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farmacevtska nadzorna služba
1 Prevajalska redakcija
izobraževanje
CELEX: 31991L0412
ker je Komisija po posvetovanju s farmacevtskimi nadzornimi službami držav članic objavila podrobne smernice, navedene v členu 27a Direktive 81/851/EGS, v obliki "Navodil za dobro proizvodno prakso za zdravila";
Whereas the detailed guidelines mentioned in Article 27a of Directive 81/851/EEC have been published by the Commission after consultation with the pharmaceutical inspection services of the Member States in the form of a "Guide to good manufacturing practice for medicinal products";
2 Prevajalska redakcija
izobraževanje
Za zdravila, za katera velja farmacevtska zakonodaja države, ki uvaža, ne pa tudi države, ki izvaža, pristojna lokalna nadzorna služba, ki je pripravljena izvesti inšpekcijski pregled ustreznih postopkov izdelave, izvede pregled skladno s svojimi lastnimi GMP, ali pa, v kolikor specifičnih zahtev GMP ni, skladno z veljavnimi načeli GMP države, ki uvaža.
With respect to medicinal products covered by the pharmaceutical legislation of the importing Party but not the exporting one, the locally competent inspection service willing to carry out an inspection of the relevant manufacturing operations shall inspect in accordance with its own GMP or, in the absence of specific GMP requirements, in accordance with the applicable GMP of the importing country.
3 Prevajalska redakcija
izobraževanje
Za zdravila, za katera velja farmacevtska zakonodaja države, ki uvaža, ne pa tudi države, ki izvaža, bo pristojna lokalna nadzorna služba, ki je pripravljena izvesti inšpekcijski pregled ustreznih postopkov izdelave, izvedla pregled skladno s svojimi lastnimi GMP, ali pa, v kolikor specifičnih zahtev GMP ni, skladno z veljavnimi načeli GMP države, ki uvaža.
With respect to medicinal products covered by the pharmaceutical legislation of the importing Party but not the exporting one, the locally competent inspection service willing to carry out an inspection of the relevant manufacturing operations will inspect in accordance with its own GMP or, in the absence of specific GMP requirements, in accordance with the applicable GMP of the importing country.
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farmacevtska nadzorna služba