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Effectively from 1 January 2025, new regulatory requirements have come into effect for placing inhalation sprays containing hydrofluorocarbon (HFC) compounds, such as norflurane and apaflurane, on the European Union (EU) market. These changes stem from the updated EU Regulation (2024/573) on fluorinated greenhouse gases (F-gas Regulation), which became enforceable on 11 March 2024.
These updated regulations aim to address the environmental impact of HFCs by implementing stricter controls on their use in medical products.
Key Changes and Deadlines
1. Labelling Requirements for Inhalation Sprays
The F-gas Regulation introduces new labeling standards for packaging inhalation sprays containing HFC compounds. These changes are aimed at increasing transparency about the environmental impact of such products.
Requirements:
From 1 January 2025, products must include:
Clear indication of the HFCs contained in products
The name of the HFC compound
The Global Warming Potential (GWP) value
Quantity of HFCs in both weight and CO2 equivalent
For small-sized products, the label may be placed solely on the outer packaging and can be supplemented with a digital label (eg: QR code)
Transition Plan:
Medicines with old packaging may still be sold after 1 January 2025, provided an application for amended packaging labeling has been submitted to the Finnish Medicines Agency (Fimea) by this date
Compliance with the updated labeling requirements is mandatory for all batches by 31 December 2025
2. Quota System for HFC Imports
A quota system has been introduced to regulate the import and production of HFCs for inhalation sprays within the EU. This applies to both imported products and HFCs used in the manufacturing process.
HFC inhalers imported from outside the EU are subject to the quota system if the annual import exceeds 10 to CO2-eq
This equates to approximately 6.99 kg of norflurane and 3.11 kg of apaflurane
Manufacturers and importers must register in the F-gas portal and comply with the guidelines provided by the Environmental Administration
For more detailed instructions and clarifications, companies are welcome to send inquiries to info@arqon.com
Source: Finnish Medicines Agency (Fimea)
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