Questions and Answers on Labelling Flexibilities for COVID-19 Vaccines

The European Medicines Agency (EMA) released an updated version of the Questions and Answers (Q&A) document relating to labelling flexibilities for COVID-19 vaccines. The document is primarily based on the previously published Memorandum of Understanding (MoU).

Questions and Answers

A number of the topics resulted from questions received from COVID-19 vaccine developers during the last months. The flexibilities discussed take into account the associated logistics of early printing packaging activities. However, the agency emphasizes that any exemption described is only of a temporary nature. Marketing Authorization Holders (MAHs) shall provide information on the length such exemptions will be needed for. The duration of the exemptions may be limited to a certain time period or number of batches, and will be determined on a case by case basis. Questions regarding the packaging leaflet and the printed expiry date include, for example, the following:

  • Is it possible to market a COVID-19 vaccine with the printed package leaflet only in English?
    The majority of EU Member States, as well as Norway and Iceland, have agreed to grant a temporary exemption from the obligation to provide the printed package leaflet in their national language. Thus, package leaflets can be printed in English only. In such case alternative ways of providing access to the package leaflet in the national language must be ensured (e.g. via QR Codes). However, the Member States Austria, Belgium, Bulgaria, Croatia, Czech Republic and Greece still require the printed package leaflet in their national language.

  • Can the obligation to perform a user testing on the package leaflet be waived for all COVID-19 vaccines?
    Despite the difficulties in recruiting respondents due to isolation measures in different countries and short timelines, applicants should make every effort using alternative methods and technologies to ensure the readability of the proposed package leaflet. In case of difficulties, the approach to be applied should be discussed with the agency on a case by case basis.

  • Can the expiry date be made available via a QR code instead of being printed on the packaging components?
    The expiry date is an important element that ought to be printed on the labelling components in order to ensure the correct use of the vaccine. A QR code alone cannot replace this statutory information.

For more information please visit the EMA website on COVID-19 guidance: evaluation and marketing authorization.

Go back


Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.