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standard operating procedure on the release of assessment reports to applicants / marketing authorisation holders
standard operating procedure on the release of assessment reports to applicants/ marketing authorisation holders
standard operating procedure on referrals in accordance with the provisions of council directive 75/319/eec in the case of safety concerns related to medicinal products marketed in the european union
standard operating procedure on referrals in accordance with the provisions of council directive 75/ 319/ eec in the case of safety concerns related to medicinal products marketed in the european union
need for post-marketing data contribution to cpmp points to consider document on xenogeneic cell therapy proposals for revision to standard operating procedure on urgent safety restrictions for medicinal products authorised through the mutual recognition procedure
need for post-marketing data contribution to cpmp points to consider document on xenogeneic cell therapy proposals for revision to standard operating procedure on urgent safety restrictions for medicinal products authorised through the mutual recognition procedure
de beschreven bacteriologische bemonstering moet gebeuren volgens "sanitation standard operating procedures" (ssop's) waarin de preoperationele hygiënecontroles zijn aangegeven die moeten worden verricht op gebieden die rechtstreekse gevolgen hebben voor de producthygiëne.
the described bacteriological sampling should be applied according to sanitation standard operating procedures (ssops) specifying the pre-operational hygiene controls to be carried out in areas which have a direct bearing to product hygiene.
zebet/ecvam/colipa, standard operating procedure: balb/c 3t3 nru phototoxicity test, drafted 23 december 1997 by m. liebsch and approved 6 march 1998 by the management team of the eu/colipa project 'in vitro photoirritation'.
zebet/ecvam/colipa, standard operating procedure: balb/c 3t3 nru phototoxicity test, drafted 23 december 1997 by m. liebsch and approved 6 march 1998 by the management team of the eu/colipa project 'in vitro photoirritation'.
de lidstaten treffen de nodige maatregelen opdat de in artikel 7 van richtlijn 89/397/eeg bedoelde laboratoria beantwoorden aan de algemene criteria voor het functioneren van beproevingslaboratoria welke zijn neergelegd in europese norm en 45001, aangevuld met de "standard operating procedures", en voor een steekproefsgewijze controle op de naleving ervan door personeel dat met de kwaliteitsbewaking is belast, in overeenstemming met de oeso-beginselen nrs. 2 en 7 inzake goede laboratoriumpraktijken van afdeling ii van bijlage 2 bij het besluit van de raad van de oeso van 12 mei 1981 betreffende de wederzijdse aanvaarding van gegevens bij de beoordeling van scheikundige stoffen.
member states shall take all measures necessary to ensure that the laboratories referred to in article 7 of directive 89/397/eec comply with the general criteria for the operation of testing laboratories laid down in european standard en 45001 supplemented by standard operating procedures and the random audit of their compliance by quality assurance personnel, in accordance with the oecd principles no 2 and 7 of good laboratory practice as set out in section ii of annex 2 to the decision of the council of the oecd of 12 may 1981 concerning the mutual acceptance of data in the assessment of chemicals.