Centralised, decentralised, mutual recognition, national: the four routes and what they mean for exclusivity dates

Four doors into the same market

Centralised procedure. One application to the European Medicines Agency, one scientific opinion, one European Commission decision, and one authorisation valid in every EU member state plus Norway, Iceland and Liechtenstein. Mandatory for biotechnology products, new active substances for cancer, HIV, diabetes and several other areas, orphan medicines and advanced therapies; optional for other new active substances. The authorisation number has the form EU/1/yy/nnn/ppp, the last block identifying the presentation.

Decentralised procedure (DCP). For products not yet authorised anywhere in the EU and not required to go centrally. The applicant picks a reference member state to lead the assessment; the other chosen member states assess in parallel and, at the end, each grants its own national authorisation on the same dossier. This is the normal route for generics, which is why a generic’s licences across Europe tend to share a date.

Mutual recognition procedure (MRP). For products already authorised nationally in one member state. That authorisation is recognised by the other states the holder chooses, which then issue their own national authorisations. Used to extend an existing product into more markets.

National procedure. One member state assesses and authorises for its own market only. Still used for products intended for one market, for old products authorised before the European procedures existed, and as the first step before an MRP.

The UK, since leaving the EU, authorises nationally through the MHRA, with recognition routes that let it rely on assessments by the EMA and other reference regulators; its licence numbers keep the PL nnnnn/nnnn form, with PLGB and PLNI variants reflecting Great Britain and Northern Ireland.

Why the route matters for the dates

The first EU authorisation. Data exclusivity and the SPC term both run from the first authorisation anywhere in the EU. A product first authorised nationally in one country in 2012 and centrally in 2014 has a 2012 clock, not 2014. The route tells you where to look for that first date: the Commission’s Community Register for centralised products, the national registers for the rest.

The global marketing authorisation. Later authorisations of the same product by the same holder, by whatever route, share the first one’s clocks. A national licence, a line extension via MRP and a centralised licence can all be one global authorisation.

Parallel import. A centrally authorised product is the same product in every member state, which simplifies parallel distribution (notified to the EMA). Nationally authorised products, even from the same DCP, are legally separate authorisations, and the parallel import licence in the destination country must cross-refer to the destination authorisation.

Number formats as a map. An EU/1 number says centralised; a national number says national, DCP or MRP, and the national register’s procedure field says which. The field guide to national number formats in this section lists them country by country.

What to check

1. Which route authorised the product, and the first authorisation date by any route.
2. For nationally authorised products, the authorisation in each country you care about, with its own number and date.
3. For UK purposes, the UK authorisation and its date, which now runs its own regulatory clock.
4. Whether later products from the same holder share the global authorisation.

MPA Search records the first EU authorisation date for each product, the UK product licences in full, and the national licences of other European countries as they are added.