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Zakon o zdravilih
1 Prevajalska redakcija
izobraževanje
CELEX: 21998A0817(02)
Zakon o zdravilih 1981
Medicines Act 1981
2 Prevajalska redakcija
izobraževanje
CELEX: 21998A0817(01)
Zakon o zdravilih za živino, 1939-1978,
Stock Medicines Act, 1939-1978,
3 Končna redakcija
DRUGO
Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini (UL L 311, 28. 11. 2001, str. 67).
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
4 Končna redakcija
CELEX: 32004R0726
Ker pa sta Evropski parlament in Svet sprejela Direktivo 2001/83/ES z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini in Direktivo 2001/82/ES z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini, je treba v Uredbi (EGS) št. 2309/93 posodobiti vse sklice na sprejeti direktivi.
Moreover, since the European Parliament and the Council have adopted Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use(5) and Directive 2001/82/EC of 6 November 2001 on the Community code relating to veterinary medicinal products(6), all the references to the codified Directives in Regulation (EEC) No 2309/93 should be updated.
5 Končna redakcija
DRUGO
Direktiva 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini (UL L 311, 28. 11. 2001, str. 1).
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).
6 Končna redakcija
CELEX: 32004L0027
Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini je zaradi večje jasnosti in racionalizacije kodificirala in v enotno besedilo združila besedila zakonodaje Skupnosti o zdravilih za uporabo v humani medicini.
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(4), codified and consolidated in a single text the texts of Community legislation on medicinal products for human use, in the interests of clarity and rationalisation.
7 Končna redakcija
CELEX: 32004L0028
Direktiva 2001/82/ES Evropskega parlamenta in Sveta z dne 23. oktobra 2001, o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini [4] je kodificirala in konsolidirala zakonodajo Skupnosti o zdravilih za uporabo v veterinarski medicini v enotno besedilo v interesu jasnosti in preglednosti.
Directive 2001/82/EC of the European Parliament and of the Council of 23 October 2001 on the Community code relating to veterinary medicinal products(4) codified and consolidated previous Community legislation on veterinary medicinal products in a single text in the interests of clarity and rationalisation.
8 Končna redakcija
CELEX: 32004L0028
Zakonodaja o dovoljenjih za promet z zdravili za uporabo v veterinarski medicini ter merila, ki urejajo izdajo dovoljenj, so namenjeni krepitvi zaščite javnega zdravja.
The legislation on marketing authorisations for veterinary medicinal products, and the criteria governing the granting of authorisations, are such as to strengthen the protection of public health.
9 Končna redakcija
CELEX: 32004R0726
Agencija državam članicam in institucijam Skupnosti preskrbi najboljše možno znanstveno svetovanje o katerem koli vprašanju, ki je povezano z vrednotenjem kakovosti, varnosti in učinkovitosti zdravil za humano in veterinarsko uporabo, ki se nanjo naslovi v skladu z določbami zakonodaje Skupnosti o zdravilih.
The Agency shall provide the Member States and the institutions of the Community with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use which is referred to it in accordance with the provisions of Community legislation relating to medicinal products.
10 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.
11 Končna redakcija
CELEX: 32004R0273
Izključena so zdravila, kakor so opredeljena z Direktivo 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [13], farmacevtski pripravki, zmesi, naravni proizvodi in drugi pripravki, ki vsebujejo snovi s seznama, ki so sestavljeni tako, da jih na enostaven način ni mogoče uporabiti ali ekstrahirati z razpoložljivimi ali ekonomsko smiselnimi načini;
This excludes medicinal products as defined by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(13), pharmaceutical preparations, mixtures, natural products and other preparations containing scheduled substances that are compounded in such a way that they cannot be easily used or extracted by readily applicable or economically viable means;
12 Pravna redakcija
promet
CELEX: 21998A1016(01)
Zakon in predpisi o živilih in zdravilih, Zakon o zdravju živali in predpisi o izdaji dovoljenj za materiale živalskega izvora.
Food and Drugs Act and Regulations, Health of Animals Act and Regulations for the issuance of permits for materials of animal origin.
