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pogodbenici si medsebojno priznavata enakovrednost programov nadzora skladnosti z načeli dobre laboratorijske prakse, ki so v skladu z zgoraj navedenimi sklepi in priporočili oecd ter zakonskimi in drugimi postopki in načeli, naštetimi v oddelku iv.
the parties recognise the equivalence of each other's compliance monitoring programmes on good laboratory practice that are in accordance with the oecd decisions and recommendations mentioned above and the legislative, regulatory and administrative procedures and principles listed in section iv.
Last Update: 2010-09-22
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kjer je to primerno, se lahko poleg preskusnih metod, ki so navedene za vsako merilo, uporabijo tudi druge, če njihovo enakovrednost odobri pristojni organ, ki ocenjuje vlogo.
where appropriate, test methods other than those indicated for each criterion may be used if their equivalence is accepted by the competent body assessing the application.
Last Update: 2010-09-05
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zdravila v preskušanju, začetne materiale, ki niso omejeni na aktivne farmacevtske sestavine), se enakovrednost zahtev dobre proizvodne prakse ugotavlja v skladu s postopkom, ki ga določi odbor.
investigational medicinal products, starting materials not limited to active pharmaceutical ingredients), equivalence of gmp requirements shall be determined according to a procedure established by the committee.
Last Update: 2010-09-22
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(b) za potrditev enakovrednosti švicarskega sistema ugotavljanja skladnosti bo Švica dodala k vsakemu usklajenemu standardu pretvorbeno tabelo.
(b) to state the equivalence of the swiss systems of conformity attestation, switzerland will add to every harmonised standard a conversion table.
Last Update: 2010-09-22
Usage Frequency: 1
Quality: