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kui teade sisaldab euroopa farmakopöa sobivussertifikaati ja kui muudatus on seotud sertifikaadi saamiseks esitatud toimikuga, tuleb muudatuse tegemiseks vajalikud tõendid esitada euroopa ravimikvaliteedi direktoraadile (edqm).
for notifications including a certificate of suitability from the european pharmacopoeia and when the variation concerns the dossier submitted for the certificate, the documentation required for this change is to be submitted to the european directorate for the quality of medicines (edqm).
Last Update: 2014-11-21
Usage Frequency: 1
Quality:
volitatud asutused võtavad riskianalüüsi ja riskijuhtimise hindamise jooksul vastavushindamismenetluse raames arvesse euroopa ravimikvaliteedi direktoraadi välja antud lähteainete tse sobivussertifikaati, edaspidi „tse sobivussertifikaat”, kui see on olemas.
notified bodies shall, during the evaluation of the risk analysis and risk management in the framework of the conformity assessment procedure, take account of the tse certificate of suitability issued by the european directorate for the quality of medicines, hereinafter ‘tse certificate of suitability’, for starting materials, where available.
Last Update: 2014-11-21
Usage Frequency: 1
Quality:
volitatud asutused võtavad riskianalüüsi ja riskijuhtimise hindamise jooksul vastavushindamismenetluse raames arvesse euroopa ravimikvaliteedi direktoraadi välja antud lähteainete tse sobivussertifikaati, edaspidi "tse sertifikaat", kui see on olemas.
notified bodies shall, during the evaluation of the risk analysis and risk management in the framework of the conformity assessment procedure, take account of the tse certificate of suitability issued by the european directorate for the quality of medicines, hereinafter "tse certificate", for starting materials, where available.