S.L. 458.64 Art. 7Obligations of the licence holder.  Cap. 464.  Cap. 101. 8 [S.L.

The licence holder shall:

(a) ensure continuous compliance with all licence conditions and shall conduct activities and operations in full compliance with the provisions of these regulations and any other applicable law;

(b) appoint a managing pharmacist who shall:

(i) be a registered pharmacist in accordance with the Health Care Professions Act;

(ii) hold a valid licence to practice as a pharmacist;

(iii) possess a minimum of two (2) years professional experience in pharmaceutical management or the dispensing of medicinal products;

(c) ensure that the managing pharmacist is granted sufficient authority and resources to effectively carry out the responsibilities associated with the dispensing of medicinal products and adherence with Good Pharmacy (Dispensing) Practice standards;

(d) develop and annually update a risk management plan that addresses relevant risks, including those related to information security, business, indemnity, and dispensing medicinal products to third countries:

Provided that the plan shall comply with these regulations and any applicable guidelines issued by the Licensing Authority and shall also be certified by an approved auditor in the Maltese Islands;

(e) 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;

(f) not source, dispense or sell any medicinal product or item prohibited by the Dangerous Drugs Ordinance or any THIRD COUNTRIES FROM FREE ZONES AND CUSTOMS 458.64 AUTHORISED WAREHOUSES

other applicable law;

(g) ensure compliance with all standards and requirements for the website as may be issued by means of regulations under the Act or any other applicable law;

(h) ensure that, in the event of the absence of the managing pharmacist, a pharmacist is present to perform locum the duties of the managing pharmacist;

(i) comply with any other requirements as may be requested by the Licensing Authority in accordance with these regulations, the Act and any other applicable law;

(j) comply with the provisions of these regulations, the Act and any other applicable law.