Iskalni niz je ali predolg ali pa vsebuje preveč besed.
Prevodi: sl > en
1–50/97
Evropska agencija za vrednotenje zdravil
1 Pravna redakcija
DRUGO
EVROPSKA AGENCIJA ZA VREDNOTENJE ZDRAVIL
THE EUROPEAN AGENCY FOR THE EVALUATION OF MEDICINAL PRODUCTS
2 Pravna redakcija
promet
CELEX: 22001A1029(01)
Evropska agencija za vrednotenje zdravil
European Agency for the Evaluation of Medicinal Products
3 Pravna redakcija
promet
CELEX: 21998A1016(01)
Evropska agencija za vrednotenje zdravil (EMEA)
European Agency for the Evaluation of Medicinal Products (EMEA)
4 Končna redakcija
CELEX: 41993D1130
Evropska agencija za vrednotenje zdravil ima svoj sedež v Londonu.
The European Agency for the Evaluation of Medicinal Products shall have its seat at London.
5 Prevajalska redakcija
izobraževanje
CELEX: 41993D1130
Evropska agencija za vrednotenje zdravil ima svoj sedež v Londonu.
The European Agency for the Evaluation of Medicinal Products shall have its seat at London.
6 Pravna redakcija
DRUGO
S to uredbo se ustanovi Evropska agencija za vrednotenje zdravil.
A European Agency for the Evaluation of Medicinal Products is hereby established.
7 Pravna redakcija
DRUGO
Evropska agencija za vrednotenje zdravil, ustanovljena z Uredbo (EGS) št. 2309/93.
European Agency for the Evaluation of Medicinal Products established by Regulation (EEC) No 2309/93.
8 Končna redakcija
CELEX: 41993D1130
ob upoštevanju Uredbe Sveta (EGS) št. 2309/93 z dne 22. julija 1993, s katero je med drugim ustanovljena Evropska agencija za vrednotenje zdravil [4], in zlasti člena 74 Uredbe,
Having regard to Council Regulation (EEC) No 2309/93 of 22 July 1993 establishing inter alia a European Agency for the Evaluation of Medicinal Products (4), and in particular Article 74 thereof,
9 Končna redakcija
CELEX: 32004L0024
Ob upoštevanju posebnosti zdravil rastlinskega izvora bi bilo treba znotraj Evropske agencije za vrednotenje zdravil (v nadaljevanju "Agencija"), ki je bila ustanovljena z Uredbo Sveta (EGS) št. 2309/93 [5], ustanoviti Odbor za zdravila rastlinskega izvora.
Having regard to the particularities of herbal medicinal products, a Committee for Herbal Medicinal Products should be established within the European Agency for the Evaluation of Medicinal Products (hereinafter "the Agency") set up by Council Regulation (EEC) No 2309/93(5).
10 Končna redakcija
CELEX: 32004R0726
Na podlagi poročila Komisije o pridobljenih izkušnjah se je pokazalo, da je treba delovanje postopkov pridobivanja dovoljenj za dajanje zdravila v promet v Skupnosti izboljšati in spremeniti nekatere upravne vidike Evropske agencije za vrednotenje zdravil.
In the light of the Commission's report on the experience gained, it has proved necessary to improve the operation of the authorisation procedures for the placing of medicinal products on the market in the Community and to amend certain administrative aspects of the European Agency for the Evaluation of Medicinal Products.
11 Končna redakcija
CELEX: 32004R0726
Člen 71 Uredbe Sveta (EGS) št. 2309/93 z dne 22. julija 1993, ki določa postopke Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za ljudi in za uporabo v veterini ter ustanavlja Evropsko agencijo za vrednotenje zdravil, predpisuje, da je v šestih letih po začetku veljavnosti uredbe Komisija dolžna objaviti splošno poročilo o izkušnjah, pridobljenih kot rezultat uporabe postopkov iz te uredbe.
Article 71 of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(4) provides that, within six years of the entry into force of the Regulation, the Commission is to publish a general report on the experience acquired as a result of the operation of the procedures laid down in the Regulation.
