Work out when a generic can file and launch
Workbench dates data and market protection from the reference product's first EU authorisation under Directive 2001/83/EC. Atlas puts the filing and launch dates on the pipeline, and Fee Calculation estimates the DCP fees.
Protection dates are worked out again for each target
For each target, someone finds the reference product's first EU authorisation and counts eight, ten and eleven years by hand. The result sits in a slide without the articles behind it. The new pharma package will change the periods for later reference products.
Price the generic DCP while you plan it.
The total for the RMS and each CMS, the rates applied and how each agency takes payment, next to the filing date Workbench worked out.
RMS
CMS
From an authorisation date to a filing plan
Workbench computes the dates
Give Workbench the reference product's first EU authorisation date. It applies Article 10 of Directive 2001/83/EC and returns the filing date and both launch dates, cited.
Atlas holds the plan
The filing and launch dates go onto the Atlas pipeline as tasks with an owner and status, next to running procedures such as Rivaroxaban Ostra 20 mg under NL/H/6120/001/DC.
Fee Calculation prices the DCP
Fee Calculation estimates the agency fees for the planned DCP by RMS, CMS markets and strengths, with currencies, payment terms and the official fee references.
Date a generic DCP from the reference authorisation
The team supplies the reference product's first EU authorisation date. Workbench returns the dates that the Atlas filing plan and the DCP fee estimate depend on.
What's up next?Our reference product was first authorised in the EU on 22 June 2019. When can we file a generic DCP, when can we launch, and does the new pharma package change this?
- understanding your question…
Reference product · first EU authorisation 22 June 2019 · generic DCP
- Patents and SPCs run separately from data and market protection. Check them before fixing a launch date.
1. Short answer
File from 22 June 2027, after 8 years of data protection. Launch from 22 June 2029, or 22 June 2030 if the reference gained a new indication with significant clinical benefit in its first 8 years. The new package keeps these periods here.
2. Protection dates
3. For the filing plan
- Check the reference product's indications added before 22 June 2027.
- Put the 22 June 2027 DCP submission on the Atlas pipeline with an owner.
- Run Fee Calculation for the RMS and CMS markets planned for the DCP.
Dates your legal team can recheck
Counted from your date
Each date counts from the authorisation date you give and cites Article 10 of Directive 2001/83/EC, so legal review can redo the sum.
States which rules apply
Reference products filed before the new rules apply keep 8+2+1 (Art. 221(5)). Later ones get 8+1 as a baseline, up to 11 years, under Articles 83 and 84.
Dates on the pipeline
Filing and launch dates sit on the Atlas pipeline with an owner and status, and Fee Calculation prices the DCP for the same RMS and CMS markets.
Related on Regunaut
- Protection periods change under the package: see data exclusivity and market protection under the new directive.
- The voucher for priority antimicrobials sits in the new EU pharmaceutical Regulation.
- Definitions: data exclusivity in the Regunaut glossary.
Date your next generic filing
See Workbench, Atlas and Fee Calculation on your own products and markets in a 30-minute walkthrough.