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pregled uporabe zdravil
1 Objavljeno
RS
Ur. l. RS, št. MP 39
Uporaba preglednic hranilnih vrednosti v zdravi pripravi jedi.
Use of nutrient value tables in healthy preparation of food.
2 Objavljeno
RS
DRUGO: TRANS
Pregledni članek obravnava zdravila in sobodne pristope, ki jih uporabljamo pri sistemskem zdravljenju glivičnih okužb.
Modern antifungal agents and approaches used in systemic treatment of fungal infections are reviewed.
3 Objavljeno
RS
DRUGO: TRANS
Avtorja na osnovi pregleda literature obravnavata različne vidike uporabe antikonvulzivnih zdravil pri afektivnih motnjah:
The authors review literature on the use of anticonvulsants in patients with affective disorders.
4 Objavljeno
RS
DRUGO: TRANS
Pregledni članek osvetluje praktične vidike uporabe najbolj razširjenih skupin zdravil v različnih fazah Parkinsonove bolezni.
This review concentrates on practical management with the main classes of the antiparkinsonian drugs from the perspective of the disease progression.
5 Objavljeno
RS
Ur. l. RS, št. MP 39
Izvajanje programov kontinuiranega izobraževanja o zdravi prehrani za strokovne delavce ter praktični uporabi prehranskih standardov in normativov ter preglednice hranilnih vrednosti v zdravi pripravi hrane.
Implementation of programmes for continuous healthy nutrition education for professional workers and implementation of nutritional standards and norms in practice, elaboration of tables of nutritional values in healthy food preparation.
6 Objavljeno
RS
DRUGO: TRANS
Avtorji podajajo pregled literature o uporabi karbamazepina v psihiatriji, opišejo farmakokinetične in farmakodinamične lastnosti zdravila ter navajajo neželene učinke in najpogostejše interakcije z drugimi zdravili.
The authors review the current literature on clinical applications of carbamazepine in psychiatry. The pharmacokinetic and pharmacodynamic profiles are described. The adverse effects and drug interactions are discussed.
7 Objavljeno
RS
DRUGO: TRANS
V zvezi s perečo problematiko uprorabe in zlorabe psihoatkivnih snovi med udeleženci v prometu v SR Sloveniji smo skušali zbrati nekaj podatkov, ki bi bralca seznanili z obstoječimi seznami mamil in psihoaktivnih zdravil, z raziskavami razširjenost njihove uporabe, ki so bile in bodo narejene, z priporočenimi analiznimi metodami ter s nekaterimi pravili in smernicami pri zdravniškem pregledu, odvzemu telesnih tekočin, prevozu in hranjenju vzorcev ipd. v primerih, ko obstaja pri udeležencu v prometu sum za vožnjo pod vplivom mamil in psihoaktivnih zdravil.
Concerning actual problems of application and abuse of psychoactive substances by persons who participate in traffic in SR Slovenia we tried to collect some data of informative character related to the existing registers of narcotics and psychoactive drugs as to the investigations performed about the spreading of their application based either on previous or planned and recommended analytical methods in this branch; moreover, some rules, resp. directions applied to medical examination, e.g. taking body liquides, transport and storage of samples etc., are discussed in suspicious cases of driving vehicles under the influence of drugs and psychoactive medicines.
8 Objavljeno
finance
WTO: Ustanovitev WTO
(a) pregled plačilnobilančnega položaja in izgledov, vključno z oceno notranjih in zunanjih dejavnikov, ki vplivajo na plačilnobilančni položaj, domače ukrepe, sprejete za ponovno vzpostavitev ravnovesja na zdravi in trajni podlagi; (b) popoln opis omejitev, ki se uporabljajo iz plačilnobilančnih razlogov, njihove pravne podlage ter ukrepov, ki se izvajajo za zmanjšanje stranskih učinkov zaščite; (c) ukrepe, ki so sprejeti med zadnjim posvetovanjem za liberalizacijo uvoznih omejitev v luči sklepov Odbora; (d) načrt za odpravo in progresivno sprostitev preostalih omejitev.
