natgillin/translations-raw huggingface dataset:
Advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products.
Zdravila za napredno zdravljenje, kakor so opredeljena v členu 2 Uredbe (ES) št. 1394/2007 Evropskega parlamenta in Sveta z dne 13. novembra 2007 o zdravilih za napredno zdravljenje.
In point 3, the second subparagraph shall be replaced by the following:
drugi pododstavek točke 3 se nadomesti z:
‘After 20 May 2008, the Commission, having consulted the Agency, may present any appropriate proposal to amend this point and the European Parliament and the Council shall take a decision thereon in accordance with the Treaty.’
„Po 20. maju 2008 lahko Komisija po posvetovanju z Agencijo predloži kateri koli ustrezen predlog za spremembo te točke, Evropski parlament in Svet pa v skladu s Pogodbo o tem sprejmeta odločitev.“.
Amendments to Directive 2001/83/EC
Spremembe k Direktivi 2001/83/ES
Directive 2001/83/EC is hereby amended as follows:
Direktiva 2001/83/ES se spremeni:
in Article 1, the following point shall be inserted:
v členu 1 se vstavi naslednja točka:
Advanced therapy medicinal product:
Zdravilo za napredno zdravljenje:
A product as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products.2. in Article 3, the following point shall be added:
Izdelek, kakor je opredeljen v členu 2 Uredbe (ES) št. 1394/2007 Evropskega parlamenta in Sveta z dne 13. novembra 2007 o zdravilih za napredno zdravljenje.2. v členu 3 se doda naslednja točka:
Any advanced therapy medicinal product, as defined in Regulation (EC) No 1394/2007, which is prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient.
Katero koli zdravilo za napredno zdravljenje, kakor je opredeljeno v Uredbi (ES) št. 1394/2007, ki je pripravljeno nerutinsko v skladu s posebnimi standardi kakovosti in uporabljeno v bolnišnici v isti državi članici ob izključni poklicni odgovornosti zdravnika v skladu s posameznim receptom za posamično zdravilo za posameznega bolnika.
Manufacturing of these products shall be authorised by the competent authority of the Member State.
Izdelavo teh izdelkov odobri pristojni organ države članice.
Member States shall ensure that national traceability and pharmacovigilance requirements as well as the specific quality standards referred to in this paragraph are equivalent to those provided for at Community level in respect of advanced therapy medicinal products for which authorisation is required pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.3. in Article 4, the following paragraph shall be added:
Države članice zagotovijo, da so nacionalne zahteve po sledljivosti in farmakovigilanci kot tudi posebni standardi kakovosti iz tega odstavka enaki tistim, ki so za zdravila za napredno zdravljenje, za katera se zahteva odobritev v skladu z Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila, zagotovljeni na ravni Skupnosti.3. v členu 4 se doda naslednji odstavek:
This Directive and all Regulations referred to therein shall not affect the application of national legislation prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from these cells, on grounds not dealt with in the aforementioned Community legislation.
Ta direktiva in vse v njej navedene uredbe ne vplivajo na uporabo nacionalne zakonodaje, ki prepoveduje ali omejuje uporabo kakršne koli posebne vrste človeških ali živalskih celic ali prodajo, dobavo ali uporabo zdravil, ki vsebujejo te celice ali jih te celice sestavljajo ali so izdelane na njihovi podlagi, iz razlogov, ki jih ne obravnava zgoraj navedena zakonodaja Skupnosti.
The Member States shall communicate the national legislation concerned to the Commission.
Države članice Komisijo obvestijo o zadevni nacionalni zakonodaji.
The Commission shall make this information publicly available in a register.’;
Komisija te podatke objavi v registru.“;
in Article 6(1), the first subparagraph shall be replaced by the following:
v členu 6(1) se prvi pododstavek nadomesti z:
‘No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004, read in conjunction with Regulation (EC) No 1394/2007.’
„Zdravilo je lahko v državi članici dano na trg samo na podlagi dovoljenja za promet, ki ga pristojni organi navedene države članice izdajo v skladu s to direktivo ali ki je bilo izdano v skladu z Uredbo (ES) št. 726/2004 v povezavi z Uredbo (ES) št. 1394/2007.“
Advanced therapy medicinal products, other than tissue engineered products, which were legally on the Community market in accordance with national or Community legislation on 30 December 2008, shall comply with this Regulation no later than 30 December 2011.
