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dovoljenje za izdelavo zdravil
1 Končna redakcija
CELEX: 32004L0028
dokument, ki dokazuje, da ima izdelovalec v svoji državi dovoljenje za izdelavo zdravil za uporabo v veterinarski medicini;
a document showing that the manufacturer is authorised in his own country to produce veterinary medicinal products;
2 Končna redakcija
CELEX: 32004R0726
Pri zdravilih za humano uporabo, izdelanih v Skupnosti, so nadzorni organi pristojni organi države članice ali držav članic, ki so izdale dovoljenje za izdelavo, predvideno v členu 40(1) direktive 2001/83/ES, za zadevno zdravilo.
In the case of medicinal products for human use manufactured within the Community, the supervisory authorities shall be the competent authorities of the Member State or Member States which granted the manufacturing authorisation provided for in Article 40(1) of Directive 2001/83/EC in respect of the medicinal product concerned.
3 Končna redakcija
CELEX: 32004L0027
če niso bile opravljene kontrole zdravila in/ali sestavin ter kontrole vmesnih faz proizvodnega procesa ali če niso bile izpolnjene nekatere druge zahteve ali obveznosti v zvezi z izdanim dovoljenjem za izdelavo.”;
the controls on the medicinal product and/or on the ingredients and the controls at an intermediate stage of the manufacturing process have not been carried out or if some other requirement or obligation relating to the grant of the manufacturing authorisation has not been fulfilled.";
4 Končna redakcija
CELEX: 32004L0027
inšpekcijski pregled proizvodnih ali poslovnih zgradb izdelovalcev zdravil ali zdravilnih učinkovin, uporabljenih kot vhodne snovi, in vseh laboratorijev, ki jih imetnik dovoljenja za izdelavo uporablja za izvajanje kontrole v skladu s členom 20;
inspect the manufacturing or commercial establishments of manufacturers of medicinal products or of active substances used as starting materials, and any laboratories employed by the holder of the manufacturing authorisation to carry out checks pursuant to Article 20;
5 Končna redakcija
CELEX: 32004R0726
Pri veterinarskih zdravilih, izdelanih v Skupnosti, so nadzorni organi pristojni organi države članice ali držav članic, ki so izdale dovoljenje za izdelavo, predvideno v členu 44(1) Direktive 2001/82/ES glede izdelave zadevnega zdravila.
In the case of veterinary medicinal products manufactured within the Community, the supervisory authorities shall be the competent authorities of the Member State or Member States which granted the manufacturing authorisation provided for in Article 44(1) of Directive 2001/82/EC in respect of the manufacture of the medicinal product concerned.
6 Končna redakcija
CELEX: 32004R0726
V primeru zdravil, uvoženih iz tretjih držav, so nadzorni organi pristojni organi države članice ali držav članic, ki so uvozniku izdali dovoljenje za izdelavo, predvideno v členu 40(3) Direktive 2001/83/ES, razen če so sklenjeni ustrezni sporazumi med Skupnostjo in državo izvoznico, da se zagotavlja izvedba nadzora v državi izvoznici in da izdelovalec upošteva standarde dobre proizvodne prakse, ki so najmanj enakovredni tistim, ki jih je določila Skupnost.
In the case of medicinal products imported from third countries, the supervisory authorities shall be the competent authorities of the Member State or Member States that granted the authorisation provided for in Article 40(3) of Directive 2001/83/EC to the importer, unless appropriate agreements have been made between the Community and the exporting country to ensure that those controls are carried out in the exporting country and that the manufacturer applies standards of good manufacturing practice at least equivalent to those laid down by the Community.
7 Končna redakcija
CELEX: 32004R0726
V primeru veterinarskih zdravil, uvoženih iz tretjih držav, so nadzorni organi pristojni organi države članice ali držav članic, ki so uvozniku izdali dovoljenje za izdelavo, predvideno v členu 44(3) Direktive 2001/82/ES, razen če so sklenjeni ustrezni sporazumi med Skupnostjo in državo izvoznico, da se zagotavlja izvedba nadzora v državi izvoznici in da izdelovalec upošteva standarde dobre proizvodne prakse, ki so najmanj enakovredni tistim, ki jih je določila Skupnost.
In the case of veterinary medicinal products imported from third countries, the supervisory authorities shall be the competent authorities of the Member State or Member States that granted the authorisation provided for in Article 44(3) of Directive 2001/82/EC to the importer, unless appropriate agreements have been made between the Community and the exporting country to ensure that those controls are carried out in the exporting country and that the manufacturer applies standards of good manufacturing practice at least equivalent to those laid down by the Community.
