An agency of the European Union 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 Dosage form; Route of Administration; Container 1

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) 2

eAF Term Request Process – user perspective (day 0) MAH fills in request form and s request to Term request evaluation process (+5 day) MDMS Service desk informs MAH of term to be used 3 * In the term request form there are detailed instructions on what information is required to apply for changes in each list.

eAF Term Request Process – 5 days SLA 4

eAF Term Request Form 5 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

EUTCT access6