Zdravila za napredno zdravljenje, razen izdelkov tkivnega inženirstva, ki so bila 30. decembra 2008 v skladu z nacionalno zakonodajo ali zakonodajo Skupnosti zakonito na trgu Skupnosti, je treba uskladiti s to uredbo najpozneje do 30. decembra 2011.
Tissue engineered products which were legally on the Community market in accordance with national or Community legislation on 30 December 2008 shall comply with this Regulation no later than 30 December 2012.
Izdelke tkivnega inženirstva, ki so bili 30. decembra 2008 v skladu z nacionalno zakonodajo ali zakonodajo Skupnosti zakonito na trgu Skupnosti, je treba uskladiti s to uredbo najpozneje do 30. decembra 2012.
By way of derogation from Article 3(1) of Regulation (EC) No 297/95, no fee shall be payable to the Agency in respect of applications submitted for the authorisation of the advanced therapy medicinal products mentioned in paragraphs 1 and 2 of this Article.
Z odstopanjem od člena 3(1) Uredbe (ES) št. 297/95 se Agenciji v zvezi z vlogami, predloženimi za dovoljenje za promet z zdravili za napredno zdravljenje, navedenimi v odstavkih 1 in 2 tega člena, ne plačujejo pristojbine.
It shall apply from 30 December 2008.
Uporablja se od 30. decembra 2008.
OJ C 309, 16.12.2006, p. 15.
UL C 309, 16.12.2006, str. 15.
Opinion of the European Parliament of 25 April 2007 (not yet published in the Official Journal) and Council Decision of 30 October 2007.
Mnenje Evropskega parlamenta z dne 25. aprila 2007 (še ni objavljeno v Uradnem listu) in Sklep Sveta z dne 30. oktobra 2007.
Regulation as amended by Regulation (EC) No 1901/2006.
Uredba, kakor je bila spremenjena z Uredbo (ES) št. 1901/2006.
Directive as amended by Regulation (EC) No 1901/2006.
Direktiva, kakor je bila spremenjena z Uredbo (ES) št. 1901/2006.
Directive as last amended by Directive 2007/47/EC of the European Parliament and of the Council (OJ L 247, 21.9.2007, p. 21).
Direktiva, kakor je bila nazadnje spremenjena z Direktivo 2007/47/ES Evropskega parlamenta in Sveta (UL L 247, 21.9.2007, str. 21).
Directive as last amended by Directive 2007/47/EC.
Direktiva, kakor je bila nazadnje spremenjena z Direktivo 2007/47/ES.
OJ L 324, 10.12.2007, p. 121’;
UL L 324, 10.12.2007, str. 121.“;
Regulation as amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).’;
Uredba, kakor je bila spremenjena z Uredbo (ES) št. 1901/2006 (UL L 378, 27.12.2006, str. 1).“;
Manipulations referred to in the first indent of Article 2(1)(c)
Manipulacije iz prve alinee člena 2(1)(c)
cutting,
rezanje,
grinding,
mletje,
shaping,
oblikovanje,
centrifugation,
centrifugiranje,
soaking in antibiotic or antimicrobial solutions,
namakanje v antibiotičnih ali protimikrobnih raztopinah,
sterilization,
sterilizacija,
irradiation,
obsevanje,
cell separation, concentration or purification,
ločevanje celic, koncentriranje ali čiščenje,
filtering,
filtriranje,
lyophilization,
liofilizacija,
freezing,
zamrzovanje,
cryopreservation,
shranjevanje z zamrzovanjem,
vitrification.
vitrifikacija.
Summary of product characteristics referred to in Article 10
Povzetek glavnih značilnosti zdravila iz člena 10
Name of the medicinal product.
Ime zdravila.
Composition of the product:
Sestava izdelka:
general description of the product, if necessary with explanatory drawings and pictures,
splošni opis izdelka, po potrebi, opremljen z razlagalnimi grafičnimi prikazi in risbami;
qualitative and quantitative composition in terms of the active substances and other constituents of the product, knowledge of which is essential for proper use, administration or implantation of the product.
kakovostna in količinska sestava zdravilnih učinkovin in drugih sestavin izdelka, ki so bistvenega pomena za ustrezno uporabo, dajanje ali vsaditev izdelka.
Where the product contains cells or tissues, a detailed description of these cells or tissues and of their specific origin, including the species of animal in cases of non-human origin, shall be provided,
Kadar izdelek vsebuje celice ali tkiva, se zagotovi podroben opis teh celic ali tkiv in njihovega posebnega izvora, vključno z vrsto živali v primerih nečloveškega izvora.
For a list of excipients, see point 6.1.
