Insights

A mock-up is a graphic representation of the primary and secondary packaging, as well as the package leaflet, that faithfully reproduces the final appearance of the medicinal product.

When a variation has impact on the medicinal product texts and therefore changes are made in the content of PIL and/or internal /external label, it is necessary to update the mock-ups accordingly. This is essential to ensure that all information is correctly presented on the packaging of the medicinal product.

For medicines authorised through the centralised procedure, the inclusion of the "Blue Box" in the outer label is required. This section, outlined by a blue border, contains specific information for each member state.

Moreover, according to Article 63 of Directive 2001/83/EC it is possible to use of multilingual text, provided that the information is identical in all languages used. The only exception to this rule concerns the national-specific information included in the "Blue Box.

Regulatory Pharma Net has successfully supported companies in the revisions of mock-ups with strategic analysis and advice.

Find out more here: https://rpngroup.com/