Renewals, variations and agency responses on one timeline
Atlas puts every renewal, variation, fee and agency response on one timeline with an owner and a status. Alerts flags the updates that change an item on it, and Workbench checks the pack before it goes in.
Every procedure runs on its own clock
Renewals, variations, fees and Day 120 answers each have their own date, per product and per market. Most teams keep them in a spreadsheet and a shared calendar and update both by hand. When a checklist changes, someone has to remember which open files it affects.
Atorvastatin Ostra 20 mg3 h ago
ANVISA renewal fee is due in 4 days and no payment is recorded
Proposed: Remind Maja and finance today
Ticagrelor Ostra 90 mg6 h ago
Two Day 106 answers are still unassigned, 9 days to go
Proposed: Assign both to Klara and draft Q4 from the batch data
From a due date to a checked pack
Atlas lists what is due
The pipeline shows each procedure and task with its owner and status. The next 60 days hold the Atorvastatin ANVISA renewal fee, Ticagrelor's Day 106 answers and two UK renewals.
Alerts flags what changes them
Alerts reads MHRA and ANVISA updates against those dates. It matched the reorganised MHRA licensing guidance to the Trastuzumab and Adalimumab UK renewals.
Workbench checks the pack
Workbench reads the drafted renewal pack against the agency's requirements, cites both, and lists what is missing before the owner signs off.
Check a UK renewal pack before sign-off
Atlas has the Trastuzumab UK renewal due for submission in 12 days, and Alerts flagged two MHRA updates that touch it. Workbench checks the pack before Nina signs.
What's up next?Our Trastuzumab Ostra 150 mg UK renewal goes in within 12 days. Check the attached form and clinical overview addendum against MHRA's renewal requirements. What is missing?
- understanding your question…
Trastuzumab Ostra 150 mg · PLGB 51234/0046 · UK renewal, category 1
- An MHRA portal maintenance window falls in the submission week. Submit before it starts.
1. Short answer
Two gaps. As a converted centralised product, this renewal follows EMA's renewal content. The addendum's data lock point is more than 90 days before filing, and the batch release QP declaration is missing.
2. Renewal pack
3. Before sign-off
- Move the data lock point forward and update the addendum's summary tabulations.
- Get the batch release QP declaration on active substance GMP.
- Submit through the MHRA portal before the maintenance window on the Atlas timeline.
Every due date tied to a registration
Dates per registration
Atlas holds renewal, variation and response dates per product and market, such as PLGB 51234/0046, each with an owner and a status.
Fees beside the dates
The Fees tab shows the agency fee due on each item by product and market, like the Atorvastatin ANVISA renewal fee due in four days.
Updates matched to items
When an MHRA or ANVISA update touches a planned renewal, Alerts names the item and proposes one action for its owner.
Related on Regunaut
- Under the new directive, routine renewals of marketing authorisations end.
- The package also changes the PSUR schedule for non-EURD products.
- Under the new rules, the package moves variations to electronic, database-driven handling.
Put your next 60 days on one timeline
See Atlas, Alerts and Workbench on your own products and markets in a 30-minute walkthrough.