natgillin/translations-raw huggingface dataset:
(17) Komisija mora biti pooblaščena za sprejemanje delegiranih aktov v skladu s členom 290 Pogodbe o delovanju Evropske unije glede zaščitnih elementov ali katerih koli drugih tehničnih instrumentov, ki lahko potrdijo istovetnost zdravila na ovojnini zdravil, ki se izdajajo na recept, in za sprejemanje podrobnih pravil za zdravila, ki se vnesejo brez dajanja v promet.
(17) T he Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in respect of safety features or any other technical instrument able to confirm the authenticity of the medicinal product 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.
Vzpostaviti je treba standardizirano obliko zaščitnega elementa ali standardizirani zaščitni ukrep Unije.
A standardised form of safety feature or a standardised safety measure within the Union should be found.
V sklopu sedanjih razprav se obravnavajo le določeni tipi kodifikacije.
In the current discussion, only several types of codification are considered.
Upoštevati je tudi treba, da standardizirani zaščitni ukrep ni nujno zaščitni element, kot je 2D črtna koda ali koda RFID, lahko pa bi bil tudi zaščitni ukrep, kot je posebni hologram ali lak.
It should also be borne in mind that a standardized safety measure has not necessarily to be a safety feature, such as a 2D-Bar-Code or a RFID-Code, but it could be a safety measure, such as a special hologram or varnish, as well.
Takšna rešitev bi bila lahko cenejša in tehnično lažje izvedljiva.
Such a solution might be less expensive and technically easier to implement.
(17a) Najkasneje 36 mesecev po začetku veljavnost te direktive je treba postopek sledljivosti zdravil uskladiti na ravni Skupnosti.
(17a) Thirty-six months at the latest after the entry into force of this Directive, the traceability procedure for medicinal products should be harmonised at EU level.
Od takrat naprej mora biti na posamezni ovojnini vsakega zdravila jasno navedena serijska številka.
Thereafter , each medicinal product should be unequivocally identified by means of a serial number on its individual packaging.
Pomembno je, da se uskladijo postopki sledljivosti zdravil, tako da bodo ustrezno in funkcionalno izpolnili pričakovanja in zahteve medicinske stroke in bolnikov.
It is important to harmonise traceability procedures for medicinal products in such a way as to meet the expectations and requirements of the medical community and of patients in a suitable and effective manner.
(-1) V členu 1 se za točko 2 vstavi naslednja točka 2a:
(-1) In Article 1, the following point 2a is inserted after point 2:
Ponarejeno zdravilo:
Falsified medicinal product:
Vsako zdravilo, ki lažno ali zavajajoče predstavlja:
Any medicinal product with a false or misleading representation of:
(a) svojo istovetnost, vključno z ovojnino in oznako, ime, sestavo glede katere koli od svojih sestavin, vključno s pomožnimi snovmi, in jakosti in/ali
a) its identity, including its packaging and labelling, name, composition in respect of any of its components, including excipients, and strength; and/or
(b) svoj izvor, vključno s proizvajalcem, državo proizvodnje, državo izvora in imetnikom dovoljenja za promet z zdravili, in/ali
b) its source, including the manufacturer, country of manufactur e , country of origin, marketing authorisation holder; and/or
(c) svojo zgodovino, vključno z evidenco in dokumentacijo o distribucijskih poteh.
c) its history, including the records and documents relating to distribution channels.
Komisija je pooblaščena za posodabljanje te opredelitve na podlagi tehničnega in znanstvenega napredka ter mednarodnih sporazumov.
The Commission shall be empowered to update this definition on the basis of technical and scientific progress and international agreements.
Opredelitev ne vključuje nenamernih proizvodnih napak .
This definition does not include un intentional manufacturing errors.
ter ne zadeva kršitev zakonodaje o pravicah intelektualne in industrijske lastnine ali patentnih pravicah.
This definition is without prejudice to infringements of legislation on intellectual and industrial property rights or patent rights.
Sporazumni predlog spremembe vključuje predloge sprememb 16 (Matias), 123 (Krahmer), 124 (Buşoi), 125 (Merkies), 126 (Weisgerber, Ulmer), 127 (Chatzimarkakis), 128 (Tremopoulos, Rivasi), 129 (Rossi), 130 (Buşoi), 131 (Merkies), 132 (Weisgerber, Ulmer), 133(Krahmer), 134 (Tremopulos, Rivasi), 135 (Chatzimarkakis), 136 (Rossi), 137 (Buşoi), 138 (Chatzimarkakis), 139 (Rossi), 140 (Krahmer), 141 (Tremopulos, Rivasi), 142 (Merkies), 143(Weisgerber, Ulmer), 144 (Buşoi), 145 (Weisgerber, Ulmer), 146 (Merkies), 147 (Chatzimarkakis), 148 (Rossi), 149 (Krahmer), 150 (Tremopulos, Rivasi), 151 (Merkies), 152 (Weisgerber, Ulmer), 153 (Chatzimarkakis), 154 (Rossi), 155 (Krahmer) in 156 (Tremopulos, Rivasi).
