S.L. 458.64 · Online Dispensing Of Medicinal Products (S.L. 458.64)
S.L. 458.64 Art. 10Refusal to grant or renew licence. 10 [S.L.
(1) The Licensing Authority may refuse to grant or renew a licence in accordance with these regulations on any of the following grounds:
(a) where the applicant has failed to meet all or any of the requirements established in these regulations during the application stage;
(b) where the Licensing Authority has reasonable grounds to believe that the medicinal products to be dispensed do not meet established safety and quality standards, as prescribed by relevant health authorities;
(c) where the applicant or the managing pharmacist nominated by the applicant has previously been found to be in violation of any of the provisions of these regulations and the Act;
(d) where the applicant lacks the necessary facilities, equipment, personnel or managing pharmacist to ensure safe and effective storage, handling, and dispensing of medicinal products in conformity with these regulations, the Act and any applicable law;
(e) where the applicant has engaged in any act of misrepresentation, deceit, or fraudulent conduct related to the application process or the operation of the licensed premises;
(f) where the granting or renewal of the licence would pose a significant risk to public health or safety, considering the potential consequences of the online dispensing activities;
(g) where the applicant has failed to demonstrate technical capacity, operational capability, or financial resources necessary for the lawful, safe and effective online dispensing services;
(h) for any other reason that would normally be a valid reason for the refusal or renewal of the licence, including criminal convictions and regulatory actions;
(i) for any other reason which the Licensing Authority deems appropriate in accordance with these regulations, the Act, or any other applicable law.
(2) In the event of a refusal to grant or renew a licence, the Licensing Authority shall provide written notice to the applicant, specifying the grounds for such refusal and any applicable rights to appeal the decision. THIRD COUNTRIES FROM FREE ZONES AND CUSTOMS 458.64 AUTHORISED WAREHOUSES
(3) The applicant shall have the right to request a review of the decision to refuse, grant or renew the licence, in accordance with the procedures established in these regulations.