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Requirements of the EU F-gas regulation for placing on the market and import of metered dose inhalers containing HFC propellants

31.12.2024

New requirements for placing metered dose inhalers containing HFC substances, such as norflurane or apaflurane as propellants on the EU market will apply from 1 January 2025. These are based on EU Regulation (2024/573) on fluorinated greenhouse gases (F-Gas Regulation), which came into force on 11 March 2024 and is directly applicable legislation in EU member states. The Finnish Environment Institute (Syke) is the national competent authority and market surveillance authority for the EU F-Gas Regulation. The Finnish Medicines Agency (Fimea) is responsible for licensing and supervisory tasks in the pharmaceutical sector.

Labelling requirements – additional time to update labels

New labelling requirements for the packaging of metered dose inhalers containing HFC substances (F-Gas Regulation Art 12 and Implementing Regulation on Labelling Art 1):

From 1 January 2025, products placed on the market must include information that the product contains HFC substances, the name of the substance, the GWP value, and the quantity (weight and CO2-eq.)
For small products, the label may only be on the outer packaging, and it may be complemented by a digital label (e.g., QR code)

It has become apparent that meeting the new labelling requirements by 1 January 2025 is challenging. To ensure that the supply of medicines is not interrupted, the Finnish Environment Institute (Syke) and Fimea provide guidance on how to proceed:

Medicines may still be sold in old packaging after 1 January 2025, but an application for a change in packaging labelling in accordance with Article 61.3 of the Medicinal Products Directive (2001/83/EC) must be submitted to Fimea by 1 January 2025. Syke and Fimea require that changes to the packaging labelling be implemented in the next possible batch, and at the latest, the packaging labelling must comply with the EU F-Gas Regulation by 31 December 2025.

Quota System Introduced: Import of metered dose inhalers from outside the EU from 1 January 2025

The quantity of HFC substances imported from outside the EU and manufactured on the EU market is regulated by a quota system. From 1 January 2025, this also applies to metered dose inhalers containing HFC substances (F-Gas Regulation, Art 19) and HFC compounds manufactured or imported for the manufacture of metered dose inhalers (F-Gas Regulation, Art 16). Metered dose inhalers containing HFC substances imported from outside the EU (i.e., not imports from another EU country) must be included in the HFC quota system if the annual import is at least 10 tonnes CO2-eq. This corresponds to, for example, 6.99 kg for norflurane and 3.11 kg for apaflurane.

Instructions for importing metered dose inhalers containing more than 10 tonnes CO2-eq. HFC substances can be found on the environmental administration's website, under the section "Advice on importing equipment and products containing F-gases". If your company imports HFC substances for the manufacture of metered dose inhalers from outside the EU, instructions for complying with the legal requirements can be found under the section "Advice on importing F-gases as bulk". In addition, companies receiving HFC substances for the manufacture of metered dose inhalers must be registered in the F-gas portal (instructions and a step-by-step guide).