13 Pravna redakcija
promet
CELEX: 22003D0154
Zvezni zakon z dne 15. decembra 2000 o zdravilih in medicinskih pripomočkih (RO 2001 2790)
Federal law of 15 December 2000 on medicinal products and medical devices (RO 2001 2790)
14 Pravna redakcija
promet
CELEX: 22003D0154
Zvezni zakon z dne 15. decembra 2000 o zdravilih in medicinskih pripomočkih (RO 2001 2790)
Federal law of December 15, 2000 on medicinal products and medical devices (RO 2001 2790)
15 Pravna redakcija
promet
CELEX: 22003D0154
Zvezni zakon z dne 15. decembra 2000 o zdravilih in medicinskih pripomočkih (RO 2001 2790)
Federal Law of 15 December 2000 on medicinal products and medical devices (RO 2001 2790)
16 Pravna redakcija
promet
CELEX: 22001A1029(01)
Veljavni zakoni, predpisi in upravne določbe o zdravilih, zahtevah DPP za zdravila, overjanju in potrjevanju
The applicable laws, regulations and administrative provisions stipulating medicinal products, GMP requirements for medicinal products, verification and confirmation
17 Pravna redakcija
promet
CELEX: 21998A1016(01)
Zakon o živilih in zdravilih ter Predpisi o medicinskih pripomočkih (predloženi za razglasitev leta 1998), kakor so spremenjeni,
the Food and Drugs Act and Medical Devices Regulations (proposed for promulgation 1998) as amended from time to time,
18 Pravna redakcija
promet
CELEX: 21998A1016(01)
Ta licenca je izdana v skladu z Zakonom in predpisi o živilih in zdravilih (Del 1A in 2) za naslednje dejavnosti in kategorije zdravil:
This licence is issued in accordance with the Food and Drugs Act & Regulations (Division 1A & 2) for the following activities and categories of drugs:
19 Pravna redakcija
promet
CELEX: 21998A1016(01)
Ta licenca je izdana v skladu z Zakonom in predpisi o živilih in zdravilih (Del 1A in 2) za naslednje dejavnosti in kategorije zdravil:
This licence is issued in accordance with the Food and Drugs Act & Regulations (Division 1 A & 2) for the following activities and categories of drugs:
20 Pravna redakcija
promet
CELEX: 22003D0154
Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini (UL L 311, 28.11.2001, str. 67)
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67)
21 Pravna redakcija
promet
CELEX: 22003A1219(01)
Direktiva Komisije 2003/63/ES z dne 25. junija 2003 o spremembi Direktive 2001/83/ES Evropskega parlamenta in Sveta o zakoniku Skupnosti o zdravilih za ljudi(UL L 159, 27.6.2003, str. 46).
Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (OJ L 159, 27.6.2003, p. 46).
22 Pravna redakcija
promet
CELEX: 22003D0154
Direktiva 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini (UL L 311, 28.11.2001, str. 1)
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1)
23 Pravna redakcija
DRUGO
ker so podobne določbe določene v zvezi z zdravili za uporabo v veterini v direktivi Sveta 93/40/EGS z dne 14. junija 1993, ki spreminja direktivi 81/851/EGS in 81/852/EGS o približevanju zakonodaje držav članic v zvezi z zdravili za uporabo v veterini fn
whereas similar provisions have been laid down in respect of veterinary medicinal products by Council Directive 93/40/EEC of 14 June 1993 amending Directives 81/85 I/EEC and 81/852/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products (4);
24 Pravna redakcija
DRUGO
da hrani podrobne evidence o vseh zdravilih za uporabo v veterinarski medicini, ki jih dobavlja, vključno z vzorci, v skladu z zakoni držav, kamor so pošiljke namenjene.
keep detailed records of all veterinary medicinal products supplied by him, including samples, in accordance with the laws of the countries of destination.
25 Pravna redakcija
DRUGO
Druga direktiva Sveta 75/319/EGS z dne 20. maja 1975 o približevanju določb zakonov in drugih predpisov v zvezi z lastniškimi zdravili (UL št. L 147, 9. 6. 1975, str. 13),
Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ No L 147, 9.6.1975, p. 13),
26 Pravna redakcija
promet
CELEX: 22004D0003
(4) Direktivo Komisije 2003/63/ES z dne 25. junija 2003 o spremembi Direktive 2001/83/ES Evropskega parlamenta in Sveta o zakoniku Skupnosti o zdravilih za uporabo v humani medicini fn je treba vključiti v Sporazum.
(4) Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use(4) is to be incorporated into the Agreement.
