Scope
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
1. Is it possible to dispense with patient information on the basis of Art. 14 para. 2 TPLRO and only produce information for healthcare professionals instead?
2. Will Swissmedic accept information for healthcare professionals that is entirely in English and in SmPC format?
3. Will Swissmedic accept international versions (EU packaging) of English-language primary packaging?
4. Will Swissmedic accept international versions (EU packaging) of English-language secondary packaging? Amended 1 May 2022
5. Will Swissmedic accept package leaflets with a QR code that takes users to the current approved version of the information for healthcare professionals?
6. Does Swissmedic insist on information for healthcare professionals being provided as a package leaflet with a QR code, or is it sufficient to have a QR code on the secondary packaging (e.g. folding carton), for example?
7. Will Swissmedic accept patient information that is entirely in English and in SmPC format? Amended 1 May 2022
8. Will Swissmedic accept the EU label?
9. For COVID-19 vaccines, does Swissmedic accept a QR code (with an appropriately registered and currently valid expiry date) instead of printed expiry dates on the folding carton or label? New since 22 December 2020
10. Will Swissmedic accept a QR code that links to all currently approved patient information for COVID-19 medicinal products? New since 1 May 2022
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.
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.