natgillin/translations-raw huggingface dataset:
Pri ocenjevanju, s katerim se določi, katera zdravila so najbolj tvegana, kar zadeva ponarejanje, je treba upoštevati kompleksnost distribucijske verige zdravila.
The assessment to determine which drugs are most at risk of counterfeiting should take into account the complexity of the distribution chain of a product.
Nekatera zdravila (na primer imunoglobuline) proizvajalec neposredno dobavi bolnišnici ali drugi zdravstveni ustanovi.
Certain products (for example immunoglobulins) are delivered directly by the manufacturer to the hospital or other healthcare setting.
Seveda je manj priložnosti, da ponaredki vstopijo v zelo kratko dobavno verigo.
There are clearly fewer opportunities for counterfeits to enter that very short supply chain.
Člen 54 a – odstavek 4 – pododstavek 3 – točka b
Article 54a – paragraph 4 – subparagraph 3 – point b
(b) število primerov ponaredkov v tretjih državah in Skupnosti ;
(b) The number of incidences of falsifications in third countries and within the Community ;
(b) število in pogostost primerov v preteklosti ali zabeleženih primerov ponarejenih zdravil v Uniji in razvoj teh primerov v preteklosti ;
(b) The number and frequency of past incidences of reported cases of falsified medicin al products within the Union and the evolution of those incidences in the past ;
Člen 54 a – odstavek 4 – pododstavek 3 – točka d
Article 54a – paragraph 4 – subparagraph 3 – point d
(d) posebne značilnosti zadevnih zdravil;
(d) the specific characteristics of the products concerned;
Člen 54 a – odstavek 4 – pododstavek 3 – točka e
Article 54a – paragraph 4 – subparagraph 3 – point e
(e) resnost bolezni, katerih zdravljenju so namenjena.
(e) the severity of the conditions intended to be treated.
Člen 54 a – odstavek 4 – pododstavek 3 – točka e a (novo)
Article 54a - paragraph 4 - subparagraph 3 - point e a (new)
(ea) tveganje za javno zdravje.
(ea) the risk to public health .
Varovanje javnega zdravja je bistveno.
Public health protection is essential.
Člen 54 a – odstavek 4 – pododstavek 3 – točka e b (novo)
Article 54a – paragraph 4 – subparagraph 3 – point e b (new)
(eb) če se zdravilo dobavlja neposredno (brez udeležbe tretjih strani, kot so distributerji na debelo, trgovci ali posredniki) v zdravstveno ustanovo, kjer se neposredno daje bolniku.
(e b ) whether the product is delivered directly, without the involvement of third parties, such as wholesale distributors, traders or brokers, to a healthcare setting in which the product is administered directly to the patient.
Člen 54a – odstavek 4 – pododstavek 4
Article 54a – paragraph 4 – subparagraph 4
Na podlagi teh meril se lahko za nekatera zdravila ali kategorije zdravil opustijo zahteve iz točk (a) in (b) odstavka (1) tega člena.
On the basis of these criteria, the requirements referred to in points (a) and (b) of paragraph ( 1 ) of this Article may be waived for certain products or product categories.
Na podlagi teh meril se lahko za nekatera zdravila ali kategorije zdravil , tudi za generična zdravila, opustijo zahteve iz točk (a) in (b) odstavka (1) tega člena.
On the basis of these criteria, the requirements referred to in points (a) and (b) of paragraph 1 of this Article may be waived for certain products or product categories, including generic medicinal products.
Sporazumni predlog spremembe vključuje predloge sprememb 32 (Matias), 271 (Perello Rodriquez), 272 (Parvanova, Yannakoudakis, Sonik), 273 (Liese) in 274 (Krahmer).
This compromise amendment covers AM 32 (Matias), 271 (Perello Rodriquez), 272 (Parvanova/ Yannakoudakis/Sonik), 273 (Liese), 274 (Krahmer)
Člen 54 a – odstavek 4 – pododstavek 4 a (novo)
Article 54 a – paragraph 4 – subparagraph 4 a (new)
Zaščitni elementi se lahko uporabijo prostovoljno za vsa zdravila, ne glede na njihov status (na recept ali brez njega), imetniki dovoljenja za promet pa jih lahko uporabijo na svojih zdravilih.
