natgillin/translations-raw huggingface dataset:
enable the qualified person referred to in Article 97 to carry out his or her duties, particularly by providing access to all the necessary documents and premises, and by placing at his or her disposal all the necessary technical equipment and testing facilities;
v skladu s členom 96 vodi podrobne evidence o vseh zdravilih za uporabo v veterinarski medicini, ki jih imetnik dovoljenja za proizvodnjo dobavlja, in vzorce vsake serije;
give at least a 30 days prior notice to the competent authority before the replacement of the qualified person referred to in Article 97 or, if prior notice is not possible because the replacement is unexpected, inform the competent authority immediately;
zdravila za uporabo v veterinarski medicini dobavlja samo veletrgovcem zdravil za uporabo v veterinarski medicini;
have at its disposal the services of staff complying with the legal requirements existing in the relevant Member State as regards both manufacture and controls;
nemudoma obvesti pristojni organ in imetnika dovoljenja za promet z zdravilom, če imetnik dovoljenja za proizvodnjo pridobi informacije, da so zdravila za uporabo v veterinarski medicini, ki sodijo v okvir njegovega dovoljenja za proizvodnjo, ponarejena ali zanje obstaja sum, da so ponarejena, ne glede na to, ali je distribucija teh zdravil za uporabo v veterinarski medicini potekala po zakoniti dobavni verigi ali na nezakonit način, vključno s tistimi, ki se nezakonito prodajajo s sredstvi storitev informacijske družbe;
allow the representatives of the competent authority access to the premises at any time;
upošteva dobro proizvodno prakso za zdravila za uporabo v veterinarski medicini in za vhodne snovi uporablja samo učinkovine, ki so bile proizvedene v skladu z dobro proizvodno prakso za učinkovine in je njihova distribucija potekala v skladu z dobro distribucijsko prakso za učinkovine;
keep detailed records of all veterinary medicinal products which the holder of a manufacturing authorisation supplies in accordance with Article 96, and keep samples of each batch;
preveri, da je vsak proizvajalec, distributer in uvoznik v Uniji, od katerega imetnik dovoljenja za proizvodnjo pridobi učinkovine, registriran pri pristojnem organu države članice, v kateri imajo proizvajalec, distributer in uvoznik sedež, v skladu s členom 95;
only supply veterinary medicinal products to wholesale distributors of veterinary medicinal products;
izvaja revizije na podlagi ocene tveganja proizvajalcev, distributerjev in uvoznikov, od katerih imetnik dovoljenja za proizvodnjo pridobi učinkovine.
inform the competent authority and the marketing authorisation holder immediately if the holder of a manufacturing authorisation obtains information that veterinary medicinal products which fall within the scope of its manufacturing authorisation are, or are suspected of being, falsified irrespective of whether those veterinary medicinal products were distributed within the legal supply chain or by illegal means, including illegal sale by means of information society services;
Komisija z izvedbenimi akti sprejme ukrepe v zvezi z dobro proizvodno prakso za zdravila za uporabo v veterinarski medicini in učinkovine, ki se uporabljajo kot vhodne snovi, iz točke (j) odstavka 1 tega člena.
comply with good manufacturing practice for veterinary medicinal products and use as starting materials only active substances which have been manufactured in accordance with good manufacturing practice for active substances and distributed in accordance with good distribution practice for active substances;
Člen 94
verify that each manufacturer, distributor and importer within the Union from whom the holder of a manufacturing authorisation obtains active substances is registered with the competent authority of the Member State in which the manufacturer, distributor and importer are established, in accordance with Article 95;
Potrdila o dobri proizvodni praksi
perform audits based on a risk assessment on the manufacturers, distributors and importers from whom the holder of a manufacturing authorisation obtains active substances.
Pristojni organ proizvajalcu izda potrdilo o dobri proizvodni praksi za njegov proizvodni obrat v 90 dneh od inšpekcijskega pregleda, če je bilo pri inšpekcijskem pregledu ugotovljeno, da proizvajalec izpolnjuje zahteve iz te uredbe in izvedbenega akta iz člena 93(2).
The Commission shall, by means of implementing acts, adopt measures on good manufacturing practice for veterinary medicinal products and active substances used as starting materials, referred to in point (j) of paragraph 1 of this Article.
Če izidi inšpekcijskega pregleda iz odstavka 1 tega člena pokažejo, da proizvajalec ne spoštuje dobre proizvodne prakse, se taka informacija vnese v zbirko podatkov o proizvodnji in prometu na debelo iz člena 91.
