EU MAA — Application Form (eAF) & Cover Letter — GLPI-103
📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.
This is a mock / simulation document, made for a portfolio and for learning. The drug (GLPI-103), the sponsor, the people, and the data are all fictional. It is not a real regulatory submission and has no clinical, legal, or regulatory standing. What is real is the shape of the thing — the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.
What it is. The executed-style EU centralised Marketing Authorisation Application form (eAF) and cover letter.
Why it exists. The eAF is the structured application that opens the EU centralised procedure — naming the active substance, legal basis, indication, manufacturers, QPPV, and RMP. It is the European counterpart to Form 356h.
How it is produced here. This is a region-specific administrative document, assembled to the local filing and labeling conventions. Its operational and label content is written to stay consistent with the (simulated) clinical data.
Format & governing standard. Regulation (EC) 726/2004 (centralised) · Directive 2001/83/EC · eCTD EU M1
EU MAA — Application Form (eAF) & Cover Letter — GLPI-103
| Field | Value |
|---|---|
| Document ID | M1-EU-eAF |
| Version | 1.0 |
| Status | Final (mock executed) |
| Region | EMA (EU) |
| Standard | Regulation (EC) 726/2004 (centralised) · Directive 2001/83/EC · eCTD EU M1 |
| Confidentiality | Confidential — portfolio use |
[MOCK — administrative identifiers fictional]An executed-style rendering of the EU centralised Marketing Authorisation Application form and cover letter. Consistent with M1-EU (SmPC) and the dossier.
Change History
| Version | Date | Author | Summary of Change |
|---|---|---|---|
| 1.0 | 2026-07-05 | Regulatory Affairs (EU) | Initial executed-style eAF and cover letter |
1. Cover Letter
Virtual Biopharma Inc. (EU representative: Virtual Biopharma B.V., Amsterdam [MOCK])
Date: 2026-07-05 · To: European Medicines Agency, Amsterdam.
Re: Marketing Authorisation Application (centralised procedure) — GLPI-103, EMEA/H/C/00xxxx [MOCK].
Virtual Biopharma Inc. submits this MAA under the centralised procedure (mandatory scope — new active substance for diabetes mellitus) for GLPI-103, for adults with type 2 diabetes mellitus inadequately controlled on metformin. Scientific Advice was obtained (EMA/SA); the Paediatric Investigation Plan (PIP) is agreed/deferred as described (M1 pediatric plan). The eCTD dossier contains Modules 1–5, the proposed SmPC/Annexes/Package Leaflet, and the EU-RMP. The (Co-)Rapporteur appointments are noted. Yours faithfully, — [Signature] [MOCK].
2. eAF — Application Form (executed-style) [MOCK]
| Field | Entry |
|---|---|
| Applicant | Virtual Biopharma Inc. (EU rep: Virtual Biopharma B.V.) |
| Invented name | GLPI-103 [MOCK] |
| Active substance | GLPI-103 (synthetic peptide GLP-1/APJ dual agonist) |
| Pharmaceutical form(s) / strength(s) | Solution for injection 1/2/4 mg; tablet 2/4/8 mg |
| Route(s) | Intravenous (once weekly); oral (once daily) |
| ATC code | A10B (placeholder) [MOCK] |
| Legal basis | Article 8(3) of Directive 2001/83/EC (full/complete application) |
| Procedure | Centralised (Regulation 726/2004), new active substance |
| Therapeutic indication | Treatment of adults with T2DM inadequately controlled on metformin |
| Orphan / conditional / accelerated | Not orphan; standard assessment [MOCK] |
| Manufacturers (DS, DP, batch release) | Listed with GMP certificates (M3-AR §3.2.R) |
| Qualified Person (pharmacovigilance) — QPPV | Named; EU PSMF location referenced [MOCK] |
| RMP version | EU-RMP (RMP-EU) |
| PIP decision | EMA Paediatric Committee decision referenced [MOCK] |
3. Accompanying EU Administrative Content
Proposed SmPC, Annex II, labelling (outer/immediate) and Package Leaflet with user-consultation (readability) statement (M1-EU); EU-RMP (RMP-EU); environmental risk assessment (ERA) for the active substance; letters of access to any Active Substance Master Files/CEPs as applicable [MOCK].
4. Cross-References
M1-0 (administrative index); M1-EU (SmPC + Annexes); RMP-EU; M1 pediatric plan (PIP); M2.1 (CTD ToC).
Comments (0)
No comments yet. Be the first to say something!