Transcript How to request additional terms in eAF

eAF Term Request Process
Presented by: Isabel Chicharo
MDMS Lead Data Officer
An agency of the European Union
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 emails request to
[email protected]
* In the term request form there
are detailed instructions on what
information is required to apply for
changes in each list.
3
(+5 day)
Term request
evaluation process
MDMS Service desk
informs MAH of term to
be used
eAF Term Request Process – 5 days SLA
eAF Term Request process
4
Term availability
EV V Support
MDMS Data Officers
MDMS
Service Desk
Applicant
Phase
(Day 0)
Fill in Term Request Form
Email Term Request
(Day 5)
Use suggested term in eAF
(Day 1)
Receive Term request
Forward call to owner
(Day 4)
Forward email to applicant and
close call
Use term the following day
(Day 2)
Create Change request in EUTCT
Validate Change Request
(Day 4)
Create Vet Substance in EUTCT
(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 OR
Inform no EV code & close call
(Day 2-4)
Term in EUTCT
(Day 3-5)
Term in eAF
eAF Term Request Form
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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
6
EUTCT access