S.L. 458.64 Art. 2Interpretation. Cap. 458.    Cap. 37. 2 [S.L.  Cap. 598. 3  Cap. 464. 4 [S.L.

In these regulations, unless the context otherwise requires:

"Act" means the Medicines Act;

"consumer" means an individual residing in a third country who receives medicinal products in accordance with these regulations;

"Customs Authorised Warehouse" means any authorised government warehouse for lodging, storage and securing of goods in accordance with article 2 of the Customs Ordinance, and in accordance with the applicable procedures under Article 240 of the Union Customs Code, as may be applicable from time to time;

"dispensing service" means a licensed operation and its associated premises, located in a Free Zone or Customs Authorised Warehouse which processes requests for the dispensing and supply of medicinal products and dispatches such products via mail in accordance with these regulations;

"EEA market" means the internal market comprising the THIRD COUNTRIES FROM FREE ZONES AND CUSTOMS 458.64 AUTHORISED WAREHOUSES

Member States of the European Union together with the EEA EFTA States, namely Iceland, Liechtenstein, and Norway, as established under the Agreement on the European Economic Area, within which the free movement of goods, persons, services, and capital is ensured.

"EU market" means the internal market comprising the Member States of the European Union, within which the free movement of goods, persons, services, and capital is guaranteed under the Treaty on the Functioning of the European Union and relevant Union legislation.

"European Union licensed wholesale distributor" means any wholesale dealer licensed in accordance with Title III of the Act, the provisions of any regulation or rules made thereunder, and any applicable European Union law governing such licences;

"Free Zone" shall have the same meaning as assigned to it in the Malta Free Zones Act;

"Good Manufacturing Practice" means that part of quality assurance which ensures that products are consistently produced, imported and controlled in accordance with the quality standards appropriate to their intended use and in accordance with these regulations;

"Good Pharmacy (Dispensing) Practice" means the standards applicable to the proper sourcing, storage, record-keeping and dispensing that may, from time to time, be issued by means of regulations under the Act;

"Licensing Authority" means the Licensing Authority established by article 3 of the Act;

"licence" means a licence issued by the Licensing Authority in accordance with these regulations to operate an online dispensing service for medicinal products from the Free Zones and Customs Authorised Warehouses to consumers residing in third countries;

"logo" means the logo authorised by the Licensing Authority signifying compliance with these regulations and any other applicable law;

"managing pharmacist" shall be interpreted in accordance with article 75 of the Act;

"Medicines Authority" means the Medicines Authority established by article 4 of the Act;

"medicinal products" shall have the same meaning as assigned to it in the Act;

"Minister" shall have the same meaning as assigned to it in the Act;

"MRA countries" means those third countries which hold a Mutual Recognition Agreement with the European Union;

"Regulation (EU) 2016/679" means the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation);

"online dispensing of medicinal products" means the dispensing of medicinal products to consumers residing in third countries from the premises of a licence holder in accordance with these regulations and any other applicable law, including any guidelines issued by the Licensing Authority from time to time;

"premises" means any physical location or facility, including but not limited to buildings, warehouses, or other structures, located within a Free Zone or Customs Authorised Warehouse, which is approved by the Licensing Authority for the storage, handling, and dispensing of medicinal products intended for consumers residing in third countries;

"registered pharmacist" shall be interpreted in accordance with article 13 of the Health Care Professions Act;

"Special Purpose Assurance Report" means a formal, independent report prepared and signed by a certified auditor or audit firm;

"third country" means any country outside the European Union or the European Economic Area;

"WHO Listed Authorities Level 4" means regulatory bodies recognised by the World Health Organization for meeting rigorous safety and quality standards;

"website" means a digital platform or website through which prescriptions are received and the dispensing of medicinal products to consumers residing in third countries is facilitated;

"website URL" means the Website Uniform Resource THIRD COUNTRIES FROM FREE ZONES AND CUSTOMS 458.64 AUTHORISED WAREHOUSES

Locator which signifies the address of a unique resource on the internet.