natgillin/translations-raw huggingface dataset:
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) Da bi zagotovili visoko raven varovanja javnega zdravja, mora biti proizvodnja aktivnih farmacevtskih učinkovin in pomožnih učinkovin skladna z zadevno dobro proizvodno prakso , ki velja v Uniji, ne glede na to, ali se te sestavine proizvajajo v Uniji ali uvažajo.
(13) With a view to ensuring a high level of protection for public health, the manufacture of active pharmaceutical ingredients or excipients should be subject to the relevant good manufacturing practices in force within the Union irrespective of whether those ingredients were manufactured in the Union or imported.
V zvezi s proizvodnjo aktivnih farmacevtskih učinkovin v tretjih državah je treba zagotoviti upoštevanje dobre proizvodne prakse z večkratnimi obveznimi inšpekcijskimi pregledi, ki jih izvajajo pristojni organi Uniji ali organi držav, s katerimi so sklenjeni veljavni sporazumi o vzajemnem priznavanju, ki med drugim pokrivajo tudi aktivne farmacevtske učinkovine .
With regard to the manufacture of active pharmaceutical ingredients in third countries, it should be ensured that good manufacturing practice is complied with, by means of repeated mandatory inspections carried out by the competent Union authorities or the authorities of countries with which mutual recognition agreements covering, inter alia, active pharmaceutical ingredients, are in force.
Gotovost, kar zadeva vir in kakovost aktivnih farmacevtskih učinkovin, je bistvenega pomena.
Certainty as to the source and quality of active pharmaceutical ingredients is of essential importance.
Da se zagotovi skladnosti z dobro proizvodno prakso, je treba redno izvajati temeljite inšpekcijske preglede proizvodnih obratov.
To ensure compliance with good manufacturing practice, thorough inspections of production facilities need to be carried out on a regular basis.
(13a) Farmacevtske pomožne snovi, ki niso aktivne farmacevtske učinkovine in se uporabljajo v proizvodnji zdravil, mora imetnik dovoljenja za proizvodnjo ustrezno nadzorovati, tako da jih preveri in potrdi, da so primerne za uporabo v proizvodnji zdravil v skladu z načeli dobre proizvodne prakse ter da preverjanje zagotavlja ustrezno raven varovanja javnega zdravja.
(13a) Pharmaceutical excipients, other than active pharmaceutical ingredients, used in drug product manufacturing should be subject to appropriate controls by the manufacturing authorisation holder such that the excipients are checked and verified by the manufacturing authorisation holder to be suitable for use in the production of drug products in accordance with good manufacturing practices and that the verification provides for an adequate level of protection of public health.
Vključitev pomožnih snovi v področje uporabe je pomembna, vendar je treba pomožne snovi obravnavati ločeno od aktivnih farmacevtskih učinkovin, zanje pa morajo veljati tudi posebne zahteve, drugačne od zahtev za aktivne farmacevtske učinkovine.
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.
Imetnik dovoljenja za proizvodnjo je odgovoren za zagotavljanje kakovosti pomožnih snovi, ki mora ustrezati svojemu namenu, ta določba pa je že vključena v dobro proizvodno prakso EU za zdravila za uporabo v humani medicini.
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.
(15a) Države članice morajo zagotoviti varovanje javnega zdravja državljanov in ohraniti konkurenčnost evropskih podjetij tako, da naložijo učinkovite, sorazmerne, odvračalne in enakovredne kazni, da bi preprečile vstop ponarejenih zdravil v zakonito farmacevtsko verigo.
(15a) Member States should ensure public health and safeguard the competitiveness of European firms by imposing effective, proportionate, dissuasive and equivalent penalties aimed at preventing falsified medicinal products from entering the legal supply chain.
Za učinkovito preprečevanje ponarejanja zdravil morajo države članice uvesti učinkovite, sorazmerne in odvračalne zakonske predpise, ki pa zagotavljajo tudi enotne kazni na evropski ravni.
In order effectively to combat the counterfeiting of medicinal products, the Member States need both to adopt a set of effective, proportionate and dissuasive legal provisions and ensure that uniform penalties apply at European level.
(17a) Za ugotavljanje istovetnosti vsakega posameznega pakiranja zdravila, ki se izdaja na recept, razen radiofarmacevtskih izdelkov, morajo biti med zaščitnimi elementi nekatere značilnosti proizvoda (t.j. oznaka proizvoda, rok uporabe, številka serije).
