natgillin/translations-raw huggingface dataset:
Za zagotovitev varnosti zdravil je treba upoštevati vse, ki delujejo v tem sektorju, in ne le distributerje na debelo, za vse pa morajo veljati stroga akreditacija, preverjanje in sistem dobre prakse.
To ensure the safety of pharmaceutical products, due account needs to be taken of all those working in the sector– not just wholesale distributors – all of whom need to be subject to a rigorous accreditation, verification and good practice system.
Člen 1 – točka 13 – točka -a a (novo)
Article 1 – point 13 - point -a a (new)
Člen 80 – točka c a (novo)
Article 80 – point c a (new)
(-a a) Doda se naslednja točka (ca):
(-a a) The following point (ca) is added:
„(ca) naključno morajo preverjati, ali so zdravila, ki so jih kupili, ponarejena, tako da preverijo zaščitni element na zunanji ovojnini, kot je navedeno v točki (o) člena 54;“
'(ca) they must randomly verify that the medicinal products they have purchased are not falsified by checking the safety feature on the outer packaging, as referred to in point (o) of Article 54;'
Zdravila vsebujejo številne vidne in prikrite zaščitne elemente, pri večini katerih farmacevtski distributerji na debelo ne morejo ugotoviti pristnosti, razen če jim o tem proizvajalec posreduje informacije.
Medicinal products contain numerous overt and covert safety features the majority of which cannot be authenticated by pharmaceutical wholesalers unless information about such has been communicated to them by the manufacturer.
Vendar lahko trgovci na debelo naključno preverjajo istovetnost posameznih zavitkov, ki na zunanji ovojnini vsebujejo zaščitni element s serijsko številko v strojno berljivi obliki, če imajo dostop do zbirke podatkov, ki vsebuje te informacije.
However, wholesalers are able to randomly check the identity of individual packs which contains on their outer packaging a carrier (safety feature) comprising an individual number in a machine readable format and provided they have access to the database containing this information.
Člen 80 – točka e
Article 80 – point e
(e) voditi morajo dokumentacijo v obliki nabavnih/prodajnih računov, na računalniku ali v kateri koli drugi obliki, ki vsebuje vsaj naslednje informacije o vsakem poslu, pri katerem se zdravila prejmejo, odpošljejo ali se z njimi trguje:
(e) they must keep records either in the form of purchase/sales invoices or on computer, or in any other form, giving for any transaction in medicinal products received, dispatched or traded at least the following information:
(e) voditi morajo dokumentacijo v obliki nabavnih/prodajnih računov, na računalniku ali v kateri koli drugi obliki, ki vsebuje vsaj naslednje informacije o vsakem poslu, pri katerem se zdravila prejmejo, odpošljejo , se z njimi trguje ali se posredujejo :
(e) they must keep records either in the form of purchase/sales invoices or on computer, or in any other form, giving for any transaction in medicinal products received, dispatched , traded or brokered at least the following information:
– ime zdravila,
- name of the medicinal product,
– količina, ki je bila prejeta, dobavljena ali se je z njo trgovalo,
- quantity received, supplied or traded,
– količina, ki je bila prejeta, dobavljena , se je z njo trgovalo ali je bila posredovana ,
- quantity received, supplied , traded or brokered ,
– ime in naslov dobavitelja ali prejemnika, kot je primerno ;“.
- name and address of the supplier or consignee, as appropriate ;’ ;
– ime in naslov dobavitelja ali prejemnika, kot je primerno ,
- name and address of the supplier or consignee, as appropriate ,
– nacionalna identifikacijska številka, kadar je to ustrezno.
- national identification number, where appropriate,
Za zagotovitev varnosti zdravil je treba upoštevati vse, ki delujejo v tem sektorju, in ne le distributerje na debelo, za vse pa morajo veljati stroga akreditacija, preverjanje in sistem dobre prakse.
To ensure the safety of pharmaceutical products, due account needs to be taken of all those working in the sector – not just wholesale distributors – all of whom need to be subject to a rigorous accreditation, verification and good practice system.
