natgillin/translations-raw huggingface dataset:
Where an urgent safety restriction is taken by the holder or imposed by a relevant authority or the Commission, the holder shall submit the corresponding application for variation within 15 days following the initiation of that restriction.
Če nujni varnostni ukrep sprejme imetnik ali ga uvede ustrezni organ ali Komisija, imetnik predloži ustrezno vlogo za spremembo v 15 dneh po uvedbi tega ukrepa.
Amendments to the decision granting the marketing authorisation and implementation
Spremembe odločbe o izdaji dovoljenja za promet z zdravilom in začetek uveljavitve
Amendments to the decision granting the marketing authorisation
Spremembe odločbe o izdaji dovoljenja za promet z zdravilom
The amendment to the decision granting the marketing authorisation resulting from the procedures laid down in Chapters II and III shall be made:
Sprememba odločbe o dovoljenju za promet z zdravilom na podlagi postopkov iz poglavij II in III se izvede:
within 30 days following receipt of the information referred to in Article 11(1)(c) and Article 17(1)(c), where the concerned variation leads to a six-month extension of the period referred to in Article 13(1) and (2) of Council Regulation (EEC) No 1768/92 [10], in accordance with Article 36 of Regulation (EC) No 1901/2006;
v 30 dneh po prejemu informacij iz členov 11(1)(c) in 17(1)(c), če je posledica zadevne spremembe šestmesečno podaljšanje roka iz člena 13(1) in (2) Uredbe Sveta (EGS) št. 1768/92 [10] v skladu s členom 36 Uredbe (ES) št. 1901/2006;
within two months following receipt of the information referred to in Article 11(1)(c) and Article 17(1)(c), in the case of major variations of type II and minor variations of type IA which do not require immediate notification for the continuous supervision of the medicinal product concerned;
v dveh mesecih po prejemu informacij iz členov 11(1)(c) in 17(1)(c) pri večjih spremembah tipa II in manjših spremembah tipa IA, ki jih ni treba takoj priglasiti zaradi stalnega nadzora zadevnega zdravila;
within six months following receipt of the information referred to in Article 11(1)(c) and Article 17(1)(c), in the other cases.
v šestih mesecih po prejemu informacij iz členov 11(1)(c) in 17(1)(c), v drugih primerih.
Where the decision granting a marketing authorisation is amended as a result of one of the procedures laid down in Chapters II, III and IV, the relevant authority or, in the case of centralised marketing authorisations, the Commission shall notify the amended decision without delay to the holder.
Če se odločba o izdaji dovoljenja za promet z zdravilom spremeni zaradi enega od postopkov iz poglavij II, III in IV, ustrezni organ ali pri centraliziranih dovoljenjih za promet Komisija takoj obvesti imetnika o spremenjeni odločbi.
Implementation of variations
Začetek uveljavitve sprememb
A minor variation of type IA may be implemented any time before completion of the procedures laid down in Articles 8 and 14.
Manjša sprememba tipa IA se lahko uveljavi kadar koli pred koncem postopkov iz členov 8 in 14.
Where a notification concerning one or several minor variations of type IA is rejected, the holder shall cease to apply the concerned variation(s) immediately after receipt of the information referred to in Articles 11(1)(a) and 17(1)(a).
Če se priglasitev ene ali več manjših sprememb tipa IA zavrne, imetnik preneha izvajati zadevno spremembo oziroma spremembe takoj po prejemu informacij iz členov 11(1)(c) in 17(1)(c).
Minor variations of type IB may only be implemented in the following cases:
Manjše spremembe tipa IB se lahko uveljavijo samo v naslednjih primerih:
after the competent authority of the reference Member State has informed the holder that it has accepted the notification pursuant to Article 9, or after the notification is deemed accepted pursuant to Article 9(2);
ko pristojni organ referenčne države članice obvesti imetnika, da je sprejel priglasitev v skladu s členom 9, ali potem ko se priglasitev šteje za sprejeto v skladu s členom 9(2);
after the Agency has informed the holder that its opinion referred to in Article 15 is favourable, or after that opinion is deemed favourable pursuant to Article 15(2);
ko Agencija obvesti imetnika, da je njeno mnenje iz člena 15 pozitivno, ali potem ko se mnenje šteje za pozitivno v skladu s členom 15(2);
after the reference authority referred to in Article 20 has informed the holder that its opinion is favourable.
ko referenčni organ iz člena 20 obvesti imetnika, da je njegovo mnenje pozitivno.