27 Pravna redakcija
promet
CELEX: 22001A1029(01)
Direktiva Sveta 65/65/EGS z dne 26. januarja 1965 o približevanju določb, ki jih opredeljuje zakon, uredba ali upravni ukrep v zvezi z lastniškimi zdravili, in spremembe Direktive
Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products and amendments thereto
28 Pravna redakcija
promet
CELEX: 22001A1029(01)
Druga Direktiva Sveta 75/319/EGS z dne 20. maja 1975 o približevanju določb, ki jih opredeljuje zakon, uredba ali upravni ukrep v zvezi z lastniškimi zdravili, in spremembe Direktive
Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products and amendments thereto
29 Pravna redakcija
DRUGO
Direktiva Sveta 65/65/EGS z dne 26. januarja 1965 o približevanju določb zakonov in drugih predpisov v zvezi z zdravili (UL št. 22, 9. 2. 1965, str. 369/65), kakor je bila spremenjena z:
Council Directive 65/65/EEC of the 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ No 22, 9.2.1965, p. 369/65), as amended by:
30 Pravna redakcija
DRUGO
ker je treba upoštevati predpise Skupnosti o veterinarskih zdravilih in zlasti Direktivo Sveta 81/851/EGS z dne 28. septembra 1981 o približevanju zakonov držav članic o veterinarskih zdravilih fn in Direktivo Sveta 81/852/EGS z dne 28. septembra 1981 o približevanju zakonov držav članic o analitskih, farmako-toksikoloških in kliničnih standardih ter protokolih o preskušanju veterinarskih zdravil fn, kakor je bila spremenjena z Direktivo 87/20/EGS fn;
Whereas Community rules regarding veterinary medicinal products, and in particular Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of Member States relating to veterinary medicinal products fn, and Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products fn, as amended by Directive 87/20/EEC fn, should be taken into account;
31 Pravna redakcija
DRUGO
Direktiva Sveta 81/851/EGS z dne 28. septembra 1981 o približevanju zakonodaje držav članic v zvezi z veterinarskimi zdravili (UL št. L 317, 6. 11. 1981, str. 1), kakor je bila spremenjena z:
Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (OJ No L 317, 6.11.1981, p. 1), as amended by:
32 Pravna redakcija
DRUGO
Druga direktiva Sveta 75/319/EGS z dne 20. maja 1975 o približevanju določb zakonov in drugih predpisov v zvezi z lastniškimi zdravili (UL št. L 147, 9. 6. 1975, str. 13), kakor je bila spremenjena z:
Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ No L 147, 9.6.1975, p. 13), as amended by:
33 Pravna redakcija
DRUGO
ker so določene medicinski pripomočki namenjeni aplikaciji zdravil v smislu Direktive Sveta 65/65/EGS z dne 26. januarja 1965 o približevanju določb zakonov in drugi predpisov v zvezi z zaščitenimi zdravili fn;
Whereas certain medical devices are intended to administer medicinal products within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (4);
34 Pravna redakcija
promet
CELEX: 22003D0154
Za Švico je postopek za uradno sprostitev serij opisan v členu 17 Zveznega zakona o zdravilih in medicinskih pripomočkih ter v členih 18 do 21 Odloka Švicarske agencije za terapevtske izdelke o zahtevah za dovoljenje za promet za zdravila.
For Switzerland, the official batch release procedure is specified in Article 17 of the Federal Law on medicinal products and medical devices and in Articles 18 to 21 of the Ordinance of the Swiss Agency for Therapeutic Products on the requirements for the marketing authorisation of medicinal products.
35 Pravna redakcija
DRUGO
ob upoštevanju Direktive Sveta 75/319/EGS z dne 20. maja 1975 o približevanju zakonskih in upravnih predpisov v zvezi z zdravili fn, kakor je bila nazadnje spremenjena z Direktivo 93/39/EGS fn, in zlasti člena 15 Direktive,
Having regard to Council Directive 75/319/EEC of 20 May 1975, on the approximation of provisions laid down by law, regulations or administrative action relating to medicinal products (1), as last amended by Directive 93/39/EEC (2), and in particular Article 15 thereof,
36 Pravna redakcija
DRUGO
Direktiva Sveta z dne 22. decembra 1986, ki spreminja Direktivo 65/65/EGS o približevanju določb iz zakonov in drugih predpisov v zvezi z zdravili, ki jih je moč dobiti brez recepta (87/21/EGS) (UL L 15, 17. 1. 1987, str. 36).
Council Directive of 22 December 1986 amending Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (87/21/CEE) (OJ L 15, 17.1.1987, p. 36)
37 Pravna redakcija
obramba
CELEX: 32004L0010
(4) Direktiva 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini fn in Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini fn določata, da se neklinični preskusi farmacevtskih proizvodov izvajajo v skladu z načeli dobre laboratorijske prakse (DLP), ki veljajo v Skupnosti za kemične snovi in skladnost s katerimi zahteva tudi druga zakonodaja Skupnosti.