V večini držav članic se za vse transakcije uporablja nacionalna identifikacijska številka (naročanje in povrnitev stroškov).
In most EU Member States a national identification number is used for all transactions (ordering and reimbursement).
Člen 80 – točka g
Article 80 – point g
(aa) Točka (g) se nadomesti z naslednjim:
(aa) Point (g) is replaced by the following:
„(g) ravnati morajo v skladu z načeli in smernicami dobre distribucijske prakse , prakse trgovanja in prakse posredovanja za zdravila, kot jih določa člen 84.“
'(g) they must comply with the principles and guidelines of good distribution, trading and brokering practice s for medicinal products as laid down in Article 84.'
Člen 80 – točka i – odstavek 1
Article 80 – point i – paragraph 1
(i)pristojni organ morajo obvestiti o zdravilih, ki jih prejmejo in za katera ugotovijo, da kršijo, ali sumijo, da kršijo kar koli od naslednjega:
(i)they must inform the competent authority of products they receive which they identify as infringing, or they suspect of infringing, either of the following:
(i) pristojni organ morajo obvestiti o zdravilih, ki jih prejmejo , s katerimi trgujejo ali jih posredujejo, in za katera ugotovijo, da kršijo, ali sumijo, da kršijo kar koli od naslednjega:
(i) they must inform the competent authority of products they receive , trade or broker which they identify as infringing, or they suspect of infringing, either of the following:
Člen 80 – točka i – odstavek 2
Article 80 – point i – paragraph 2
Poleg tega se, kadar so te kršitve ali domnevne kršitve povezane s ponarejenim zdravilom, obvesti imetnik dovoljenja za promet ali blagovne znamke, ki je bila ponarejena .
Moreover, in cases where these infringements or suspected infringement s relate to a falsified medicinal product, the holder of the marketing authorisation or of the trademark that has been falsified shall be informed.
Poleg tega se, kadar je to lažno predstavljanje ali domnevno lažno predstavljanje povezano s ponarejenim zdravilom, obvesti imetnike dovoljenj za proizvodnjo in promet.
Moreover, in cases where these falsified representations or suspected falsified representations relate to a falsified medicinal product, the holders of both the manufacturing authorisation and the marketing authorisation shall be informed.
Tudi imetnik dovoljenja za promet ali proizvodnjo obvesti pristojne organe in druge udeležence v dobavni verigi, kadar obstaja sum, da so v dobavno verigo prišla ponarejena zdravila.
In the same way, the holder of a marketing or manufacturing authorisation shall inform both the competent authorities as well as other supply chain operators in cases where falsified products are suspected of having infiltrated the legal supply chain.
Direktiva se ukvarja s vprašanjem ponarejanja zdravil in njegovih zdravstvenih vidikov, ne pa ponarejanja z vidika pravic intelektualne lastnine.
This Directive tackles the issue of falsification of medicinal products in its health aspects and not counterfeiting from an Intellectual Property Rights standpoint.
Da se izognemo zmedi, je treba odstraniti vsakršno omembo blagovne znamke.
Any mention of trademark should therefore be deleted to avoid confusion.
Poleg tega bo obveznost informiranja, naložena vsem udeležencem v zakoniti dobavni verigi, pripomogla k najvišji ravni preglednosti in sledljivosti.
In addition an information obligation imposed on all actors involved in the legal supply chain will help in attaining the maximum level of transparency and traceability.
Člen 1 – točka 13 – točka (c)
Article 1 – point 13 – point c
Člen 80 – pododstavka 1 a in 1 b
Article 80 – subparagraphs 1 a and 1 b
Za namen točke (b) morajo imetniki dovoljenja za promet na debelo, kadar se zdravilo pridobi pri drugem distributerju na debelo, sami ali prek organa, ki ga za to pooblasti pristojni organ države članice, preveriti skladnost dobaviteljskega distributerja na debelo z dobro distribucijsko prakso.