12 Končna redakcija
CELEX: 32004L0027
Člen 71 Uredbe Sveta (EGS) št. 2309/93 z dne 22. julija 1993, ki določa postopke Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za ljudi in za uporabo v veterini ter ustanavlja Evropsko agencijo za vrednotenje zdravil je določil, da mora Komisija v šestih letih od začetka veljavnosti uredbe objaviti splošno poročilo o izkušnjah, pridobljenih pri izvajanju postopkov za pridobitev dovoljenja za promet z zdravilom, ki so določeni v tej uredbi in drugih pravnih predpisih Skupnosti.
Article 71 of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(5) provided that, within six years of its entry into force, the Commission was required to publish a general report on the experience acquired as a result of the operation of the marketing authorisation procedures laid down in that Regulation and in other Community legal provisions.
13 Končna redakcija
CELEX: 32004L0028
Člen 71 Uredbe Sveta (EGS) št. 2309/93 z dne 22. julija 1993 o postopkih Skupnosti za pridobitev dovoljenja za promet z zdravili in nadzor nad zdravili za uporabo v humani in veterinarski medicini ter o ustanavljanju Evropske agencije za vrednotenje zdravil [5], je določil, da se v šestih letih od začetka njene veljavnosti od Komisije zahteva objava splošnega poročila o pridobljenih izkušnjah na podlagi postopkov izdajanja dovoljenj za promet, ki so določeni v navedeni uredbi in drugih predpisih zakonodaje Skupnosti.
Article 71 of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(5) provided that, within six years of its entry into force, the Commission was required to publish a general report on the experience acquired as a result of the operation of the marketing authorisation procedures laid down in that Regulation and in other Community legal provisions.
14 Pravna redakcija
DRUGO
ker mora biti torej mogoče, da Evropska agencija za vrednotenje zdravil na zahtevo podjetja opravi vrednotenje katerega koli zdravila za uporabo v veterini, ki vsebuje novo zdravilno učinkovino, ki je na dan začetka veljavnosti te uredbe še nobena država članica ni dovolila za uporabo za živali;
Whereas therefore it must be possible for the European Agency for the Evaluation of Medicinal Products to carry out an evaluation, at the request of a company, of any veterinary medicinal product containing a new active substance which, on the date of entry into force of this Regulation, was not authorised by any Member State for use in animals;
15 Pravna redakcija
DRUGO
'Agencija' pomeni Evropsko agencijo za vrednotenje zdravil.
'Agency' means the European Agency for the Evaluation of Medicinal Products.
16 Pravna redakcija
finance
CELEX: 32003L0063
(4) Pri sestavljanju dokumentacije za vlogo za pridobitev dovoljenja za promet z zdravilom vlagatelji upoštevajo znanstvene smernice o kakovosti, varnosti in učinkovitosti zdravil za ljudi, ki jih je sprejel Odbor za lastniška zdravila (CPMP) in objavila Evropska agencija za vrednotenje zdravil (EMEA) in druge farmacevtske smernice Skupnosti, ki jih je Komisija objavila v različnih zvezkih Pravil, ki urejajo zdravila v Evropski skupnosti.
(4) In assembling the dossier for application for marketing authorisation, applicants shall also take into account the scientific guidelines relating to the quality, safety and efficacy of medicinal products for human use as adopted by the Committee for Proprietary Medicinal Products (CPMP) and published by the European Medicine Evaluation Agency (EMEA) and the other pharmaceutical Community guidelines published by the Commission in the different volumes of The rules governing medicinal products in the European Community.
17 Pravna redakcija
DRUGO
ker je zato treba ustanoviti Evropsko agencijo za vrednotenje zdravil ('Agencija');
Whereas it is therefore necessary to establish a European Agency for the Evaluation of Medicinal Products ('the Agency');
18 Pravna redakcija
DRUGO
UREDBA SVETA (ES) št. 297/95 z dne 10. februarja 1995 o pristojbinah, ki se plačujejo Evropski agenciji za vrednotenje zdravil
Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products
19 Pravna redakcija
DRUGO
ki določa postopke Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za ljudi in za uporabo v veterini ter ustanavlja Evropsko agencijo za vrednotenje zdravil
laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products
20 Pravna redakcija
DRUGO
Namen te uredbe je določiti postopke Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za ljudi in za uporabo v veterini ter ustanoviti Evropsko agencijo za vrednotenje zdravil.
