S.L. 458.64 Art. 1Citation, scope and applicability.

(1) The title of these regulations is the Online

Dispensing of Medicinal Products to Third Countries from Free Zones and Customs Authorised Warehouse Regulations.

(2) The scope of these regulations is to govern the sourcing, storage, handling, online dispensing, and export of medicinal products from Free Zones and Customs Authorised Warehouses in Malta to consumers residing in third countries. They establish licensing, operational, and compliance requirements to ensure the safety, quality, and traceability of such medicinal products.

(3) These regulations shall apply to the sourcing, storage, handling, online dispensing, and export of medicinal products from the Free Zones or Customs Authorised Warehouses in Malta, for the purpose of sale to consumers residing in third countries.