For the purpose of point (b), in the case where the product is obtained from another wholesale distributor, holders of the wholesale distribution authorisation must verify compliance with good distribution practices of the supplying wholesale distributor either by themselves or through a body accredited for that purpose by the competent authority of a Member State.
Za namen točke (b) morajo imetniki dovoljenja za promet na debelo, kadar se zdravilo pridobi pri drugem distributerju na debelo, sami ali prek organa, ki ga za to pooblasti pristojni organ države članice, preveriti skladnost dobaviteljskega distributerja na debelo z dobro distribucijsko prakso , pri čemer prek zbirke podatkov Skupnosti iz člena 111(6) tudi preverijo, ali ima dovoljenje za distribucijo na debelo .
For the purpose of point (b), in the case where the product is obtained from another wholesale distributor, holders of the wholesale distribution authorisation must verify compliance with good distribution practices of the supplying wholesale distributor either by themselves or through a body accredited for that purpose by the competent authority of a Member State , including checking that the latter is an authorised wholesale distributor through the Community database, as referred to in Article 111(6).
Kadar se zdravilo pridobi pri proizvajalcu ali uvozniku, morajo imetniki dovoljenja za promet na debelo preveriti, ali ima proizvajalec ali uvoznik dovoljenje za proizvodnjo.
Where the product is obtained from the manufacturer or importer, holders of the wholesale distribution authorisation must verify that the manufacturer or importer holds a manufacturing authorization.
Kadar se zdravilo pridobi pri proizvajalcu ali uvozniku, morajo imetniki dovoljenja za promet na debelo prek zbirke podatkov Skupnosti iz člena 116(6) preveriti, ali ima proizvajalec ali uvoznik dovoljenje za proizvodnjo.
Where the product is obtained from the manufacturer or importer, holders of the wholesale distribution authorisation must verify that the manufacturer or importer holds a manufacturing authorization through the Community database, as referred to in Article 111(6).
Kadar se zdravila pridobijo s trgovanjem ali posredovanjem, morajo imetniki dovoljenja za promet na debelo in imetniki dovoljenja za trgovanje ali posredovanje prek zbirke podatkov Skupnosti iz člena 111(6) preveriti, ali imajo udeležene osebe ali subjekti potrebna dovoljenja.
When products are obtained through trading or brokering, the holders of the wholesale distribution, trading or brokering authorisation must verify that the persons or entities involved hold the necessary authorisations through the Community database, as referred to in Article 111(6).
(13a) Člen 84 se nadomesti z naslednjim:
(13a) Article 84 is replaced by the following:
„Člen 84
‘Article 84
Komisija objavi smernice o dobri distribucijski praksi, praksi trgovanja in praksi posredovanja za zdravila.
The Commission shall publish guidelines on good distribution , trading and brokering practice s for medicinal products .
V ta namen se posvetuje z Odborom za lastniška zdravila in Odborom za farmacijo, ustanovljenim z Direktivo Sveta 75/320/EGS 1 .
To this end, it shall consult the Committee for Proprietary Medicinal Products and the Pharmaceutical Committee established by Council Decision 75/320/EEC 1 .
1 UL L 147, 9.6.1975, str.
1 OJ L 147, 9.6.1975, p.
Proizvajalci morajo ravnati v skladu s smernicami za dobro proizvodno prakso, distributerji na debelo pa s smernicami za dobro distribucijsko prakso.
Currently manufacturers must comply with guidelines on Good Manufacturing Practices (GMP) and wholesale distributors must comply with guidelines on Good Distribution Practices (GDP) however traders and brokers currently do not have to comply with any equivalent practices related to their specific field of activity, namely the trade or brokerage of medicinal products.
Vendar trgovci in posredniki še nimajo enakovredne prakse, v skladu s katero morajo ravnati na svojem posebnem področju delovanja, namreč na področju prodaje ali posredovanja zdravil.
Therefore, guidelines on good trade practice and guidelines on good brokerage practice should be set-up.
