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eAF Term Request Process. Presented by: Isabel Chicharo MDMS Lead Data Officer. Controlled Term Lists in use by eAF. Container category; Country Quantity operator; Units of Measurement; MRL Species; MRL provision; Tissue; Special precaution for storage Substances; Target Species

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eaf term request process

eAF Term Request Process

Presented by: Isabel Chicharo

MDMS Lead Data Officer

controlled term lists in use by eaf
Controlled Term Lists in use by eAF
  • Container category; Country
  • Quantity operator; Units of Measurement; MRL Species; MRL provision; Tissue; Special precaution for storage
  • Substances; Target Species
  • Dosage form; Route of Administration; Container
eaf term request process1
eAF Term Request Process
  • No CRs allowed: Container category; Country
  • Change request process:
    • Receive and approve (MDMS team): Quantity operator; Units of Measurement; MRL Species; MRL provision; Tissue; Special precaution for storage; Substances H
    • Receive and forward for internal approval: Substances V (EV Vet support); Target Species (CVMP)
    • Receive and forward for external approval: Dosage form (EDQM); Route of Administration (EDQM); Container (EDQM)
eaf term request process user perspective
eAF Term Request Process – user perspective

* In the term request form there are detailed instructions on what information is required to apply for changes in each list.

eaf term request form
eAF Term Request Form
  • Standard word form
  • Multiple terms can be requested at one time
  • 2. Product and application details
  • 3. Missing substances and excipients
  • 4. Missing terms for other drop downs
  • Indication of which eAF list it relates to
  • Indication of required details
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