The safety features may be used voluntarily for all medicinal products irrespective of their prescription status and the marketing authorisation holders may employ the safety features on their products.
Ker imajo farmacevtska podjetja največ znanja in izkušenj pri svojih zdravilih in so najprimernejša, da ocenijo tveganje, bi jim moralo biti omogočeno, da uporabijo zaščitne elemente kot previdnostni ukrep.
As pharmaceutical companies have the most expertise on their products and are therefore suited best to assess the level of risk they should be able to employ the safety feature as a precautionary option.
Člen 54 a – odstavek 4 – pododstavek 5
Article 54 a – paragraph 4 – subparagraph 5
Pri ukrepih iz tega odstavka se primerno upoštevajo legitimni interesi glede varovanja poslovno zaupnih informacij ter varstvo pravic industrijske in poslovne lastnine.
The measures referred to in this paragraph shall take due account of the legitimate interests to protect information of a commercially confidential nature and of the protection of industrial and commercial property rights.
Ukrepi iz tega odstavka so skladni z zadevnimi določbami prava Unije o varstvu osebnih podatkov in primerno upoštevajo vsaj vse naslednje:
The measures referred to in this paragraph shall comply with the relevant provisions of Union law with regard to the protection of personal data and shall take due account of at least all the following:
(a) stroškovno učinkovitost sistema, da se zagotovi, da je vsak ukrep uporabljen na podlagi analize stroškov in koristi;
(a) the cost-effectiveness of the system, in order to guarantee that any measure that is applied is based on a cost-benefit analysis;
(b) lastništvo in zaupnost podatkov, ustvarjenih z uporabo zaščitnega elementa za ugotavljanje istovetnosti, potrditev pristnosti in sledljivost zdravil;
(b) t he ownership and confidentiality of the data generated by the use of the safety feature to identify, to authenticate and to trace medic in al products;
( c ) legitimne interese glede varovanja poslovno zaupnih informacij.
( c ) the legitimate interests to protect information of a commercially confidential nature .
Države članice zagotovijo, da se ne zbirajo ali poslovno obdelujejo podatki, ki bi omogočili povezavo med zdravili in bolniki, katerim so namenjena, ter da se ohrani zaupnost podatkov, ustvarjenih z uporabo zaščitnih elementov za preverjanje pristnosti zdravil.
Member States shall ensure that no collection or commercial processing of data takes place that would enable a link to be made between the medicinal products provided and the corresponding patients and shall ensure that the confidentiality of data generated by the use of safety features to authenticate medic in al products is safeguarded.
Člen 54 a – odstavek 4 – pododstavek 5 a (novo)
Article 54 a – paragraph 4 – subparagraph 5 a (new)
Ukrepi iz tega odstavka se posodabljajo vsako leto na podlagi poročila Komisije v skladu s členom 46(1a).
The measures referred to in this paragraph shall be updated every year on the basis of the Commission report pursuant to Article 46( 1a ).
Z uporabo zaščitnih elementov za preverjanje pristnosti zdravil se tvorijo podatki osebne narave, ki so lahko občutljivi.
The use of safety features to authenticate medicines generates data that may be personally sensitive.
Za informacije o osebni porabi zdravil bi morali veljati zadevni predpisi o varstvu podatkov.
Information about personal medicine consumption should be subject to relevant data protection laws.
Vprašanje ponarejanja se razlikuje od varstva pravic industrijske in poslovne lastnine.
The issue of falsification is different from the protection of industrial and commercial property rights.
Pomembno je, da se na podlagi letnega poročila posodobijo zahteve o uporabi zaščitnega elementa.
It is important to update the requirements on the application of the safety feature based on the annual report.
