S.L. 458.64 Art. 4Application for an online dispensing licence. 5

(1) An application for a licence in accordance with these regulations shall be submitted to the Licensing Authority and shall include the following information:

(a) the name and address of the applicant;

(b) the address of the website URL and, or the address of the premises located within a Free Zone or Customs Authorised Warehouse intended for the dispensing of medicinal products to third countries;

(c) the equipment and control facilities as may be required by these regulations, under the Act and any other applicable law;

(d) the name of the managing pharmacist responsible for overseeing dispensing operations and ensuring compliance with good dispensing practices as outlined by, or under these regulations.

(e) a detailed plan outlining the quality management system that shall be implemented to ensure the safety, authenticity, and efficacy of medicinal products, with a commitment to full implementation upon licensure;

(f) documented procedures or a plan for their development, to prevent the dispensing of counterfeit, unauthorised, or substandard medicinal products through online platforms, with confirmation that these procedures shall be fully in place prior to the commencement of operations;

(g) an outline of the applicant’s approach to complying with Good Pharmacy (Dispensing) Practice, including a commitment to implement the necessary procedures for the storage, handling, and dispensing of medicinal products within the premises, prior to operation;

(h) a data management plan that ensures full traceability of each medicinal product from point of source to country of destination in accordance with these regulations;

(i) the address of the hosting location of the website and of the servers where the data related to the online dispensing operations shall be stored, including confirmation that the hosting complies with cybersecurity requirements;

(j) any other information, documentation or evidence as may be requested by the Licensing Authority in accordance with these regulations, under the Act and any other applicable law.

(2) Upon submission of the application, an application fee in accordance with the First Schedule shall be payable to the Medicines Authority.

(3) For the purposes of these regulations, any notice may be served electronically at the email address provided by the applicant to the Licensing Authority. Such service shall, unless otherwise provided in these regulations, be deemed duly served if delivered to the most recent residential or email address furnished by the applicant, provided that proof of delivery is available:

Provided that proof of delivery may include, but shall not be limited to, a delivery receipt, server log entry, acknowledgment of receipt from the recipient, or confirmation generated by a registered electronic delivery system.