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Background: In Malta, off-label prescribing of medicines in children stands at 45%, mainly because of failure by prescribers to follow the dosing recommendations in the product literature. In addition, registration procedures of pharmaceuticals may inadvertently contribute to this high incidence of off-label prescribing. Methods: A literature review was conducted to identify regulatory provisions relating to the registration of medicines in Malta that could give rise to off-label use. Furthermore, the product literature of the 2 classes of medicines most commonly prescribed in children, antibiotics and respiratory medicines, were reviewed. This was done in order to gauge whether the different registration routes implemented in Malta to market these medicines could give rise to off-label use. Results: The national registration procedure relating to Article 126a of Directive 2001/83/EC and, to a lesser extent, line extensions, parallel importation, and the provision detailed in Article 11 of Directive 2001/83/EC were found to lead to discrepancies and potentially misleading inclusions in the product literature. These, in turn, may well contribute to off-label use of medicines in children. Conclusions: Off-label prescribing does not necessarily mean that efficacy and safety data are unavailable. Variances in the product literature of medicines having the same active ingredients but imported from different countries may cause divergent prescribing practices, leading to inadvertent off-label use. The various stakeholders, including member states such as Malta, should devise strategies to harmonize the most recent labeling information in order to support the safe and effective use of pediatric medicines, thereby decreasing off-label use. [ABSTRACT FROM AUTHOR]