Supplementary protection certificate for medicinal products. Recast
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With the Council of the EU, which is preparing its first-reading position.
Last active 06 Feb 2026
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What this bill does
In plain terms: what it changes and who it affects.
This proposal recasts EU rules on medicinal SPCs and adds a central EU procedure for obtaining national SPCs in multiple Member States.
Who it affects
It affects pharmaceutical innovators seeking extended patent protection, generic and biosimilar manufacturers, and patients and health systems affected by medicine market entry timing.
Core of the proposal
- Creates a central EUIPO examination procedure for SPC applications based on European patents and centralised marketing authorisations.
- Requires national offices to grant or refuse designated SPCs according to the EUIPO examination opinion.
- Bars separate national SPC applications where the centralised route is available for that product and Member State.
- Keeps the manufacturing waiver for generics and biosimilars for export and limited pre-expiry stockpiling.
Key provisions
- Takes effect
- It enters into force on the twentieth day after Official Journal publication; centralised-application rules apply one year later.
- Transitional law
- Pending national SPC applications and already granted national SPCs are not affected by the new centralised procedure.
Articles changed · 2 across 2 laws
- Regulation (EC) No 469/2009 (32009R0469)
- entire act: recasts and repeals the entire regulation
- Regulation (EU) 2019/933 (32019R0933)
- entire act: incorporates prior amendments to Regulation (EC) No 469/2009 in the recast
Latest update
05 Jun 2026The most recent development in this bill's progress.
1st reading – Council of the EU → 1st reading – Council of the EU
1st reading – Council of the EU → 1st reading – Council of the EU
Documents
1 recentSourcesOEILEUR-LexEU Law Tracker