The purpose of this Regulation is to lay down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and to establish a European Agency for the Evaluation of Medicinal Products.
21 Pravna redakcija
promet
CELEX: 21998A1016(01)
direktor Evropske agencije za vrednotenje zdravil, 7 Westferry Circus, Canary Wharf, London E14 4HB, Združeno Kraljestvo. Tel. (44-171) 418 84 00, faks 418 84 16.
the Director of the European Agency for the Evaluation of Medicinal Products, 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom. Tel. (44-171) 418 84 00, fax 418 84 16.
22 Pravna redakcija
DRUGO
UREDBA SVETA (ES) št. 2743/98 z dne 14. decembra 1998 o spremembah Uredbe (ES) št. 297/95 o pristojbinah, ki se plačujejo Evropski agenciji za vrednotenje zdravil
Council Regulation (EC) No 2743/98 of 14 December 1998 amending Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products
23 Pravna redakcija
DRUGO
UREDBA KOMISIJE (ES) št. 494/2003 z dne 18. marca 2003 o spremembah Uredbo Sveta (ES) št. 297/95 o pristojbinah, ki se plačujejo Evropski agenciji za vrednotenje zdravil
Commission Regulation (EC) No 494/2003 of 18 March 2003 amending Council Regulation (EC) No 297/95 on the fees payable to the European Agency for the Evaluation of Medicinal Products
24 Pravna redakcija
DRUGO
V ta namen je treba ustanoviti Odbor za zdravila za uporabo v veterinarski medicini v okviru Evropske agencije za vrednotenje zdravil, določeno z zgoraj navedeno Uredbo (EGS) št. 2309/93.
For this purpose, a Committee for Veterinary Medicinal Products should be set up in accordance with the European Agency for the Evaluation of Medicinal Products laid down in the aforementioned Regulation (EEC) No 2309/93.
25 Pravna redakcija
promet
CELEX: 22003A1219(01)
Uredba Sveta (ES) št. 297/95 z dne 10. februarja 1995 o pristojbinah, ki se plačujejo Evropski agenciji za vrednotenje zdravil, (UL L 35, 15.2.1995, str. 1), kakor je bila spremenjena z:
Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (OJ L 35, 15.2.1995, p. 1), as amended by:
26 Pravna redakcija
promet
CELEX: 22001A1029(01)
Uredba Sveta (EGS) št. 2309/93 z dne 22. julija 1993 o določitvi postopkov Skupnosti za odobritev in nadzor zdravil za humano in veterinarsko rabo ter o ustanovitvi Evropske agencije za vrednotenje zdravil in spremembe Uredbe
Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products and amendments thereto
27 Pravna redakcija
promet
CELEX: 22003D0108(01)
(2) UREDBA KOMISIJE (ES) št. 494/2003 z dne 18. marca 2003 o spremembah Uredbe Sveta (ES) št. 297/95 o pristojbinah, ki se plačujejo Evropski agenciji za vrednotenje zdravil fn se vključi v Sporazum,
(2) Commission Regulation (EC)No 494/2003 of 18 March 2003 amending Council Regulation (EC) No 297/95 on the fees payable to the European Agency for the Evaluation of Medicinal Products fn is to be incorporated into the Agreement,
28 Pravna redakcija
DRUGO
Za pridobitev dovoljenja iz člena 3, oseba, odgovorna za dajanje zdravila v promet, pošlje vlogo Evropski agenciji za vrednotenje zdravil (v nadaljnjem besedilu 'agencija'), ki je ustanovljena v skladu z naslovom IV.
In order to obtain the authorization referred to in Article 3, the person responsible for placing a medicinal product on the market shall submit an application to the European Agency for the Evaluation of Medicinal Products, hereinafter referred to as 'the Agency', set up under Title IV.
29 Pravna redakcija
DRUGO
Uredba Sveta (EGS) št. 2309/93 z dne 22. julija 1993, ki določa postopke Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za ljudi in za uporabo v veterini ter ustanavlja Evropsko agencijo za vrednotenje zdravil (UL L 214, 24.8.1993, str. 1).
Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal products (OJ L 214, 24.8.1993, p. 1).
30 Pravna redakcija
promet
CELEX: 22003A1219(01)
Uredba Sveta (EGS) št. 2309/93 z dne 22. julija 1993, ki določa postopke Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za ljudi in veterinarskih zdravil ter ustanavlja Evropsko agencijo za vrednotenje zdravil(UL L 214, 24.8.1993, str. 1), kakor je bila spremenjena z:
Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the evaluation of Medicinal Products (OJ L 214, 24.8.1993, p. 1), as amended by:
31 Pravna redakcija
DRUGO
v odboru naj bi bili tudi trije predstavniki združenj bolnikov, ki jih določi Komisija, in tri druge osebe, ki jih prav tako določi Komisija na priporočilo Evropske agencije za vrednotenje zdravil (v nadaljevanju Agencija);
this Committee should also include three representatives of patients' associations, designated by the Commission, and three other persons, also designated by the Commission, on a recommendation from the European Agency for the Evaluation of Medicinal Products (hereinafter referred to as 'the Agency");
32 Pravna redakcija
DRUGO
ob upoštevanju uredbe Sveta (EGS) št. 2309/93 z dne 22. julija 1993, ki določa postopke Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za ljudi in za uporabo v veterini ter ustanavlja Evropsko agencijo za vrednotenje zdravil fn, zlasti člena 5(3) navedene uredbe,
Having regard to Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (1), and in particular Article 3(5) thereof,
33 Pravna redakcija
DRUGO
ob upoštevanju uredbe Sveta (EGS) št. 2309/93 z dne 22. julija 1993, ki določa postopke Skupnosti za izdajo dovoljenja in nadzor zdravil za ljudi in za uporabo v veterini ter ustanavlja Evropsko agencijo za vrednotenje zdravil fn, kakor jo spreminja uredba Komisije (ES) št. 649/98 fn, zlasti člena 15(4) in 37(4) omenjene uredbe,
Having regard to Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evalutaion of Medicinal Products (1), as amended by Commission Regulation (EC) No 649/98 (2), and in particular Articles 15(4) and 37(4) thereof,
34 Pravna redakcija
promet
CELEX: 22003D0154
Uredba Sveta (EGS) št. 2309/93 z dne 22. julija 1993, ki določa postopke Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za ljudi in za uporabo v veterini ter ustanavlja Evropsko agencijo za vrednotenje zdravil, kakor je bila nazadnje spremenjena z Uredbo Komisije (ES) št. 649/98 z dne 23. marca 1998 (UL L 88, 24.3.1998, str. 7)
Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the evaluation of medicinal products, as last amended by Commission Regulation (EC) No 649/98 of 23 March 1998 (OJ L 88, 24.3.1998, p. 7)
35 Pravna redakcija
DRUGO
ker lahko Skupnost le po enotni znanstveni oceni najvišjega možnega standarda kakovosti, varnosti ali učinkovitosti tehnološko naprednih zdravil, ki se opravi v Evropski agenciji za vrednotenje zdravil, izda dovoljenje za promet po hitrem postopku, ob zagotavljanju tesnega sodelovanja med Komisijo in državami članicami;
Whereas only after a single scientific evaluation of the highest possible standard of the quality, safety or efficacy of technologically advanced medicinal products, to be undertaken within the European Agency for the Evaluation of Medicinal Products, should a marketing authorization be granted by the Community by a rapid procedure ensuring close cooperation between the Commission and Member States.