(4) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products fn and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use fn lay down that non-clinical tests on pharmaceutical products are to be carried out in accordance with the principles of good laboratory practice (GLP) in force in the Community for chemical substances, compliance with which is also required by other Community legislation.
38 Pravna redakcija
DRUGO
Direktiva Sveta z dne 26. januarja 1965 o približevanju zakonskih in drugih predpisov v zvezi z zdravili (65/65/EGS), kakor je bila nazadnje spremenjena z Direktivo Sveta 93/39/EGS z dne 14. junija 1993 (UL L 214, 24. 8. 1993, str. 22)
Council Directive of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (65/65/EEC) as last amended by Council Directive 93/39/EEC of 14 June 1993 (OJ L 214, 24.8.1993, p. 22)
39 Pravna redakcija
DRUGO
Direktiva Sveta z dne 28. septembra 1981 o približevanju zakonov držav članic v zvezi z veterinarskimi zdravili (81/8 51/EGS), kakor je bila nazadnje spremenjena z Direktivo Sveta 90/676/EGS z dne 13. decembra 1990 (UL L 373, 31. 12. 1990, str. 15)
Council Directive of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (81/8 51/EEC) as last amended by Council Directive 90/676/EEC of 13 December 1990 (OJ L 373, 31.12.1990, p. 15)
40 Pravna redakcija
DRUGO
Zaradi tehnične prilagoditve Priloge I k Direktivi 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini fn je primerno v to uredbo uvesti določbe o spremembah v zvezi z glavnimi dosjeji plazme in glavnimi dosjeji virusnih antigenov.
Due to the technical adaptation of Annex I to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code related to medicinal products for human use(5), it is appropriate to introduce in this Regulation provisions on variations related to plasma master files and vaccine antigen master files.
41 Pravna redakcija
finance
CELEX: 32003R1085
(2) Zaradi tehnične prilagoditve Priloge I k Direktivi 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini fn je primerno v to uredbo uvesti določbe o spremembah v zvezi z glavnimi dosjeji plazme in glavnimi dosjeji virusnih antigenov.
(2) Due to the technical adaptation of Annex I to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code related to medicinal products for human use(5), it is appropriate to introduce in this Regulation provisions on variations related to plasma master files and vaccine antigen master files.
42 Pravna redakcija
DRUGO
ob upoštevanju Direktive Sveta 81/851/EGS z dne 28. septembra 1981 o približevanju zakonodaje držav članic v zvezi z zdravili za uporabo v veterinarski medicini fn, kakor je bila nazadnje spremenjena z Direktivo 93/40/EGS fn, in zlasti člena 23 Direktive,
Having regard to Council Directive 81/8 51/EEC of 28 September 1981, on the approximation of legislation of the Member States relating to veterinary medicinal products (3), as last amended by Directive 93/40/EEC (4), and in particular Article 23 thereof,
43 Pravna redakcija
DRUGO
Direktiva Sveta 90/677/EGS z dne 13. decembra 1990 o razširitvi področja uporabe Direktive 81/851/EGS o približevanju zakonodaje držav članic v zvezi z veterinarskimi zdravili ter določitvi dodatnih določb za imunološka veterinarska zdravila (UL št. L 373, 31. 12. 1990, str. 26).
Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products (OJ No L 373, 31.12.1990, p. 26).
44 Pravna redakcija
DRUGO
če ni nobenega zdravila, kot ga navaja točka (a), zdravilo, ki ima v zadevni državi članici dovoljenje za promet za uporabo pri ljudeh v skladu z Direktivo 2001/83/ES Evropskega Parlamenta ter Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini( fn ) ali z Uredbo (EGS) št. 2309/93;
if there is no product as referred to in point (a), of a medicinal product authorized for use in the Member State concerned in human beings in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use (l) or under Regulation (EEC) No 2309/93;
45 Pravna redakcija
DRUGO
Direktiva Sveta 89/381/EGS z dne 14. junija 1989 o razširitvi področja uporabe direktiv 65/65/EGS in 75/319/EGS o približevanju določb zakonov in drugih predpisov v zvezi z lastniškimi zdravili ter določitvi posebnih določb za zdravila, pridobljena iz človeške krvi ali človeške plazme (UL št. L 181, 28. 6. 1989, str. 44).
Council Directive 89/381/EEC of 14 June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human plasma (OJ No L 181, 28.6.1989, p. 44).