(a) an overview of the balance-of-payments situation and prospects, including a consideration of the internal and external factors having a bearing on the balance-of-payments situation and the domestic policy measures taken in order to restore equilibrium on a sound and lasting basis; (b) a full description of the restrictions applied for balance-of-payments purposes, their legal basis and steps taken to reduce incidental protective effects; (c) measures taken since the last consultation to liberalize import restrictions, in the light of the conclusions of the Committee; (d) a plan for the elimination and progressive relaxation of remaining restrictions.
9 Končna redakcija
CELEX: 32004L0027
pregled prostorov, evidenc in dokumentov imetnika dovoljenja za promet z zdravilom ali vseh podjetij, ki jih imetnik dovoljenja z promet z zdravilom uporablja za izvajanje dejavnosti, opisanih v naslovu IX, ter zlasti členov 103 in 104;
inspect the premises, records and documents of marketing authorisation holders or any firms employed by the marketing authorisation holder to perform the activities described in Title IX, and in particular Articles 103 and 104.";
10 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.
11 Končna redakcija
DRUGO
Posvetovalni odbor za uresničevanje Direktive 89/105/EGS v zvezi s preglednostjo ukrepov, ki urejajo določanje cen zdravil za človeško uporabo in njihovo vključitev v področje državnih sistemov zdravstvenega zavarovanja:
Consultative Committee for the implementation of Directive 89/105/EEC relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems:
12 Končna redakcija
CELEX: 32004L0028
Pristojni organ obvesti vse druge države članice, v katerih ima zdravilo za uporabo v veterinarski medicini dovoljenje za promet, kakor tudi Evropski direktorat za kakovost zdravil o nameravanem pregledu zadevnih serij ali serije.
The competent authority shall inform all the other Member States in which the veterinary medicinal product is authorised as well as the European Directorate for the Quality of Medicines of its intention to control batches or the batch in question.
13 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;
14 Končna redakcija
CELEX: 32004R0324
Najvišje mejne vrednosti ostankov je treba določiti v okviru Odbora za zdravila za uporabo v veterinarski medicini le po pregledu vseh ustreznih podatkov glede varnosti ostankov zadevne snovi za porabnika živil živalskega izvora in vpliva ostankov na industrijsko predelavo živil.
Maximum residue limits should be established only after the examination within the Committee for Veterinary Medicinal Products of all the relevant information concerning the safety of residues of the substance concerned for the consumer of foodstuffs of animal origin and the impact of residues on the industrial processing of foodstuffs.
15 Končna redakcija
CELEX: 32004R0546
Najvišje mejne vrednosti ostankov je treba določiti v okviru Odbora za zdravila za uporabo v veterinarski medicini le po pregledu vseh ustreznih informacij glede varnosti ostankov zadevne snovi za porabnika živil živalskega izvora in vpliva ostankov na industrijsko predelavo živil.
Maximum residue limits should be established only after the examination within the Committee for Veterinary Medicinal Products of all the relevant information concerning the safety of residues of the substance concerned for the consumer of foodstuffs of animal origin and the impact of residues on the industrial processing of foodstuffs.
16 Končna redakcija
CELEX: 32004L0027
Pristojni organ lahko opravi nenapovedane inšpekcijske preglede tudi v prostorih izdelovalcev zdravilnih učinkovin, uporabljenih kot vhodne snovi, ali v prostorih imetnikov dovoljenja za promet z zdravili, če so mnenja, da obstajajo razlogi za sum o neupoštevanju načel in smernic dobre proizvodne prakse iz člena 47.
The competent authority may also carry out unannounced inspections at the premises of manufacturers of active substances used as starting materials, or at the premises of marketing authorisation holders whenever it considers that there are grounds for suspecting non-compliance with the principles and guidelines of good manufacturing practice referred to in Article 47.
