COVID-19: early market release by Responsible Persons (RPs)

According to Art. 13 MPLO, the decision on whether to release a batch for placing on the market rests with authorisation holders’ Responsible Persons (RPs). In doing so, the RPs verify whether the batch has been manufactured in accordance with applicable GMP rules and whether it complies with the specific requirements of authorisation.

If Annexes 4 and 5 of COVID-19 Ordinance 2 list a medicinal product as essential for preventing and treating coronavirus disease (COVID-19), authorisation holders can apply to Swissmedic to deviate from the manufacturing process approved as part of the authorisation process and place the resulting batches on the market before Swissmedic has issued approval.

In the current extraordinary emergency, companies are frequently only able to comply with the general rule on market release under Art. 13 MPLO to a limited extent. In accordance with Art. 4l para. 4 of COVID-19 Ordinance 2, Swissmedic has specified the following criteria that RPs have to consider when releasing such medicinal products for the market early.

1. By virtue of their role, RPs have to be closely involved in submitting applications for exceptions. Before releasing batches for the market, RPs must always factor in the current review status of their application and be able to implement the feedback they receive from Swissmedic.
2. If the application involves deviations from the manufacturing process that require process validation, RPs must ensure that the necessary validations are planned and quality-related deviations are reported to Swissmedic without delay.
3. If the application involves changes to medicinal product labelling or packaging, RPs must ascertain whether the change in labelling or packaging could create a risk of confusion and ensure that traceability is still guaranteed.
4. If the application involves changes to the packaging design, RPs must verify whether the information for healthcare professionals enclosed with the product is correct and understandable (e.g. language).
5. If the application involves deviations from test methods (e.g. using faster test methods during medicinal product manufacturing), RPs must plausibility check the equivalence of the modified test methods.
6. If the application involves changes to the sterility testing of terminally sterilised medicinal products, RPs must ensure that technical release includes an assessment of the relevant in-process control data and sterilisation parameters that were used to demonstrate the sterility of the batch.
7. The release decision for each affected batch must document that the batch was released for market early and list the additional tests and measures that the RP performed for the purpose of releasing the batch or once the batch had been released.
8. As part of the process of approving applications, Swissmedic may impose additional specific conditions. When releasing batches for market early, RPs must ensure compliance with these conditions as soon as they have been communicated to the authorisation holder.
9. RPs must notify Swissmedic immediately – and within no more than 48 hours – of complaints, quality defects and serious ADRs that may be connected with the requested deviation or change and which could jeopardise the quality of the batch, and be ready at any time to withdraw the batch from the market very quickly if it is necessary to do so.