Za seznam pomožnih snovi glej točko 6.1.
Pharmaceutical form.
Farmacevtska oblika.
Clinical particulars:
Klinični podatki:
therapeutic indications,
terapevtske indikacije;
posology and detailed instructions for use, application, implantation or administration for adults and, where necessary, for children or other special populations, if necessary with explanatory drawings and pictures,
odmerjanje in podrobna navodila za uporabo, aplikacijo, vsaditev ali dajanje odraslim, in po potrebi, otrokom ali drugim posebnim uporabnikom, po potrebi z razlagalnimi grafičnimi prikazi in risbami;
contra-indications,
kontraindikacije;
special warnings and precautions for use, including any special precautions to be taken by persons handling such products and administering them to or implanting them in patients, together with any precautions to be taken by the patient,
posebna opozorila in previdnostni ukrepi pri uporabi, vključno z vsemi posebnimi previdnostnimi ukrepi, ki jih morajo osebe, ki imajo opraviti s takimi zdravili in jih dajejo ali vsadijo bolnikom, upoštevati skupaj z vsemi previdnostnimi ukrepi, ki jih mora upoštevati bolnik;
interaction with other medicinal products and other forms of interactions,
medsebojno delovanje z drugimi zdravili in druge oblike interakcij;
use during pregnancy and lactation,
uporaba med nosečnostjo in dojenjem;
effects on ability to drive and to use machines,
vpliv na sposobnost vožnje in upravljanje s stroji;
undesirable effects,
neželeni učinki;
overdose (symptoms, emergency procedures).
preveliko odmerjanje (simptomi, nujni ukrepi).
Pharmacological properties:
Farmakološki podatki:
pharmacodynamic properties,
farmakodinamične lastnosti;
pharmacokinetic properties,
farmakokinetične lastnosti;
preclinical safety data.
neklinični podatki o varnosti.
Quality particulars:
Podatki o kakovosti:
list of excipients, including preservative systems,
seznam pomožnih snovi, vključno s sistemi konzerviranja;
incompatibilities,
inkompatibilnosti;
shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time,
rok uporabnosti, in če je potrebno, po rekonstituciji zdravila ali po prvem odpiranju stične ovojnine;
special precautions for storage,
posebna navodila za shranjevanje;
nature and contents of container and special equipment for use, administration or implantation, if necessary with explanatory drawings and pictures,
vrsta in vsebina ovojnine ter posebne opreme za uporabo, dajanje ali vsaditev, če je potrebno, skupaj z razlagalnimi grafičnimi prikazi in risbami;
special precautions and instructions for handling and disposal of a used advanced therapy medicinal product or waste materials derived from such product, if appropriate and, if necessary, with explanatory drawings and pictures.
posebni previdnostni ukrepi ter navodila za ravnanje in odlaganje uporabljenih zdravil za napredno zdravljenje ali odpadkov, ki iz njih nastanejo, če je to primerno in, če je potrebno, opremljen z razlagalnimi grafičnimi prikazi in risbami.
Marketing authorisation holder.
Imetnik dovoljenja za promet.
Marketing authorisation number(s).
Številka(-e) dovoljenja za promet z zdravilom.
Date of the first authorisation or renewal of the authorisation.
Datum prve pridobitve ali podaljšanja dovoljenja za promet.
Date of revision of the text.
Datum pregleda besedila.
Labelling of outer/immediate packaging referred to in Article 11
Označevanje zunanje/stične ovojnine iz člena 11
The name of the medicinal product and, if appropriate, an indication of whether it is intended for babies, children or adults; the international non-proprietary name (INN) shall be included, or, if the product has no INN, the common name;
Ime zdravila in, če je primerno, navedba, ali je zdravilo namenjeno dojenčkom, otrokom ali odraslim; dodati je treba mednarodno nelastniško ime (INN), ali če to ne obstaja, običajno splošno ime;
A description of the active substance(s) expressed qualitatively and quantitatively, including, where the product contains cells or tissues, the statement ‘This product contains cells of human/animal [as appropriate] origin’ together with a short description of these cells or tissues and of their specific origin, including the species of animal in cases of non-human origin;
opis zdravilne(-ih) učinkovine(-e) z navedbo kakovostne in količinske sestave ter kadar izdelek vsebuje celice ali tkiva, še navedba: „Ta izdelek vsebuje celice človeškega/živalskega [kot je ustrezno] izvora“, skupaj s kratkim opisom teh celic ali tkiv in njihovega posebnega izvora, vključno z vrsto živali v primerih nečloveškega izvora;
The pharmaceutical form and, if applicable, the contents by weight, by volume or by number of doses of the product;
farmacevtska oblika in, če je primerno, vsebina izražena v enotah mase, prostornine ali številu odmerkov zdravila;
A list of excipients, including preservative systems;
seznam pomožnih snovi, vključno s sistemi konzerviranja;
The method of use, application, administration or implantation and, if necessary, the route of administration.
postopek za uporabo, aplikacijo, vsaditev ali dajanje in, če je potrebno, pot uporabe zdravila.
If applicable, space shall be provided for the prescribed dose to be indicated;
Če je primerno, je treba zagotoviti prostor, kamor se vpiše predpisan odmerek zdravila;
A special warning that the medicinal product must be stored out of the reach and sight of children;
posebno opozorilo, da je zdravilo treba shranjevati nedosegljivo otrokom;
Any special warning necessary for the particular medicinal product;
katero koli posebno opozorilo za določeno zdravilo, če je to potrebno;
The expiry date in clear terms (month and year; and day if applicable);
jasno izražen datum izteka roka uporabnosti (mesec in leto ter dan, če je primerno);
Special storage precautions, if any;
posebna navodila za shranjevanje, če obstajajo;
Specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, where appropriate, as well as reference to any appropriate collection system in place;
posebni varnostni ukrepi za odstranjevanje neuporabljenih zdravil ali iz njih nastalih odpadnih snovi, če je to primerno, kot tudi navedba vsakega ustreznega uveljavljenega sistema zbiranja teh snovi;
The name and address of the marketing authorisation holder and, where applicable, the name of the representative appointed by the holder to represent him;
ime in naslov imetnika dovoljenja za promet in, če je to primerno, ime predstavnika, ki ga za zastopanje imenuje imetnik dovoljenja za promet;
Marketing authorisation number(s);
številko dovoljenja za promet z zdravilom;
The manufacturer’s batch number and the unique donation and product codes referred to in Article 8(2) of Directive 2004/23/EC;
serijska številka proizvajalca ter enotne oznake darovanja in izdelkov, kakor so navedene v členu 8(2) Direktive 2004/23/ES;
In the case of advanced therapy medicinal products for autologous use, the unique patient identifier and the statement ‘For autologous use only’.
v primeru zdravil za napredno zdravljenje za avtologno uporabo enotna identifikacijska oznaka bolnika in izjava „samo za avtologno uporabo“.
Package leaflet referred to in Article 13
Navodilo za uporabo iz člena 13
For the identification of the advanced therapy medicinal product:
Za identifikacijo zdravila za napredno zdravljenje:
the name of the advanced therapy medicinal product and, if appropriate, an indication of whether it is intended for babies, children or adults.
ime zdravila za napredno zdravljenje in, če je primerno, navedba, ali je zdravilo namenjeno dojenčkom, otrokom ali odraslim.
The common name shall be included;
Navede se tudi splošno ime;
the therapeutic group or type of activity in terms easily understandable for the patient;
terapevtsko skupino ali način delovanja v bolniku lahko razumljivem jeziku;
where the product contains cells or tissues, a description of those cells or tissues and of their specific origin, including the species of animal in cases of non-human origin;
kadar zdravilo vsebuje celice ali tkiva, se zagotovi podroben opis teh celic ali tkiva in njihovega posebnega izvora, vključno z vrsto živali v primerih nečloveškega izvora;
where the product contains medical devices or active implantable medical devices, a description of those devices and their specific origin;
kadar zdravilo vsebuje medicinske pripomočke ali medicinske pripomočke za vsaditev, opis teh pripomočkov in njihovega posebnega izvora.
The therapeutic indications;
terapevtske indikacije;
A list of information which is necessary before the medicinal product is taken or used, including:
seznam podatkov, ki jih je treba poznati pred jemanjem ali uporabo zdravila, vključno s:
contra-indications;
kontraindikacijami;
appropriate precautions for use;
ustreznimi previdnostni ukrepi za uporabo;
forms of interaction with other medicinal products and other forms of interaction (e.g. alcohol, tobacco, foodstuffs) which may affect the action of the medicinal product;
oblikami medsebojnega delovanja z drugimi zdravili ter drugimi oblikami interakcij (npr. alkohol, tobak, hrana), ki lahko vplivajo na delovanje zdravila;
special warnings;
posebnimi opozorili;
if appropriate, possible effects on the ability to drive vehicles or to operate machinery;
če je to primerno, z morebitnimi vplivi na sposobnost vožnje ali upravljanja s stroji;
the excipients, knowledge of which is important for the safe and effective use of the medicinal product and which are included in the detailed guidance published pursuant to Article 65 of Directive 2001/83/EC.
pomožnimi snovmi, za katere je znano, da so pomembne za varno in učinkovito uporabo zdravil in so zajete v podrobnih smernicah, objavljenih v skladu s členom 65 Direktive 2001/83/ES.
