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Document 52023PC0222
Unitary supplementary certificate for medicinal products, amending Regulation (EC) No 1901/2066
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013
- Initiative summary:
- While the EU legislation on Supplementary Protection Certificates (SPCs) is fit for purpose, their administration and enforcement at national level leads to fragmentation, which hampers their effectiveness and efficiency. A unified SPC procedure and of a unitary SPC would strengthen the single market for pharmaceuticals and agrochemicals, and make SPCs fit to support the twin digital and green transition.
- EuroVoc thesaurus:
- single market; pharmaceutical legislation; market approval; medicinal product; European patent
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- Documents:
- Ares(2022)1726335 (Call for evidence for an impact assessment)
- Leading service:
- Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
- Planned adoption period:
- 01/01/2022 - 31/03/2022
- Check the status of this initiative on the Better Regulation Portal
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- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 4
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- Documents:
- COM/2023/222 final (Proposal for a regulation)
- Leading service:
- Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
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- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 8