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turklāt oficiālos partijas izlaidumus, ko veic eksportējošās puses iestāde, atzīs otra puse.
in addition, official batch releases carried out by an authority of the exporting party will be recognised by the other party.
Last Update: 2017-02-15
Usage Frequency: 1
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piemērojot partijas oficiālās izlaišanas procedūru, partijas oficiālo izlaišanu, ko veic eksportējošās puses iestāde (uzskaitītas ii iedaļā), atzīst otra puse.
when an official batch release procedure applies, official batch releases carried out by an authority of the exporting party (listed in section ii) will be recognised by the other party.
Last Update: 2017-02-15
Usage Frequency: 1
Quality:
b) zālēm, uz ko attiecas importējošās (ne eksportējošās) puses tiesību akti farmācijas jomā, vietējais kompetentais pārbaudes dienests, kas vēlas veikt attiecīgo ražošanas darbību pārbaudi, veic pārbaudi, vadoties pēc savas lrp vai, ja nav īpašu lrp prasību, pēc importētājas puses piemērojamās lrp.
(b) 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.
Last Update: 2017-02-15
Usage Frequency: 1
Quality: