Supplementary protection certificate for medicinal products (recast)
This procedure aims to update the rules for Supplementary Protection Certificates (SPCs), which extend the duration of patent protection for medicinal products. This extension compensates for the long time required to obtain regulatory marketing authorization, encouraging pharmaceutical innovation by allowing companies to recover research and development costs.
This will primarily affect pharmaceutical companies and healthcare providers. The changes aim to harmonize the application process across the EU and ensure a balanced approach between rewarding innovation and providing timely access to generic medicines.
Documents
Supplementary protection certificate for medicinal products (recast)
report · EN · 2026-05-02
Supplementary protection certificate for medicinal products (recast)
proposal · EN · 2026-05-02
Supplementary protection certificate for medicinal products (recast)
report · EN · 2026-05-02
Supplementary protection certificate for medicinal products (recast)
proposal · EN · 2026-05-02
Supplementary protection certificate for medicinal products (recast)
proposal · EN · 2026-05-02
Supplementary protection certificate for medicinal products (recast)
report · EN · 2026-05-02
Supplementary protection certificate for medicinal products (recast)
proposal · EN · 2026-05-02
Supplementary protection certificate for medicinal products (recast)
report · EN · 2026-05-02
Supplementary protection certificate for medicinal products (recast)
proposal · EN · 2026-05-02
Supplementary protection certificate for medicinal products (recast)
report · EN · 2026-05-02
Supplementary protection certificate for medicinal products (recast)
position · EN · 2026-05-02
Supplementary protection certificate for medicinal products (recast)
report · EN · 2026-05-02