This compromise amendment covers AM 16 (Matias), 123 (Krahmer), 124 (Buşoi), 125 (Merkies), 126 (Weisgerber/Ulmer), 127 (Chatzimarkakis), 128 (Tremopoulos/Rivasi), 129 (Rossi), 130 (Buşoi), 131 (Merkies), 132 (Weisgerber/Ulmer), 133(Krahmer), 134 (Tremopoulos/Rivasi), 135 (Chatzimarkakis), 136 (Rossi), 137 (Buşoi), 138 (Chatzimarkakis), 139 (Rossi), 140 (Krahmer), 141 (Tremopoulos/Rivasi), 142 (Merkies), 143(Weisgerber/Ulmer), 144 (Buşoi), 145 (Weisgerber/Ulmer), 146 (Merkies), 147 (Chatzimarkakis), 148 (Rossi), 149 (Krahmer), 150 (Tremopoulos/Rivasi), 151 (Merkies), 152 (Weisgerber/Ulmer), 153 (Chatzimarkakis), 154 (Rossi), 155 (Krahmer), 156 (Tremopoulos/Rivasi)
(-1a) V členu 1 se za točko 2a vstavi naslednja točka 2b:
(-1a) In Article 1, the following point 2b is inserted after point 2a:
Zdravilna učinkovina, uporabljena kot vhodna snov:
Active substance used as starting material:
Vsaka snov ali mešanica snovi, namenjena uporabi v proizvodnji zdravil, ki z uporabo v proizvodnji postane zdravilna učinkovina tega zdravila.
Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product.
Take snovi so namenjene zagotavljanju farmakološke dejavnosti ali drugih neposrednih učinkov pri diagnosticiranju, zdravljenju, lajšanju in preprečevanju bolezni ali za učinkovanje na sestavo in delovanje telesa.
Such substances are intended to furnish pharmacological activity or have other direct effect s in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body.
(-1b) V členu 1 se vstavi naslednja točka 3a:
(-1 b ) In Article 1, the following point 3a is inserted:
Vsaka sestavina farmacevtske oblike, razen zdravilne učinkovine.
Any constituent of a pharmaceutical form apart from the active substance.
Pomožne snovi so med drugim polnila, razgrajevala, drsiva, barvila, antioksidanti, konzervansi, dodatki, stabilizatorji, zgoščevalci, emulgatorji, sredstva za povečanje topnosti in prepustnosti, snovi za izboljšanje okusa in arome, pa tudi sestavine zunanjih delov zdravil, kot so želatinske kapsule.
Excipients include fillers, disintegrants, lubricants, colouring matters, antioxidants, preservatives, adjuvants, stabilisers, thickeners, emulsifiers, solubilisers, permeation enhancers, flavouring and aromatic substances, as well as the constituents of the outer covering of the medicinal products, such as gelatine capsules.
Potrebna je opredelitev pomožnih snovi, saj so sestavni del končnega izdelka.
A definition on excipients is needed.
Opredelitev je skladna s smernicami za pomožne snovi Odbora za zdravila za uporabo v humani medicini Evropske agencije za zdravila.
As an excipient is an essential part of the finished medicinal product The definition is in accordance with the European Medicines Agency CHMP Guidelines on excipients.
Člen 1 – točka 17a
Article 1 – point 17a
Trgovanje z zdravili :
Trading of medicinal products:
Trgovanje z zdravili:
Trading of medicinal products:
Vse dejavnosti, ki obsegajo neodvisno pogajanje v imenu druge osebe o prodaji ali nakupu zdravil ali zaračunavanje ali posredovanje zdravil, razen izdajanja zdravil javnosti, in ne spadajo v opredelitev prometa na debelo.
All activities consisting of negotiating independently on behalf of another person the sale or the purchase of medicinal products , or billing or brokering medicinal products, apart from supplying medicinal products to the public, and not falling under the definition of wholesale distribution.
