natgillin/translations-raw huggingface dataset:
(2) Komisija skladno s postopkom iz člena 121(2) sprejme smernice , v katerih so podrobno opredeljene zahteve iz točk od (a) do (d) odstavka 1.
(2) The Commission , in accordance with the procedure set out in Article 121(2), shall adopt guidelines defining in detail the requirements set out in points (a) to (d) of paragraph 1.
(2) Komisija z delegiranimi akti v skladu s členom 121a in pod pogoji iz členov 121b in 121c sprejme merila , v katerih so podrobno opredeljene zahteve iz točk od (a) do (d) odstavka 1 , ter z ustreznimi instrumenti in morebiti celo z izrednimi ukrepi zagotovi preverjanje ter kasneje nadzor nad kakovostjo načel in varnostjo .
(2) The Commission shall, by means of delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c, adopt criteria defining in detail the requirements set out in points (a) to (d) of paragraph 1 , performing by means of the appropriate instruments, and possibly also by taking extraordinary measures, the verification and subsequent monitoring of the quality of the principles and safety .
Člen 1 – točka 16 a (novo)
Article 1 - point 16 a (new)
Člen 116 – odstavek 2
Article 116 - paragraph 2
(16a) V členu 116 se odstavek 2 nadomesti z naslednjim:
(16a) In Article 116 , paragraph 2 is replaced by the following:
Dovoljenje za promet se začasno prekliče, umakne, ukine ali spremeni, če so podrobni podatki v vlogi, kot to določajo člen 8 ali členi 10, 10a, 10b, 10c in 11, nepravilni ali niso bili dopolnjeni v skladu s členom 23, ali v primeru, ko inšpekcijski pregledi iz člena 111 odkrijejo pomanjkanje skladnosti z dobro proizvodno ali distribucijsko prakso ali kadar kontrole, navedene v členu 112, niso bile opravljene.
An authorisation shall also be suspended, revoked, withdrawn or varied where the particulars supporting the application as provided for in Article 8 or Articles 10, 10a, 10b, 10c and 11 are incorrect or have not been amended in accordance with Article 23, or when the inspections referred to in Article 111 demonstrate lack of compliance with g ood m anufacturing p ractices or g ood d istribution p ractices , or where the controls referred to in Article 112 have not been carried out .
Namen pristojnega organa za inšpekcijske preglede je, da popravi stanje, kadar stvari ne tečejo po načrtih; zato je primerno izrecno omeniti, da v primeru, ko so pri inšpekcijskem pregledu odkrite nepravilnosti, imetnik pooblastila nosi posledice dokler ni vzpostavljeno prvotno stanje.
The aim of having the competent authority carrying out inspections is to remedy the situation when something is not working according to plan; it is thus relevant to mention explicitly that when an inspection unveils irregularities the holder of the authorization will have to bear the consequences until the situation is reversed.
V določenih primerih bo to pomenilo izgubo pooblastila.
In certain cases this will mean losing the authorization.
Člen 118a
Article 118a
Pristojni organi izdajo akreditacijo iz členov 46(f) in 80(b), če lahko vlagatelj dokaže, da je sposoben preverjati skladnost z dobro proizvodno prakso ali dobro distribucijsko prakso pri distributerjih na debelo.
The competent authorities shall issue the accreditation referred to in Articles 46(f) and 80(b) if the applicant can demonstrate that he is competent to carry out verification of compliance with good manufacturing practices or, in the case of wholesale distributors, good distribution practices.
Pristojni organi izdajo akreditacijo iz členov 46(f) in 80(b), če lahko vlagatelj dokaže, da je sposoben preverjati skladnost z dobro proizvodno prakso ali dobro distribucijsko prakso pri distributerjih na debelo ali v primerih trgovcev in posrednikov skladnost z dobro prakso trgovanja in z dobro prakso posredovanja.
The competent authorities shall issue the accreditation referred to in Articles 46(f) and 80(b) if the applicant can demonstrate that he is competent to carry out verification of compliance with good manufacturing practices or, in the case of wholesale distributors, good distribution practices or, in the case of traders, good trading practices or, in the case of brokers, good brokering practices .
Proizvajalci morajo ravnati v skladu z dobro proizvodno prakso, distributerji na debelo pa z dobro distribucijsko prakso, trgovcem in posrednikom pa ni treba ravnati v skladu z enakovrednimi praksami ali smernicami.
Currently manufacturers must comply with Good Manufacturing Practices (GMP), wholesale distributors must comply with Good Distribution Practices (GDP) however traders and brokers do not have to comply with any equivalent practices or guidelines.
