An agency of the European Union

eAF Term Request Process

Presented by: Isabel ChicharoMDMS 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

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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

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* 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

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eAF Term Request process

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Phase

(Day 0)Fill in Term Request Form

Email Term Request

(Day 2-3)Enter subst in XEVMPD

Inform (no) EV code & close call

(Day 2-3)Enter subst in EV vet

Forward call, Substance details & EV code to EUTCT ORInform no EV code & close call

(Day 2)Create Change request in EUTCT

Validate Change Request

(Day 2-4)Term in EUTCT

(Day 3-5)Term in eAF

(Day 4)Forward email to applicant and

close callUse term the following day

(Day 5)Use suggested term in eAF

(Day 4)Create Vet Substance in EUTCT

(Day 1)Receive Term requestForward call to owner

eAF Term Request Form

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• 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 access7