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Your portfolio. Add a molecule and its strengths here — each strength is a separate application. Click a molecule, a strength, or a country cell to open its full dossier, split by country.
The most recent version of every dossier component — Tier 3 documents, EU MA references, adapted artwork, and the SmPC / PIL / labelling working files — is collected here for a dedicated OneDrive folder your team accesses. When live, the backend pushes each latest version automatically to the OneDrive link below (via Microsoft Graph, server-side). For now, download the dossier pack — a ZIP foldered to the exact same structure the live sync uses — and drop it into that OneDrive folder.
Expiry watch across the whole portfolio — every dated certificate (CPP, GMP per site, ML, CoA, trademark…) with the days remaining until it lapses. Agencies require these to be valid at the time of assessment, so an expired GMP or CPP can stall a submission. Expired and within 30 days show red, within 90 days amber. Once a product’s MA is granted in a market, its certificates are no longer required for that market — those rows are marked “MA granted” and drop out of the alarm counts. Click a row to open its dossier. Set each document’s expiry in the Tier 3 vault — the watch reads the dates you enter (it can’t read inside the files; when live, the backend will OCR dates off the certificates and e-mail reminders before each one expires).
Flags uploaded parts that don’t meet this market’s expectations, from the metadata you enter and the links the tool tracks — expired or expiring documents, an output whose source was updated after it (so it’s stale), missing source/traceability, plus legalisation, CPP recency and INN checks on Tier 3 documents. Set a part’s “valid until” date on its file to enable expiry checks. It reads the data you record, not the file contents — it can’t confirm a translation is in the right language or that text matches the reference.
Cross-checks the manufacturer-provided dossier against this market’s legal requirements: which scientific modules (M2–M5) the supplier has provided, what still needs local adaptation (national Module 1, local-language SmPC / PIL / labelling) and whether the required certificates are present and valid. It checks presence, format expectation, language and validity from what you record — it does not read inside the files, so it can’t confirm the scientific content itself conforms. When live, the backend reads each module and checks textual / scientific conformity to the legislation.
When every required item for the dossier filed to the agency is present and valid, generate a CTD-ordered submission pack (M1 national · M2–M5 supplier · certificates · artwork · references) as a ZIP with an index, scoped to this strength and country. The first-import batch analysis (reference/impurity standards, HPLC columns, methods, CoA + samples) is a separate pre-launch step — it is tracked on its own below and in Dossier readiness, and is not part of this submission pack. It is not a validated eCTD sequence (no eCTD backbone / lifecycle) — run it through your eCTD publishing/validation step before filing. When live, the backend can build and lodge the validated sequence.
In North Macedonia the first-import batch analysis is a single pre-launch laboratory step \u2014 the imported batch is tested using the manufacturer’s reference / impurity standards, HPLC columns and validated methods (plus CoA + samples). It is obligatory for commercialization, whatever the EU history. The only part that depends on EU history is the registration-stage quality re-analysis: it is required only if fewer than three EU MAs back the dossier. Record and upload the three EU MAs below; once 3 are referenced that single re-analysis item is marked waived \u2014 the first-import batch analysis and its materials stay required.
The single place to upload everything for this molecule. The quick view below shows the manufacturer inputs at a glance — uploaded \u2713 / missing; the All dossier documents section underneath holds an upload slot for every part. Files are wired to one source of truth: the Modules 2\u20135 uploads are the same files as the checklist supplier-module slots; the EN SmPC / PIL feed the national adaptation source; certificates (CPP, GMP per site, ML, CoA\u2026) are uploaded here with their site, issue / expiry dates and legalisation, so the validity & expiry checks run automatically. Uploading an input ticks it as received and advances the dossier items it feeds.
Every document this market needs, grouped as in the checklist. Upload here and it lands in the same place the dossier, submission pack and OneDrive sync read from. Certificates get inline fields for site / issuer, issue & expiry dates, legalisation and market scope — you can hold several of one type (a CPP per reference country, a GMP per site), each with its own validity. Confirm each one to feed the dossier checklist. Uploading advances the matching checklist item automatically.
Marks every item done for . Optionally log the key dates so this product also feeds the efficiency metrics — all fields optional, and they go into the lifecycle.
Log the real dates as they happen for this application (a single strength in one country). Each agency round — questions in, responses out — is its own entry, so you can add as many iterations as the review takes. The tool computes the cycle times from your dates.
The supplier’s artwork team (e.g. Adalvo) provides the initial template for each component — the die-cut, dimensions and EU-approved box. PPN / Farma Trejd then adapt that template into the PPN brand (house style: a name ending “PPN Rx”) and this market’s language, producing the preliminary artwork (typically carton, blister foil, and patient leaflet). It goes back to the supplier, who allocate an artwork item code per component — carton …C, foil …F, leaflet …P (e.g. ARTDB036988C) — tied to the strength and pack size, and issue the final die-cuts / print proofs for sign-off. A component is only done once that code is received; codes are re-checked at ordering, so a pack-size mismatch is caught before manufacturing. When every component is coded, the Module 1 “labelling / mock-ups” item ticks. After approval, an artwork change is filed as a variation (Type IA/IB). The manufacturer’s review usually comes back with feedback (size, color, wording…); log each item under a component, record the manual change you make, and a component only counts as done once its feedback is resolved.