Major variations of type II may only be implemented in the following cases:
Večje spremembe tipa II se lahko uveljavijo samo v naslednjih primerih:
30 days after the competent authority of the reference Member State has informed the holder that it has accepted the variation pursuant to Article 10, under the condition that the documents necessary for the amendment to the marketing authorisation have been provided to the Member States concerned;
30 dni po tem ko pristojni organ referenčne države članice obvesti imetnika, da je sprejel spremembo v skladu s členom 10, pod pogojem, da so bili dokumenti, potrebni za spremembo dovoljenja za promet, predloženi zadevnim državam članicam;
after the Commission has amended the decision granting the marketing authorisation in accordance with the accepted variation and notified the holder accordingly;
ko Komisija spremeni odločbo o izdaji dovoljenja za promet z zdravilom v skladu s sprejeto spremembo in o tem obvesti imetnika;
30 days after the reference authority referred to in Article 20 has informed the holder that its final opinion is favourable, unless an arbitration procedure in accordance with Article 13 or a referral procedure in accordance with Article 35 of Directive 2001/82/EC or Article 31 of Directive 2001/83/EC has been initiated.
30 dni po tem, ko referenčni organ iz člena 20 obvesti imetnika, da je njegovo končno mnenje pozitivno, razen če je bil sprožen arbitražni postopek v skladu s členom 13 ali postopek napotitve v skladu s členom 35 Direktive 2001/82/ES ali členom 31 Direktive 2001/83/ES.
An extension may only be implemented after the relevant authority or, in the case of extensions to a centralised marketing authorisation, the Commission has amended the decision granting the marketing authorisation in accordance with the approved extension and notified the holder accordingly.
Razširitev se lahko uveljavi, ko ustrezni organ ali pri razširitvah centraliziranih dovoljenj za promet z zdravili Komisija spremeni odločbo o izdaji dovoljenja za promet z zdravilom v skladu z odobreno razširitvijo in o tem obvesti imetnika.
Urgent safety restrictions and variations which are related to safety issues shall be implemented within a time frame agreed by the holder and the relevant authority and, in the case of a centralised marketing authorisation, the Commission.
Nujni varnostni ukrepi in spremembe, povezane z varnostnimi vprašanji, se uveljavijo v časovnem okviru, za katerega se dogovori imetnik z ustreznim organom, pri centraliziranih dovoljenjih za promet z zdravili pa s Komisijo.
By way of derogation from the first subparagraph, urgent safety restrictions and variations related to safety issues which concern marketing authorisations granted in accordance with Chapter 4 of Directive 2001/82/EC or Chapter 4 of Directive 2001/83/EC shall be implemented within a time frame agreed by the holder and the competent authority of the reference Member State, in consultation with the other relevant authorities.
Z odstopanjem od prvega pododstavka se nujni varnostni ukrepi in spremembe, povezane z varnostnimi vprašanji, ki se nanašajo na dovoljenja za promet z zdravili, izdana v skladu s poglavjem 4 Direktive 2001/82/ES ali poglavjem 4 Direktive 2001/83/ES, uveljavijo v časovnem okviru, za katerega se dogovorita imetnik in pristojni organ referenčne države članice po posvetovanju z drugimi ustreznimi organi.
Where requested by a relevant authority, the holder shall supply without delay any information related to the implementation of a given variation.
Na zahtevo ustreznega organa imetnik takoj predloži katere koli informacije v zvezi z začetkom uveljavitve določene spremembe.
By two years from the date referred to in the second subparagraph of Article 28, the Commission services shall assess the application of this Regulation as regards the classification of variations, with a view to proposing any necessary amendments to adapt Annexes I, II and V to take account of scientific and technical progress.
V dveh letih od datuma iz drugega pododstavka člena 28 službe Komisije ocenijo uporabo te uredbe v zvezi z razvrstitvijo sprememb z namenom predložitve kakršnih koli potrebnih sprememb za prilagoditev prilog I, II in V, da se upošteva znanstveni in tehnični napredek.
Repeal and transitional provision
Razveljavitev in prehodna določba
Regulations (EC) No 1084/2003 and (EC) No 1085/2003 are hereby repealed.
Uredbi (ES) št. 1084/2003 in (ES) št. 1085/2003 se razveljavita.
References to the repealed Regulations shall be construed as references to this Regulation.
Sklicevanje na razveljavljeni uredbi se šteje kot sklicevanje na to uredbo.
By way of derogation from paragraph 1, Regulations (EC) Nos 1084/2003 and 1085/2003 shall continue to apply to valid notifications or applications for variations which are pending at the date referred to in the second subparagraph of Article 28.
