According to Art. 14 Abs. 2 TPA a medicinal product imported in parallel must meet the same requirements as the medicinal product already authorised in Switzerland, in particular with regard to labelling and product information.
However, the affixing of labels to cover deviating information (e.g. different drug name) on infusion bags to be imported in parallel should be avoided in order to ensure that the particle-free nature of the parenteral solution can still be reliably checked.
In addition, a possible negative effect of the adhesive on the primary container and/or contents must be avoided (additional quality documentation must be required when applying labels to the infusion bags). In the case of infusion bags, labels with deviations from the original Swiss medicinal product should therefore only be affixed to the secondary container and not to the primary containers.
