S.L. 458.64 Art. 23Fines (multi) and punishment. 20 [S.L. Annual Licence Fee 21

Unless otherwise provided in these regulations, any person who breaches any provision of these regulations shall be guilty of an offence and shall on conviction, be subject to a fine (multa) of not less than five thousand euro (€5,000), but not exceeding fifty thousand euro (€50,000), or to imprisonment for a term not exceeding two (2) years, or to both such fine and imprisonment.

FIRST SCHEDULE

Fees payable for the issuing or annual renewal of an online dispensing licence (regulation 4)

(a) Applicants for the issuance of an online dispensing licence shall pay the following fees:

(i) Dispensing services only: thirty-five thousand euro (€35,000);

(ii) Website only: thirty-five thousand euro (€35,000);

(iii) Both dispensing services and a Website: fifty-two thousand and five hundred euro (€52,500):

Provided that upon submission of the application, the applicant shall pay:

(iv) the sum of fifteen thousand euro (€15,000) in the case of an application under sub-paragraph (i) or (ii); or

(v) the sum of twenty thousand euro (€20,000) in the case of an application under sub-paragraph (iii);

and the balance shall become due and payable following THIRD COUNTRIES FROM FREE ZONES AND CUSTOMS 458.64 AUTHORISED WAREHOUSES

confirmation by the Licensing Authority that the application is complete and meets the necessary requirements and shall be settled in full prior to the issuance of the licence(s).

The application fee covers the first year of operation, and no additional annual licensing fee shall be due for the first year.

(b) (i) Starting from the second year of operation, a licence holder shall be required to pay an annual licensing fee, in accordance with the applicable turnover tiers outlined in the Second Schedule (Part I).

(ii) The annual licensing fee shall be determined based on the licensee’s annual turnover and the nature of the services provided, which shall fall under one of the following categories:

• Dispensing Services Only;

• Online Website Only;

• Both Dispensing and Online Website;

(iii) If a license is granted after the start of the calendar year, the annual fee shall be calculated on a pro rata basis, based on the number of full months remaining in the year.

(c) The amount shall be determined by dividing the pro rata applicable annual licensing fee by twelve (12) months and multiplying it by the number of remaining months in the calendar year.

(d) Any licence issued after the fifteenth day of a month shall be considered as having commenced in the following month for fee calculation purposes.

(e) (i) Inspection and audit fees shall be payable to the Medicines Authority as required under these regulations, in accordance with the fee structure provided in the Second Schedule (Part II).

(ii) The licence holder shall not be liable for inspection or audit fees unless an inspection or audit has been duly conducted.

SECOND SCHEDULE (Part I)

From To Dispensing Online Dispensing and services only Storefront only Online storefront € € € € €

Turnover - 5,000,000 35,000 35,000 52,500 Tier 1 Turnover 5,000,000 10,000,000 55,000 55,000 82,500 Tier 2 Turnover 10,000,000 15,000,000 72,500 72,500 108,750 Tier 3 Turnover 15,000,000 20,000,000 87,500 87,500 131,250 Tier 4 Turnover 20,000,000 25,000,000 100,000 100,000 150,000 Tier 5 Turnover 25,000,000 30,000,000 110,000 110,000 165,000 Tier 6 Turnover 30,000,000 35,000,000 117,500 117,500 176,250 Tier 7 Turnover 35,000,000 40,000,000 122,500 122,500 183,750 Tier 8 Turnover 40,000,000 45,000,000 125,000 125,000 187,500 Tier 9 Turnover 45,000,000 50,000,000 125,000 125,000 187,500 Tier 10

(Part II)

Audit and Inspection Fees: 160 Euro per hour (minimum chargeable is 5,000 Audit Fee Euro) 160 Euro per hour (minimum chargeable is 5,000 Inspection Fee Euro)