Core Task Information
ID
example-task-shelf-life-update
Status
requested
Priority
routine
Code
Update Shelf Life (update-shelf-life)
Authored
2024-07-17T13:24:34.123Z
Last Updated
2024-07-17T13:24:34.123+00:00
Parties Involved
Requested Performer (Regulatory Authority)
European Medicines Agency (EMA)
Identifier: ORG-EMA-001
Address: Domenico Scarlattilaan 6, 1083 HS Amsterdam, Netherlands
Phone: +31 88 781 6000
Email: info@ema.europa.eu
Owner – Marketing Authorization Holder (MAH)
PharmaCorp International Ltd
Identifier: ORG-MAH-98765
Address: Industriering 42, 9491 Ruggell, Liechtenstein
Phone: +423 377 6000
Email: regulatory@pharmacorp.li
Input Documents
7 documents
Module 1
Cover Letter
1.0
cover-letter-variation-ib-ci4.pdf
Application Form
1.2
eu-application-form.xml
Module 2
Quality Overall Summary – Drug Substance & Product
2.3
qos-shelf-life-update-v2.docx
Module 3
Updated Stability Data (Drug Substance)
3.2.S.7.3
stability-ds-36m.pdf
Updated Stability Data (Drug Product)
3.2.P.8.3
stability-dp-36m-final-report.pdf
Revised MedicinalProductDefinition (FHIR JSON)
APIX-MPD
MedicinalProductDefinition/example-ma.json
Module 4
No content submitted yet
Module 5
No content submitted yet
Regional
No content submitted yet
Expected Output
No content submitted yet