The boxes and package inserts for vaccines against the new coronavirus will be in English only, at least temporarily, due to the urgency in the production of drugs, which meant that the authorities had to “relax” several rules.
The information was yesterday disclosed by the National Medicines Authority (Infarmed), which through its website shared the document created by the European Medicines Agency (EMA), which contains “questions and answers on the labels of vaccines against viral disease”.
The document contains “guidelines on how the development of vaccines can be streamlined with regard to the information on the medicine, namely the Package Leaflet and Labeling, allowing rapid and large-scale distribution in the European Union”, reveals Infarmed.
One of the issues in the report is precisely whether vaccine packaging can come in English only. The EMA says yes, because “all EU Member States have agreed to grant an exception” to the rule that medicines must always come in the national language of each country.
For that reason, he clarifies, “the external and immediate labeling can be printed in English only”, he reveals, stressing that vaccine manufacturers “do not even have to contact the respective Competent National Authorities (ANC) to request this exception”, just inform directly the EMA.
However, EMA notes that manufacturers are obliged “to provide translations of product information in electronic attachments in all languages of the European Economic Area (EEA), according to the standard procedure”.
Regarding package inserts, the same exception applies, except for the member states that did not agree with it, they are Belgium, Bulgaria, Croatia, Czech Republic, France, Greece and Holland. There is also a QR code, which directs users to a page yesterday, which contains the leaflets in the national language of each country.
The Agency notes, however, that this is not a final decision, it is “temporary”, and may still be changed. What has not been clarified is how long it will last.
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