(17a) In order to identify each individual package of medicinal products subject to medical prescription other than radiopharmaceuticals, certain product characteristics (i.e. product code, expiry date, lot number) should appear amongst the safety features.
Ti podatki morajo biti v strojno berljivi obliki, usklajeni na evropski ravni, in temeljiti na enem od mednarodnih standardov označevanja.
This information should be available in a machine-readable format which is harmonised across Europe using an international coding standard.
Neprekinjen sistem preverjanja zdravil bi moral omogočati sistematski nadzor serijske številke na vsakem zavitku 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.
Zato bi morala biti vsa zdravila na recept, razen radiofarmacevtskih izdelkov, označena s serijsko številko za določanje istovetnosti posameznega pakiranja, ki bo usklajena in standardizirana po vsej Evropi.
This requires that all prescription-only medicinal products, other than radiopharmaceuticals, carry a serialisation number that identifies the individual package in a harmonised and standardised way across Europe.
(18a) Države članice bi morale sodelovati pri izvajanju obstoječih omejitev v zvezi z nezakonito trgovino z zdravili na internetu, med drugim prek Europola.
(18a) The Member States should cooperate to enforce existing restrictions on illegal trading in medicinal products over the Internet, including by means of Europol.
(-1) V členu 1 se vstavi naslednja točka 3a:
(-1) In Article 1, the following point 3a is inserted:
Pomožne snovi so med drugim na primer 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, na primer želatinske kapsule.“
Excipients include, for example, 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, for example gelatine capsules."
Potrebna je opredelitev pomožnih snovi, Pomožna snov je 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 AgencyCHMP Guidelines on excipients.
(-1a) V členu 1 se vstavi naslednja točka 5a:
(-1a) In Article 1, the following point 5a is inserted:
Vsako zdravilo, ki je bilo namerno ponarejeno, kar zadeva:
Any medicinal product that has been deliberately falsified in relation to its:
(a) istovetnost, vključno z ovojnino, oznako, ime in sestavo tako glede sestavin, vključno s pomožnimi snovmi, kot zdravilnih učinkovin in njihovih odmerkov;
(a) identity, including its packaging, labelling, name or composition in terms of both ingredients, including exipients and active ingredients, or the dosage thereof;
(b) izvor, vključno s proizvajalcem, državo proizvodnje, državo izvora in imetnika dovoljenja za promet z zdravili;
(b) source, including the manufacturer, the country of manufacture, the country of origin or the marketing authorisation holder;
(c) zgodovino, vključno z evidencami in dokumenti, ki omogočajo ugotavljanje istovetnosti distribucijske verige.
(c) history, including the registers or documents enabling the distribution chain to be identified.
Komisija v sodelovanju z Agencijo in oblastmi držav članic sprejme akte za posodobitev te opredelitve na podlagi tehničnega in znanstvenega napredka ter mednarodnih sporazumov.
The Commission shall, in cooperation with the Agency and Member State authorities, adopt acts updating this definition on the basis of technical and scientific progress and international agreements.
Navedeni akti, katerih namen je sprememba nebistvenih elementov te uredbe 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.
Ta opredelitev ni povezana s kršitvami zakonodaje o pravicah intelektualne in industrijske lastnine ali patentnih pravicah.
This definition is not related to infringements of legislation on intellectual and industrial property rights or patent rights.
Ta opredelitev ne vključuje proizvodnih napak.“
This definition does not include manufacturing errors.'
Če želimo učinkovito preprečiti vstop ponarejenih zdravil v zakonito farmacevtsko dobavno verigo je treba jasno in izčrpno opredeliti, kaj pomeni izraz „ponarejeno zdravilo“, nenazadnje tudi zaradi poostritve kazni.
In order to be able effectively to combat the entry of falsified medicines into the legal supply chain, we need a clear and exhaustive definition of the term 'falsified medicinal product', not least with a view to tightening up penalties.
Iz opredelitve je treba izključiti morebitne tovarniške napake.
Manufacturing errors should not be included in the definition.
