natgillin/translations-raw huggingface dataset:
Within 60 days of receipt of a request as referred to in paragraph 6, the Committee shall re-examine its opinion.
V 15 dneh po prejemu mnenja iz člena 83(5) ter ob upoštevanju postopkov iz člena 83(6) in (7) Komisija pripravi osnutek sklepa.
The reasons for the conclusion reached shall be annexed to the assessment report referred to in paragraph 5.
Če osnutek sklepa ni v skladu z mnenjem Agencije, Komisija v prilogi k osnutku sklepa poda tudi podrobno obrazložitev razlogov za razlike.
Article 84
Komisija osnutek sklepa pošlje državam članicam.
Decision following the Union interest referral
Komisija z izvedbenimi akti na podlagi osnutka sklepa sprejme sklep o napotitvi zaradi interesov Unije.
Within 15 days of receipt of the opinion referred to in Article 83(5), and subject to the procedures referred to in Article 83(6) and (7), the Commission shall prepare a draft decision.
Razen če v obvestilu o napotitvi v skladu s členom 82 ni drugače navedeno, se sklep Komisije uporablja za zdravila za uporabo v veterinarski medicini, na katera se nanaša napotitev.
If the draft decision is not in accordance with the opinion of the Agency, the Commission shall also provide a detailed explanation of the reasons for the differences in an annex to that draft decision.
Kadar so bila zdravila za uporabo v veterinarski medicini, na katera se nanaša napotitev, odobrena v skladu z nacionalnim postopkom, postopkom vzajemnega priznavanja ali decentraliziranim postopkom, se sklep Komisije iz odstavka 3 naslovi na vse države članice in pošlje v vednost zadevnim imetnikom dovoljenj za promet.
The Commission shall forward the draft decision to Member States.
Pristojni organi in zadevni imetniki dovoljenja za promet za skladnost s sklepom Komisije iz odstavka 3 tega člena sprejmejo vse potrebne ukrepe za dovoljenja za promet z zadevnimi zdravili za uporabo v veterinarski medicini v 30 dneh od uradnega obvestila, razen če v tem sklepu ni določen drugačen rok.
The Commission shall, by means of implementing acts, take a decision on the Union interest referral.
Med temi ukrepi je po potrebi zahteva, da imetnik dovoljenja za promet vloži vlogo za spremembo iz člena 62(1).
Unless otherwise stated in the referral notification in accordance with Article 82, the decision of the Commission shall apply to the veterinary medicinal products concerned by the referral.
V primeru, da se napotitev nanaša na zdravila za uporabo v veterinarski medicini, odobrena s centraliziranim postopkom, Komisija pošlje svoj sklep iz odstavka 3 imetniku dovoljenja za promet, sporoči pa ga tudi državam članicam.
Where the veterinary medicinal products concerned by the referral have been authorised in accordance with the national, mutual recognition or decentralised procedures, the decision of the Commission referred to in paragraph 3 shall be addressed to all Member States and communicated for information to the marketing authorisation holders concerned.
Zdravila za uporabo v veterinarski medicini, odobrena na nacionalni ravni, za katera se uporabi postopek napotitve, se obravnavajo v postopku vzajemnega priznavanja.
Competent authorities and marketing authorisation holders concerned shall take any necessary action with regard to the marketing authorisations for the veterinary medicinal products concerned to comply with the decision of the Commission referred to in paragraph 3 of this Article within 30 days of its notification, unless a different period is laid down in that decision.
POGLAVJE V
Such action shall include, where appropriate, a request to the marketing authorisation holder to submit an application for a variation referred to in Article 62(1).
HOMEOPATSKA ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
In the case of centrally authorised veterinary medicinal products concerned by the referral, the Commission shall send its decision referred to in paragraph 3 to the marketing authorisation holder and shall communicate it also to the Member States.
Člen 85
Nationally authorised veterinary medicinal products which have been subject to a referral procedure shall be transferred to a mutual recognition procedure.
Homeopatska zdravila za uporabo v veterinarski medicini
CHAPTER V
Homeopatska zdravila za uporabo v veterinarski medicini, ki izpolnjujejo pogoje iz člena 86, se registrirajo v skladu s členom 87.
HOMEOPATHIC VETERINARY MEDICINAL PRODUCTS
Za homeopatska zdravila za uporabo v veterinarski medicini, ki ne izpolnjujejo pogojev iz člena 86, se uporablja člen 5.
Homeopathic veterinary medicinal products
Registracija homeopatskih zdravil za uporabo v veterinarski medicini
Homeopathic veterinary medicinal products that meet the conditions set out in Article 86 shall be registered in accordance with Article 87.
