EU first marketing authorisations
Data exclusivity, market protection and the term of an SPC all run from one date: the first time the product was authorised anywhere in the European Union. MPA holds that date, and the country it was granted in, for each product, so the regulatory clocks can be read without searching the registers one by one.
What it holds
- The date and country of the first marketing authorisation in the European Union for each product, by any route.
- Where the first authorisation was central, the SPC term counts from the date the holder was notified of the decision, usually a few days after the decision itself; the patents dataset applies that rule in its SPC expiry.
- The same product’s patent and SPC position alongside, if you subscribe to it, so the regulatory and patent clocks can be read off one record.
- Markets
- EU-wide.
- Not included
- The UK’s own clock, which runs from the UK authorisation. UK authorisation dates are in the product licences dataset.
Who uses it, and why
- Generics and biosimilar companiesAn abridged application can only refer to the reference product’s data once eight years have passed since this date, so a development programme is timed to it.
- Originators, brand and portfolio teamsTo see how long regulatory protection lasts for their own products and their competitors’, where it outlasts the patents.
- Patent attorneys and legal teamsThe first EU authorisation is the second input to the SPC term, and the date cited on the certificate.
- Consultancies and advisersTo read the regulatory protection behind a product’s headline expiry date, for a due diligence or a valuation.
Questions it answers
When, and in which country, was this product first authorised in the EU?
When can an abridged application for a generic or biosimilar refer to the reference product’s data?
Does regulatory protection outlast the patents and SPCs, and so block generics when no patent does?
Which date sets the SPC term for this product, and does the register use the same one?
Which products reach the end of their data protection in the next few years?
Which of the five clocks on a product runs last?
How it is searched
Assessing a product
- 1Search by substance or product.
- 2Read the date and country of the first EU authorisation.
- 3Count the regulatory clocks from it: eight years of data exclusivity, then market protection, under rules that are being reformed.
- 4If you also subscribe to patents and SPCs, compare those dates with the patent and SPC expiry for each country to see which clock runs last.
Finding opportunities
- 1Work through a whole list of products in one go to see when each was first authorised.
- 2From the dates, see which products reach the end of their data protection in the next few years, so a programme can be started in time.
- 3Add the patent and SPC position to find products where regulatory protection, not a patent, sets the date.
- 4Ask us for a horizon view of which products open up when, across a portfolio.
Expert support, included
Which authorisation counts as the first, whether a later product shares a global authorisation with an older one, and how the new EU rules change the periods are questions we answer as part of every subscription.
What to read first
All resources- ExplainersPatent cover, data exclusivity and market protectionPatents are only one of the barriers between a generic and the market. Regulatory data protection runs on its own clock from the first EU authorisation and can block generics when no patent does. What the 8+2+1 rule means, how the UK and EU now differ, and what the 2026 reform changes.
- ExplainersCentralised, decentralised, mutual recognition, nationalA medicine reaches the European market by one of four procedures. Each produces a different kind of authorisation, a different number format, and a different first-authorisation date. What the routes are, how to recognise them from a licence number, and why the route matters for SPC and exclusivity calculations.
- Regulatory changesThe EU's new data and market exclusivity rulesThe agreed EU pharmaceutical package keeps eight years of data protection but cuts baseline market protection from two years to one, with one-year extensions that have to be earned and an eleven-year cap. Adopted by the Council in September 2026, awaiting Parliament's vote, and applying only to products filed from late 2028. What changes, what does not, and what it means for generic entry dates.
- ExplainersWhy some SPC expiry dates moved by a few daysSince the Court of Justice's 2015 Seattle Genetics ruling, the SPC term for a centrally authorised product is counted from the day the holder was notified of the Commission's decision, not the decision itself. The difference is days, every SPC on that authorisation moves by them, and the registers did not all correct themselves. How the rule works, what Incyte added, and how to check.
- ExplainersThe generic development timeline in EuropeA generic cannot be filed until year eight of the reference product's data protection and cannot be sold until year ten, so development is timed backwards from a date. What each step takes for an oral solid, where the Bolar exemption covers it, what the application costs in time, why complex generics and biosimilars start years earlier, and what the programme means for the launch date everyone else is watching.
- ExplainersOne product, five clocksPatent expiry, SPC expiry, paediatric extension, data exclusivity and market protection are five separate clocks on one product. They start from different events, run under different laws, and the last one to stop sets the real loss-of-exclusivity date. A one-page map, with a checklist.
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