S.L. 458.64 Art. 16Dispensing and export controls. 14 [S.L.

(1) Medicinal products procured in accordance with these regulations shall only be dispensed to consumers residing in third countries.

(2) The licence holder shall be entirely responsible for ensuring that all dispensed medicinal products comply with these regulations and ensure that all medicinal products dispensed, fully comply with all relevant legislative, regulatory and quality standards applicable in the third country in respect of the importation of medicinal products by the patient for personal use.

(3) Licence holders shall: THIRD COUNTRIES FROM FREE ZONES AND CUSTOMS 458.64 AUTHORISED WAREHOUSES

(a) prohibit the redistribution or dispensing of any medicinal product in their supply within the European Union;

(b) not dispense any medicinal product which is banned or otherwise subject to restrictions in the jurisdiction of the country of destination.

(c) comply with any other requirements as may be requested by the Licensing Authority in accordance with these regulations, the Act and any other applicable laws.