S.L. 458.64 Art. 3Online dispensing licence and regulatory standards.

(1) No person shall engage in the dispensing of medicinal products from the Free Zones and Customs Authorised

Warehouses in Malta to consumers residing in third countries, unless they hold a valid licence issued by the Licensing Authority in accordance with the provisions of these regulations.

(2) The online dispensing of medicinal products under this regulation shall be conducted in accordance with recognised standards of Good Pharmacy (Dispensing) Practices. Licence holders shall ensure that all medicinal products dispensed meet high standards of safety, quality, and efficacy as stipulated in these regulations.

(3) The licence holder shall bear full responsibility for all activities carried out under these regulations, including compliance with any applicable regulatory requirements in the country of destination.