36 Pravna redakcija
DRUGO
Del C te direktive se ne uporablja za proizvode, ki jih ureja Uredba Sveta (EGS) št. 2309/93 z dne 22. julija 1993 o določitvi postopkov Skupnosti za odobritev in nadzor zdravil za humano in veterinarsko uporabo ter ustanovitvi Evropske agencije za vrednotenje zdravil fn, pod pogojem da vključuje oceno tveganja za okolje, enakovredno oceni iz te direktive.
Part C of this Directive does not apply to products covered by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (1), provided that it includes an environmental risk assessment equivalent to that provided for by this Directive.
37 Pravna redakcija
DRUGO
ob upoštevanju Uredbe Sveta (EGS) št. 2309 z dne 22. julija 1993 o določitvi postopkov Skupnosti za pridobitev dovoljenja in nadzor zdravil za uporabo v humani in veterinarski medicini in ustanovitvi Evropske agencije za vrednotenje zdravil fn, kakor je bila spremenjena z Uredbo Komisije (ES) št. 649/98 fn, in zlasti členov 15(4) in 37(4) Uredbe,
Having regard to Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(1), as amended by Commission Regulation (EC) No 649/98(2) and in particular Articles 15(4) and 37(4) thereof,
38 Pravna redakcija
DRUGO
Primerno je zagotoviti poenostavljen in hiter postopek priglasitev, ki bo omogočal uvedbo nekaterih manjših sprememb, ki ne vplivajo na odobreno kakovost, varnost ali učinkovitost zdravila, brez predhodnega vrednotenja s strani Evropske agencije za vrednotenje zdravil (v nadaljnjem besedilu "Agencija").
It is appropriate to provide for a simplified and rapid notification procedure to enable the introduction of certain minor changes, which do not affect the approved quality, safety or efficacy of the product, without prior evaluation by the European Agency for the evaluation of medicinal products (hereinafter referred to as "the Agency").
39 Pravna redakcija
finance
CELEX: 32003R1085
(4) Primerno je zagotoviti poenostavljen in hiter postopek priglasitev, ki bo omogočal uvedbo nekaterih manjših sprememb, ki ne vplivajo na odobreno kakovost, varnost ali učinkovitost zdravila, brez predhodnega vrednotenja s strani Evropske agencije za vrednotenje zdravil (v nadaljnjem besedilu "Agencija").
(4) It is appropriate to provide for a simplified and rapid notification procedure to enable the introduction of certain minor changes, which do not affect the approved quality, safety or efficacy of the product, without prior evaluation by the European Agency for the evaluation of medicinal products (hereinafter referred to as "the Agency").
40 Pravna redakcija
finance
CELEX: 32003L0063
- Spremembe, s katerimi se dopolnjuje glavna dokumentacija o plazmi, morajo slediti postopku vrednotenja, ki ga določa Uredba Komisije (ES) št. 542/95 fn o preučitvi sprememb dovoljenja za promet z zdravilom, ki spada v področje Uredbe Komisije (EGS) št. 2309/93 z dne 22. julija 1993, ki določa postopke Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za ljudi in uporabo v veterini ter ustanavlja Evropsko agencijo za vrednotenje zdravil fn.
- Changes subsequently introduced to the terms of a Plasma Master File must follow evaluation procedure laid down by Commission Regulation (EC) No 542/95(12) concerning the examination of variations to the terms of a marketing authorisation falling within the scope of Council regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(13).