17 Končna redakcija
CELEX: 32004L0028
Pristojni organ lahko opravi tudi nenajavljene inšpekcijske preglede v prostorih izdelovalcev zdravilnih učinkovin, ki se uporabljajo kot vhodne snovi za zdravila za uporabo v veterinarski medicini, in v prostorih imetnika dovoljenja za promet z zdravilom, kadar koli meni, da obstajajo razlogi za dvom o neskladnosti z določbami iz člena 51.
The competent authority may also carry out unannounced inspections at the premises of manufacturers of active substances used as starting materials for veterinary medicinal products, and of the premises of the marketing authorisation holder whenever it considers that there are grounds for suspecting non-compliance with the provisions of Article 51.
18 Končna redakcija
CELEX: 32004L0028
Pristojni organ zadevne države članice s ponavljajočimi in če je potrebno, z nenajavljenimi inšpekcijskimi pregledi ter, kadar je to primerno, z zahtevo, da uradni državni laboratorij ali laboratorij, pooblaščen za ta namen, opravi preskuse na vzorcih, zagotovi, da se izpolnjujejo pravne zahteve glede zdravil za uporabo v veterinarski medicini.
The competent authority of the Member State concerned shall ensure, by means of repeated inspections and, if necessary, unannounced inspections, and where appropriate, by asking an Official Medicines Control Laboratory or a laboratory designated for that purpose to conduct tests on samples, that the legal requirements relating to veterinary medicinal products are complied with.
19 Končna redakcija
CELEX: 32004L0028
V primeru, da veterinar uporabi določila odstavkov 1 in 2 tega člena, mora hraniti ustrezne evidence o datumu pregleda živali, o lastniku, o številu zdravljenih živali, o diagnozi, o predpisanih zdravilih, o odmerkih danih zdravil, o trajanju zdravljenja in o priporočeni karenci ter mora zagotoviti, da so najmanj pet let na voljo pristojnim organom za inšpekcijske preglede.
When a veterinarian has recourse to the provisions of paragraphs 1 and 2 of this Article, he shall keep adequate records of the date of examination of the animals, details of the owner, the number of animals treated, the diagnosis, the medicinal products prescribed, the doses administered, the duration of treatment and the withdrawal periods recommended, and shall make these records available for inspection by the competent authorities for a period of at least five years.
20 Pravna redakcija
DRUGO
o pregledu sprememb dovoljenja za promet z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini, ki spadajo v področje Uredbe Sveta (EGS) št. 2309/93
concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93
21 Pravna redakcija
DRUGO
Pristojni organ zadevne države članice mora s ponavljanjem pregledov zagotoviti, da so izpolnjene pravne zahteve glede zdravil za uporabo v veterinarski medicini.
The competent authority of the Member State concerned shall ensure by means of repeated inspection that the legal requirements relating to veterinary medicinal products are complied with.
22 Pravna redakcija
DRUGO
Uvesti je treba tudi dodatna pojasnila v zvezi z ponovnim pregledom označevanja, navodila za uporabo/vloženega lističa ali povzetka glavnih značilnosti zdravila;
Further clarification should be introduced as regards revision of the labelling, the package leaflet/insert or the summary of product characteristics;
23 Pravna redakcija
finance
CELEX: 32003R1085
(10) Uvesti je treba tudi dodatna pojasnila v zvezi z ponovnim pregledom označevanja, navodila za uporabo/vloženega lističa ali povzetka glavnih značilnosti zdravila;
(10) Further clarification should be introduced as regards revision of the labelling, the package leaflet/insert or the summary of product characteristics;
24 Pravna redakcija
DRUGO
Kadar odbor meni, da je za dokončanje pregleda vlagateljeve vloge potrebno opraviti poseben pregled mesta izdelave zadevnega zdravila za uporabo v veterini, lahko to zahteva.
Where it considers it necessary in order to complete its examinination of an application, the Committee may require the applicant to submit to a specific inspection of the manufacturing site of the veterinary medicinal product concerned.
25 Pravna redakcija
promet
CELEX: 22003A1219(01)
Uredba Komisije (ES) št. 1084/2003 z dne 3. junija 2004 o pregledu sprememb pogojev dovoljenja za promet z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini, ki ga je izdal pristojni organ države članice (UL L 159, 27. 6. 2003, str. 1).