Člen 54 a – odstavek 4 a (novo)
Article 54a – paragraph 4 a (new)
Države članice, ki so že uvedle zaščitne elemente za zdravila, svoje sisteme temu ustrezno prilagodijo.
Member States having already introduced safety features for medicinal products shall adapt their systems accordingly.
Za te države članice se uporablja največ štiriletno prehodno obdobje od začetka veljavnosti te direktive.
For those Member States, a transitional period of maximum 4 years from entry into force of this D irective shall apply.
Člen 54 a – odstavek 4 b (novo)
Article 54a – paragraph 4 b (new)
Odstavka 2 in 3 veljata tudi za imetnika dovoljenja za proizvodnjo, ki delno ali v celoti odstrani ali prekrije zaščitne elemente, ki jih izvirni proizvajalci zdravil, ki se izdajajo na recept, uporabljajo prostovoljno za namene iz odstavka 2.
Paragraphs 2 and 3 shall also apply to a manufacturing authorisation holder who partly or fully removes or covers up safety features that are applied on a voluntary basis to medicinal products that are subject to medical prescription by the original manufacturer for purposes referred to in paragraph 2.
Tudi ko bo direktiva začela veljati, se najbrž še nekaj let ne bodo uporabljali konkretni ukrepi.
Even after the Directive comes into force, it is unlikely that any concrete measures will actually be in place for some years.
Zato bi morali začasni ukrepi veljati, dokler ne bo mogoče izvajati predvidenih ukrepov.
As a result, interim measures should continue until the full measures can be put into place.
V slednjih bi bilo treba med drugim zahtevati, da imetniki dovoljenj za proizvodnjo (tudi tisti, ki izdelke prepakirajo), ki odstranijo ali prekrijejo zaščitne elemente, ki jih je prostovoljno namestil izdelovalec, te elemente nadomestijo z enakovrednimi vidnimi zaščitnimi elementi, ter da so dosledno odgovorni, če zaradi njihovih dejanj ponarejena zdravila vstopijo v dobavno verigo.
These measures should require inter alia that manufacturing authorization holders, (including repackagers) who remove or cover up overt safety features applied on a voluntary basis by the originator, replace them with equivalent overt safety features, and be held strictly liable in the case of counterfeits entering the supply chain as a result of their actions.
V členu 63 se odstavek 1 nadomesti z naslednjim:
In Article 63, paragraph 1 is replaced by the following:
Podrobni podatki za označevanje iz členov 54, 55, 59 in 62 so napisani v uradnem jeziku ali jezikih države članice, kjer je zdravilo v prometu.
The particulars for labelling listed in Articles 54, 55 , 59 and 62 shall appear in the official language or languages of the Member State where the product is placed on the market.
Prvi pododstavek ne preprečuje navedbe teh podrobnih podatkov v več jezikih pod pogojem, da se isti podatki navedejo v vseh jezikih, ki se uporabljajo.
The first subparagraph shall not prevent these particulars from being indicated in several languages, provided that the same particulars appear in all the languages used.
Za nekatera zdravila sirote se podrobni podatki iz člena 54 lahko na podlagi utemeljene zahteve navedejo samo v enem izmed uradnih jezikov Unije .
In the case of certain orphan medicinal products, the particulars listed in Article 54 may, on reasoned request, appear in only one of the official languages of the Union .
Dodajanje člena 55 zagotavlja, da so ime imetnika dovoljenja za promet, datum poteka veljave, serijska številka in metoda upravljanja prikazani v uradnem jeziku/uradnih jezikih države članice, kjer je zdravilo dano na trg.
Adding Article 55 ensures that the name of the marketing authorisation holder, the expiry date, the batch number and the method of administration are displayed in the official language(s) of the Member State where the product is placed on the market.
Uskladitev označenih informacij bi bila lahko potrebna v primeru vzporedne trgovine, zaradi česar bi bilo treba pretisni omot prelepiti z nalepko, kar nekateri vzporedni trgovci že izvajajo (na primer za uskladitev imen zdravil z odobrenim imenom na nacionalnem trgu in zaradi posebnih napotkov za odmerjanje (na primer med tednom)).