Člen 1 – točka 17 a
Article 1 – point 17a
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, razen fizičnega ravnanja in izdajanje zdravil javnosti, in ne spadajo v opredelitev prometa na debelo.“
All activities consisting of the sale , purchase or billing of medicinal products , apart from the physical handling and supply of medicinal products to the public, and not falling under the definition of wholesale distribution.’
Člen 1 – točka 17 b (novo)
Article 1 – point 17 b (new)
1a) V členu 1 se vstavi naslednja točka 17b:
1a) In Article 1, the following point 17b is inserted:
Posredovanje zdravil:
Brokering of medicinal products:
Vse dejavnosti, ki ne vključujejo posedovanja zdravil in/ali fizičnega rokovanja z njimi ter obsegajo neodvisno pogajanje ali pogajanje o prodaji ali nakupu zdravil v imenu druge osebe ali zaračunavanje v imenu druge osebe ali vse vrste posredovanja zdravil, razen prometa na debelo in maloprodaje.“
All activities not including the possession and/or physical handling of medicinal products and consisting of negotiating independently on behalf of another person the sale or purchase of medicinal products or in billing on behalf of another person or engaging in any form of brokering of medicinal products with the exception of wholesale and retail distribution .'
Če želimo učinkovito preprečiti vstop ponarejenih zdravil v zakonito farmacevtsko dobavno verigo, je treba jasno in izčrpno opredeliti vse udeležence, ki delujejo v sektorju, ne samo proizvajalcev in distributerjev na debelo, temveč tudi trgovce in posrednike.
In order to be able effectively to combat the entry of falsified medicines into the legal supply chain, we need a clear and exhaustive definition of all those working in the sector – not only producers and wholesale distributors, but also traders and brokers of medicinal products.
Člen 1 – točka 18 b (novo)
Article 1 – point 18 b (new)
(1b) V členu 1 se vstavi naslednja točka 18b:
(1b) In Article 1, the following point 18b is inserted:
Osebe, pooblaščene za izdajanje zdravil:
Persons authorised to supply medicinal products:
osebe ali subjekti, ki imajo dovoljenje za promet na debelo, pri čemer so izključeni osebe ali subjekti, oproščeni obveznosti, da imajo pooblastilo za izdajanje zdravil.“
Persons or entities in the possession of a wholesale distribution authorisation without prejudice to persons or entities exempt from holding an authorisation to supply medicinal products."
Treba je vključiti opredelitev, ki bo razlagala pomen „oseb, pooblaščenih za izdajo zdravil“, saj ste ta izraz v sedanji direktivi uporablja brez opredelitve.
A definition should be included to explain the meaning of “persons authorized to supply medicinal products” as this terms is used in the current Directive without definition.
Opredelitev je potrebna za zagotovitev ustrezne in neprekinjene dobave zdravil prek oseb, pooblaščenih za izdajanje zdravil javnosti.
This definition is needed to ensure the adequate and continuous supply of medicines through persons authorized to supply medicinal products to the public.
Za učinkovito zaščito pred ponarejenimi zdravili je treba jasno določiti vse udeležence v dobavni verigi ali okoli nje, opredeliti njihove dejavnosti, zanje izdati vsa potrebna dovoljenja, jih nadzorovati in pregledovati.
In order to provide effective protection against counterfeit medicines all participants in and around the supply chain should be clearly identified, their activities defined, fully licensed, controlled and inspected.
(2a) V členu 2 se vstavi naslednji odstavek 3a:
(2a) In Article 2, the following paragraph 3a is inserted:
Določbe te direktive ne posegajo v pravico držav članic, da omejijo ali prepovejo trgovino z zdravili, ki se izdajo na zdravniški recept, na internetu.“
The provisions of this Directive shall be without prejudice to the right of the Member States to restrict or prohibit trading in prescription medicinal products over the Internet.'
Člen 1 – točka 3 – točka (a)
Article 1 – point 3 – point a
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 .’
V ta namen imetnik dovoljenja za proizvodnjo zagotovi, da proizvodne dejavnosti potekajo v skladu s smernicami in standardi dobre proizvodne prakse, ki veljajo v Uniji, in sicer z opravljanjem obveznih pregledov pristojnih organov Unije ali organov držav, s katerimi so sklenjeni sporazumi o vzajemnem priznavanju, ki med drugim obsegajo aktivne farmacevtske učinkovine.“
To this end, the holder of the manufacturing authorisation shall ensure that production operations are conducted in accordance with the guidelines and standards of good manufacturing practice in force within the Union through the performance of mandatory inspections by the competent Union authorities or the authorities of countries with which mutual recognition agreements covering, inter alia, active pharmaceutical ingredients, are in force.'
