S.L. 458.64 Art. 15Consumer safety protections. 13

(1) Licence holders shall offer consumers access and contact details of the managing pharmacist for guidance regarding medicinal products.

(2) An electronic verification and decommissioning system shall be maintained to ensure adherence to the principles of safety, quality, and regulatory compliance.

(3) The dispensed medicinal product shall be delivered to consumers in third countries in suitable tertiary outer packaging that is properly labelled and that preserves the integrity of the medicinal product, including its primary and secondary packaging. The contents of each package shall be accurately declared on the relevant customs documentation as may be required from time to time and shall be designated as "Medicinal Products for Personal Use".

(4) The Licensing Authority shall not be held responsible for any infringements or breaches committed by the licence holder in failing to adhere to the consumer’s country of destination’s laws and regulations.

(5) The licence holder shall ensure that all medicinal products dispensed for delivery to consumers in a third country comply with the legislation regulating prescription applicable in the country of destination. In particular, the licence holder shall observe the following requirements:

(a) the quantity and form of the medicinal product shall be consistent with the specific prescription requirements established by the regulatory authorities of the country of destination;

(b) in jurisdictions where a general prescription may be accepted for a full supply, the licence holder shall adhere to local practices to ensure compliance;

(c) the period of validity of the prescription shall also conform to the regulations of the country of destination, ensuring that prescriptions are honoured only within the authorised time frame.