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pharmaceutical inspection service
1 Pravna redakcija
DRUGO
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 against its own GMP or, in the absence of specific GMP requirements, against the applicable GMP of the importing Party.
V zvezi z zdravili, ki jih pokriva farmacevtska zakonodaja pogodbenice, ki uvaža, ne pa tudi izvoznice, pristojna lokalna inšpekcijska služba, ki je pripravljena izvesti pregled ustreznih proizvodnih postopkov, slednje preveri glede na svojo lastno dobro proizvodno prakso ali, če ni specifičnih zahtev GMP, glede na veljavno GMP pogodbenice uvoznice.
2 Pravna redakcija
promet
With respect to medicinal products/drugs 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 against its own GMPs if relevant, or, in the absence of specific GMP requirements, against the applicable GMPs of the importing Party.
Glede zdravil, ki jih zajemajo farmacevtski predpisi pogodbenice uvoznice, ne pa predpisi pogodbenice izvoznice, lokalna pristojna inšpekcijska služba, ki je pripravljena opraviti pregled zadevnih proizvodnih procesov, opravi pregled glede na svoje GMP, če pridejo v poštev, če posebnih GMP ni, pa glede na ustrezne GMP pogodbenice uvoznice.
3 Prevajalska redakcija
izobraževanje
CELEX: 31991L0412
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";
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";
4 Prevajalska redakcija
izobraževanje
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.
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.
5 Prevajalska redakcija
izobraževanje
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.
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.
Prevodi: en > sl
1–5/5
pharmaceutical inspection service