Člen 84 a (novo)
Article 84 a (new)
(13b) Vstavi se naslednji člen 84a:
(13b) T he following Article 84a is inserted:
„Člen 84a
'Article 84a
Komisija objavi posebne smernice o dobri proizvodni praksi za aktivne farmacevtske učinkovine in posebne smernice o dobri proizvodni praksi za pomožne snovi.
The Commission shall publish guidelines on specific good manufacturing practices for active pharmaceutical ingredients and specific good manufacturing practices for excipients.
V ta namen se posvetuje z Odborom za lastniška zdravila, ustanovljenim z Direktivo Sveta 75/319/EGS, in Odborom za farmacijo, ustanovljenim s Sklepom Sveta 75/320/EGS, ob upoštevanju dobre proizvodne prakse enakovrednih veljavnih sistemov, kot so HACCP in ISO9001/ISO22000, ter posebnih pravilnikov, kot so dobra proizvodna praksa Evropske zveze za kozmetične učinkovine (EFfCI) in smernice za farmacevtske pomožne snovi (IPEC/PQG).“
To this end, it shall consult the Committee for Proprietary Medicinal Products established under Council Directive 75/319/EEC and the Pharmaceutical Committee established by Council Decision 75/320/EEC, taking into account the GMP equivalent systems in force such as HACCP and ISO9001/ISO22000 and the voluntary rules such as the EFfCI GMP and the IPEC PQG Guide for pharmaceutical excipients.'
Za pomožne snovi in aktivne farmacevtske učinkovine morajo veljati zadevne dobre proizvodne prakse, razvite na evropski ravni.
Both excipients and API should be subject to relevant good manufacturing practices developed at the European level.
Komisija mora oblikovati posebna načela dobre proizvodne prakse za aktivne farmacevtske učinkovine in posebna načela dobre proizvodne prakse za pomožne snovi.
The Commission is called to develop specific GMP for API and specific GMPs for excipients.
V zvezi s pomožnimi snovmi mora Komisija upoštevati enakovredne sisteme v dobrih proizvodnih praksah v skladu z Uredbo ES o HACCP (analiza tveganj in kritičnih kontrolnih točk), kot so smernice o dobri proizvodni praksi za kozmetične učinkovine, ki jih je leta 2005 izdala Evropska zveza za kozmetične učinkovine (EFfCI).
Concerning the excipients, the Commission should take into account in GMPs equivalent systems in accordance to the EC regulation on HACCP ( Hazard analysis and Critical Control Points), the EFfCI (European Federation for Cosmetics Ingredients) GMP Guides for cosmetic ingredients (2005).
Ta pravila se lahko uporabijo tudi v farmacevtski industriji.
These rules can also be used in the pharmaceutical industry.
Člen 85a
Article 85a
Za promet na debelo v tretje države se ne uporabljajo člen 76, člen 80(c) in (i) ter člena 81 in 82.
In the case of wholesale distribution to third countries Article 76, Article 80(c) and (i), and Articles 81 and 82 shall not apply.
Poleg tega se ne uporablja člen 80(b), kadar se izdelek prejme neposredno iz tretje države.
Moreover, Article 80(b) shall not apply where a product is directly received from a third country.
Države članice sprejmejo vse ustrezne ukrepe za zagotavljanje, da z njihovega ozemlja v tretje države niso poslana ali izvožena nobena ponarejena zdravila.
Member States shall take all appropriate actions to ensure that no falsified medicinal products are distributed or exported from their territory to third countries.
Ta direktiva ne posega v določbe Konvencije o začasnem uvozu (Istanbulska konvencija) v zvezi z dobavo zdravil tretjim državam v izrednih razmerah.
This Directive is without prejudice to provisions of the Convention relating to temporary admission ( Istanbul Convention) as regards the supply of medicin al products to third countries in the case of emergency situations.
