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21 the mah also reworded the entire section 4.8 undesirable effects in accordance with current guidelines and with the qrd comments received.
imetnik dovoljenja za promet z zdravilom je preoblikoval tudi celotni razdelek 4. 8 neželeni učinki v skladu s trenutnimi smernicami in prejetimi pripombami po pregledu kakovosti dokumentacije.
the documentation submitted, the scientific discussion within the committee and the new wording proposed in the updated guideline on spc dated october 2005 and the latest qrd template,
predlagal vlagatelj, so bili ovrednoteni na podlagi predložene dokumentacije, znanstvene razprave znotraj odbora in novega besedila, predlaganega v posodobljenih smernicah o spc iz oktobra 2005 ter zadnje predloge qrd,
the member states and the commission agree that germany will pursue the detailed examination for the dossier for qrd 133 wp (bacillus subtilis strain qst 713)
države članice in komisija se strinjajo, da bo nemčija izvedla podroben pregled dokumentacije za qrd 133 wp (bacillus subtilis sev qst 713).
due to the long-standing post marketing experience, the well characterised safety profile and the large exposure of the product the prac recommended to amend the psur frequency to 10-yearly and to amend annex ii accordingly to reflect the current qrd template sentence referring to the eurd list.
odbor prac zaradi dolgotrajnih izkušenj iz obdobja trženja zdravila, dobro znanega varnostnega profila in velike izpostavljenosti zdravilu priporoča spremembo pogostnosti psur na 10 let in ustrezno spremembo priloge ii, da bo odražala stavek iz trenutne predloge qrd, ki se nanaša na seznam eurd.