8 Pravna redakcija
DRUGO
dokument, ki dokazuje, da ima izdelovalec v svoji državi dovoljenje za izdelavo zdravil za uporabo v veterinarski medicini;
a document showing that the manufacturer is authorized in his own country to produce veterinary medicinal products;
9 Pravna redakcija
DRUGO
dovoljenje za izdelavo zadevnih zdravil,
manufacturing authorization for the medicinal products concerned,
10 Pravna redakcija
DRUGO
z ustreznim dovoljenjem (za izdelavo zadevne farmacevtske oblike ali zdravila).
Site appropriately authorised (to manufacture the pharmaceutical form or product concerned).
11 Pravna redakcija
DRUGO
Podobno, se dovoljenje za izdelavo zahteva tudi za zdravila za uporabo v veterinarski medicini, namenjena za izvoz.
This manufacturing authorization shall likewise be required for veterinary medicinal products intended for export.
12 Pravna redakcija
DRUGO
Dovoljenje iz odstavka 1, se zahteva za celoten in del postopka izdelave ter za različne postopke delitve zdravila na manjše enote, pakiranja ali opremljanja zdravila.
The authorization referred to in paragraph 1 shall be required both for total and partial manufacture and for the various processes of dividing up, packaging or presentation.
13 Pravna redakcija
DRUGO
Vzorec za preskušanje varnosti mora biti vzet iz serije ali serij, izdelanih v skladu s procesom izdelave, opisanim v vlogi za pridobitev dovoljenja za promet z zdravilom.
The sample used for safety testing shall be taken from a batch or batches produced according to the manufacturing process described in the application for marketing authorization.
14 Pravna redakcija
DRUGO
Poleg ukrepov, predvidenih v členu 84, lahko pristojni organ države članice, bodisi začasno ustavi izdelavo ali uvoz zdravil za uporabo v veterinarski medicini iz tretjih držav, ali prekliče ali ukine dovoljenje za izdelavo za tisto kategorijo pripravkov, ali za vse pripravke v primeru, če niso bila upoštevana določila, ki zadevajo izdelavo ali uvoz iz tretjih držav.
The competent authority of a Member State may, in addition to the measures provided for in Article 84, either suspend manufacture or imports of veterinary medicinal products from third countries or suspend or withdraw the manufacturing authorization for a category of preparations or for all preparations in the event of non-compliance with the provisions regarding manufacture or imports from third countries.
15 Pravna redakcija
DRUGO
Države članice sprejmejo vse potrebne ukrepe, da bi si zadevni pristojni organi lahko medsebojno izmenjevali ustrezne informacije, še posebno glede skladnosti z zahtevami, sprejetimi za dovoljenje za izdelavo, ali za dovoljenje za promet z zdravili.
Member States shall take all measures necessary to ensure that the competent authorities concerned communicate the appropriate information to each other, in particular regarding compliance with the requirements adopted for manufacturing authorization, or for authorization to place products on the market.
16 Pravna redakcija
DRUGO
Vzorci, ki se uporabljajo za preskušanje učinkovitosti je treba vzeti iz serije ali več serij, izdelanih v skladu s procesom izdelave, opisanim v vlogi za pridobitev dovoljenja za promet z zdravilom.
The samples used for efficacy trials shall be taken from a batch or batches produced according to the manufacturing process described in the application for marketing authorization.
17 Pravna redakcija
DRUGO
Opis postopka izdelave, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom v skladu s členom 12(3)(d) je treba izdelati tako, da bo podan ustrezen opis narave uporabljenih postopkov.
The description of the manufacturing method accompanying the application for marketing authorization pursuant to Article 12(3)(d), shall be drafted in such a way as to give an adequate description of the nature of the operations employed.
18 Pravna redakcija
DRUGO
Na zahtevo izdelovalca ali izvoznika zdravil za uporabo v veterinarski medicini, ali organov tretje države uvoznice, morajo države članice izdati potrdilo, da ima tak izdelovalec dovoljenje za izdelavo.
At the request of the manufacturer or exporter of veterinary medicinal products, or the authorities of an importing third country, Member States shall certify that such manufacturer is in possession of the manufacturing authorization.
19 Pravna redakcija
DRUGO
Opis postopka izdelave, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom v skladu z členom 12(3)(d) mora biti napisan tako, da podaja ustrezen strnjen pregled o značilnostih uporabljenih postopkov.
The description of the manufacturing method accompanying the application for marketing authorization pursuant to Article 12(3)(d), shall be drafted in such a way as to give an adequate synopsis of the nature of the operations employed.
20 Pravna redakcija
DRUGO
Države članice sprejmejo ukrepe, da imetnik dovoljenja za promet z zdravilom in, kjer je to ustrezno, imetnik dovoljenja za izdelavo, predloži dokazila o opravljenih kontrolnih preskusih zdravila za uporabo v veterinarski medicini in/ali sestavin in vmesnih proizvodov v procesu izdelave, v skladu z metodami, določenimi za namen dovoljenja za promet z zdravilom.
Member States shall take all appropriate measures to ensure that the marketing authorization holder and, where appropriate, the holder of the manufacturing authorization furnish proof of the control tests carried out on the veterinary medical product and/or on the constituents and intermediate products of the manufacturing process, in accordance with the methods laid down for the purposes of marketing authorization.
21 Pravna redakcija
DRUGO
Pri zdravilih, izdelanih v Skupnosti, so nadzorni organi pristojni organi države članice ali držav članic, ki izdajo dovoljenje za izdelavo iz člena 16 direktive 75/319/EGS glede izdelave zadevnega zdravila.
In the case of medicinal products manufactured within the Community, the supervisory authorities shall be the competent authorities of the Member State or Member States which have granted the manufacturing authorization provided for in Article 16 of Directive 75/319/EEC in respect of the manufacture of the medicinal product concerned.
22 Pravna redakcija
DRUGO
Podrobni podatki ter dokumentacija, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom, v skladu z členom 12(3)(i) ter (j) in členom 13(1) mora vključevati podrobne podatke, ki se nanašajo na kontrolne preskuse, ki se izvajajo v vmesni fazi postopka izdelave zato, da se zagotovi konsistentnost procesa izdelave in končnega izdelka.
The particulars and documents accompanying an application for marketing authorization, pursuant to Article 12(3)(i) and (j) and Article 13(1), shall include particulars relating to the control tests which are carried out on intermediate products with a view to verifying the consistency of the production process and the final product.
23 Pravna redakcija
DRUGO
Priloga k administrativnim podatkom so kopije dokumentov, ki dokazujejo, da ima izdelovalec dovoljenje za izdelavo imunoloških zdravil za uporabo v veterinarski medicini, kot to določa člen 44 (skupaj s kratkim opisom mestom izdelave).
Annexed to the administrative data shall be copies of a document showing that the manufacturer is authorized to produce immunological veterinary medicinal products, as defined in Article 44 (with a brief description of the production site).
24 Pravna redakcija
DRUGO
Pri zdravilih za uporabo v veterini, izdelanih v Skupnosti, so nadzorni organi pristojni organi države članice ali držav članic, ki izdajo dovoljenje za izdelavo člena 24 direktive 81/851/EGS glede izdelave zadevnega zdravila za uporabo v veterini.
In the case of veterinary medicinal products manufactured within the Community, the supervisory authorities shall be the competent authorities of the Member State or Member States which have granted the manufacturing authorization provided for in Article 24 of Directive 85/85 I/EEC in respect of the manufacture of the veterinary medicinal product concerned.
25 Pravna redakcija
DRUGO
Da bi olajšali pretok zdravil za uporabo v veterinarski medicini ter da bi preprečili podvajanje kontrole, ki se že izvaja v eni državi članici, se morajo določiti minimalne zahteve za izdelavo ter uvoz zdravil iz tretjih držav ter za izdajo ustreznih dovoljenj za zdravila za uporabo v veterinarski medicini.
In order to facilitate the movement of veterinary medicinal products and to prevent the checks carried out in one Member State from being repeated in another, minimum requirements for manufacture and imports from third countries, and the grant of corresponding authorizations, should be applied to veterinary medicinal products.
26 Pravna redakcija
DRUGO
Podrobni podatki ter dokumentacija, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom, v skladu s členom 12(3)(i) ter (j) in tudi členom 13(l), mora vsebovati podrobne podatke, ki se nanašajo na kontrolne preskuse izdelka, ki se lahko izvedejo v vmesni fazi postopka izdelave, z namenom da bi zagotovili konsistentnost med tehničnimi lastnostmi ter postopkom izdelave.
The particulars and documents accompanying an application for marketing authorization, pursuant to Article 12(3)(i) and (j) and also Article 13(1), shall include particulars relating to the product control tests that may be carried out at an intermediate stage of the manufacturing process, with a view to ensuring the consistency of the technical characteristics and the production process.