Vse dejavnosti, ki obsegajo prodajo, nakup ali zaračunavanje zdravil in aktivnih farmacevtskih sestavin , razen fizičnega ravnanja in izdajanja zdravil javnosti, in ne spadajo v opredelitev prometa na debelo.
All activities consisting of the sale , purchase or billing of medicinal products and active pharmaceutical ingredients, apart from the physical handling and supply of medicinal products to the public, and not falling under the definition of wholesale distribution.
V direktivi je treba uporabiti lahko razumljive opredelitve, katerih pomen ne zbuja negotovosti.
Definitions used in the Directive should be easily understood and should not result in any uncertainty as to their meaning.
Zato je v opredelitvah treba razločevati med trgovanjem in posredovanjem, saj trgovanje vključuje primere, v katerih je trgovec lastnik zdravila, posredovanje pa ne, ne eni ne drugi pa zdravil ne posedujejo fizično, zato ne morejo nadzorovati ravnanja z njimi.
Therefore, definitions must distinguish between trading and brokering, the former includes cases where the trader is owner of the product, the latter not, whereas both take no physical possession of products and therefore do not control their handling.
Člen 1 – točka 17 b (novo)
Article 1 - point 17 b (new)
(1a) V členu 1 se za točko 17a vstavi naslednja točka 17b:
(1a) In Article 1, the following point 17b is inserted after point 17a:
Vse dejavnosti, povezane s prodajo ali nabavo zdravil, aktivnih farmacevtski učinkovin ali pomožnih snovi za dobavo na drobno ali distribucijo na debelo, kot to določa točka 17 tega člena, ki ne vključujejo fizičnega ravnanja in predstavljajo neodvisno posredovanje v imenu druge pravne osebe ali posameznika.
All activities in relation to sale or purchase of medicinal products, active pharmaceutical ingredients or excipients except for retail supply and wholesale distribution as defined in point 17 of this Article , that do not include physical handling and that consist of mediating independently and on behalf of another legal or natural person .
Treba je razlikovati med trgovanjem in posredovanjem.
A distinction between trading and brokering is necessary.
Člen 1 – točka 17 c (novo)
Article 1 – point 17 c (new)
(1b) V členu 1 se za točko 17b vstavi naslednja točka 17c:
(1 b ) In Article 1, the following point 17 c is inserted after point 17 b :
Nadzorovana distribucijska veriga:
Managed d istribution c hain
Sistem distribucije, pri katerem proizvajalec dobavlja zdravilo neposredno (brez udeležbe tretjih strani, kot so distributerji na debelo ali trgovci) v zdravstveno ustanovo, kjer se neposredno daje bolniku.
System of distribution where the manufacturer delivers a medicinal product directly, without the involvement of third parties such as wholesale distributors or traders, to a healthcare setting in which the product is dispensed directly to the patient.
Nekatera zdravila (na primer imunoglobuline) proizvajalec neposredno dobavi bolnišnici ali drugi zdravstveni ustanovi, ki je končni uporabnik.
Certain products (for example immunoglobulins) are delivered directly by the manufacturer to the hospital or other end-using healthcare setting.
Ker je nevarnost, da bi ponarejena zdravila vstopila v to verigo, zelo majhna, je upravičeno izvzetje teh zdravil iz obvezne uporabe zaščitnih elementov.
As the risk of a counterfeit product entering this chain is very low, there is a case for these products to be exempted from having to carry safety features.
Zato bi bilo koristno, da se opredeli, kaj pomeni nadzorovana distribucijska veriga.
As such, it would be helpful to define what a Managed Distribution Chain means.
(3) Ne glede na odstavek 1 in člen 3(4) se naslov IV te direktive uporablja za zdravila, namenjena samo izvozu, in vmesne spojine ter zdravilne učinkovine, ki se uporabljajo kot vhodne snovi.
(3) Notwithstanding paragraph 1 and Article 3(4), Title IV of this Directive shall apply to medicinal products intended only for export and to intermediate products and active substances used as starting materials.
(3) Ne glede na odstavek 1 in člen 3(4) se naslov IV te direktive uporablja za zdravila, namenjena samo izvozu, in vmesne spojine ter zdravilne učinkovine, ki se uporabljajo kot vhodne snovi , in pomožne snovi .
(3) Notwithstanding paragraph 1 and Article 3(4), Title IV of this Directive shall apply to medicinal products intended only for export and to intermediate products and active substances used as starting materials and excipients .
Ponarejene pomožne snovi lahko resno ogrožajo zdravje in jih je treba vključiti v področje uporabe te direktive.
