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Document 52023PC0221
Reform of the Supplementary Protection Certificates (SPC) regime – unitary SPC and centralised procedure
Voorstel voor een VERORDENING VAN HET EUROPEES PARLEMENT EN DE RAAD betreffende het aanvullende beschermingscertificaat met eenheidswerking voor gewasbeschermingsmiddelen
- 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:
- fytosanitair product; verkoopvergunning; fytosanitaire wetgeving; Europees octrooi; geneesmiddel; farmaceutische wetgeving; interne markt
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- Documents:
-
COM/2023/221 final (Proposal for a regulation)
Impact assessment
SWD/2023/119 final (Summary of impact assessment)
Staff working document - Leading service:
- Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
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- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 8
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- Documents:
- Ares(2022)1726335 (Call for evidence for an impact assessment)Ares(2022)1726335 (Call for evidence for an impact assessment)
- Leading service:
- Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
- Consultation duration (weeks):
- 4
- Planned adoption period:
- 01/01/2023 - 31/03/2023
- Check the status of this initiative on the Better Regulation Portal