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Supporting Pharma companies to follow New F-Gas Regulation (EU) 2024/573

Supporting Pharma companies to follow New F-Gas Regulation (EU) 2024/573

Project Summary

A leading pharmaceutical MAH for MDIs partnered with Celegence to comply with the new F-Gas Regulation (EU) 2024/573. Celegence supported portal registration, quota calculations, reporting, and labeling updates. This ensured quota allocation, seamless compliance, supply continuity, and a sustainable framework for ongoing regulatory adherence.

Challenges

With the introduction of Regulation (EU) 2024/573, the client needed to ensure compliance with strict F-Gas requirements.

  • Limited understanding of new regulation
  • Not aware of the new requirements such as registering in F-Gas portal, Quota calculation, Quota Authorisation, Labelling requirements etc.

Highlights:

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Assisted the client in registering on the EU F-Gas Portal

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Ensured correct categorization of MDIs under medical exemptions while aligning with compliance obligations

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Gathered historical data on propellant use across product lines

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Standardized calculation models to estimate annual consumption under the new regulation

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Identified authorized quota holders within the EU

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Facilitated communication and agreements to secure quota allocations for continued supply

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Prepared and submitted timely reports via the F-Gas Portal

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Ensured data accuracy in line with EU reporting templates

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Reviewed existing packaging and labelling

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Implemented updates to meet new requirements on F-Gas content disclosure

Project Achievements

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The client achieved seamless compliance with the 2024 regulation

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Secured F-Gas quota to safeguard MDI production and supply continuity

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Enhanced transparency through accurate reporting and updated labelling

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Built a sustainable framework for ongoing regulatory adherence

Need Support with EU F-Gas Regulation (2024/573)?

Celegence helps pharma companies secure quotas, manage F-Gas reporting, and update labelling for MDI products—ensuring compliance and supply continuity. Email us at info@celegence.com to discuss your regulatory needs.

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