Z odstopanjem od odstavka 1 se uredbi (ES) št. 1084/2003 in (ES) št. 1085/2003 še naprej uporabljata za formalno popolne priglasitve ali vloge za spremembe, ki še niso zaključene na datum iz drugega pododstavka člena 27.
It shall apply from 1 January 2010.
Uporabljati se začne 1. januarja 2010.
By way of derogation from the second subparagraph, the recommendations on unforeseen variations provided for in Article 5 may be requested, delivered and published from the date of entry into force referred to in the first subparagraph.
Z odstopanjem od drugega pododstavka se lahko zahtevajo priporočila o nepričakovanih spremembah iz člena 5, ki se pošljejo in objavijo po datumu začetka veljavnosti iz prvega pododstavka.
OJ L 15, 17.1.1987, p. 38.
UL L 15, 17.1.1987, str. 38.
Changes to the active substance(s):
Spremembe zdravilne učinkovine oziroma učinkovin:
replacement of a chemical active substance by a different salt/ester complex/derivative, with the same therapeutic moiety, where the efficacy/safety characteristics are not significantly different;
nadomestitev kemične zdravilne učinkovine z različnimi oblikami soli / estra kompleksa / derivata, pri čemer ostane struktura s terapevtskim delovanjem enaka, če se lastnosti glede učinkovitosti / varnosti bistveno ne razlikujejo;
replacement by a different isomer, a different mixture of isomers, of a mixture by an isolated isomer (e.g. racemate by a single enantiomer), where the efficacy/safety characteristics are not significantly different;
nadomestitev z drugim izomerom, drugo zmesjo izomerov, nadomestitev zmesi z izoliranim izomerom (npr. racemata z enim samim enantiomerom), če se lastnosti glede učinkovitosti / varnosti bistveno ne razlikujejo;
replacement of a biological active substance with one of a slightly different molecular structure where the efficacy/safety characteristics are not significantly different, with the exception of:
nadomestitev biološke učinkovine s snovjo z nekoliko drugačno molekulsko strukturo, če se lastnosti glede učinkovitosti / varnosti bistveno ne razlikujejo, razen:
changes to the active substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza;
sprememb učinkovine v sezonskih, predpandemičnih ali pandemičnih cepivih proti človeški gripi,
modification of the vector used to produce the antigen or the source material, including a new master cell bank from a different source, where the efficacy/safety characteristics are not significantly different;
sprememba vektorja, ki se uporablja za pridobivanje antigena ali izvornega materiala, vključno s spremembo izvora celične banke, če se lastnosti glede učinkovitosti / varnosti bistveno ne razlikujejo;
a new ligand or coupling mechanism for a radiopharmaceutical, where the efficacy/safety characteristics are not significantly different;
novi ligand ali mehanizem vezave za radiofarmacevtski izdelek, če se lastnosti glede učinkovitosti varnosti bistveno ne razlikujejo;
change to the extraction solvent or the ratio of herbal drug to herbal drug preparation where the efficacy/safety characteristics are not significantly different.
sprememba ekstrakcijskega topila ali razmerja med rastlinsko drogo in pripravkom iz rastlinske droge, če se lastnosti glede učinkovitosti/varnosti bistveno ne razlikujejo.
Changes to strength, pharmaceutical form and route of administration:
Spremembe jakosti, farmacevtske oblike in načina dajanja zdravila:
change of bioavailability;
sprememba biološke uporabnosti;
change of pharmacokinetics e.g. change in rate of release;
sprememba farmakokinetike, npr. hitrosti sproščanja;
change or addition of a new strength/potency;
sprememba ali dodatek nove jakosti/aktivnosti;
change or addition of a new pharmaceutical form;
sprememba ali dodatek nove farmacevtske oblike;
change or addition of a new route of administration [1].
sprememba ali dodatek nove poti uporabe zdravila [1].
Other changes specific to veterinary medicinal products to be administered to food-producing animals: change or addition of target species.
Druge spremembe, značilne za zdravila za uporabo v veterinarski medicini, ki se dajejo živalim, namenjenim za prehrano ljudi: sprememba ali dodatek ciljnih vrst.
For parenteral administration, it is necessary to distinguish between intra-arterial, intravenous, intramuscular, subcutaneous and other routes.
Pri parenteralni uporabi je treba razlikovati med intraarterijskimi, intravenskimi, intramuskularnimi, subkutanimi in drugimi načini.
For administration to poultry, respiratory, oral and ocular (nebulisation) routes used for vaccination are considered to be equivalent routes of administration.
Pri dajanju perutnini se štejejo respiratorne, oralne in očesne (nebulizacijske) poti cepljenja za enakovredne poti.
