In relation to Commission Implementing Regulation (EU) 2024/2174 of 2 September 2024 laying down rules for the application of Regulation (EU) 2024/573 of the European Parliament and of the Council as regards the format of the labels for certain products and equipment containing fluorinated greenhouse gases and repealing Commission Implementing Regulation (EU) 2015/2068 (hereinafter: the Implementing Regulation), the European Medicines Agency (EMA) published Questions and answers on labeling requirements for centrally authorized metered dose inhalers containing fluorinated greenhouse gases in order to facilitate the implementation of the provisions of the Implementing Regulation affecting the metered dose inhalers containing fluorinated greenhouse gases. The document directly concerns centrally authorised medicinal products, however it should also be taken into account for medicinal products that have been authorised via DCP/MRP or national procedure.
By 1.1.2025, MA holders of the respective medicinal products should ensure that these products are labelled in accordance with the provisions of the Implementing Regulation.
The corresponding wording should be introduced within an ongoing variation affecting Product information. In case no relevant variation is ongoing or anticipated, a notification under article 61(3) of the Directive 2001/83/EC should be submittted. If the medicinal product is marketed in Slovenia and labelled in Slovenian language (either monolingual or multilingual), the updated labelling mock-ups must also be submitted in the respective application.
The application should be submitted to JAZMP as soon as possible, taking into account the timelines of the respective post-authorisation procedure.
The QRD statements for metered dose inhalers containing fluorinated greenhouse gases (in all EU/EEA official languages) that need to be implemented in the PI are published on the EMA website.
In case of additional questions or any difficulties with the implementation of the new requirements regarding fluorinated greenhouse gases, please contact .
