220-Dictionary of Pharmaceutical Medicine, 2nd Edition-Gerhard Nahler Annette Mollet-3211898352-S

67error of measurement (E of M) → see error. escape medication.escape medication → see rescue medication.essential documents Documents absolutely necessary according toGCP for the correct and complete documentation of a clinical trialand kept in the Trial Master File.essential drug list (EDL) List of pharmaceutical products deemedabsolutely necessary for treatment of patients; issued by nationalgovernments (non-listed products may be banned!), but also bythe who.essential requirements (ERs) Requirements to be fulfilled by a medicaldevice before the CE-marking can be affixed.essentially similar products (EC): “A proprietary medicinal productwill be regarded as essentially similar to another product if ithas the same qualitative and quantitative composition in terms ofactive principles (substances), and the pharmaceutical form is thesame and, when necessary, bioequivalence with the first producthas been demonstrated by appropriate bioavailability studiescarried out”; this applies also to different oral forms for immediaterelease, e.g. tablets and capsules (however there is no supportfor using indications, doses or dosing schedules as additional criterion);→ see also pharmaceutical equivalent, therapeuticequivalent; either the original manufacturer has to give permissionor the second applicant must be able to show that its “similar”product makes a significant contribution to patient care; this otherproduct must have received marketing authorisation in the EUmore than 6 or 10 years ago in the concerned member states in theapplied pharmaceutical forms, strengths and route of administration;→ see also market exclusivity.establishment licence application (ELA) US term for applicationfor marketing authorisation of well-characterised biotechnologyproducts; → see also new drug application.establishment inspection report (EIR) Result after a FDA-inspection;reports are classified as NAI (no action indicated) = the investigatoris in compliance, VAI-1 (voluntary action indicated) =objectionable condition or practice was corrected during the inspectionand the conditions had minimal effect on the integrity(validity of data or rights of research subjects) of the study, VAI-2= objectionable condition or practice has not been corrected duringthe inspection and the conditions had minimal effect on theintegrity of the study; VAI-2C only deficiency found was related toan inadequate consent form; VAI-3 = response to a letter of adversefindings requested or a follow-up inspection initiated; VAI-3R responseto a letter of adverse findings has been received and accepted;VAI-3F a follow-up “for cause” inspection initiated; OAI =est