The following variations shall be classified as minor variations of type IA:
Naslednje spremembe se razvrstijo kot manjše spremembe tipa IA:
variations of purely administrative nature that are related to the identity and contact details of:
čisto administrativne spremembe, ki se nanašajo na identiteto in kontaktne podatke:
the holder;
imetnika,
the manufacturer or supplier of any starting material, reagent, intermediate, active substance used in the manufacturing process or finished product;
izdelovalca ali dobavitelja vhodnih snovi, reagenta, intermediata ali zdravilne učinkovine, ki se uporabljajo v postopku izdelave;
variations related to the deletion of any manufacturing site, including for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place;
spremembe, ki so povezane z opustitvijo katerega koli mesta izdelave, vključno z mestom izdelave zdravilne učinkovine, intermediata ali končnega izdelka, mestom pakiranja, izdelovalcem, odgovornim za sproščanje serij, in mestom, kjer poteka kontrola serij;
variations related to minor changes to an approved physico-chemical test procedure, where the updated procedure is demonstrated to be at least equivalent to the former test procedure, appropriate validation studies have been performed and the results show that the updated test procedure is at least equivalent to the former;
spremembe, ki so povezane z manjšimi spremembami odobrenega postopka preskušanja, če se za novi postopek dokaže, da je najmanj enakovreden prejšnjemu postopku preskušanja, če se izvedejo ustrezne validacijske študije in rezultati pokažejo, da je novi postopek preskušanja najmanj enakovreden prejšnjemu;
variations related to changes made to the specifications of the active substance or of an excipient in order to comply with an update of the relevant monograph of the European Pharmacopoeia or of the national pharmacopoeia of a Member State, where the change is made exclusively to comply with the pharmacopoeia and the specifications for product specific properties are unchanged;
spremembe, ki so povezane s spremembo zdravilne učinkovine ali pomožne snovi zaradi uskladitve s posodobljeno monografijo Evropske farmakopeje ali nacionalne farmakopeje države članice, če se naredi sprememba izključno zaradi uskladitve s farmakopejo, specifikacije za lastnosti, značilne za izdelek, pa ostanejo nespremenjene;
variations related to changes in the packaging material not in contact with the finished product, which do not affect the delivery, use, safety or stability of the medicinal product;
spremembe, ki so povezane s spremembami materiala za pakiranje, ki ne vplivajo na dostavo, uporabo, varnost ali stabilnost zdravila;
variations related to the tightening of specification limits, where the change is not a consequence of any commitment from previous assessment to review specification limits and does not result from unexpected events arising during manufacture.
spremembe, ki so povezane z zoženjem specifikacijskih mej, če sprememba ni posledica kakršnih koli zavez iz predhodnih ocen glede ponovnega pregleda specifikacijskih mej in ni posledica nepredvidenih dogodkov med izdelavo.
The following variations shall be classified as major variations of type II:
Naslednje spremembe se razvrstijo kot večje spremembe tipa II:
variations related to the addition of a new therapeutic indication or to the modification of an existing one;
spremembe, ki so povezane z dodatkom nove terapevtske indikacije ali spremembo sedanje;
variations related to significant modifications of the summary of product characteristics due in particular to new quality, pre-clinical, clinical or pharmacovigilance findings;
spremembe, ki so povezane z znatnimi spremembami povzetka glavnih značilnosti zdravila, zlasti zaradi novih kakovostnih, predkliničnih, kliničnih ugotovitev ali ugotovitev o farmakovigilanci;
variations related to changes outside the range of approved specifications, limits or acceptance criteria;
spremembe, ki so povezane s spremembami, ki se ne nanašajo na odobrene specifikacije, meje ali sprejeta merila;
variations related to substantial changes to the manufacturing process, formulation, specifications or impurity profile of the active substance or finished medicinal product which may have a significant impact on the quality, safety or efficacy of the medicinal product;
spremembe, ki so povezane z znatnimi spremembami postopka izdelave, formulacije, specifikacij ali profila nečistosti zdravilne učinkovine ali končnega zdravila, ki lahko znatno vplivajo na kakovost, varnost ali učinkovitost zdravila;
variations related to modifications in the manufacturing process or sites of the active substance for a biological medicinal product;
spremembe, ki so povezane s spremembami postopka ali kraja izdelave zdravilne učinkovine za biološko zdravilo;
variations related to the introduction of a new design space or the extension of an approved one, where the design space has been developed in accordance with the relevant European and international scientific guidelines;
spremembe, ki so povezane z uvedbo novega prostora za oblikovanje (design space) ali razširitvijo odobrenega, če je bil ta razvit v skladu z ustreznimi evropskimi in mednarodnimi znanstvenimi smernicami;
variations concerning a change to or addition of a non-food producing target species;
spremembe, ki se nanašajo na spremembo ali dodatek ciljnih vrst živali, ki niso namenjene prehrani ljudi;
variations concerning the replacement or addition of a serotype, strain, antigen or combination of serotypes, strains or antigens for a veterinary vaccine against avian influenza, foot-and-mouth disease or bluetongue;
spremembe, ki se nanašajo na nadomestitev ali dodatek serotipa, seva, antigena ali kombinacije serotipov, sevov ali antigenov za veterinarsko cepivo proti aviarni influenci, slinavki in parkljevki ali bolezni modrikastega jezika;
variations concerning the replacement of a strain for a veterinary vaccine against equine influenza;
spremembe, ki se nanašajo na nadomestitev seva za veterinarsko cepivo proti influenci konj;
variations related to changes to the active substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza;
spremembe, ki so povezane s spremembami zdravilne učinkovine sezonskega, predpandemičnega ali pandemičnega cepiva proti človeški gripi;
variations related to changes to the withdrawal period for a veterinary medicinal product.
