jih upošteva v tej direktivi.
(13 b ) Where good manufacturing practices for excipients or equivalent systems are already in place and well-regulated, they should be taken into account in this Directive.
Za pomožne snovi, ki se uporabljajo drugod, na primer v hrani, že obstajajo sistemi, enakovredni dobri proizvodni praksi, kot so sistem HACCP in/ali standard ISO9001/ISO22000 ter obvezni certifikat kakovosti EDQM.
Excipients in other applications, such as food, already have GMP equivalent systems in place like HACCP and/or ISO9001/ISO22000 and mandatory EDQM certification.
Poleg tega je med farmacevtskimi proizvajalci po svetu že dobro uveljavljena proizvodna praksa EFfCI (za kozmetične sestavine) pri pregledovanju proizvajalcev pomožnih izdelkov.
Moreover, the EFfCI GMP (cosmetics) is already well accepted by pharmaceutical manufacturers worldwide when auditing the producers of excipients.
(14) Za lažje izvrševanje in nadzorovanje pravil Skupnosti v zvezi z zdravilnimi učinkovinami, ki se uporabljajo kot vhodne snovi, morajo proizvajalci ali uvozniki teh učinkovin priglasiti svoje dejavnosti.
(14) In order to facilitate enforcement and control of Community rules relating to active substances used as starting material, the manufacturers or importers of those substances should notify their activity.
(14) Za lažje izvrševanje in nadzorovanje pravil Unije v zvezi z zdravilnimi učinkovinami, ki se uporabljajo kot vhodne snovi, morajo proizvajalci , uvozniki ali distributerji teh učinkovin priglasiti svoje dejavnosti.
(14) In order to facilitate enforcement and control of Union rules relating to active substances used as starting material, the manufacturers , importers or distributors of those substances should notify their activity.
(15) Da se zagotovi podobna raven varovanja zdravja ljudi v vsej Skupnosti in prepreči izkrivljanje na notranjem trgu, je treba okrepiti usklajena načela in smernice za inšpekcijske preglede imetnikov dovoljenj za proizvodnjo zdravil in promet na debelo z zdravili ter proizvajalcev zdravilnih učinkovin.
(15) To ensure a similar level of protection of human health throughout the Community , and to avoid distortions in the internal market, the harmonised principles and guidelines for inspections of holders of manufacturing and wholesaler authorisations of medicinal products as well as manufacturers of active substances should be strengthened.
To mora prispevati tudi k zagotavljanju delovanja veljavnih sporazumov o vzajemnem priznavanju, ki temeljijo na učinkovitih in primerljivih inšpekcijskih pregledih ter izvrševanju v vsej Skupnosti .
This should also help to ensure the functioning of existing mutual recognition agreements which rely on efficient and comparable inspection and enforcement throughout the Community .
(15) Da se zagotovi podobna raven varovanja zdravja ljudi v vsej Uniji in prepreči izkrivljanje na notranjem trgu, je treba okrepiti usklajena načela in smernice za inšpekcijske preglede imetnikov dovoljenj za proizvodnjo zdravil in promet na debelo z zdravili ter proizvajalcev in distributerjev zdravilnih učinkovin.
(15) To ensure a similar level of protection of human health throughout the Union , and to avoid distortions in the internal market, the harmonised principles and guidelines for inspections of holders of manufacturing and wholesaler authorisations of medicinal products as well as manufacturers and distributors of active substances should be strengthened.
To mora prispevati tudi k zagotavljanju delovanja veljavnih sporazumov o vzajemnem priznavanju, ki temeljijo na učinkovitih in primerljivih inšpekcijskih pregledih ter izvrševanju v vsej Uniji .
This should also help to ensure the functioning of existing mutual recognition agreements which rely on efficient and comparable inspection and enforcement throughout the Union .
(15a) Države članice morajo uvesti učinkovite kazni za dejanja, povezana s ponarejanjem zdravil.
(15a) Member States should impose effective sanctions for acts involving falsified medicin al products .
Te kazni morajo biti vsaj enakovredne tistim, ki se ponavadi uporabljajo za nezakonita dejanja, povezana z narkotiki.
Those sanctions should at least be equivalent to those typically applied for illegal acts involving narcotics.
Komisija lahko pripravi splošne smernice za tak učinkovit sistem kazenskih sankcij.
The Commission may issue general guidelines for such an effective criminal sanctions regime.
V Direktivo 2001/83/ES je treba vključiti posebne določbe za izvrševanje zahtev glede novih zaščitnih elementov.
Specific provisions should be included in Directive 2001/83/EC for enforcing the new safety feature requirements.
Za zdravila z dovoljenjem ali drugače zakonita zdravila, ki imajo kakovostne napake zaradi napak v proizvodnji ali nadaljnjega ravnanja, se mora uporabljati ustrezna zakonodaja Unije ali nacionalna zakonodaja.
In cases of authorised or otherwise legitimate medicinal products with quality defects due to mistakes in the manufacturing or subsequent handling, the relevant Union or national legislation should apply.
(15b) Za delovanje notranjega trga je treba uvesti zaščitne elemente za zdravila, usklajene na ravni Evropske unije.
(15 b ) It is necessary for the operation of the internal market to establish EU-wide harmonised safety features for medicinal products.
(16) Ukrepe, potrebne za izvajanje te direktive, je treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil.
(16) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred by the Commission .
(16) V skladu s členom 291 Pogodbe o delovanju Evropske unije se pravila in splošna načela, na podlagi katerih države članice nadzirajo izvajanje izvedbenih pooblastil Komisije, določijo vnaprej z uredbo, sprejeto po rednem zakonodajnem postopku.
(16) In accordance with Article 291 TFEU, rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers shall be laid down in advance by a Regulation adopted in accordance with the ordinary legislative procedure.
Do sprejetja nove uredbe in glede na nujnost čimprejšnjega sprejetja in izvajanja te direktive bi morale države članice izvajati nadzor v skladu z določbami Sklepa Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih pooblastil , če so te določbe skladne s spremenjenimi pogodbami.
Pending the adoption of that new Regulation, given the necessity of adopting and implementing this Directive as soon as possible, control by the Member States should be exercised in accordance with the provisions of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission , insofar as those provisions remain compatible with the Treaties.
Vendar je treba sklicevanja na te določbe nadomestiti s sklicevanji na pravila in načela v novi uredbi, takoj ko bo začela veljati.
References to those provisions should nevertheless be replaced with references to the rules and principles set out in the new Regulation as soon as that Regulation enters into force.
(17) Komisija mora biti predvsem pooblaščena za sprejemanje ukrepov glede zaščitnih elementov na ovojnini zdravil, ki se izdajajo na recept, in za sprejemanje podrobnih pravil za zdravila, ki se vnesejo brez dajanja v promet.
(17) In particular the Commission should be empowered to adopt measures regarding safety features that shall appear on the packaging of medicinal products subject to medical prescription and to adopt detailed rules for medicinal products introduced without being placed on the market.
Ker gre za ukrepe splošnega dosega, namenjene spreminjanju nebistvenih določb z dopolnitvijo, jih je treba sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.
Since those measures are of general scope and are designed to amend non-essential elements by supplementing it, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.