Commission Regulation (EC) No 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State (OJ L 159, 27.6.2003, p. 1).
26 Pravna redakcija
DRUGO
Kadar je zaradi spremembe posledično treba ponovno pregledati povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo/vloženi listič, se to šteje za del spremembe.
Where a variation requires consequential revision of the summary of product characteristics, labelling and package leaflet/insert, this is considered as part of the variation.
27 Pravna redakcija
promet
CELEX: 22004D0003
(2) Uredbo Komisije (ES) št. 1084/2003 z dne 3. junija 2004 o pregledu sprememb pogojev dovoljenja za promet z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini, ki ga je izdal pristojni organ države članice fn, je treba vključiti v Sporazum.
(2) Commission Regulation (EC) No 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State(2) is to be incorporated into the Agreement.
28 Pravna redakcija
promet
CELEX: 22004D0003
(3) Uredbo Komisije (ES) št. 1085/2003 z dne 3. junija 2004 o pregledu sprememb pogojev dovoljenja za promet z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini, ki spadajo v področje Uredbe Sveta (EGS) št. 2309/93 fn, je treba vključiti v Sporazum.
(3) Commission Regulation (EC) No 1085/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93(3) is to be incorporated into the Agreement.
29 Pravna redakcija
finance
CELEX: 32003L0063
a) Opis postopka proizvodnje, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom na podlagi člena 8(3)(d), je zasnovan tako, da daje ustrezen strnjen pregled vrste uporabljenih delovnih postopkov.
a) The description of the manufacturing method accompanying the application for Marketing Authorisation pursuant to Article 8 (3) (d), shall be drafted in such a way as to give an adequate synopsis of the nature of the operations employed.
30 Pravna redakcija
promet
CELEX: 22004D0003
Uredba Komisije (ES) št. 1085/2003 z dne 3. junija 2004 o pregledu sprememb pogojev dovoljenja za promet z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini, ki spadajo v področje Uredbe Sveta (EGS) št. 2309/93, je treba vključiti v Sporazum (UL L 159, 27. 6. 2003, str. 24)."
Commission Regulation (EC) No 1085/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93 (OJ L 159, 27.6.2003, p. 24)."
31 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.
32 Pravna redakcija
DRUGO
Pred uveljavitvijo te uredbe in po posvetu z Odborom za zdravila za uporabo v veterini se dela A in B priloge ponovno pregledata, kar zadeva zdravila za uporabo v veterini z vidika znanstvenega in tehničnega napredka, da bi se vnesle vse potrebne spremembe, ki bodo sprejete v skladu s postopkom, določenim v členu 72.
Before entry into force of this Regulation and after consultation of the Committee for Veterinary Medicinal Products, Parts A and B of the Annex as regards veterinary medicinal products shall be re-examined in the light of scientific and technical progress with a view to making any amendments necessary which will be adopted under the procedure laid down in Article 72.
33 Pravna redakcija
DRUGO
DIREKTIVA SVETA z dne 21.decembra 1988 v zvezi s preglednostjo ukrepov, ki urejajo določanje cen zdravil za človeško uporabo in njihovo vključitev v področje nacionalnih sistemov zdravstvenega zavarovanja (89/105/EGS)
Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems
34 Pravna redakcija
DRUGO
ker je treba izboljšati tudi preglednost in olajšati dostop na trg zdravilom za uporabo v veterini, tako da se farmacevtskim podjetjem za določeno novo in/ali inovativno zdravilo ponudi možnost ene same vrste nacionalnega dovoljenja ali dovoljenja Skupnosti ne glede na ciljno vrsto za to zdravilo;
Whereas it is also necessary to improve the transparency of and ease of access to the market in veterinary medicinal products by offering pharmaceutical companies the possibility, for a given new and/or innovative medicinal product, of a single type of national or Community authorisation whatever the target species for that product;
35 Pravna redakcija
DRUGO
Klasifikacija se lahko pregleda glede na nove znanstvene dokaze (na primer z uporabo ustreznih mnenj znanstvenih odborov, Odbora za lastniška zdravila CPMP in ukrepov Komisije za urejanje uporabe snovi, ki predstavljajo tveganje v zvezi s TSE).