An adjustment of the labelled information may be necessary in the case of parallel trade requiring the overlabelling of the blister with a sticker as it is already done by some parallel traders (for example for an adjustment of product names to the authorised name in the national market and special dosage instruction (e.g. weekdays)).
Naslov VII – Naslov
Title VII – Heading
„Promet na debelo in trgovanje z zdravili“.
Wholesale distribution and trading of medicinal products’;
„Promet na debelo , trgovanje z zdravili in njihovo posredovanje “.
Wholesale distribution , trading and brokering of medicinal products’;
Naslov VII je treba spremeniti, da bi pojasnili, da so v določbah zajeti tudi posredniki.
The heading of Title VII needs to be modified to clarify that brokers are also covered by the provisions thereunder.
(11a) V členu 76 se odstavek 3 nadomesti z naslednjim:
(11a) In Article 76, paragraph 3 is replaced by the following:
Vsak distributer, ki ni imetnik dovoljenja za promet in uvaža zdravilo iz druge države članice, obvesti imetnika dovoljenja za promet in pristojni organ v državi članici, v katero zdravilo uvaža, o nameravanem uvozu.
Any distributor, not being the marketing authorisation holder, who imports a product from another Member State shall notify the marketing authorisation holder and the competent authority in the Member State to which the product will be imported of his intention to import it.
V primeru zdravil, za katera ni bilo pridobljeno dovoljenje v skladu z Uredbo (ES) št. 726/2004, obveščanje pristojnega organa ne posega v dodatne postopke iz zakonodaje te države članice, skupaj s pristojbinami, ki se plačajo pristojnim organom za preučitev uradnega obvestila .
In the case of products which have not been granted an authorisation pursuant to Regulation (EC) No 726/2004, the notification to the competent authority shall be without prejudice to additional procedures provided for in the legislation of that Member State , including fees payable to the competent authorities for the examination of the notification .
Člen 76 – odstavek 3 a (novo)
Article 76 – paragraph 3 a (new)
(11b) V členu 76 se doda naslednji odstavek:
(11 b ) In Article 76, the following paragraph is added:
V primeru zdravil, za katera je bilo pridobljeno dovoljenje v skladu z Uredbo (ES) št. 726/2004, predloži distributer v skladu z odstavkom 3 imetniku dovoljenja in Agenciji uradno obvestilo.
In the case of products which have been granted an authorisation pursuant to Regulation (EC) No 726/2004, the distributor shall submit the notification in accordance with paragraph 3 to the marketing authorisation holder and the Agency.
Obvestilo spremlja tudi prispevek, ki se plača Agenciji za preverjanje upoštevanja pogojev, določenih v zakonodaji Unije.
The notification shall be accompanied by a fee payable to the Agency for checking that the conditions laid down in Union legislation are complied with.
(11c) V členu 77 se odstavek 1 nadomesti z naslednjim:
(11 c ) In Article 77, paragraph 1 is replaced by the following:
Države članice sprejmejo vse ustrezne ukrepe, da zagotovijo, da so promet z zdravili na debelo , trgovanje z njimi in njihovo posredovanje mogoči le na podlagi dovoljenja za promet z zdravilom, ki trgovcu na debelo , trgovcu ali posredniku omogoča vključitev v promet z zdravili na debelo z navedbo kraja, za katerega velja.
Member States shall take all appropriate measures to ensure that the wholesale distribution, trade and broker ing of medicinal products is subject to the possession of an authorization to engage in activity as a wholesaler, trader or broker in medicinal products, stating the place for which it is valid.
Zajeti je treba vse udeležence v distribucijski verigi.
It is essential to address all participants in the distribution chain.
Države članice morajo uvesti postopke za izdajo dovoljenj trgovcem in posrednikom, dejavnim na njenem ozemlju, ki so enaki postopkom za izdajo dovoljenj proizvajalcem in distributerjem na debelo.
