eAF Term Request Process

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eAF Term Request Process
Presented by Isabel Chicharo MDMS Lead Data
Officer
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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

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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)

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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.
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eAF Term Request Process 5 days SLA
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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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