46 Pravna redakcija
DRUGO
ker je pri zdravilih za uporabo v veterini doseženo enako z direktivo Sveta 81/851/EGS z dne 28. septembra 1981 o približevanju zakonodaje držav članic v zvezi z zdravili za uporabo v veterini fn ektivo Sveta 81/852/EGS z dne 28. septembra 1981 o približevanju zakonodaje držav članic v zvezi z analiznimi, farmakološko-toksikološkimi in kliničnimi standardi in protokoli, ki se nanašajo na preskušanje zdravil za uporabo v veterini fn
Whereas in the case of veterinary medicinal products, the same results have been achieved by Council Directive 81/85 I/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (1) and by Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (2);
47 Pravna redakcija
obramba
CELEX: 32004R0273
Izključena so zdravila, kakor so opredeljena z Direktivo 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini fn, farmacevtski pripravki, zmesi, naravni proizvodi in drugi pripravki, ki vsebujejo snovi s seznama, ki so sestavljeni tako, da jih na enostaven način ni mogoče uporabiti ali ekstrahirati z razpoložljivimi ali ekonomsko smiselnimi načini.
This excludes medicinal products as defined by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(13), pharmaceutical preparations, mixtures, natural products and other preparations containing scheduled substances that are compounded in such a way that they cannot be easily used or extracted by readily applicable or economically viable means;
48 Pravna redakcija
DRUGO
ker je v interesu upravne učinkovitosti zaželeno, da podatki in podrobnosti, ki morajo biti navedeni v vlogi za določitev najvišjih dovoljenih količin zaostankov za farmakološko aktivne snovi, ki se uporabljajo v zdravilih za uporabo v veterinarski medicini, v skladu z Uredbo (EGS) št. 2377/90, čim bolj ustrezajo podatkom in podrobnostim, ki jih je treba predložiti državam članicam v vlogi za dovoljenje za promet z zdravili za uporabo v veterinarski medicini, ki se vloži v skladu s členom 5 Direktive Sveta 81/851/EGS z dne 28. septembra 1981 o približevanju zakonodaj držav članic v zvezi z zdravili za uporabo v veterinarski medicini fn, kakor je bila spremenjena z Direktivo 90/676/EGS fn;
Whereas it is desirable in the interests of administrative efficiency that the information and particulars to be included in an application for the establishment of a maximum residue limit for a pharmacologically active substance used in veterinary medicinal products in accordance with Regulation (EEC) No 2377/90 should correspond as closely as possible to the information and particulars to be submitted to Member States in an application for authorization to place a veterinary medicinal product on the market submitted in accordance with Article 5 of Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (3), as amended by Directive 90/676/EEC (4);
49 Pravna redakcija
DRUGO
Te nadaljnje preiskave morajo biti izvedene v skladu s protokoli testa, kakor je določeno v Prilogi V k Direktivi Sveta 67/548/EGS z dne 27. junija 1967 o približevanju zakonov in drugih predpisov v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih snovi( fn ), ali če končna točka ni točno določena s protokoli, v skladu z drugimi mednarodno priznanimi protokoli o zdravilih za uporabo v veterinarski medicini in/ali zdravilnih učinkovinah in/ali izločenih metabolitih, če to ustreza.
These further investigations shall be carried out in accordance with the test protocols laid down in Annex V of Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), or where an end point is not adequately covered by these protocols, in accordance with other internationally recognized protocols on the veterinary medicinal product and/or the active substance(s) and/or the excreted metabolites as appropriate.
50 Pravna redakcija
DRUGO
ker so pri zdravilih za ljudi merila kakovosti, varnosti in učinkovitosti v znatni meri usklajena z direktivo Sveta 65/65/EGS z dne 26. januarja 1965 o približevanju določb zakonov ali drugih predpisov, ki se nanašajo na zdravila fn ugo direktivo Sveta 75/319/EGS z dne 20. maja 1975 o približevanju določb zakonov in drugih predpisov, ki se nanašajo na lastniška zdravila fn rektivo Sveta 75/318/EGS z dne 20. maja 1975 o približevanju zakonodaje držav članic v zvezi z analiznimi farmakološko-toksikološkimi in kliničnimi standardi in protokoli, ki se nanašajo na preskušanje zdravil za uporabo v veterini fn
Whereas, in the case of medicinal products for human use, the criteria of quality, safety and efficacy have been extensively harmonized by Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (5), and the Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation and administrative action relating to proprietary medicinal products (6), and by Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical pharmaco-toxicological and clinical standards and protocols in respect of the testing of medicinal products (7);
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