Labelling and Packaging Flexibilities for Covid-19 Vaccines

Recommendation

5/6 June 2024

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The European Commission (EC) recently published labelling and packaging flexibilities for COVID-19 vaccines. According to the EC, "flexibility in the labelling and packaging requirements can facilitate the rapid deployment of the vaccine by increasing production capacity, reducing transport costs and storage space, and improving the distribution of the doses between Member States".

According to the EC it will thus be possible for a temporary period:

• to limit the information on the immediate and outer packaging to one EU official language, preferably English.
• to allow the creation of multilingual labels and labelling simplification via omission of particulars.
• to accept multi-dose containers for COVID-19 vaccines (e.g 5 or 10-dose vials).
• to provide package leaflets separately by the marketing authorization holder (MAH) (i.e. leaflets that are not included inside the product cartons).
• to make package leaflets available in electronic form in all languages (inclusion of a QR code as an additional means of accessing the package leaflet in the respective national language(s) is recommended).
• to omit country specific blue box requirements.
• to use one Global Trade Identification Number (GTIN) for serialization, where possible.

According to the Memorandum of Understanding (MoU) on regulatory flexibility for COVID-19 vaccines a more detailed guidance on the flexibilities for the labelling and packaging requirements for Covid-19 vaccines will be developed by EMA / HMA, as needed.