Product information exemptions for COVID‍-‍19 vaccines

The Swedish Medical Products Agency has great respect for the importance of language in avoiding patient safety risks when handling medicines at the distribution stage, in pharmacies and at healthcare providers. At the same time, the legislation allows for granting exemptions where justified, for example to increase the availability of a medicinal product.

In order to be able to deliver Covid-19 vaccines immediately after approval, discussions are taking place with the European Medicines Agency (EMA) on accepting certain exemptions with regard to labelling and information sheets. The aim is to facilitate a multilingual market and to be able to share available vaccines between countries.

Not a general exemption

The companies involved must apply to the Swedish Medical Products Agency for such exemptions for the vaccines that will be distributed to Sweden.

Applications for exemptions for the vaccines to be distributed to Sweden are made both to the EMA and to the Swedish Medical Products Agency. National exemptions will ultimately be decided by the Swedish Medical Products Agency for each vaccine.

Packaging with labelling and/or information sheets in languages other than Swedish, preferably English, can then be admitted to the Swedish market. The EMA has published a Q&A for more guidance for the companies affected.

Any exemptions could then be accepted until the World Health Organisation (WHO) officially announces that the pandemic is over.

General exemptions for safety features are not accepted, so as to avoid the risk of forgery.

Approved Swedish product information is always published here on the Swedish Medical Products Agency's website.

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