Postopek registracije se uporablja za homeopatsko zdravilo za uporabo v veterinarski medicini, ki izpolnjuje vse naslednje pogoje:
Homeopathic veterinary medicinal products that do not meet the conditions set out in Article 86 shall be subject to Article 5.
daje se po poti, ki je opisana v Evropski farmakopeji ali, če je tam ni, v farmakopejah, ki se uradno uporabljajo v državah članicah;
Article 86
stopnja razredčitve je zadostna, da je zajamčena njegova varnost, ter ne sme vsebovati več kot enega dela matične tinkture na 10000 delov;
Registration of homeopathic veterinary medicinal products
na njegovem označevanju ali v drugih informacijah o njem niso navedene nobene terapevtske indikacije.
A homeopathic veterinary medicinal product that meets all of the following conditions shall be subject to a registration procedure:
Države članice lahko poleg postopkov iz tega poglavja vzpostavijo tudi druge postopke za registracijo homeopatskih zdravil za uporabo v veterinarski medicini.
it is administered by a route described in the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States;
Člen 87
it has a sufficient degree of dilution to guarantee its safety, and shall not contain more than one part per 10000 of the mother tincture;
Vloga in postopek za registracijo homeopatskih zdravil za uporabo v veterinarski medicini
it has no therapeutic indication appearing on its labelling or in any information relating thereto.
V vlogo za registracijo homeopatskega zdravila za uporabo v veterinarski medicini se vključijo naslednji dokumenti:
Member States may lay down procedures for the registration of homeopathic veterinary medicinal products in addition to those laid down in this Chapter.
znanstveno ime ali drugo ime iz farmakopeje za homeopatske surovine, skupaj z navedbo poti uporabe, farmacevtske oblike ter stopnje razredčitve, ki naj se registrira;
Article 87
dokumentacija z opisom, kako se homeopatske surovine pridobivajo in nadzirajo, ter utemeljitvijo njihove homeopatske uporabe na podlagi ustrezne bibliografije; v primeru homeopatskega zdravila za uporabo v veterinarski medicini, ki vsebuje biološke snovi, opis sprejetih ukrepov za zagotavljanje odsotnosti patogenov;
Application and procedure for registration of homeopathic veterinary medicinal products
dokumentacija o proizvodnji in nadzoru za vsako farmacevtsko obliko ter opis metode redčenja in potenciranja;
The following documents shall be included in the application for a registration of a homeopathic veterinary medicinal product:
dovoljenje za proizvodnjo zadevnih homeopatskih zdravil za uporabo v veterinarski medicini;
scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks, together with a statement of the route of administration, pharmaceutical form and degree of dilution to be registered;
kopije registracij za ista homeopatska zdravila za uporabo v veterinarski medicini v drugih državah članicah;
a dossier describing how the homeopathic stock or stocks are obtained and controlled, and justifying their homeopathic use, on the basis of an adequate bibliography; in the case of homeopathic veterinary medicinal products containing biological substances, a description of the measures taken to ensure the absence of pathogens;
besedilo, ki se navede v navodilu za uporabo, na zunanji ovojnini in stični ovojnini homeopatskega zdravila za uporabo v veterinarski medicini, ki se registrira;
the manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentisation;
podatke o stabilnosti homeopatskega zdravila za uporabo v veterinarski medicini,
the manufacturing authorisation for the homeopathic veterinary medicinal products concerned;
v primeru homeopatskega zdravil za uporabo v veterinarski medicini za živalske vrste za proizvodnjo živil so učinkovine tiste farmakološke učinkovine, ki so dovoljene v skladu z Uredbo (ES) št. 470/2009 in vsemi drugimi akti, sprejetimi na njeni podlagi.
copies of any registrations obtained for the same homeopathic veterinary medicinal products in other Member States;
Vloga za registracijo se lahko nanaša na serijo homeopatskih zdravil za uporabo v veterinarski medicini, ki imajo enako farmacevtsko obliko in so pridobljene iz istih homeopatskih surovin.
the text to appear on the package leaflet, outer packaging and immediate packaging of the homeopathic veterinary medicinal products to be registered;
Pristojni organ lahko določi pogoje, pod katerimi se lahko registrirana homeopatska zdravila za uporabo v veterinarski medicini dajo na voljo.
data concerning the stability of the homeopathic veterinary medicinal product;
Postopek registracije homeopatskega zdravila za uporabo v veterinarski medicini se zaključi v 90 dneh od predložitve veljavne vloge.
in the case of homeopathic veterinary medicinal products intended for food-producing animal species, the active substances shall be those pharmacologically active substances allowed in accordance with Regulation (EC) No 470/2009 and any acts adopted on the basis thereof.