Article 94
Ugotovitve na podlagi inšpekcijskega pregleda proizvajalca veljajo po vsej Uniji.
Certificates of good manufacturing practice
Brez poseganja v kakršne koli morebitne dogovore med Unijo in tretjo državo lahko pristojni organ, Komisija ali Agencija zahteva, da se pri proizvajalcu s sedežem v tretji državi izvede inšpekcijski pregled iz odstavka 1.
Within 90 days of an inspection, the competent authority shall issue a certificate of good manufacturing practice of the manufacturer for the manufacturing site concerned if the inspection establishes that the manufacturer in question is in compliance with the requirements laid down in this Regulation and with the implementing act referred to in Article 93(2).
Preden se zdravila za uporabo v veterinarski medicini dobavijo v Unijo, njihovi uvozniki zagotovijo, da ima proizvajalec s sedežem v tretji državi potrdilo o dobri proizvodni praksi, ki ga je izdal pristojni organ, ali, če je tretja država pogodbenica sporazuma, sklenjenega med Unijo in tretjo državo, enakovredno potrditev.
If the outcome of the inspection referred to in paragraph 1 of this Article is that the manufacturer does not comply with good manufacturing practice, such information shall be entered into the manufacturing and wholesale distribution database referred to in Article 91.
Člen 95
The conclusions reached following an inspection of a manufacturer shall be valid throughout the Union.
Uvozniki, proizvajalci in distributerji učinkovin s sedežem v Uniji
A competent authority, the Commission or the Agency may require a manufacturer established in a third country to undergo an inspection as referred to in paragraph 1, without prejudice to any arrangements which may have been concluded between the Union and a third country.
Uvozniki, proizvajalci in distributerji učinkovin, ki se uporabljajo kot vhodne snovi v zdravilih za uporabo v veterinarski medicini, ki imajo sedež v Uniji, svojo dejavnost registrirajo pri pristojnem organu države članice, v kateri imajo sedež, in ravnajo v skladu z dobro proizvodno prakso ali dobro distribucijsko prakso, kakor je ustrezno.
Importers of veterinary medicinal products shall ensure, before those products are supplied to the Union, that the manufacturer established in a third country is in possession of a certificate of good manufacturing practice issued by a competent authority or, where the third country is party to an arrangement concluded between the Union and the third country, there is an equivalent confirmation.
Obrazec za registracijo dejavnosti pri pristojnemu organu vključuje vsaj naslednje informacije:
Article 95
ime ali naziv podjetja in stalni naslov ali registrirani kraj poslovanja;
Importers, manufacturers and distributors of active substances established in the Union
učinkovine, ki bodo predmet uvoza, proizvodnje ali distribucije;
Importers, manufacturers and distributors of active substances used as starting materials in veterinary medicinal products, that are established in the Union, shall register their activity with the competent authority of the Member State in which they are established and shall comply with good manufacturing practice or good distribution practice, as applicable.
podatke o prostorih in tehnični opremi.
The registration form for registering the activity with the competent authority shall include at least the following information:
Uvozniki, proizvajalci in distributerji učinkovin iz odstavka 1 predložijo obrazec za registracijo pristojnemu organu vsaj 60 dni pred nameravanim začetkom opravljanja dejavnosti.
name or company name and permanent address or registered place of business;
Uvozniki, proizvajalci in distributerji učinkovin, ki so opravljali dejavnost pred 28. januarjem 2022, predložijo obrazec za registracijo pristojnemu organu do 29. marca 2022.
the active substances which are to be imported, manufactured or distributed;
Pristojni organ se lahko na podlagi ocene tveganja odloči, da opravi inšpekcijski pregled.
particulars regarding the premises and the technical equipment.
Če pristojni organ v 60 dneh od prejema obrazca za registracijo obvesti, da bo opravljen inšpekcijski pregled, se dejavnost ne začne izvajati, dokler pristojni organ ne obvesti, da se lahko začne izvajati.
The importers, manufacturers and distributors of active substances referred to in paragraph 1 shall submit the registration form to the competent authority at least 60 days prior to the intended start of their activity.
V takem primeru pristojni organ opravi inšpekcijski pregled in uvoznikom, proizvajalcem in distributerjem učinkovin iz odstavka 1 sporoči njegove rezultate v 60 dneh od obvestila, da namerava opraviti inšpekcijski pregled.
The importers, manufacturers and distributors of active substances in operation before 28 January 2022 shall submit the registration form to the competent authority by 29 March 2022.
Če v 60 dneh po prejemu obrazca za prijavo pristojni organ ni obvestil, da bo opravljen inšpekcijski pregled, se lahko dejavnost začne izvajati.
The competent authority may, based on a risk assessment, decide to carry out an inspection.
Uvozniki, proizvajalci in distributerji učinkovin iz odstavka 1 pristojnemu organu letno sporočijo popis sprememb, ki so nastale glede informacij, podanih v obrazcu za registracijo.
If the competent authority notifies within 60 days of receipt of the registration form that an inspection will be carried out, the activity shall not begin before the competent authority has notified that the activity may start.
Vse spremembe, ki bi lahko vplivale na kakovost ali varnost učinkovin, ki so predmet proizvodnje, uvoza ali distribucije, se sporočijo nemudoma.
In such a case, the competent authority shall carry out the inspection and communicate to the importers, manufacturers and distributors of active substances referred to in paragraph 1 the results of the inspection within 60 days of the notification of its intention to carry out the inspection.
Pristojni organi vnesejo informacije, podane v skladu z odstavkom 2 tega člena in členom 132, v zbirko podatkov o proizvodnji in prometu na debelo iz člena 91.
If within 60 days of receipt of the registration form the competent authority has not notified that an inspection will be carried out, the activity may start.
Ta člen ne posega v člen 94.
The importers, manufacturers and distributors of active substances referred to in paragraph 1 shall communicate annually to the competent authority the changes which have taken place as regards the information provided in the registration form.
Komisija z izvedbenimi akti sprejme ukrepe v zvezi z dobro distribucijsko prakso za učinkovine, ki se uporabljajo kot vhodne snovi v zdravilih za uporabo v veterinarski medicini.
Any changes that may have an impact on the quality or safety of the active substances that are manufactured, imported or distributed shall be notified immediately.
Člen 96
Competent authorities shall enter the information provided in accordance with paragraph 2 of this Article and with Article 132 in the manufacturing and wholesale distribution database referred to in Article 91.
Vodenje evidenc
This Article shall be without prejudice to Article 94.
Imetnik dovoljenja za proizvodnjo evidentira naslednje informacije v zvezi z vsemi zdravili za uporabo v veterinarski medicini, ki jih dobavlja:
The Commission shall, by means of implementing acts, adopt measures on good distribution practice for active substances used as starting materials in veterinary medicinal products.
datumom transakcije;
Article 96
ime zdravila za uporabo v veterinarski medicini in, če je ustrezno, številko dovoljenja za promet ter farmacevtsko obliko in jakost, kakor je ustrezno;
Record keeping
dobavljeno količino;
The holder of a manufacturing authorisation shall record the following information in respect of all veterinary medicinal products that it supplies:
ime ali naziv podjetja in stalni naslov ali registrirani kraj poslovanja prejemnika;
date of the transaction;
številko serije;
name of the veterinary medicinal product, and marketing authorisation number if applicable, as well as pharmaceutical form and strength, as appropriate;
rok uporabnosti.
quantity supplied;
Evidence iz odstavka 1 so na voljo za inšpekcijske preglede pristojnih organov eno leto po izteku roka uporabnosti serije ali vsaj pet let po evidentiranju, kar je daljše.
name or company name and permanent address or registered place of business of the recipient;
Člen 97
batch number;
Usposobljena oseba, pristojna za proizvodnjo in sprostitev serije
date of expiry.
Imetnik dovoljenja za proizvodnjo ima stalno na voljo storitve, ki jih opravlja vsaj ena usposobljena oseba, ki izpolnjuje pogoje iz tega člena in je odgovorna zlasti za opravljanje dolžnosti, določenih v tem členu.
The records referred to in paragraph 1 shall be available for inspection by competent authorities for one year after the date of expiry of the batch or at least five years from recording, whichever is longer.
Usposobljena oseba iz odstavka 1 ima univerzitetno diplomo iz ene ali več naslednjih znanstvenih disciplin: farmacija, humana medicina, veterinarska medicina, kemija, farmacevtska kemija in tehnologija ali biologija.
Article 97
Usposobljena oseba iz odstavka 1 mora v enem ali več podjetjih, ki imajo dovoljenje za proizvodnjo, pridobiti vsaj dve leti praktičnih izkušenj na področju zagotavljanja kakovosti zdravil, kvalitativne analize zdravil, kvantitativne analize učinkovin ter preverjanja, ki je potrebno za zagotovitev kakovosti zdravil za uporabo v veterinarski medicini.
Qualified person responsible for manufacturing and batch release
Trajanje praktičnega dela iz prvega pododstavka se lahko skrajša za eno leto, če univerzitetni program traja najmanj pet let, ter za eno leto in pol, če univerzitetni program traja najmanj šest let.
The holder of a manufacturing authorisation shall have permanently at its disposal the services of at least one qualified person who fulfils the conditions laid down in this Article and is responsible, in particular, for carrying out the duties specified in this Article.
Imetnik dovoljenja za proizvodnjo, ki je fizična oseba, lahko sam prevzame odgovornost iz odstavka 1, če osebno izpolnjuje pogoje iz odstavkov 2 in 3.
The qualified person referred to in paragraph 1 shall hold a university degree in one or more of the following scientific disciplines: pharmacy, human medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, or biology.
Pristojni organ lahko določi ustrezne upravne postopke, da preveri, ali usposobljena oseba iz odstavka 1 izpolnjuje pogoje iz odstavkov 2 in 3.
The qualified person referred to in paragraph 1 shall have acquired practical experience over at least two years, in one or more undertakings which are authorised manufacturers, in the activities of quality assurance of medicinal products, of qualitative analysis of medicinal products, of quantitative analysis of active substances and the checking necessary to ensure the quality of veterinary medicinal products.
Usposobljena oseba iz odstavka 1 zagotovi, da je vsaka serija zdravil za uporabo v veterinarski medicini proizvedena v skladu z dobro proizvodno prakso in testirana v skladu s pogoji dovoljenja za promet z zdravilom.
The duration of practical experience required in the first subparagraph may be reduced by one year where a university course lasts for at least five years and by a year and a half where the university course lasts for at least six years.
Ta usposobljena oseba pripravi poročilo o nadzoru v zvezi s tem.
The holder of the manufacturing authorisation, if a natural person, may assume the responsibility referred to in paragraph 1, if he or she personally fulfils the conditions referred to in paragraphs 2 and 3.
Takšna poročila o nadzoru so veljavna po vsej Uniji.
The competent authority may lay down appropriate administrative procedures to verify that a qualified person referred to in paragraph 1 fulfils the conditions referred to in paragraphs 2 and 3.
Kadar se zdravila za uporabo v veterinarski medicini uvozijo, usposobljena oseba iz odstavka 1 zagotovi, da so bili za vsako uvoženo proizvodno serijo v Uniji opravljeni celoviti kvalitativna in kvantitativna analiza vsaj vseh učinkovin ter vsi ostali testi, potrebni za zagotovitev kakovosti zdravil za uporabo v veterinarski medicini v skladu z zahtevami dovoljenja za promet, in da je proizvedena serija skladna z dobro proizvodno prakso.
The qualified person referred to in paragraph 1 shall ensure that each batch of the veterinary medicinal products is manufactured in compliance with good manufacturing practice, and tested in compliance with the terms of the marketing authorisation.
Usposobljena oseba iz odstavka 1 vodi evidence v zvezi z vsako sproščeno proizvodno serijo.
That qualified person shall draw up a control report to that effect.
Te evidence se vodijo sproti, po vsaki izvedeni operaciji, in so na voljo pristojnemu organu eno leto po izteku roka uporabnosti serije ali vsaj pet let po evidentiranju, kar je daljše.
Such control reports shall be valid throughout the Union.
Kadar se zdravila za uporabo v veterinarski medicini, proizvedena v Uniji, izvozijo in nato znova uvozijo v Unijo iz tretje države, se uporablja odstavek 6.
Where veterinary medicinal products are imported, the qualified person referred to in paragraph 1 shall ensure that each imported production batch has undergone in the Union a full qualitative and a quantitative analysis of at least all the active substances, and all the other tests necessary to ensure the quality of the veterinary medicinal products in accordance with the requirements of the marketing authorisation and that the batch manufactured is in compliance with good manufacturing practice.
Kadar se zdravila za uporabo v veterinarski medicini uvozijo iz tretjih držav, s katerimi ima Unija sklenjene sporazume glede uporabe standardov dobre proizvodne prakse, ki so vsaj enakovredni tistim iz člena 93(2), in se dokaže, da so bili testi iz odstavka 6 tega člena izvedeni v državi izvoza, lahko usposobljena oseba pripravi poročilo o nadzoru iz odstavka 6 tega člena, ne da bi bili opravljeni testi iz odstavka 7 tega člena, razen če pristojni organ države članice uvoza odloči drugače.
The qualified person referred to in paragraph 1 shall keep records in respect of each released production batch.
Člen 98
Those records shall be kept up to date as operations are carried out and shall remain at the disposal of the competent authority for one year after the date of expiry of the batch or at least five years from recording, whichever is longer.
Potrdila o zdravilih za uporabo v veterinarski medicini
Where veterinary medicinal products manufactured in the Union are exported and subsequently imported back into the Union from a third country, paragraph 6 shall apply.
Na zahtevo proizvajalca ali izvoznika zdravil za uporabo v veterinarski medicini ali organov tretje države uvoznice pristojni organ ali Agencija potrdi, da:
Where veterinary medicinal products are imported from third countries with which the Union has made arrangements regarding application of standards of good manufacturing practice at least equivalent to those laid down in accordance with Article 93(2) and it is demonstrated that the tests referred to in paragraph 6 of this Article have been carried out in the exporting country, the qualified person may draw up the control report referred to in paragraph 6 of this Article without the necessary tests referred to in paragraph 7 of this Article being carried out, unless the competent authority of the Member State of importation decides otherwise.
ima proizvajalec dovoljenje za proizvodnjo;
Article 98
ima proizvajalec potrdilo o dobri proizvodni praksi iz člena 94 ali
Certificates of veterinary medicinal products
je bilo za zadevno zdravilo za uporabo v veterinarski medicini izdano dovoljenje za promet v tej državi članici ali, v primeru zahteve Agenciji, da je bilo izdano centralizirano dovoljenje za promet z zdravilom.
On the request of a manufacturer or an exporter of veterinary medicinal products, or of the authorities of an importing third country, the competent authority or the Agency shall certify that:
Pri izdaji takih potrdil pristojni organ ali Agencija, kakor je ustrezno, upošteva ustrezne prevladujoče upravne dogovore v zvezi z vsebino in obliko takšnih potrdil.
the manufacturer holds a manufacturing authorisation;
POGLAVJE VII
the manufacturer possesses a certificate of good manufacturing practice as referred to in Article 94; or
DOBAVA IN UPORABA
the veterinary medicinal product concerned has been granted a marketing authorisation in that Member State or, in the case of a request to the Agency, that it has been granted a centralised marketing authorisation.
Promet na debelo
When issuing such certificates, the competent authority or the Agency, as applicable, shall take into account the relevant prevailing administrative arrangements with regard to the content and format of such certificates.
Člen 99
CHAPTER VII
Dovoljenja za promet na debelo
SUPPLY AND USE
Za promet zdravil za uporabo v veterinarski medicini na debelo je potrebno dovoljenje za promet na debelo.
Wholesale distribution
Sedež imetnikov dovoljenja za promet na debelo je v Uniji.
Article 99
Dovoljenja za promet na debelo veljajo po vsej Uniji.
Wholesale distribution authorisations
Države članice se lahko odločijo, da za dobavo manjših količin zdravil za uporabo v veterinarski medicini od enega trgovca na drobno drugemu v isti državi članici dovoljenje za promet na debelo ni potrebno.
The wholesale distribution of veterinary medicinal products shall be subject to the holding of a wholesale distribution authorisation.
Z odstopanjem od odstavka 1 imetniku dovoljenja za proizvodnjo ni treba imeti dovoljenja za promet na debelo za zdravilo za uporabo v veterinarski medicini, ki ga zajema dovoljenje za proizvodnjo.
The holders of a wholesale distribution authorisation shall be established in the Union.
Komisija z izvedbenimi akti sprejme ukrepe o dobri distribucijski praksi za zdravila za uporabo v veterinarski medicini.
Wholesale distribution authorisations shall be valid throughout the Union.
Člen 100
Member States may decide that supplies of small quantities of veterinary medicinal products from one retailer to another in the same Member State shall not be subject to the requirement of holding a wholesale distribution authorisation.
Vloga in postopki za dovoljenje za promet na debelo
By derogation from paragraph 1, a holder of a manufacturing authorisation shall not be required to hold a wholesale distribution authorisation for the veterinary medicinal products covered by the manufacturing authorisation.
Vloga za pridobitev dovoljenja za promet na debelo se predloži pristojnemu organu države članice, kjer se veletrgovec nahaja.
The Commission shall, by means of implementing acts, adopt measures on good distribution practice for veterinary medicinal products.
Predlagatelj v vlogi dokaže, da so izpolnjene naslednje zahteve:
Article 100
predlagatelj ima na voljo tehnično usposobljeno osebje in zlasti vsaj eno osebo, imenovano za odgovorno osebo, ki izpolnjuje pogoje, določene v nacionalnem pravu;
Application and procedures for wholesale distribution authorisations
predlagatelj ima primerne in dovolj velike prostore v skladu z zahtevami relevantne države članice za shranjevanje in ravnanje z zdravili za uporabo v veterinarski medicini;