See which licences a regulatory update affects
Alerts reads each EMA and national update against your portfolio and names the registrations it touches. Atlas holds those registrations, and Workbench checks what the update asks of each one.
Finding the update is only half the work
EMA and the national agencies publish guidance, Q&As and notices every week. Someone still has to read each one against the product list and decide which licences it touches. Done by hand, that check happens late, or only for the obvious products.
Watch the markets you sell in.
Alerts reads only the agencies you pick: here, the 14 feeds Ostra watches. Select a country on the map to add or drop its feed.
Select a country to watch it. Also watched, beyond the map: European Union, Brazil, United States, Canada, Japan.
From a published update to a named task
Alerts reads the update
Alerts watches EMA and the national agencies, and reads each update against your registrations rather than a keyword list.
It names the registrations
Each match points at an Atlas record with its procedure and market, such as Desloratadine Ostra 5 mg under PL/H/9999/001/DC.
Workbench checks the detail
Where the reading needs a closer look, Workbench checks your draft against the new guidance and cites both. The approved action lands on the Atlas timeline with an owner.
Check a flagged variation against the new examples
Alerts matched EMA's revised classification examples to two Ostra products. Workbench checks the Desloratadine package before it is filed.
What's up next?EMA revised its variation classification examples. Does our Desloratadine shelf-life extension still qualify as Type IB, and does anything else in the portfolio move?
- understanding your question…
Desloratadine Ostra 5 mg · PL/H/9999/001/DC · shelf-life extension
1. Short answer
Yes. The extension to 36 months stays Type IB under B.II.f.1(b), provided the stability data cover the full period. The Infliximab CEP update remains a Type IA under the same examples.
2. Products checked
3. Before filing
- Confirm the real-time stability data cover 36 months at the approved conditions.
- File the Type IB through RMS Poland before the deadline on the Atlas timeline.
- Keep the Infliximab CEP update on its Type IA route.
Every update read against the products you hold
Matched to registrations
A reading names procedure numbers and markets from Atlas, not a category such as "centralised products".
One proposed action
Each reading ends with one next step, an owner and a date. Approve it and it sits on the Atlas timeline.
Checked before filing
Workbench reads your draft against the new guidance and cites both, so a reviewer can see why the classification holds.
Related on Regunaut
- The largest regulatory change on the horizon is the new EU pharma package, covered topic by topic.
- Track where it stands on the EU pharma package legislative timeline.
Read the next update against your portfolio
See Alerts, Atlas and Workbench on your own products and markets in a 30-minute walkthrough.