Zato je za nadaljnje obravnavanje „najšibkejšega člena“ v distribucijski verigi pomembno, da trgovci in posredniki upoštevajo smernice, kot so dobra praksa trgovanja in dobra praksa posredovanja, oblikovane zlasti za osebe ali subjekte, vključene v trgovanje ali posredovanje zdravil.
Therefore, to further address the “weakest link” in the distribution chain it is important that traders comply with guidelines such as “Good Trade Practices” and brokers with “Good Brokerage Practices” specifically established for persons or entities involved in the trading or brokering of medicinal products.
Člen 118 b
Article 118b
Države članice določijo pravila o kaznih, ki se uporabljajo za kršitve nacionalnih predpisov, sprejetih v skladu s to direktivo, in storijo vse potrebno, da se zagotovi njihovo izvajanje.
The Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented.
Države članice obvestijo Komisijo o teh predpisih najpozneje do [ vstaviti datum 18 mesecev po objavi ] in jo nemudoma obvestijo o kakršni koli poznejši spremembi, ki vpliva nanje.
The Member States shall notify those provisions to the Commission by [ insert concrete date 18 months after publication] at the latest and shall notify it without delay of any subsequent amendment affecting them.
Brez poseganja v načelo subsidiarnosti lahko države članice predpišejo pravila o kaznih za kršitve določb te direktive in sprejmejo vse potrebne ukrepe, da zagotovijo njihovo izvajanje.
Without prejudice to the principle of subsidiarity, Member States shall lay down the rules on penalties applicable to infringements of provisions of this Directive and shall take all measures necessary to ensure that they are implemented.
Kazni, ki se uporabljajo in so lahko kazenske sankcije, upoštevajo ogroženost javnega zdravja zaradi ponarejenih zdravil.
Applicable penalties, which may be criminal penalties, shall take into account the threat to public health posed by the falsification of medicinal products.
Predvidene kazni so učinkovite, sorazmerne , odvračalne in enakovredne ter med drugim obsegajo naslednje oblike ravnanja:
The penalties provided for shall be , effective, proportionate and dissuasive and equivalent , and shall cover, inter alia, the following forms of behaviour:
(1) proizvodnjo ponarejenih zdravil, zdravilnih učinkovin, pomožnih snovi, delov, snovi in dodatkov;
(1) manufacturing falsified medicinal products, active substances, excipients, parts, materials and accessories;
(2) dobavo ali ponujanje dobave, vključno s posredovanjem, trgovanjem, imetjem na zalogi, uvozom in izvozom ponarejenih zdravil, zdravilnih učinkovin, pomožnih snovi, delov, snovi in dodatkov;
(2) supplying or offering to supply, including brokering, trafficking, keeping in stock, importing and exporting falsified medicinal products, active substances, excipients, parts, materials and accessories;
(3) izdelavo ponarejenih dokumentov ali nedovoljeno spreminjanje dokumentov;
(3) making false documents or tampering with documents;
(4) pomoč ali prikrivanje pri kateri koli od navedenih kršitev;
(4) aiding and abetting any of the above-mentioned infringements;
(5) poskus izvedbe katere koli od navedenih kršitev.
(5) attempting to commit any of the above-mentioned infringements.
Države članice obvestijo Komisijo o teh predpisih najpozneje do [ šest mesecev po datumu objave te direktive ] in jo nemudoma obvestijo o kakršni koli poznejši spremembi, ki vpliva nanje.
The Member States shall notify those provisions to the Commission by [ 6 months after the date of publication of this Directive ] at the latest and shall notify it without delay of any subsequent amendment affecting them.
Ponarejanje zdravil je hudo kaznivo dejanje, ki ogroža človeška življenja.
The falsification of medicinal products is a severe criminal activity which endangers human lives.
To bi se moralo odražati na sankcijah za ponarejanje.
Sanctions against falsification should reflect this.
Pri določanju kazni, ki se uporabljajo, je treba upoštevati ogroženost javnega zdravja zaradi ponarejenih zdravil.
The threat to public health represented by the falsification of counterfeit medicines must be recognised when laying down the rules on penalties applicable.
Kazni naj bi torej bile višje od kazni, ki se uporabljajo pri kaznovanju ponarejanja ali poneverjanja drugih vrst izdelkov.
The penalties should therefore be superior to the ones applicable to the falsification or counterfeiting of other kind of good or products.
