Take an authorised product into its next markets
Atlas shows where each product is authorised and what it costs to hold. Workbench checks the route into a new market, such as a repeat use of an existing DCP, and Fee Calculation prices the filing agency by agency.
Expansion questions get answered from scattered files
BD asks where a product could go next. RA answers from a licence spreadsheet, the national registers and the fee table from the last filing. Each answer takes days, and the cost estimate is often out of date before it reaches the business case.
Price the filing before you commit to a market.
The total per market, the rates applied and how each agency takes payment, for the procedure and strengths you plan.
RMS
CMS
From current licences to a priced filing
Atlas shows the footprint
The Apixaban Ostra 5 mg record lists DK/H/3311/001/DC with Denmark as RMS and SI, HR, PL and HU as CMS, plus the UK and Mexico licences and the submission in Brazil.
Workbench checks the route
Workbench checks whether new member states can join through a repeat use of the DCP, what the RMS needs first and which apixaban products the national registers list. Each point is cited.
Fee Calculation prices it
Fee Calculation estimates the agency fees with Denmark as RMS and each new CMS, with currencies, payment terms and the official fee references.
Check a repeat use before committing to markets
Atlas shows Ostra already holds Desloratadine in Czechia, Slovakia and Romania, but not Apixaban. Workbench checks whether Apixaban can follow through its Danish DCP.
What's up next?Apixaban Ostra 5 mg is authorised under DK/H/3311/001/DC. Can we add Czechia, Slovakia and Romania by repeat use, and what does Denmark need from us first?
- understanding your question…
Apixaban Ostra 5 mg · DK/H/3311/001/DC · repeat use to CZ, SK and RO
- Registers show authorisations, not patent or SPC status. Confirm the IP position in each market before filing.
1. Short answer
Yes. All three can join as new CMS in a repeat use of the Danish DCP. Ask DKMA first for an updated assessment report under Article 28(2); the new CMS then have 90 days to recognise it.
2. Before the start
3. Next steps
- Send DKMA the request for an updated assessment report and agree a start date.
- Price the filing in Fee Calculation with Denmark as RMS and CZ, SK and RO as CMS.
- Prepare Czech, Slovak and Romanian product information for the national phase.
Licences, route and fees for the same product
Licences per market
Atlas lists each registration with its procedure number, RMS, CMS and status, so the markets a product is missing from show on its record.
Cited route check
Workbench cites the Directive article, the CMDh guidance and the register entries behind each point of its answer.
Fees with references
Fee Calculation shows each agency's fee, currency and payment terms, with the official fee schedule it used.
Related on Regunaut
- Most new multi-country filings run through the decentralised procedure (DCP).
- Existing authorisations extend to new markets through the mutual recognition procedure (MRP) and its repeat-use waves.
- Price the filing with authority fee calculation per procedure and country.
Plan your next market from current licences
See Atlas, Workbench and Fee Calculation on your own products and markets in a 30-minute walkthrough.