Under Art. 21 para. 1 of COVID-19 Ordinance 3 (SR 818.101.24), Swissmedic can, during the process of reviewing authorisation applications and on the basis of a risk/benefit analysis, authorise deviations from the applicable legal requirements for medicinal products that are intended to prevent or combat COVID-19. The FAQs below are based on this provision of COVID-19 Ordinance 3 and apply generally to medicinal products intended to prevent or combat COVID-19.
Questions and answers on the packaging and labelling requirements for medicinal products intended to prevent or combat COVID-19
Yes, patient information can be omitted on the basis of Art. 14 para. 2 TPLRO. Information for healthcare professionals is sufficient.
Yes, provided the medicinal product is only administered in hospitals or administration centres such as regional vaccination centres, neither additional translations in the official Swiss languages and TPLRO-compliant format nor structure are required.
Yes. Once the medicinal product is being distributed via the standard distribution channels at the latest, at least the most important information must be stated on the secondary packaging according to TPLRO (such as marketing authorisation number, marketing authorisation holder in Switzerland and dispensing category).
Yes. However, the QR code must be designed so that it leads users to the information for healthcare professionals approved by Swissmedic. Where electronic solutions such as these are used, information for healthcare professionals should ideally be available in all the official Swiss languages required by Art. 26 para. 2 TPO.
The information for healthcare professionals approved by Swissmedic should always (also) be published on https://www.swissmedicinfo.ch.
A QR code on the folding carton is sufficient. See the answer to question 5 for further details of how QR codes should be implemented.
No, the patient information for medicinal products must be provided in all three Swiss official languages according to Art. 26 para. 2 of the Therapeutic Products Ordinance (TPO SR 812.212.21) and comply with the format as stated in the Therapeutic Products Licensing Requirements Ordinance (TPLRO, SR 812.212.22). If, in the extraordinary pandemic situation, the medicinal product is only administered by a healthcare professional, patient information can be dispensed with according to Art. 14 para. 2 TPLRO (see question 1).
No, Swissmedic always carries out its own independent assessment. Accordingly, labels that deviate from EMA requirements are possible. However, Swissmedic is conducting a close scientific dialogue with its partner authorities, including the EMA, and will take appropriate account of the exceptional situation created by the pandemic in its decisions and in issues relating to labelling.
Yes. Since stability data are being obtained on an ongoing basis, Swissmedic accepts the registering of the (variable) expiry date on the folding carton or label by way of a QR code.
No. The patient information cannot solely be made available via a QR code as not all patients are able to access the information via QR code.