Člen 118 b a (novo)
Article 118b a (new)
Člen 118ba
Article 118ba
Kazni iz člena 118b morajo biti enakovredne tistim, ki se ponavadi uporabljajo za nezakonita dejanja, povezana z mamili, in morajo biti enake v vseh državah članicah v skladu z osnutkom konvencije Sveta Evrope o ponarejanju zdravil in podobnih kaznivih dejanjih, ki ogrožajo javno zdravje.
The penalties referred to in Article 118b should be equivalent to those typically applied for illegal acts related to narcotics and should be equivalent in all Member States in accordance with the draft Convention of the Council of Europe on the counterfeiting of medical products and similar crimes involving threats to public health.
Nadomešča predlog spremembe 44 iz osnutka poročila.
Replaces Amendment 44 in draft report.
Člen 118 b b (novo)
Article 118b b (new)
Člen 118bb
Article 118bb
Komisija za izmenjavo podatkov o sprejetih ukrepih za boj proti ponarejanju zdravil, vključno z veljavnimi sistemi kaznovanja, vzpostavi mrežo, ki bo povezovala Komisijo, Agencijo in pristojne organe v državah članicah ter vključevala organizacije bolnikov in potrošnikov.
The Commission shall establish a network between the Commission, the Agency and the competent authorities in the Member States and involve patients' and consumers' organisations to ensure the exchange of information on the measures taken to combat the falsification of medicinal products, including on the penalties systems in place.
Cilj te mreže je opredeliti najboljše prakse in prispevati k povečanemu sodelovanju na področju preprečevanja in izvrševanja.
This network shall aim at defining best practices and shall contribute to increased cooperation in the area of prevention and enforcement.
Komisija, Agencija in pristojni organi v državah članicah tej mreži letno poročajo o sprejetih ukrepih.
The Commission, the Agency and the competent authorities in the Member States shall report annually to this network on the actions they have undertaken.
Izmenjava podatkov in najboljših praks bo pripomogla k boljšemu izvrševanju in oblikovanju enotnejšega kazenskega sistema po vsej Evropski uniji.
Exchange of information and best practices will help improve enforcement and create a somewhat uniform sanctions regime throughout the EU.
Člen 118 c
Article 118c
Države članice pri uporabljanju te direktive storijo vse, kar je potrebno, da se zagotovi sodelovanje med pristojnimi organi za zdravila in carinskimi organi.
Member States, in applying this Directive, shall take the necessary measures to ensure cooperation between competent authorities for medicinal products and customs authorities.
Ob tem države članice v sodelovanju z zdravstvenimi delavci in s farmacevtsko industrijo sprejmejo potrebne ukrepe za spodbuditev usposabljanja carinskih uslužbencev, da bi jim pomagali pri spoprijemanju s pojavom ponarejenih zdravil.
In that connection, Member States, working in coordination with healthcare professionals, and the pharmaceuticals industry, shall take the necessary measures to encourage training for customs officers to help them deal with the phenomenon of falsified medicinal products.
Usklajevanje je okrepljeno z mednarodnimi programi sodelovanja, ki jih izvaja Komisija.
That coordination shall be strengthened by international cooperation programmes conducted by the Commission.
Države članice sprejmejo potrebne ukrepe, s katerimi zagotovijo carinskim uslužbencem vire, ki jih potrebujejo, zlasti pa jim priskrbijo tehnologijo, ki je bistvena za odkrivanje ponarejenih zdravil.
Member States shall take the necessary measures to ensure that customs officers are provided with the resources they need and shall supply, in particular, the technology essential to the work of detecting falsified medicinal products.
Komisija do ...* pripravi poročilo o ustreznih sprejetih ukrepih.
The Commission shall draw up a report by ...* on the relevant action taken.
* UL: 36 mesecev po datumu objave te direktive
* OJ: 36 months after the date of publication of this Directive
Izobraževanje carinskih uslužbencev je učinkovito orodje v boju proti ponarejanju zdravil, zato je treba ukrepati, da se jim zagotovi ustrezno usposabljanje.
Training for customs officers is an effective tool to combat the falsification of medicinal products.
Poleg tega jim je treba priskrbeti opremo, ki jo potrebujejo za čim učinkovitejše izvajanje svojih nalog.
Steps must therefore be taken to ensure that customs professionals receive appropriate training.
Člen 118 c a (novo)
Article 118c a (new)
Člen 118ca
Article 118c a
Komisija v tesnem sodelovanju z državami članicami sprejme ukrepe, usklajene s pristojnimi organi tretjih držav, v katerih so tranzitna območja, kjer se skladiščijo zdravila.