Imetnik registracije homeopatskih zdravil za uporabo v veterinarski medicini ima enake obveznosti kot imetnik dovoljenja za promet, v skladu s členom 2(5).
An application for registration may cover a series of homeopathic veterinary medicinal products of the same pharmaceutical form and derived from the same homeopathic stock or stocks.
Registracija za homeopatsko zdravilo za uporabo v veterinarski medicini se izda samo predlagatelju s sedežem v Uniji.
The competent authority may determine the conditions under which the registered homeopathic veterinary medicinal product may be made available.
Zahteva o sedežu v Uniji velja tudi za imetnike registracije.
The procedure of registration of a homeopathic veterinary medicinal product shall be completed within 90 days of the submission of a valid application.
POGLAVJE VI
A registration holder of homeopathic veterinary medicinal products shall have the same obligations as a marketing authorisation holder, subject to Article 2(5).
PROIZVODNJA, UVOZ IN IZVOZ
A registration for a homeopathic veterinary medicinal product shall only be granted to an applicant established in the Union.
Člen 88
The requirement to be established in the Union shall also apply to registration holders.
Dovoljenja za proizvodnjo
CHAPTER VI
Dovoljenja za proizvodnjo se zahtevajo za izvajanje katere koli od naslednjih dejavnosti:
MANUFACTURING, IMPORT AND EXPORT
proizvodnjo zdravil za uporabo v veterinarski medicini, tudi če so namenjena samo za izvoz,
Article 88
sodelovanje pri katerem koli delu proizvodnega postopka zdravila za uporabo v veterinarski medicini ali pri zaključni fazi, vključno s sodelovanjem pri predelavi, zbiranju, pakiranju, ponovnem pakiranju, označevanju in ponovnem označevanju, skladiščenju, sterilizaciji, testiranju, sprostitvi ali za dobavo zdravila za uporabo v veterinarski medicini v okviru tega postopka ali
Manufacturing authorisations
uvoz zdravil za uporabo v veterinarski medicini.
A manufacturing authorisation shall be required in order to carry out any of the following activities:
Ne glede na odstavek 1 tega člena se lahko države članice odločijo, da se dovoljenje za proizvodnjo ne zahteva za pripravo, delitev zdravila na manjše enote, spremembe pri pakiranju ali predstavitvi zdravil za uporabo v veterinarski medicini, kadar se ti postopki izvajajo izključno za neposredni javni promet na drobno v skladu s členoma 103 in 104.
to manufacture veterinary medicinal products even if intended only for export;
Kadar se uporablja odstavek 2, se vsaki manjši enoti priloži navodilo za uporabo ter na njej jasno navede številko serije in datum izteka roka uporabnosti.
to engage in any part of the process of manufacturing a veterinary medicinal product or of bringing a veterinary medicinal product to its final state, including engagement in the processing, assembling, packaging and repackaging, labelling and relabelling, storing, sterilising, testing or releasing it for supply as part of that process; or
Pristojni organi dovoljenja za proizvodnjo, ki jih izdajo, evidentirajo v zbirki podatkov o proizvodnji in prometu na debelo, vzpostavljeni v skladu s členom 91.
to import veterinary medicinal products.
Dovoljenja za proizvodnjo veljajo po vsej Uniji.
Notwithstanding paragraph 1 of this Article, Member States may decide that a manufacturing authorisation shall not be required for preparation, dividing up, changes in packaging or presentation of veterinary medicinal products, where those processes are carried out solely for retail directly to the public in accordance with Articles 103 and 104.
Člen 89
Where paragraph 2 applies, the package leaflet shall be given with each divided part and the batch number and expiry date shall be clearly indicated.
Vloga za dovoljenje za proizvodnjo
The competent authorities shall record the manufacturing authorisations granted by them in the database on manufacturing and wholesale distribution set up in accordance with Article 91.
Vloga za dovoljenje za proizvodnjo se predloži pristojnemu organu v državi članici, kjer je mesto proizvodnje.
Manufacturing authorisations shall be valid throughout the Union.
Vloga za pridobitev dovoljenja za proizvodnjo zajema vsaj naslednje informacije:
Article 89
zdravila za uporabo v veterinarski medicini, ki se bodo proizvajala ali uvažala;
Application for manufacturing authorisation
ime ali naziv podjetja in stalni naslov ali registrirani kraj poslovanja predlagatelja;
An application for a manufacturing authorisation shall be submitted to a competent authority in the Member State in which the manufacturing site is located.
farmacevtske oblike, ki se bodo proizvajale ali uvažale;
An application for a manufacturing authorisation shall contain at least the following information:
podrobnosti o mestu proizvodnje, kjer se bodo zdravila za uporabo v veterinarski medicini proizvajala ali uvažala;
veterinary medicinal products which are to be manufactured or imported;
izjavo, da predlagatelj izpolnjuje zahteve iz členov 93 in 97.
name or company name and permanent address or registered place of business of the applicant;
Člen 90
pharmaceutical forms which are to be manufactured or imported;
Postopek za izdajo dovoljenj za proizvodnjo
details about the manufacturing site where the veterinary medicinal products are to be manufactured or imported;
Pred izdajo dovoljenja za proizvodnjo pristojni organ izvede inšpekcijski pregled mesta proizvodnje.
a statement to the effect that the applicant fulfils the requirements laid down in Articles 93 and 97.
Pristojni organ od predlagatelja lahko zahteva, da predloži dodatne informacije poleg tistih, navedenih v vlogi v skladu s členom 89.
Article 90
Kadar pristojni organ uveljavi to pravico, se rok iz odstavka 4 tega člena lahko odloži ali prekliče, dokler predlagatelj ne predloži zahtevanih dodatnih podatkov.
Procedure for granting of manufacturing authorisations
Dovoljenje za proizvodnjo velja samo za mesto proizvodnje in farmacevtske oblike, ki so navedene v vlogi iz člena 89.
Before granting a manufacturing authorisation, the competent authority shall carry out an inspection of the manufacturing site.
Države članice določijo postopke za izdajo ali zavrnitev dovoljenj za proizvodnjo.
The competent authority may require the applicant to submit further information in addition to that supplied in the application pursuant to Article 89.
Ti postopki ne smejo biti daljši od 90 dni od datuma, ko pristojni organ prejme vlogo za pridobitev dovoljenja za proizvodnjo.
Where the competent authority exercises that right, the time limit referred to in paragraph 4 of this Article shall be suspended or revoked until the applicant has submitted the additional data required.
Dovoljenje za proizvodnjo se lahko izda pogojno, pod pogojem da predlagatelj sprejme ukrepe ali uvede posebne postopke v določenem roku.
A manufacturing authorisation shall apply only to the manufacturing site and the pharmaceutical forms specified in the application referred to in Article 89.
Kadar je bilo dovoljenje za proizvodnjo zdravil dano pogojno, se začasno odvzame ali odvzame, če te zahteve niso izpolnjene.
Member States shall lay down procedures for granting or refusing manufacturing authorisations.
Člen 91
Such procedures shall not exceed 90 days from receipt by the competent authority of an application for manufacturing authorisation.
Zbirka podatkov o proizvodnji in prometu na debelo
A manufacturing authorisation may be granted conditionally, subject to a requirement for the applicant to undertake actions or introduce specific procedures within a given time period.
Agencija vzpostavi in vzdržuje zbirko podatkov Unije o proizvodnji, uvozu in prometu na debelo (v nadaljnjem besedilu: zbirka podatkov o proizvodnji in prometu na debelo).
Where a manufacturing authorisation has been conditionally granted, it shall be suspended or revoked if the requirements are not complied with.
Zbirka podatkov o proizvodnji in prometu na debelo vsebuje informacije o izdaji, začasnem odvzemu ali odvzemu dovoljenj za proizvodnjo s strani pristojnih organov, dovoljenjih za promet na debelo, potrdilih o dobri proizvodni praksi ter registraciji proizvajalcev, uvoznikov in distributerjev učinkovin.
Article 91
Pristojni organi v zbirki podatkov o proizvodnji in prometu na debelo evidentirajo informacije o dovoljenjih za proizvodnjo in promet na debelo ter potrdilih, izdanih v skladu s členi 90, 94 in 100, skupaj z informacijami o uvoznikih, proizvajalcih in distributerjih učinkovin, registriranih v skladu s členom 95.
Database on manufacturing and wholesale distribution
Agencija v sodelovanju z državami članicami in Komisijo pripravi funkcionalne specifikacije za zbirko podatkov o proizvodnji in prometu na debelo, med drugim tudi format za elektronsko pošiljanje podatkov.
The Agency shall establish and maintain a Union database on manufacturing, import and wholesale distribution (‘manufacturing and wholesale distribution database’).
Agencija zagotovi, da se informacije, poslane v zbirko podatkov o proizvodnji in prometu na debelo, združijo in da postanejo dostopne in se delijo.
The manufacturing and wholesale distribution database shall include information regarding the grant, suspension or revocation by competent authorities of any manufacturing authorisations, wholesale distribution authorisations, certificates of good manufacturing practice, and registrations of manufacturers, importers and distributors of active substances.
Pristojni organi imajo celovit dostop do zbirke podatkov o proizvodnji in prometu na debelo.
Competent authorities shall record in the manufacturing and wholesale distribution database information on manufacturing and wholesale distribution authorisations and certificates granted in accordance with Articles 90, 94 and 100 together with information on importers, manufacturers and distributors of active substances registered in accordance with Article 95.
Splošna javnost ima dostop do informacij v zbirki podatkov o proizvodnji in prometu na debelo brez možnosti, da jih spreminja.
The Agency shall, in collaboration with Member States and the Commission, draw up functional specifications, including the format for electronic submissions of data, for the manufacturing and wholesale distribution database.
Člen 92
The Agency shall ensure that information reported to the manufacturing and wholesale distribution database is collated and made accessible and that the information is shared.
Spremembe dovoljenj za proizvodnjo na zahtevo
The competent authorities shall have full access to the manufacturing and wholesale distribution database.
Če imetnik dovoljenja za proizvodnjo zahteva spremembo tega dovoljenja za proizvodnjo, postopek za pregled takšne zahteve ne traja dlje kot 30 dni od dneva, ko pristojni organ prejme zahtevo.
The general public shall have access to information in the manufacturing and wholesale distribution database, without the possibility to change that information therein.
Pristojni organ to obdobje v utemeljenih primerih, med drugim tudi, ko je potreben inšpekcijski pregled, lahko podaljša na 90 dni.
Article 92
Zahteva iz odstavka 1 zajema opis zahtevane spremembe.
Changes to manufacturing authorisations on request
V obdobju iz odstavka 1 pristojni organ od imetnika dovoljenja za proizvodnjo lahko zahteva, da v določenem roku predloži dodatne informacije, lahko pa se odloči tudi za izvedbo inšpekcijskega pregleda.
If the holder of a manufacturing authorisation requests a change in that manufacturing authorisation, the procedure for examining such a request shall not exceed 30 days from the day on which the competent authority receives the request.
Postopek se do predložitve dodatnih informacij začasno ustavi.
In justified cases, including when an inspection is necessary, that period of time may be extended by the competent authority to 90 days.
Pristojni organ zahtevo iz odstavka 1 oceni, imetnika dovoljenja za proizvodnjo obvesti o rezultatu ocene in, kadar je to ustrezno, spremeni dovoljenje za proizvodnjo ter posodobi zbirko podatkov o proizvodnji in prometu na debelo.
The request referred to in paragraph 1 shall contain a description of the requested change.
Člen 93
Within the period referred to in paragraph 1, the competent authority may require the holder of the manufacturing authorisation to provide supplementary information within a set time limit and may decide to perform an inspection.
Obveznosti imetnika dovoljenja za proizvodnjo
The procedure shall be suspended until such time as the supplementary information has been provided.
Imetnik dovoljenja za proizvodnjo:
The competent authority shall assess the request referred to in paragraph 1, inform the holder of the manufacturing authorisation of the outcome of the assessment and, where appropriate, amend the manufacturing authorisation, and update, where appropriate, the manufacturing and wholesale distribution database.
ima na voljo prostore, tehnično opremo ter zmogljivosti za testiranje, ki so primerni in zadostujejo za dejavnosti, navedene v njegovem dovoljenju za proizvodnjo;
Article 93
ima na voljo storitve vsaj ene usposobljene osebe iz člena 97 in zagotovi, da ta oseba deluje v skladu z navedenim členom;
Obligations of the holder of a manufacturing authorisation
omogoči usposobljeni osebi iz člena 97, da opravlja svoje dolžnosti, zlasti tako, da ji omogoči dostop do vseh potrebnih dokumentov in prostorov ter ji da na razpolago vso potrebno tehnično opremo in prostore za testiranje;
The holder of a manufacturing authorisation shall:
vsaj 30 dni pred zamenjavo usposobljene osebe iz člena 97 o tem obvesti pristojni organ, če pa predhodno obvestilo ni mogoče, ker je zamenjava nepričakovana, o tem takoj obvesti pristojni organ;
have at its disposal suitable and sufficient premises, technical equipment and testing facilities, for the activities stated in its manufacturing authorisation;
ima na voljo storitve osebja, ki izpolnjuje pravne zahteve v relevantni državi članici v zvezi s proizvodnjo in nadzorom;
have at its disposal the services of at least one qualified person referred to in Article 97 and ensure that the qualified person operates in compliance with that Article;
predstavnikom pristojnega organa kadar koli dovoli vstop v svoje prostore;