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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. 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

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

  2. 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

  3. 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)

  4. 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.

  5. eAF Term Request Process – 5 days SLA

  6. 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

  7. EUTCT access

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