The Commission, working closely with the Member States, shall take concerted measures with the competent authorities of third countries which have transit areas in which medicinal products are stored.
Komisija sprejme potrebne ukrepe za zagotovitev, da zaseganje sumljivih izdelkov ne bo namenjeno oviranju trgovine z zakonitimi generičnimi zdravili.
The Commission shall take the necessary measures to ensure that seizures of suspect products do not serve to hamper trade in legal generic medicinal products.
Komisija v sklopu mednarodnega sodelovanja dovoli zaseg sumljivih izdelkov, da se lahko izvedejo potrebni pregledi.
In the context of international cooperation, the Commission shall authorise the impounding of suspect products so that the necessary checks can be carried out.
Nadzoru tranzitnih območij je treba posvetiti posebno pozornost, in sicer v sodelovanju s pristojnimi organi zadevnih tretjih držav.
Particularly close attention must be paid to the surveillance of transit areas, on the basis of cooperation with the competent authorities of the third countries concerned.
Izhodišče za ukrepanje morajo biti predvsem pomisleki glede javnega zdravja, ukrepati pa je treba ustrezno tveganjem, povezanim z distribucijo ponarejenih zdravil, ter v sodelovanju z lokalnimi organi, zato da se zaščitijo bolniki.
Action must primarily be based on public health considerations which reflect the risks associated with the distribution of falsified medicinal products, in a spirit of cooperation with local authorities and in order to protect patients.
Člen 118 c b (novo)
Article 118c b (new)
Člen 118c
Article 118c b
Komisija in države članice tesno sodelujejo s Svetom Evrope pri vzpostavitvi evropske konvencije o odpravi ponarejanja zdravil in trgovanja s ponarejenimi zdravili.
The Commission and the Member States shall cooperate closely with the Council of Europe on the establishment of a European Convention on the suppression of the falsification of medicinal products and trafficking in falsified medicin al products .
Konvencija bo zajemala civilne in kazenskopravne vidike ponarejanja zdravil in trgovanja z njimi.
The Convention covers the civil and criminal law aspects of falsification and trafficking of falsified medicinal products.
Komisija v sodelovanju z državami članicami in pod okriljem Združenih narodov podpre pripravo mednarodne konvencije o boju proti ponarejenim zdravilom, da bi zagotovili strožje kazni za ponarejevalce.
The Commission, working with the Member States, shall support the drafting, under the auspices of the United Nations, of an international convention on the combating of the falsification of medicinal products, with a view to ensuring that stiffer penalties are imposed on those guilty of such falsification.
Ugotovljeno je bilo, da je ponarejanje zdravil dejavnost, ki jo vodijo mednarodne kriminalne združbe, in da tega vprašanja, povezanega z javnim zdravjem, ni mogoče rešiti zgolj znotraj meja Evropske unije.
It has been noticed that the falsification of medicinal products has become an activity led by international criminal networks and it is not possible to tackle this public health issue only inside EU borders.
Zato bi morale Evropska unija in države članice podpirati podpis in ratifikacijo nove mednarodne konvencije Sveta Evrope.
Therefore, the European Union and Member States should support the signature and ratification of the new International Convention of the Council of Europe.
Člen 121a
Article 121a
(17a) Vstavi se naslednji člen 121a:
(17a) The following Article 121a is inserted:
(1)Pooblastilo za sprejetje delegiranih aktov iz členov 46(f), 47(3), 52b(2), 54a(4), 85c(5), 85e(2) in 111b(2) se Komisiji dodeli za nedoločen čas.
(1)The power to adopt the delegated acts referred to in Article s 46(f), 47(3), 52b(2), 54a(4), 85c(5), 85e(2) and 111b(2) shall be conferred on the Commission for an indeterminate period of time.
(2) Komisija takoj po sprejetju delegiranega akta o njem hkrati uradno obvesti Evropski parlament in Svet.
(2) As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
(3) Pooblastilo za sprejetje delegiranih aktov se Komisiji dodeli pod pogoji iz členov 121b in 121c.
(3) The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 121b and 121c.
Člen 121 b
Article 121b
(17a) Vstavi se naslednji člen 121b:
(17a) The following Article 121b is inserted:
Člen 121b
Article 121b
Evropski parlament ali Svet lahko kadar koli prekliče prenos pooblastila iz členov 46(f), 47(3), 52b(2),54a(4), 85c(5), 85e(2) in 111b(2).
The delegation of power referred to in Article s 46(f), 47(3), 52b (2), 54a ( 4 ) , 85c(5), 85e(2) and 111b(2) may be revoked at any time by the European Parliament or by the Council.
Institucija, ki je začela notranji postopek o morebitnem preklicu prenosa pooblastila, o tem skuša obvestiti drugo institucijo in Komisijo v razumnem času pred sprejetjem končne odločitve, pri čemer navede preneseno pooblastilo, ki bi lahko bilo preklicano, in morebitne razloge za njegov preklic.
The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation and possible reasons for a revocation.
Z odločitvijo o preklicu preneha veljati prenos pooblastila, navedenega v tej odločitvi.
The decision of revocation shall put an end to the delegation of the power specified in that decision.
Člen 121 c
Article 121c
(17a) Vstavi se naslednji člen 121c:
(17a) The following Article 121c is inserted:
Člen 121c
Article 121c
Evropski parlament ali Svet lahko ugovarja delegiranemu aktu v dveh mesecih od dne uradnega obvestila.
The European Parliament or the Council may object to a delegated act within a period of two months from the date of notification.
Če do izteka tega obdobja ne Evropski parlament ne Svet ne ugovarjata delegiranemu aktu, se ta objavi v Uradnem listu Evropske unije in začne veljati z dnem, ki je v njem določen.
If , on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and enter into force at the date stated therein.
Delegirani akt se lahko objavi v Uradnem listu Evropske unije in začne veljati pred koncem navedenega obdobja, če sta Evropski parlament in Svet obvestila Komisijo, da ne nameravata ugovarjati.
The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections.
Če Evropski parlament ali Svet ugovarja delegiranemu aktu, ta ne začne veljati.
If the European Parliament or the Council objects to a delegated act, it shall not enter into force.
Institucija, ki mu ugovarja, za to navede razloge.
The institution which objects shall state the reasons for objecting to the delegated act.
1) Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje [vstaviti datum 18 mesecev po objavi].
1 ) Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [insert concrete date 18 months after publication] at the latest.
Komisiji takoj sporočijo besedilo teh predpisov ter korelacijsko tabelo med navedenimi predpisi in to direktivo.
They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
Te predpise začnejo uporabljati [vstaviti datum 18 mesecev po objavi + en dan].
They shall apply those provisions from [insert concrete date 18 months after publication + one day].
Te predpise začnejo uporabljati [vstaviti datum 12 mesecev po objavi + en dan].
They shall apply those provisions from [insert concrete date 12 months after publication + one day].
Vendar pa začnejo države članice uporabljati:
However, the Member States shall apply:
(a) predpise, potrebne za uskladitev s členom 1(4), če se nanašajo na člena 46b(2)(b) in 46b(3) Direktive 2001/83/ES, kakor je spremenjena s to direktivo, [vstaviti datum 24 mesecev po objavi];
(a) the provisions necessary to comply with Article 1(4) in so far as it relates to Articles 46b(2)(b) and 46b(3) of Directive 2001/83/EC as amended by this Directive from [insert concrete date 24 months after publication];
(a) predpise, potrebne za uskladitev s členom 1(4), če se nanašajo na člena 46b(2)(b) in 46b(3) Direktive 2001/83/ES, kakor je spremenjena s to direktivo, [vstaviti datum 12 mesecev po objavi];
(a) the provisions necessary to comply with Article 1(4) in so far as it relates to Articles 46b(2)(b) and 46b(3) of Directive 2001/83/EC as amended by this Directive from [insert concrete date 12 months after publication],
(b) predpise, potrebne za uskladitev s členom 1(6), (8) in (9) [vstaviti datum 48 mesecev po objavi].
(b) the provisions necessary to comply with Article 1(6),(8) and (9) from [insert concrete date 48 months after publication].
(b) predpise, potrebne za uskladitev s členom 1(6), (8) in (9) [vstaviti datum 24 mesecev po objavi].
(b) the provisions necessary to comply with Article 1(6),(8) and (9) from [insert concrete date 24 months after publication].
2 ) Države članice sporočijo Komisiji besedilo temeljnih predpisov nacionalne zakonodaje, sprejetih na področju, ki ga ureja ta direktiva.
2 ) Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Države članice sporočijo Komisiji besedilo temeljnih predpisov nacionalne zakonodaje, sprejetih na področju, ki ga ureja ta direktiva.
Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Za varovanje javnega zdravja in interesov bolnikov, lekarnarjev in proizvajalcev je ključno, da so roki kar najkrajši.
For reasons of public health protection and in the interest of patients, pharmacists and manufactures, it is essential to keep the deadlines as short as possible.