41 Pravna redakcija
DRUGO
ker direktiva Sveta 93/39/EGS z dne 14. junija 1993, ki spreminja direktive 65/65/ESG, 75/318/EGS in 75/319/EGS v zvezi z zdravili fn da se ob nesoglasju med državami članicami o kakovosti, varnosti ali učinkovitosti zdravila, za katero velja decentralizirani odobritveni postopek Skupnosti, zadeva razreši z zavezujočo odločbo Skupnosti, ki sledi znanstveni oceni vključenih vprašanj, ki se opravi v Evropski agenciji za vrednotenje zdravil;
Whereas Council Directive 93/39/EEC of 14 June 1993 amending Directive 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products (3) has provided that in the event of a disagreement between Member States about the quality, safety or efficacy of a medicinal product which is the subject of the decentralized Community authorization procedure, the matter should be resolved by a binding Community decision following a scientific evaluation of the issues involved within a European medicinal product evaluation agency;
42 Pravna redakcija
DRUGO
Z izjemo tistih zdravil, za katera se zahteva centralizirani postopek pridobitve dovoljenja Skupnosti za promet, ki je bil uveljavljen z Uredbo Sveta (EGS) št. 2309/93 z dne 22. julija 1993 in ki določa postopke Skupnosti za pridobitev dovoljenja za promet z zdravili in nadzor nad zdravili za uporabo v humani in veterinarskim medicini ter ustanavlja Evropsko agencijo za vrednotenje zdravil( fn ), morajo dovoljenje za promet v eni državi članici priznati pristojni organi drugih držav članic, razen če obstajajo utemeljeni razlogi za domnevo, da bi pridobitev dovoljenja za promet z zadevnim zdravilom za uporabo v veterinarski medicini lahko predstavljala tveganje za zdravje ljudi ali živali, ali za okolje;
With the exception of those medicinal products which are subject to the centralised Community authorization procedure established by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (7), a marketing authorization in one Member State ought to be recognized by the competent authority of the other Member States unless there are serious grounds for supposing that the authorization of the veterinary medicinal product concerned may present a risk to human or animal health, or to the environment;
43 Prevajalska redakcija
izobraževanje
CELEX: 32001L0082
Agencija: Evropska agencija za vrednotenje zdravil, ustanovljena z Uredbo (EGS) št. 2309/93.
Agency: European Agency for the Evaluation of Medicinal Products established by Regulation (EEC) No 2309/93.
44 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
Agencija: Evropska agencija za vrednotenje zdravil, ustanovljena z Uredbo (EGS) št. 2309/93.
Agency: The European Agency for the Evaluation of Medicinal Products established by Regulation (EEC) No 2309/93.
45 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
Evropska agencija za vrednotenje zdravil, ustanovljena z Uredbo (EGS) št. 2309/93.
The European Agency for the Evaluation of Medicinal Products established by Regulation (EEC) No 2309/93.
46 Prevajalska redakcija
izobraževanje
CELEX: 22000D1109(29)
Zato je bila z Uredbo Sveta (EGS) št. 2309/93 [9] ustanovljena Evropska agencija za vrednotenje zdravil, v nadaljnjem besedilu "Agencija".
Therefore, the European Agency for the Evaluation of Medicinal Products, hereinafter referred to as "the Agency" was established by Council Regulation (EEC) No 2309/93(9).
47 Prevajalska redakcija
izobraževanje
CELEX: 31995R0540
ker naj bi bila Evropska agencija za vrednotenje zdravil (v nadaljnjem besedilu "agencija") odgovorna za usklajevanje dejavnosti držav članic na področju spremljanja neželenih učinkov zdravil (farmakovigilanco);
Whereas the European Agency for the Evaluation of Medicinal Products (hereinafter referred to as 'the Agency') should be responsible for coordinating the activities of the Member States in the field of monitoring of adverse reactions to medicinal products (pharmacovigilance);
48 Prevajalska redakcija
izobraževanje
CELEX: 41993D1130
ob upoštevanju Uredbe Sveta (EGS) št. 2309/93 z dne 22. julija 1993, s katero je med drugim ustanovljena Evropska agencija za vrednotenje zdravil [4], in zlasti člena 74 Uredbe,
Having regard to Council Regulation (EEC) No 2309/93 of 22 July 1993 establishing inter alia a European Agency for the Evaluation of Medicinal Products (4), and in particular Article 74 thereof,
49 Prevajalska redakcija
izobraževanje
CELEX: 32002R0178
Pristojnost Evropske agencije za vrednotenje zdravil
Competence of the European Agency for the Evaluation of Medicinal Products
50 Prevajalska redakcija
izobraževanje
CELEX: 21998D0709(15)
EMEA (omrežje Evropske agencije za vrednotenje zdravil)
EMEA (European medicine evaluation agency network)
Prevodi: sl > en
1–50/97
Evropska agencija za vrednotenje zdravil