The list shall also take into account the particular condition of certain categories of users, such as children, pregnant or breastfeeding women, the elderly, persons with specific pathological conditions;
Ta seznam upošteva tudi posebne pogoje nekaterih skupin uporabnikov, kot so otroci, nosečnice ali doječe matere, starejši, osebe s posebnimi bolezenskimi stanji;
The necessary and usual instructions for proper use, and in particular:
običajni podatki, potrebni za pravilno uporabo, zlasti:
the posology;
odmerjanje;
the method of use, application, administration or implantation and, if necessary, the route of administration;
postopek uporabe, aplikacije, dajanja ali vsaditve in, če je potrebno, pot uporabe zdravila;
and, as appropriate, depending on the nature of the product:
in, če je primerno, glede na naravo zdravila:
the frequency of administration, specifying if necessary the appropriate time at which the medicinal product may or must be administered;
pogostost uporabe zdravila, in, če je potrebno, navedba primernega časa, ko se zdravilo sme ali mora jemati;
the duration of treatment, where it should be limited;
trajanje zdravljenja, kadar bi moralo biti omejeno;
the action to be taken in case of an overdose (such as symptoms, emergency procedures);
ukrepi, ki jih je treba sprejeti v primeru prevelikega odmerjanja (npr. simptomi, nujni postopki);
information on what to do when one or more doses have not been taken;
podatki o načinu ukrepanja, če je bolnik izpustil enega ali več odmerkov;
a specific recommendation to consult the doctor or the pharmacist, as appropriate, for any clarification on the use of the product;
posebno priporočilo, naj se bolnik glede pojasnil o uporabi zdravila posvetuje z zdravnikom ali farmacevtom, kakor je primerno;
A description of the adverse reactions which may occur under normal use of the medicinal product and, if necessary, the action to be taken in such a case; the patient should be expressly asked to communicate any adverse reaction which is not mentioned in the package leaflet to his doctor or pharmacist;
opis neželenih učinkov, ki se lahko pojavijo pri običajni uporabi zdravila, in če je potrebno, ukrepi, ki jih je treba sprejeti v takem primeru; bolnika je treba izrecno pozvati, da o vseh neželenih učinkih, ki niso navedeni v navodilu, takoj obvesti zdravnika ali farmacevta;
A reference to the expiry date indicated on the label, with:
navedba glede datuma izteka roka uporabnosti, navedenega na ovojnini:
a warning against using the product after that date;
z opozorilom, da se zdravilo po navedenem datumu izteka roka uporabnosti ne sme uporabljati;
where appropriate, special storage precautions;
s posebnimi navodili za shranjevanje, kadar je primerno;
if necessary, a warning concerning certain visible signs of deterioration;
z opozorilom v zvezi z določenimi vidnimi znaki kvarjenja, kadar je potrebno;
the full qualitative and quantitative composition;
s polno kakovostno in količinsko sestavo zdravila;
the name and address of the marketing authorisation holder and, where applicable, the name of his appointed representatives in the Member States;
z imenom in naslovom imetnika dovoljenja za promet, in če je to primerno, imenom predstavnika, ki ga imetnik dovoljenja imenuje v državah članicah;
the name and address of the manufacturer;
z imenom in naslovom proizvajalca;
The date on which the package leaflet was last revised.
datum zadnjega pregleda navodila za uporabo.
Corrigendum to Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004
Popravek Uredbe (ES) št. 1394/2007 Evropskega parlamenta in Sveta z dne 13. novembra 2007 o zdravilih za napredno zdravljenje ter o spremembi Direktive 2001/83/ES in Uredbe (ES) št. 726/2004
(Official Journal of the European Union L 324 of 10 December 2007)
(Uradni list Evropske unije L 324 z dne 10. decembra 2007)
On page 131, Article 28, Amendments to Directive 2001/83/EC, point 4:
Stran 131, člen 28, spremembe k Direktivi (ES) št. 2001/83/ES, točka 4:
in Article 6(1), the first subparagraph shall be replaced by the following:
v členu 6(1) se prvi pododstavek nadomesti z naslednjim: