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Prevodi: sl > en
1–4/4
ureditvena odločba
1 Končna redakcija
CELEX: 32004L0027
Da zagotovijo sprejetje ustreznih in usklajenih ureditvenih odločb o zdravilih, za katere je bilo izdano dovoljenje v Skupnosti, ter ob upoštevanju informacij o neželenih učinkih zdravila v predpisanih pogojih uporabe, države članice vzpostavijo sistem farmakovigilance.
In order to ensure the adoption of appropriate and harmonised regulatory decisions concerning the medicinal products authorised within the Community, having regard to information obtained about adverse reactions to medicinal products under normal conditions of use, the Member States shall operate a pharmacovigilance system.
2 Pravna redakcija
DRUGO
Da bi se spodbudila varovanje zdravja ljudi in živali ter potrošnikov zdravil v vsej Skupnosti in dokončno oblikovanje notranjega trga s sprejetjem enotnih ureditvenih odločb ki temeljijo na znanstvenih merilih glede dajanja zdravil v promet in njihovo uporabo,, je cilj agencije zagotoviti državam članicam in institucijam Skupnosti najboljše možne znanstvene nasvete glede katerega koli vprašanja o oceni kakovosti, varnosti in učinkovitosti zdravil za ljudi ali uporabo v veterini, ki je nanjo naslovljena v skladu z določbami zakonodaje Skupnosti, ki se nanaša na zdravila.
In order to promote the protection of human and animal health and of consumers of medicinal products throughout the Community, and in order to promote the completion of the internal market through the adoption of uniform regulatory decisions based on scientific criteria concerning the placing on the market and use of medicinal products, the objectives of the Agency shall be to 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, the safety, and the 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.
3 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
Da zagotovijo sprejetje ustreznih ureditvenih odločb o zdravilih, za katere je bilo izdano dovoljenje v Skupnosti, ter ob upoštevanju informacij o neželenih učinkih zdravila v predpisanih pogojih uporabe, države članice vzpostavijo sistem farmakovigilance.
In order to ensure the adoption of appropriate regulatory decisions concerning the medicinal products authorized within the Community, having regard to information obtained about adverse reactions to medicinal products under normal conditions of use, the Member States shall establish a pharmacovigilance system.
4 Prevajalska redakcija
izobraževanje
CELEX: 32004L0027
Da zagotovijo sprejetje ustreznih in usklajenih ureditvenih odločb o zdravilih, za katere je bilo izdano dovoljenje v Skupnosti, ter ob upoštevanju informacij o neželenih učinkih zdravila v predpisanih pogojih uporabe, države članice vzpostavijo sistem farmakovigilance.
In order to ensure the adoption of appropriate and harmonised regulatory decisions concerning the medicinal products authorised within the Community, having regard to information obtained about adverse reactions to medicinal products under normal conditions of use, the Member States shall operate a pharmacovigilance system.
Prevodi: sl > en
1–4/4
ureditvena odločba