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S.L. 458.64 · Online Dispensing Of Medicinal Products (S.L. 458.64)

S.L. 458.64 ст. 21Administrative penalties and proceedings. 17 18 [S.L.         Cap. 12.

ДействуетОфициальный текст

(1) When the Licensing Authority has reasonable cause to believe that:

(a) an offence against the regulations has been committed by any person; and

(b) having regard to the previous conduct of the person concerned, it would be appropriate to impose an administrative penalty under this regulation, the Licensing Authority may cause a notice in writing in accordance with sub-regulation (2) in the appropriate form to be served on such person.

(2) A notice as provided for in sub-regulation (1) shall specify:

(a) the date and nature of the offence;

(b) a summary of the facts upon which the allegation that an offence has been committed is based, this being sufficient for the purpose of fully and fairly informing the person of the allegation against him;

(c) any other matter, not being related to previous convictions, that the Licensing Authority considers relevant in the given circumstances, for the imposition of an administrative penalty, including any precautionary suspension of the licence that is issued in accordance with these regulations; and

(d) the amount of the administrative penalty due, which amount shall be decided in accordance with the severity of the case and the previous conduct of the person concerned:

Provided that the administrative penalty imposed shall not exceed the amount of twenty-three thousand, two hundred and ninety-three euro and seventy-three cents (€23,293.73):

Provided further that in addition to the administrative penalty as imposed under this paragraph, the Licensing Authority may also order the suspension or revocation of the licence:

Provided further that in any event, the Licensing Authority shall have the option to issue a warning instead of an administrative penalty, if it considers that in the interests of fairness and equity, depending on the circumstances of the case, it is preferable to do so.

(3) Any person on whom a notice under sub-regulation (2) is served may, within thirty (30) days after such service, by notice in writing in the appropriate form served on the Licensing Authority, require that proceedings in respect of the alleged offence shall be dealt with by the court, in which case the provisions of sub-regulation (7) shall apply.

(4) Any person on whom a notice under sub-regulation (2) is served may by notice in writing served on the Licensing Authority:

(a) admit the offence; and

(b) pay the amount of the administrative penalty to the Medicines Authority within thirty (30) days after the notice of the penalty is served upon him or after such subsequent period as the Licensing Authority may determine. THIRD COUNTRIES FROM FREE ZONES AND CUSTOMS 458.64 AUTHORISED WAREHOUSES

(5) The administrative penalty imposed under sub-regulation

(2)(d) shall be due as a civil debt enforceable by the competent court of civil jurisdiction in favour of the Government and the declaration by the person on whom the administrative penalty is imposed, that he admits the charge shall constitute an executive title for the purposes of article 253 of the Code of Organization and Civil Procedure.

(6) Without prejudice to any other provision of these regulations or of any other law, where an offence has been admitted under this regulation, no charge may be brought in respect of the offence against any person by whom it has been admitted, unless such person fails to effect payment within the time limit provided in the notice.

(7) In the case that a person on whom a notice under sub-regulations (1) and (2), either does not admit the offence within thirty

(30) days from the service of the notice, or chooses to proceed with the proceedings mentioned under sub-regulation (3), the Licensing Authority shall institute proceedings or cause proceedings to be instituted before the Court in respect of the alleged offence:

Provided that where the licence holder is not habitually resident or established in Malta, such person shall be deemed to have submitted to the jurisdiction of the Courts and tribunals of Malta in respect of any matter arising under or in connection with these regulations, and service effected in accordance with this regulation shall be deemed valid and binding.