spremembe, ki so povezane s spremembami karence za zdravilo za uporabo v veterinarski medicini.
Cases for grouping variations referred to in Article 7(2)(b)
Primeri združevanja sprememb v skupine v skladu s členom 7(2)(b)
One of the variations in the group is an extension of the marketing authorisation.
Ena od sprememb v skupini je razširitev dovoljenja za promet z zdravilom.
One of the variations in the group is a major variation of type II; all other variations in the group are variations which are consequential to this major variation of type II.
Ena od sprememb v skupini je večja sprememba tipa II, vse druge spremembe v skupini pa so spremembe, ki so posledice te večje spremembe tipa II.
One of the variations in the group is a minor variation of type IB; all other variations in the group are minor variations which are consequential to this minor variation of type IB.
Ena od sprememb v skupini je manjša sprememba tipa IB, vse druge spremembe v skupini pa so manjše spremembe, ki so posledice te manjše spremembe tipa IB.
All variations in the group relate solely to changes of administrative nature to the summary of product characteristics, labelling and package leaflet or insert.
Vse spremembe v skupini se nanašajo izključno na administrativne spremembe povzetka glavnih značilnosti zdravila, označevanja in navodil za uporabo.
All variations in the group are changes to an Active Substance Master File, Vaccine Antigen Master File or Plasma Master File.
Vse spremembe v skupini so spremembe glavne dokumentacije o zdravilni učinkovini, glavne dokumentacije o antigenu cepiva ali glavnega dosjeja o plazmi.
All variations in the group relate to a project intended to improve the manufacturing process and the quality of the medicinal product concerned or its active substance(s).
Vse spremembe v skupini se nanašajo na projekt, ki je namenjen za izboljšanje postopka izdelave in kakovosti zadevnega zdravila ali njegove zdravilne učinkovine oziroma učinkovin.
All variations in the group are changes affecting the quality of a human pandemic influenza vaccine.
Vse spremembe v skupini so spremembe, ki vplivajo na kakovost pandemičnega cepiva proti človeški gripi.
All variations in the group are changes to the pharmacovigilance system referred to in points (ia) and (n) of Article 8(3) of Directive 2001/83/EC or points (k) and (o) of Article 12(3) of Directive 2001/82/EC.
Vse spremembe v skupini so spremembe sistema farmakovigilance iz točk (ia) in (n) člena 8(3) Direktive 2001/83/ES ali točk (k) in (o) člena 12(3) Direktive 2001/82/ES.
All variations in the group are consequential to a given urgent safety restriction and submitted in accordance with Article 22.
Vse spremembe v skupini so posledica nekega varnostnega ukrepa in so predložene v skladu s členom 22.
All variations in the group relate to the implementation of a given class labelling.
Vse spremembe v skupini se nanašajo na označevanje posamezne skupine zdravil.
All variations in the group are consequential to the assessment of a given periodic safety update report.
Vse spremembe v skupini so posledica ocene redno posodobljenega poročila o varnosti zdravila.
All variations in the group are consequential to a given post-authorisation study conducted under the supervision of the holder.
Vse spremembe v skupini so posledica neke študije po izdaji dovoljenja za promet z zdravilom, ki se izvede pod imetnikovim nadzorom.
All variations in the group are consequential to a specific obligation carried out pursuant to Article 14(7) of Regulation (EC) No 726/2004.
Vse spremembe v skupini so posledica posebne obveznosti, ki se izpolni v skladu s členom 14(7) Uredbe (ES) št. 726/2004.