27 Pravna redakcija
DRUGO
Usposobljena oseba si mora v enem ali več podjetjih, ki imajo dovoljenje za izdelavo najmanj dve leti pridobivati praktične izkušnje na področju analize kakovosti zdravil, količinske analize zdravilnih učinkovin ter preskušanja in preverjanja, ki je potrebno za zagotovitev kakovosti zdravil za uporabo v veterinarski medicini.
The qualified person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized manufacturers, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of veterinary medicinal products.
28 Pravna redakcija
DRUGO
K administrativnim podatkom je treba priložiti dokument, ki dokazuje, da ima izdelovalec dovoljenje za izdelavo zadevnih zdravil za uporabo v veterinarski medicini, opredeljenih v členu 44, skupaj s seznamom držav, v katerih je bilo dovoljenje za promet izdano, kopije povzetkov glavnih značilnosti zdravila v skladu s členom 14, kot so ga odobrile države članice ter seznam držav, v katerih je bila vložena vloga.
Annexed to the administrative data shall be a document showing that the manufacturer is authorized to produce the veterinary medicinal products concerned, as defined in Article 44, together with a list of countries in which authorization has been granted, copies of all the summaries of product characteristics in accordance with Article 14 as approved by Member States and a list of countries in which an application has been submitted.
29 Pravna redakcija
DRUGO
Potem, ko je že bilo izdano dovoljenje za promet z zdravilom, mora imetnik, glede metod izdelave ter kontrolnih metod, ki jih določa člen 12(3)(d) ter (i), upoštevati dosežke na področju znanosti in tehnologije ter uvesti morebitne spremembe, ki so potrebne, da bi omogočile izdelavo in preverjanje zdravila s splošno veljavnimi znanstvenimi metodami.
After a marketing authorization has been issued, the holder must, in respect of the manufacturing methods and control methods provided for in Article 12(3)(d) and (i), take account of scientific and technical progress and introduce any changes that may be required to enable that veterinary medicinal product to be manufactured and checked by means of generally accepted scientific methods.
30 Prevajalska redakcija
izobraževanje
CELEX: 32004L0028
dokument, ki dokazuje, da ima izdelovalec v svoji državi dovoljenje za izdelavo zdravil za uporabo v veterinarski medicini;
a document showing that the manufacturer is authorised in his own country to produce veterinary medicinal products;
31 Prevajalska redakcija
RS
EMEA
Imetnik dovoljenja za izdelavo zdravila:
Manufacturing Authorisation Holder:
32 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
Odgovorna oseba v najmanj dveh letih pridobi praktične izkušnje v enem ali več podjetjih, ki imajo dovoljenje za izdelavo zdravil, iz dejavnosti kakovostne analize zdravil, količinske analize zdravilnih učinkovin ter preskušanja in preverjanja za potrebe zagotavljanja kakovosti zdravil.
The qualified person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products.
33 Prevajalska redakcija
RS
EMEA
IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, vo
MANUFACTURING AUTHORISATION HOLDERS on
34 Prevajalska redakcija
RS
EMEA
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
35 Prevajalska redakcija
RS
EMEA
IMETNIKI DOVOLJENJ ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
36 Prevajalska redakcija
RS
EMEA
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
MANUFACTURING AUTHORISATION HOLDERRESPONSIBLE FOR BATCH RELEASE
37 Prevajalska redakcija
RS
EMEA
IMETNIKI DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE
A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
38 Prevajalska redakcija
RS
EMEA
A IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
39 Prevajalska redakcija
RS
EMEA
A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
A MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
40 Prevajalska redakcija
RS
EMEA
IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
THE MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
41 Prevajalska redakcija
RS
EMEA
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE do
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE no
42 Prevajalska redakcija
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EMEA
23 A IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
23 A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
43 Prevajalska redakcija
RS
EMEA
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, KI JE ODGOVOREN ZA SPROŠČANJE SERIJE
A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
44 Prevajalska redakcija
RS
EMEA
12 A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
13 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
45 Prevajalska redakcija
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EMEA
26 A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
28 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
46 Prevajalska redakcija
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EMEA
22 A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
22 A MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
47 Prevajalska redakcija
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EMEA
113 A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
106 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
48 Prevajalska redakcija
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EMEA
47 A. IMETNIKI DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE
46 A MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
49 Prevajalska redakcija
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EMEA
9/ 24 A IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
9/ 24 A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
50 Prevajalska redakcija
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EMEA
Družba odgovorna za izdelavo zdravila Zerene Imetnik dovoljenja za promet: za Meda AB:
Marketing Authorisation holder: Meda AB Pipers väg 2 S-170 09 Solna Sweden
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dovoljenje za izdelavo zdravil