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Efficient Management of Controlled Term Requests in eAF Process

This document outlines the structured process for submitting and managing requests for controlled term lists in the electronic Application Framework (eAF). It details the categories of containers, country specifics, quantity operators, units of measurement, MRL species, and more. The process emphasizes the need for clear instructions on the term request form, stipulating that multiple terms can be requested simultaneously. With a service level agreement (SLA) of 5 days, the process also delineates the internal and external approval steps required for substances and dosage forms, ensuring regulatory compliance.

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Efficient Management of Controlled Term Requests in eAF 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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