The classification may be reviewed in the light of new scientific evidence (for example using relevant opinions from the Scientific Committees, the Committee for Proprietary Medicinal Products CPMP and Commission Measures regulating the use of material presenting risks as regards TSE).
36 Pravna redakcija
DRUGO
Take osebe morajo hraniti podrobne evidence o vsem poslovanju s snovmi, ki se lahko uporabljajo za izdelavo zdravil za uporabo v veterinarski medicini ter morajo te podatke hraniti za dobo najmanj treh let za potrebe pregledov pooblaščenih organov.
Such persons must maintain detailed records of all dealings in substances which may be used in the manufacture of veterinary medicinal products and keep these records available for inspection by the competent authorities for a period of at least three years.
37 Pravna redakcija
finance
CELEX: 32003L0063
Kadar je to primerno, se v vlogo za pridobitev dovoljenja za promet z zdravilom vključi pregled ocene tveganja, kjer so ovrednotena možna tveganja za okolje zaradi uporabe in/ali odstranjevanja zdravila ter predlogi ustreznih zahtev za označevanje.
Where applicable, applications for marketing authorisations shall include a risk assessment overview evaluating possible risks to the environment due to the use and/or disposal of the medicinal product and make proposals for appropriate labelling provisions.
38 Pravna redakcija
DRUGO
Direktiva Sveta 89/105/EGS z dne 21.decembra 1988 v zvezi s preglednostjo ukrepov, ki urejajo določanje cen zdravil za človeško uporabo in njihovo vključitev v področje nacionalnih sistemov zdravstvenega zavarovanja (UL št. L 40, 11. 2. 1989, str. 8).
Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ No L 40, 11.2.1989, p. 8).
39 Pravna redakcija
DRUGO
Pri zdravilih, ki se uvažajo iz tretjih držav, so nadzorni organi pristojni organi držav članic, v katerih se opravljajo pregledi, omenjeni v členu 22(1)(b) direktive 75/319/EGS, razen če se sklenejo ustrezni dogovori med Skupnostjo in državo izvoznico, s katerimi se zagotovi, da se ti pregledi opravljajo v državi izvoznici in da izdelovalec uporablja standarde dobre proizvodne prakse, ki so vsaj enakovredni tistim, ki jih določa Skupnost.
In the case of medicinal products imported from third countries, the supervisory authorities shall be the competent authorities of the Member States in which the controls referred to in Article 22 (1) (b) of Directive 75/319/EEC are carried out unless appropriate arrangements 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.
40 Pravna redakcija
DRUGO
Pri zdravilih za uporabo v veterini, ki se uvažajo iz tretjih držav, so nadzorni organi pristojni organi držav članic, v katerih se opravljajo pregledi, omenjeni v členu 30(1)(b) direktive 81/851/EGS, razen če se sklenejo ustrezni sporazumi med Skupnostjo in državo izvoznico, s katerimi se zagotovi, da se ti pregledi opravljajo v državi izvoznici in da izdelovalec uporablja standarde dobre proizvodne prakse, ki so vsaj enakovredni tistim, ki jih določa Skupnost.
In the case of veterinary medicinal products imported from third countries, the supervisory authorities shall be the competent authorities of the Member States in which the controls referred to in Article 30 (1) (b) of Directive 81/851/EEC are carried out unless appropriate arrangements 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.
41 Pravna redakcija
DRUGO
Na zahtevo Komisije oseba, ki je odgovorna za dajanje zdravila za uporabo v veterini v promet, tudi pregleda analizne metode detekcije, določene v točki 8 drugega odstavka člena 5 direktive 81/851/EGS, in predlaga kakršne koli spremembe, ki so lahko potrebne, da bi se upošteval tehnični in znanstveni napredek.