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 betweens firm being inspected and the bodies inspecting them could give rise to a risk of corruption.
Imetnik dovoljenja za promet zagotovi, da se pomožne snovi ocenijo kot primerne za uporabo v zdravilih po posebni dobri proizvodni praksi, kot 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 pharmaceutical products following the 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 achieved is described in a quality system which is available for inspection by competent authorities.
Člen 1 – točka 3 – točka (b)
Article 1 – point 3 - point b
Člen 46 – točka (g)
Article 46 – point g
„(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, 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.'
Člen 46 – točka g a (novo)
Article 46 – point g a (new)
„(ga) biti pravno odgovoren za točnost rezultatov inšpekcijskih pregledov in nadzora, ki jih opravi ali jih zahteva, pri tem pa prenos odgovornosti ni mogoč.“
'(ga) to assume legal liability for the accuracy of the findings of inspections and checks he has carried out or commissioned, without it being possible to delegate that liability.'
Z inšpekcijskimi pregledi in nadzorom je treba zagotoviti, da bodo zdravila izdelana v skladu z dobrimi proizvodnimi praksami.
Inspections and checks need to be performed to ensure that medicinal products are manufactured in accordance with good manufacturing practice.
Da bi to dosegli, je treba poudariti, da je imetnik dovoljenja za proizvodnjo odgovoren tako za končne izdelke kot za nabavljene vhodne snovi.
In this connection, the manufacturing authorisation holder needs to be held liable for both the manufactured products and the starting materials purchased.
Zato je treba poudariti odgovornost proizvajalca glede rezultatov nadzora, še posebej ob predpostavki, da lahko prenese odgovornost na organ, ki je za to pooblaščen.
The manufacturer's liability for inspection findings therefore needs to be established, all the more so if he has the option of having inspections carried out by a body accredited for that purpose.
Člen 1 – točka 3 – točka b b (novo)
Article 1 – point 3 - point b b (new)
Člen 46 – točka g b (novo)
Article 46 – point g b (new)
(bb) Doda se naslednja točka (gb):
(bb) The following point (gb) is added:
„(gb) uvoz zdravilnih učinkovin iz tretjih držav je treba posebej in strogo nadzorovati, da se tako preveri dobra proizvodna praksa in s tem povezana kakovost zdravilnih učinkovin.“
' '(gb) to make the importation of the active principles from third countries subject to specific and stringent monitoring, in order to check whether good manufacturing practices have been adhered to and the intrinsic quality of the active principles.'
Treba je povečati nadzor zlasti nad uvozom zdravilnih učinkovin iz tretjih držav, vendar je treba ločiti med nadzorom nad dobro proizvodno prakso, torej nad kakovostjo zdravilnih učinkovin, in preverjanjem tako imenovanih ponaredkov ali ponarejanja, ki zadeva morebitne imetnike patenta.
It is desirable to make monitoring more stringent, particularly in the case of imports of active principles from third countries, albeit without forgetting the requirement to distinguish monitoring of good manufacturing practice (and lastly of the quality of the active principles) from checking so-called falsity or falsification, which concerns any patent-holders.
Člen 46 b – odstavek 2
Article 46b – paragraph 2
Zdravilne učinkovine, ki se uporabljajo kot vhodne snovi, se uvozijo samo, če:
Active substances used as starting material shall only be imported if:
Zdravilne učinkovine, ki se uporabljajo kot vhodne snovi, se lahko uvozijo samo, če:
Active substances used as starting material may only be imported if:
(a) so proizvedene z uporabo standardov, ki so najmanj enakovredni standardom dobre proizvodne prakse, predpisanim v Skupnosti ;
(a) they have been manufactured by applying standards of good manufacturing practice at least equivalent to those laid down by the Community ; and
(a) so proizvedene z uporabo standardov, ki so najmanj enakovredni standardom dobre proizvodne prakse, predpisanim v Uniji ; ter
(a) they have been manufactured by applying standards of good manufacturing practice at least equivalent to those laid down by the Union ; and
(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.