Falsified excipients can also pose an important risk to health and should be included in the scope of this directive.
Člen 46 – točka f – pododstavek 1
Article 46 – point f - subparagraph 1
(f) upoštevati načela in smernice dobre proizvodne prakse za zdravila in uporabljati kot vhodne snovi samo zdravilne učinkovine, ki so bile proizvedene v skladu s podrobnimi smernicami o dobri proizvodni praksi za vhodne snovi.
(f) to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials.
V ta namen imetnik dovoljenja za proizvodnjo sam ali prek organa, ki ga za to pooblasti pristojni organ države članice, preveri skladnost proizvajalca zdravilnih učinkovin z dobro proizvodno prakso.
To this end, the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a Member State.
(f) upoštevati načela in smernice dobre proizvodne prakse za zdravila in uporabljati kot vhodne snovi samo zdravilne učinkovine, ki so bile proizvedene in distribuirane v skladu s podrobnimi smernicami o dobri proizvodni in distribucijski praksi za vhodne snovi.
(f) to comply with the principles and guidelines of good manufacturing practice s for medicinal products and to use as starting materials only active substances which have been manufactured and distributed in accordance with the detailed guidelines on good manufacturing and distribution practices for starting materials.
V ta namen imetnik dovoljenja za proizvodnjo sam ali prek organa, ki ga za to pooblasti pristojni organ države članice, preveri skladnost proizvajalca in distributerja zdravilnih učinkovin z dobro proizvodno prakso.
To this end, the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer and distributor with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a Member State.
S tem predlogom spremembe se med drugim tako imenovani postopek komitologije uskladi z novim postopkom iz člena 290 Pogodbe o delovanju Evropske unije.
This amendment inter alia 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 1 – točka 3 – točka (a)
Article 1 – point 3 - point a
Člen 46 – točka f – pododstavek 1 a (novo)
Article 46 – point f – subparagraph 1 a (new)
Imetnik dovoljenja za promet zagotovi, da se pomožne snovi ocenijo kot primerne za uporabo v zdravilih po posebni dobri proizvodni praksi, ki jo je razvila Komisija v sladu s členom 47.
The manufacturing authorisation holder shall ensure that excipients are assessed as being suitable for use in medicinal products following specific good manufacturing practices as developed by the Commission in accordance with Article 47.
Imetnik dovoljenja za proizvodnjo tudi zagotovi, da je postopek za pridobitev ocene opisan v sistemu kakovosti, ki mora biti pristojnim organom na razpolago za pregled.
The manufacturing authorisation holder shall also ensure that the process by which the assessment is conducted is described in a quality system which is available for inspection by competent authorities.
Značilnosti dobavne verige se med aktivnimi farmacevtskimi učinkovinami in pomožnimi snovmi zelo razlikujejo.
Acitve Pharmaceutica Ingredients (API’s) and excipients have very different supply chain characteristics.
Za pomožne snovi in aktivne farmacevtske učinkovine bi morala veljati ustrezna dobra proizvodna praksa, razvita na evropski ravni, ki bi upoštevala njihove posebnosti.
Both excipients and active pharmaceutical ingredients should be subject to relevant good manufacturing practices developed at the European level taking into account their own specificities.
Člen 46 – točka f – pododstavek 2
Article 46 – point f – subparagraph 2
(aa) Drugi pododstavek točke (f) se nadomesti z naslednjim:
(aa) The second subparagraph of point (f) is replaced by the following:
Komisija z delegiranimi akti v skladu s členom 121a in pod pogoji iz členov 121b in 121c sprejme seznam določenih kategorij pomožnih snovi, opredeljenih na podlagi pristopa, ki temelji na oceni tveganja, ob upoštevanju njihovega izvora in predvidene uporabe.
The Commission shall adopt, by means of delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c, a list of certain categories of excipients identified on a risk-based approach taking into account their source and their intended use.
Za te kategorije pomožnih snovi proizvajalec uporablja ustrezno dobro proizvodno prakso na podlagi formalizirane ocene tveganja v skladu z veljavnimi smernicami, navedenimi v drugem odstavku člena 47, ob upoštevanju drugih primernih zahtev sistema kakovosti, ter ta postopek dokumentira.
For these categories of excipients, the manufacturer shall apply the appropriate good manufacturing practices on the basis of a formalised risk assessment in accordance with the applicable guidelines referred to in the second paragraph of Article 47, taking into account other suitable quality system requirements, and document that process .