Upon a request from the Commission, the person responsible for placing the veterinary medicinal product on the market shall also review the analytical detection methods provided for in point 8 of the second paragraph of Article 5 of Directive 81/851/EEC and propose any changes which may be necessary to take account of technical and scientific progress.
42 Pravna redakcija
DRUGO
lahko zahtevajo od predlagatelja, da predloži snovi v količinah, potrebnih, da bi se preverila analitska metoda določanja, ki jo predlaga predlagatelj v skladu s členom 12(3)(h) ter da se jo uporabi kot del rutinskih pregledov za ugotavljanje prisotnosti zaostankov zadevnih zdravil za uporabo v veterinarski medicini.
may require the applicant to submit substances in the quantities necessary to verify the analytical detection method proposed by the applicant in accordance with Article 12(3)(h) and to put it into effect as part of routine checks to reveal the presence of residues of the veterinary medicinal products concerned.
43 Pravna redakcija
DRUGO
V skladu s kakršnimi koli dogovori, ki so lahko sklenjeni med Skupnostjo in tretjimi državami skladno z drugim odstavkom člena 38, lahko Komisija po prejemu utemeljene zahteve od države članice, Odbora za zdravila za uporabo v veterini ali na lastno pobudo zahteva, da izdelovalec s sedežem v tretji državi dovoli pregled.
Subject to any arrangements which may have been concluded between the Community and third countries in accordance with the second paragraph of Article 38, the Commission may, upon receipt of a reasoned request from a Member State, the Committee for Veterinary Medicinal Products, or on its own initiative, require a manufacturer established in a third country to submit to an inspection.
44 Pravna redakcija
DRUGO
Ob upoštevanju praktičnih izkušenj pri uporabi Uredbe Komisije (ES) št. 542/95 z dne 10. marca 1995 o pregledu sprememb pogojev dovoljenja za promet, ki sodijo v okvir Uredbe Sveta (EGS) št. 2309/93 fn, kakor je bila spremenjena z Uredbo (ES) št. 1069/98 fn, je primerno poenostaviti postopek za spreminjanje dovoljenja za promet z zdravilom.
In the light of practical experience in the application of Commission Regulation (EC) No 542/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation falling within the scope of Council Regulation (EEC) No 2309/93(3), as amended by Regulation (EC) No 1069/98(4), it is appropriate to simplify the procedure for varying the terms of a marketing authorisation.
45 Pravna redakcija
finance
CELEX: 32003R1085
(1) Ob upoštevanju praktičnih izkušenj pri uporabi Uredbe Komisije (ES) št. 542/95 z dne 10. marca 1995 o pregledu sprememb pogojev dovoljenja za promet, ki sodijo v okvir Uredbe Sveta (EGS) št. 2309/93 fn, kakor je bila spremenjena z Uredbo (ES) št. 1069/98 fn, je primerno poenostaviti postopek za spreminjanje dovoljenja za promet z zdravilom.
(1) In the light of practical experience in the application of Commission Regulation (EC) No 542/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation falling within the scope of Council Regulation (EEC) No 2309/93(3), as amended by Regulation (EC) No 1069/98(4), it is appropriate to simplify the procedure for varying the terms of a marketing authorisation.
46 Pravna redakcija
DRUGO
V primeru, da veterinar uporabi določila člena 10, mora hraniti ustrezne evidence o datumu pregleda živali, o lastniku, o številu zdravljenih živali, o diagnozi, o predpisanih zdravilih, o odmerkih danih zdravil, o trajanju zdravljenja ter o priporočeni karenci. Ti podatki morajo biti na razpolago inšpektorjem pristojnih organov najmanj tri leta.
When a veterinarian has recourse to the provisions of Article 10, he shall keep adequate records of the date of examination of the animals, details of the owner, the number of animals treated, the diagnosis, the medicinal products prescribed, the dosages administered, the duration of treatment and the withdrawal periods recommended, and make these records available for inspection by the competent authorities for a period of at least three years.