Pooblaščeni distributer na debelo za vsako dobavo zdravil osebam, pooblaščenim za dobavo zdravil javnosti v tretji državi, hrani dokumentacijo v obliki nabavnih/prodajnih računov, v elektronski ali v kateri koli drugi obliki, ki vsebuje vsaj naslednje informacije o vsakem poslu, pri katerem se zdravila prejmejo ali odpošljejo:
For all supplies of medicinal products to a person authorised or entitled to supply medicinal products to the public in a third country, the authorised wholesaler shall keep records either in the form of purchase/sales invoices, electronically or in any other form, providing for each transaction in medicinal products received or dispatched at least the following information:
– ime zdravila,
— name of the medicinal product,
– prejeta ali izdana količina,
— quantity received or supplied,
– ime in naslov dobavitelja ali prejemnika, kot je primerno.
— name and address of the supplier or consignee, as appropriate;
Pooblaščeni prodajalec na debelo hrani dokumentacijo, ki mora biti na voljo pristojnim organom za inšpekcijski pregled, za obdobje petih let.
T he authorised wholesaler shall keep th o se records available to the competent authorities, for inspection purposes, for a period of five years .
Direktiva bi morala tudi zmanjšati distribucijo ponarejenih zdravil na debelo v tretje države.
The directive should also seek to reduce wholesale distribution of falsified medicines to third countries.
Manj stroga pravila za izvoz v tretje države ali tranzit preko njih bi škodovala verodostojnosti naporov Skupnosti, da okrepi mednarodno sodelovanje v boju proti ponarejenim zdravilom.
Applying weaker rules for exports or transits to third countries would harm the credibility of the Community in its attempts to strengthen international cooperation in the fight against falsified medicines.
Zato izjeme niso dovoljene.
For this reason exemptions are not allowed.
Vseeno pa je treba uporabljati določbe Istanbulske konvencije za zdravila, poslana v tretje države iz človekoljubnih razlogov v pomoč tistim, ki so jih prizadele naravne nesreče ali podobne tragedije.
Nevertheless the Istanbul Convention provisions should be applied to the medicinal products forwarded to third countries for humanitarian purposes as aid to those affected by natural disasters or similar catastrophes..
Člen 85 b
Article 85b
Osebe, ki trgujejo z zdravili, zagotovijo, da so zdravila, s katerimi trgujejo, vključena v dovoljenje za promet, ki je bilo izdano v skladu z Uredbo (ES) št. 726/2004 ali so ga izdali pristojni organi države članice v skladu s to direktivo.
Persons trading medicinal products shall ensure that the traded medicinal products are covered by a marketing authorization granted pursuant to Regulation (EC) No 726/2004 or by the competent authorities of a Member State in accordance with this Directive.
Poleg tega se uporabljajo zahteve iz člena 80(d) do (h).
In addition, the requirements set out in Article 80(d) to (h) shall apply.
Osebe, ki trgujejo z zdravili ali jih posredujejo , zagotovijo, da so zdravila, s katerimi trgujejo ali jih posredujejo , vključena v dovoljenje za promet, ki je bilo izdano v skladu z Uredbo (ES) št. 726/2004 ali so ga izdali pristojni organi države članice v skladu s to direktivo.
Persons trading or brokering medicinal products shall ensure that the traded or brokered medicinal products are covered by a marketing authorisation granted pursuant to Regulation (EC) No 726/2004 or by the competent authorities of a Member State in accordance with this Directive.
O svoji dejavnosti obvestijo pristojni organ države članice, v kateri imajo sedež.
They shall notify their activity to the competent authority of the Member State where they are established.
O svoji dejavnosti obvestijo pristojni organ države članice, v kateri imajo sedež , ki o tem obvesti Agencijo .
They shall notify their activity to the competent authority of the Member State where they are established , which shall inform the Agency .
Osebe, ki trgujejo z zdravili ali jih posredujejo, morajo preveriti, da za zdravila, s katerimi trgujejo ali jih posredujejo, velja ustrezno dovoljenje za promet.
Persons or entities trading or brokering medicinal products should be obliged to verify that products traded or brokered are covered by a valid marketing authorization.