Člen 46 – točka g
Article 46 – point g
(b) doda se naslednja točka (g):
(b) The following point (g) is added:
„(g) obvestiti pristojni organ o zdravilih, za katera izve ali za katera se sumi, da so ponarejena kot zdravila, ki naj bi jih izdelal, kar zadeva njihovo istovetnost, zgodovino ali vir.“
‘(g) to inform the competent authority of products he gets knowledge of which are or which are suspected to be falsified in relation to the identity, history or source of products manufactured by him.’
„(g) obvestiti pristojni organ o zdravilih, za katera izve ali za katera se upravičeno sumi, da so ponarejena kot zdravila, ki naj bi jih izdelal, v zakoniti ali nezakoniti dobavni verigi, tudi prek spleta, kar zadeva njihovo istovetnost, zgodovino ali vir.“
‘(g) to inform the competent authority of products he gets knowledge of which are or which are reliably suspected to be falsified in relation to the identity, history or source of products manufactured by him in the legal or illegal supply chain, including on the internet. ’
Člen 1 – točka 3 – točka b a (novo)
Article 1 - point 3 - point b a (new)
Člen 46 – točka g a (novo)
Article 46 - point g a (new)
(ba) Doda se naslednja točka (ga):
(ba) The following point (ga) is added:
„(ga) za preverjanje pristnosti in kakovosti učinkovin in pomožnih snovi.“
'(ga) to verify the authenticity and quality of the active substances and the excipients.'
Pomožne snovi so tudi lahko ponarejene in lahko ogrožajo javno zdravje.
Excipients can also be falsified and can thus also result in risks for public health.
Njihovo kakovost in pristnost je torej treba preveriti.
Their quality and authenticity should therefore be verified.
Člen 46 – odstavek 1 a (novo)
Article 46 – paragraph 1 a (new)
(ba) V členu 46 se doda naslednji odstavek:
(ba) In Article 46, t he following paragraph is added:
Komisija vsako leto Evropskemu parlamentu in Svetu predloži poročilo z zanesljivimi in natančnimi podatki o stanju in trendih na področju ponarejanja zdravil.
The Commission shall submit every year to the European Parliament and to the Council a report with reliable and accurate data on the current situation and trends in the falsification of medicin al products .
Poročilo vključuje vsaj podatke o tem, kje, kako in kdo je odkril ponarejena zdravila, njihov izvor in natančen opis narave ponarejanja.
The report shall as a minimum include where, how and by whom the falsified products were detected, their origin, and an exact description of the nature of the falsification.
Poročilo jasno ločuje ponarejena zdravila od kršitev patentov.
That report shall clearly distinguish falsified medicin al products from patent infringement s .
Za reševanje in odpravo ponarejevanja zdravil je bistvenega pomena razumevanje in ugotavljanje njihovega izvora in poglavitnih virov.
To tackle and remedy the problems of falsified medicinal products it is essential to understand and identify their origin and main sources.
Zato je treba uvesti letno poročanje
As such, annual reporting should be introduced.
Člen 46 b – odstavek 1
Article 46b – paragraph 1
(1) Države članice ustrezno ukrepajo, da zagotovijo, da je na njihovem ozemlju proizvodnja zdravilnih učinkovin, ki se uporabljajo kot vhodne snovi, vključno z zdravilnimi učinkovinami, namenjenimi izvozu, skladna z dobro proizvodno prakso za zdravilne učinkovine.
(1) Member States shall take appropriate measures to ensure that the manufacture on their territory of active substances used as starting material, including active substances that are intended for export, complies with good manufacturing practices for active substances.
(1) Države članice ustrezno ukrepajo, da zagotovijo, da sta na njihovem ozemlju proizvodnja in distribucija zdravilnih učinkovin, ki se uporabljajo kot vhodne snovi, vključno z zdravilnimi učinkovinami, namenjenimi izvozu, skladni z dobro proizvodno prakso za zdravilne učinkovine.
(1) Member States shall take appropriate measures to ensure that the manufacture and distribution on their territory of active substances used as starting material, including active substances that are intended for export, compl y with good manufacturing practices for active substances.
Člen 46 b – odstavek 2 – točka b
Article 46b - paragraph 2 - point b
(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 Skupnosti , ter da za obrat veljata nadzor in izvrševanje, ki zagotavljata , da se ni mogoče izogniti tej dobri proizvodni praksi .
(b) they are accompanied by a written confirmation from the exporting third country that the standards of good manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the Community , and that the plant is subject to control and enforcement ensuring that those good manufacturing practices cannot be circumvented .