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teise kuritarvituse käigus rikuti farmaatsiatoodete turustamislubade andmise korda.
the second abuse concerned misuses of procedures relating to the authorisation of marketing of pharmaceutical products.
Last Update: 2014-11-21
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13. juuli 1995, mis käsitleb toimeainena ferbaami või etüülasiinfossi sisaldavate taimekaitsevahendite turustamislubade tühistamist
commission decision of 13 july 1995 concerning the withdrawal of authorizations for plant protection products containing ferbam or azinphos-ethyl as active substances (95/276/ec)
Last Update: 2014-10-23
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lepinguosalised lepivad põhimõtteliselt kokku, et jätkavad nende kliiniliste uuringute aktsepteerimist turustamislubade taotlemisel.
in principle, the parties agree to continue to accept these clinical trials for the purpose of marketing authorisations applications.
komisjoni otsus, 13. juuli 1995, mis käsitleb toimeainena ferbaami või etüülasiinfossi sisaldavate taimekaitsevahendite turustamislubade tühistamist
commission decision of 13 july 1995 concerning the withdrawal of authorizations for plant protection products containing ferbam or azinphos-ethyl as active substances
eraldi süsteemi loomine nikotiinisisaldusega toodetele turustamislubade andmiseks tähendaks riigiasutustele kõrgeid halduskulusid, keerukat hindamiskriteeriumite väljatöötamisprotsessi ja farmaatsiaalase raamistiku dubleerimise ohtu.
setting up of a separate authorisation scheme for ncp would imply high administrative costs for national authorities, involve complex considerations in terms determining the criteria to be used in the evaluation and imply a risk of overlap with the pharmaceutical framework.
selleks et tagada käesoleva otsusega loodud süsteemi tõhus toimimine, peavad kooskõlastav liikmesriik, teised liikmesriigid ja komisjon jagama kohe asjakohast teavet, mis on seotud otsuse kohaldamisega ja turustamislubade väljastamisega.
in order to ensure the good functioning of the system set out by this decision, it is further necessary that the coordinating member state, the other member states and the commission immediately share the relevant information regarding applications and the granting of authorisations for marketing.