Member States should have in place procedures for authorizing ‘traders’ and ‘brokers’ who are active on their territory in the same manner as those authorization procedures which are in place for authorization manufacturers and wholesale distributors.
Če zakonodaja ne zajema dejavnosti trgovanja z zdravili in njihovega posredovanja, se lahko zgodi, da nekateri udeleženci ostanejo zunaj področja uporabe zakonodaje.
If the legislation does not address the activity of trading and brokering in medicinal products, certain participants may remain outside the scope of the legislation.
Člen 77 – odstavek 5
Article 77 – paragraph 5
(12a) V členu 77 se odstavek 5 nadomesti z naslednjim:
(12a) In Article 77, paragraph 5 is replaced by the following:
Preverjanja oseb, ki so pooblaščene za opravljanje dejavnosti prometa z zdravili na debelo , trgovanja z njimi ali njihovega posredovanja , ter inšpekcijski pregled njihovih prostorov , če je potreben, je odgovornost države članice, ki je izdala dovoljenje.
Checks on the persons authorized to engage in the activity of wholesaling, trading or brokering in medicinal products and the inspection of their premises, as applicable , shall be carried out under the responsibility of the Member State which granted the authorization.
V številnih državah članicah veliko število dovoljenj za promet na debelo miruje zaradi premajhne preglednosti statusa imetnikov.
In several Member States a large number of wholesale distribution authorizations are currently inactive, resulting in a lack of transparency with regard to their status.
To omogoča zlorabo, zlasti če lahko brezvestna oseba uporabi to dovoljenje, da v zakonito dobavno verigo uvede ponarejena zdravila.
This situation is potentially open to abuse particularly where an inactive license may be used by unscrupulous persons attempting to introduce counterfeit medicines into the legal distribution chain.
Zato je treba poostriti nadzor izdaje dovoljenj, pri čemer se neaktivna dovoljenja ukinejo ali po treh letih mirovanja začasno prekličejo.
Therefore, authorization control should be tightened, whereby an inactive license would be deemed to be revoked or suspended after 3 years of inactivity.
Člen 77 – odstavek 6
Article 77 – paragraph 6
(12b) V členu 77 se odstavek 6 nadomesti z naslednjim:
(12 b ) In Article 77, paragraph 6 is replaced by the following:
Država članica, ki je izdala dovoljenje iz odstavka 1, dovoljenje začasno prekliče ali ukine po tem, ko je obvestila imetnika dovoljenja , če niso več izpolnjeni pogoji dovoljenja ali če dovoljenje ni bilo uporabljeno več kot tri leta, razen v primerih, ko dovoljenje ni bilo uporabljeno zaradi razumno potrebnega časa za uskladitev z obveznostmi iz te direktive, in o tem takoj obvesti ostale države članice in Komisijo.
The Member State which granted the authorisation referred to in paragraph 1 shall suspend or revoke that authorisation , after having notified the holder thereof, if the conditions of authorisation cease to be met or if the authorisation has not been used for more than three years, except in cases where the authorisation was not used on account of the time reasonably necessary to comply with the obligations under this Directive, and shall forthwith inform the other Member States and the Commission thereof .
V mnogih državah članicah so bila izdana dovoljenja za promet na debelo, ki se trenutno ne uporabljajo.
In many Member States, wholesale distribution authorisations have been issued but are not currently in use.
To umetno povečuje število udeležencev in po nepotrebnem zapleta trg ter posledično tudi sistem nadzora.
This situation artificially increases the number of stakeholders and unnecessarily complicates the market and, thereby, the system of controls.
Pomembno je preprečiti, da bi se tak preklic ali razveljavitev uporabila, če je razlog za nedejavnost razumno potreben čas za izpolnitev obveznosti iz te direktive.
It is important to ensure, however, that such authorisations are not suspended or revoked in cases where they are not being used on account of the time reasonably necessary to comply with the obligations under the Directive.
Imetnika dovoljenja je treba zato predhodno obvestiti, da ne bi neutemeljeno preklicali dovoljenj.
The authorisation holder therefore needs to be notified beforehand, so as to avoid any unwarranted suspensions.
(12c) člen 78 se nadomesti z naslednjim:
(12c) Article 78 is replaced by the following:
Države članice zagotovijo, da čas postopka za preučitev vloge za dovoljenje za promet z zdravili na debelo , trgovanje z njimi ali njihovo posredovanje ne preseže 90 dni od dneva, ko pristojni organ zadevne države članice prejme vlogo.
Member States shall ensure that the time taken for the procedure for examining the application for the distribution , trad ing or broker ing authorization does not exceed 90 days from the day on which the competent authority of the Member State concerned receives the application.
Če je potrebno, pristojni organ od vlagatelja lahko zahteva, da predloži vse potrebne informacije glede pogojev dovoljenja.
The competent authority may, if need be, require the applicant to supply all necessary information concerning the conditions of authorization.
Če organ uporabi to možnost, rok, ki ga določa prvi odstavek, preneha teči do predložitve zahtevanih dodatnih informacij.
Where the authority exercises this option, the period laid down in the first paragraph shall be suspended until the requisite additional data have been supplied.
Države članice morajo uvesti postopke za izdajo dovoljenj „trgovcem“ in „posrednikom“, dejavnih na svojem področju, ki so enaki postopkom za izdajo dovoljenj proizvajalcem in distributerjem na debelo.
Member States should have in place procedures for authorizing ‘traders’ and ‘brokers’ which are active on their territory in the same manner as those authorization procedures which are in place for manufacturers and wholesale distributors.
Rok za preučitev vlog za dovoljenje za trgovanje in posredovanje mora biti enak kot za distributerje na debelo, zato je treba v to določbo vključiti tudi dovoljenja za trgovce in posrednike.
The timeframe for examining the applications for trading and brokerage authorization should be the same as for wholesale distributors and therefore the authorization of ‘traders’ and ‘brokers’ should be added in this provision.
Člen 1 – točka 12 d (novo)
Article 1 – point 12 d (new)
(12d) Vstavi se naslednji člen:
(12d) The following Article is inserted:
„Člen 79a
‘Article 79a
Komisija v sodelovanju z Agencijo in organi držav članic določi pravila in merila za pridobivanje dovoljenj za trgovanje in posredovanje.
The Commission shall, in cooperation with the Agency and Member State authorities, lay down rules and criteria for obtaining trad ing and broker ing authorisations.
Prosilci morajo izpolniti naslednje minimalne zahteve:
Applicants must fulfil the following minimum requirements:
(a) imeti morajo stalen naslov ali kontaktne podatke, da se zagotovita istovetnost in lokacija sedeža podjetja;
(a) they must have a permanent address or contact details, so as to ensure accurate identification and location of their official place of business;
(b) zagotoviti morajo, da svoje obveznosti izvajajo samo z osebami ali subjekti, ki so zmožni izpolnjevati svoje obveznosti v skladu s pogoji iz člena 80.“
(b) they must undertake to ensure that they conduct their activities only with those persons or entities that are able to fulfil their obligations under the terms of Article 80.’
Zahteve glede distribucije ne bi smele veljati samo za trgovce na debelo, temveč za vse trgovce in posrednike.
There should not only be requirements on distribution for wholesalers but for all traders and brokers.
Člen 1 – točka 13 – točka –a (novo)
Article 1 – point 13 - point -a (new)
Člen 80 – uvodni stavek
Article 80 – introductory sentence
(-a) Uvodno besedilo se nadomesti z naslednjim:
(-a) The introductory sentence is replaced by the following:
Imetniki dovoljenja za promet z zdravili na debelo, trgovanje z njimi ali njihovo posredovanje morajo izpolnjevati naslednje minimalne pogoje:
‘Holders of the authorisation for distributing, trading or brokering medicinal products must fulfil the following minimum requirements:’