47 Pravna redakcija
DRUGO
V primeru, da država članica ugotovi, da je vloga za pridobitev dovoljenja za promet z zadevnim zdravilom za uporabo v veterinarski medicini že v obravnavi v drugi državi članici, se lahko zadevna država članica odloči, da opusti podroben pregled vloge zato, da bi počakala na poročilo o oceni zdravila druge države članice v skladu s členom 25(4).
Where a Member State notes that an application for authorization submitted is already under active examination in another Member State in respect of that veterinary medicinal product, the Member State concerned may decide to suspend the detailed examination of the application in order to await the assessment report prepared by the other Member State in accordance with Article 25(4).
48 Pravna redakcija
DRUGO
lahko zaprosi, da v državnem laboratoriju ali pooblaščenem laboratoriju z uporabo vzorcev, ki jih zagotovi vlagatelj, preskusijo, da je analizna metoda detekcije, ki jo predlaga vlagatelj v skladu s točko 8 drugega odstavka člena 5 direktive 81/851/EGS, primerna za uporabo pri rutinskih pregledih za odkrivanje količine zaostankov nad najvišjo dovoljeno količino zaostankov, ki jo dopušča Skupnost v skladu z določbami uredbe Sveta (EGS) št. 2377/90 z dne 26. junija 1990, ki določa postopek Skupnosti za določitev najvišjih dovoljenih količin zaostankov zdravil za uporabo v veterini v živilih živalskega izvora fn
may request a State laboratory or laboratory designated for this purpose to verify, using samples provided by the applicant, that the analytical detection method proposed by the applicant in accordance with point 8 of the second paragraph of Article 5 of Directive 81/851/EEC is suitable for use in routine checks to reveal the presence of residue levels above the maximum residue level accepted by the Community in accordance with the provisions of Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (1);
49 Pravna redakcija
DRUGO
Kadar je v skladu z drugim odstavkom člena 39 direktive 81/851/EGS Komisija obveščena o pomembnih razlikah v mnenjih držav članic glede vprašanja, ali oseba, ki je odgovorna za dajanje zdravila za uporabo v veterini v promet, izdelovalec ali uvoznik s sedežem v Skupnosti izpolnjuje zahteve iz odstavka 1, lahko Komisija po posvetovanju z zadevnimi državami članicami zahteva, da inšpektor iz nadzornega organa opravi nov pregled prej omenjene osebe, izdelovalca ali uvoznika;
Where, in accordance with the second paragraph of Article 39 of Directive 81/851/EEC, the Commission is informed of serious differences of opinion between Member States as to whether the person responsible for placing the veterinary medicinal product on the market or a manufacturer or importer established within the Community is satisfying the requirements referred to in paragraph 1, the Commission may, after consultation with the Member States concerned, request an inspector from the supervisory authority to undertake a new inspection of the aforementioned person, the manufacturer or the importer;
50 Pravna redakcija
DRUGO
Najvišje dovoljene količine zaostankov je treba določiti potem, ko odbor za zdravila za uporabo v veterinarski medicini (CVMP) pregleda vse s tem povezane podatke, ki jih predložijo vlagatelji v skladu z določbami Uredbe (EGS) št. 2377/90, in ob upoštevanju vseh javno dostopnih zadevnih znanstvenih podatkov o varnosti zaostankov zadevne snovi za potrošnika živil živalskega izvora ter zlasti ob upoštevanju mnenj Znanstvenega odbora za veterinarske javnozdravstvene ukrepe (SCVPH) in ocen skupnega strokovnega odbora FAO/WHO za živilske dodatke.
Maximum residue limits should be established after examination, within the Committee for Veterinary Medicinal Products (CVMP), of all the relevant information provided by applicants in accordance with the provisions of Regulation (EEC) No 2377/90 and taking into account all publicly available relevant scientific information concerning the safety of residues of the substance concerned for the consumer of foodstuffs of animal origin and in particular opinions of the Scientific Committee on Veterinary Measures related to Public Health (SCVPH) and the evaluations of the Joint FAO/WHO Expert Committee on Food Additives.
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pregled uporabe zdravil