Nacionalni postopek uradnega obvestila je treba okrepiti z zbirko podatkov Skupnosti, za katero bodo zahteve podobne tistim za imetnike dovoljenja za promet na debelo, da bi bili vsi udeleženci pregledni.
The national notification procedure should be strengthened by a Community database similar to the requirements for the holders of wholesale distribution authorization in order to make all participants transparent.
Naslov II a (novo) – Člen 85 c (novo)
Title VII a (new) – Article 85 c (new)
(14a) Za členom 85b se vstavita naslednji naslov VIIa in člen 85c:
(14a) The following Title VIIa and Article 85c are inserted after Article 85b:
NASLOV VIIa
TITLE VIIa
SPLETNA PRODAJA
INTERNET SALES
Člen 85c
Article 85 c
Spletne lekarne zahtevajo v državah, kjer smejo delovati, posebno dovoljenje pristojnih organov.
Internet pharmacies shall, in Member States in which they are allowed to operate, require a special authorisation by the competent authority.
Komisija sprejeme logotip EU za prvo stran lekarniških spletnih strani, da javnost lahko ugotovi, ali je spletna stran, ki nudi prodajo zdravil, povezana z lekarno z dovoljenjem.
The Commission shall adopt an EU logo for the front page of internet pharmacy sites, helping the public to identify whether a website offering to sell medicinal products is connected to an authorised pharmacy.
Logotip je povezan z osrednjo spletno stranjo na ravni države članice, ki jo vzpostavi država članica in ki obiskovalcem omogoča, da preverijo verodostojnost logotipa, ter vsebuje osnovne podatke o tveganju, povezanim s spletnimi nakupi zdravil.
The logo shall be linked to a central website at Member State level, to be established by the Member State , that allows the visitor to check the authenticity of the logo and that provides background information on the risks related to buying medicinal products on the internet.
Države članice sprejmejo ustrezne ukrepe za zagotovitev, da je logotip EU iz odstavka 1 na vseh lekarniških spletnih straneh z dovoljenjem, povezanih z lekarnami na njihovem ozemlju, lekarniškim spletnim stranem brez dovoljenja pa preprečijo uporabo logotipa in povezavo z osrednjo spletno stranjo iz odstavka 1.
Member States shall take the appropriate measures to ensure that all authorised pharmacy internet sites linked to pharmacies within their territory display the EU logo referred to in paragraph 1 and to prevent non-authorised pharmacy internet sites from using the logo and linking to the central website referred to in paragraph 1.
Komisija navede spletne lekarne, ki imajo dovoljenje v eni ali več državah članicah, v zbirki podatkov EU, s katero je povezana osrednja spletna stran na ravni države članice.
The Commission shall list the internet pharmacies that are authorised in one or more of the Member States in an E U database, to which the central website at Member State level shall be linked.
Za izvajanje odstavkov 2, 3 in 4 sprejme Komisija z delegiranimi akti v skladu s členom 121a ter pod pogoji iz členov 121b in 121c direktivo, ki določa:
In order t o implement paragraph s 2, 3 and 4 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 Directive laying down:
– minimalne zahteve, ki ponarejenim zdravilom preprečujejo vstop v dobavno verigo, ki se uporablja v državah članicah, če odobrijo takšne spletne lekarne.
- the minimum requirements preventing the entry of falsified medicin al products into the supply chain to be applied by the Member States if they authorise such internet pharmacies.
Takšne zahteve preprečijo tudi povrnitev stroškov za zdravila iz spletnih virov brez dovoljenja;
Such requirements shall also prevent the reimbursement of medicinal products from unauthorised internet sources,
– vzorec logotipa EU;
- the model of the EU logo,
– vrsto minimalnih osnovnih podatkov o tveganju, povezanem s spletnim nakupom zdravil in
- the type of minimum background information on the risks related to buying medicinal products on the internet , and
– posebne postopke nadzora za izdajo dovoljenj spletnim lekarnam.
- specific control procedures for the authorisation of internet pharmacies.