S.L. 458.64 Art. 17Documentation, record-keepingand reporting. 15

(1) Licence holders shall maintain detailed transaction records and prescriptions for each medicinal product dispensed, which shall be kept for a minimum period of five (5) years which shall as a minimum include:

(a) the date of dispensing, the product details, the quantity supplied, the batch, lot numbers and registration number of dispensing pharmacist;

(b) the consumer’s details and the country of destination;

(c) comply with any other requirements as may be requested by the Licensing Authority in accordance with these regulations, the Act and any other applicable laws.

(2) Every licence holder shall, on an annual basis and at their own expense, submit to the Licensing Authority the following documents:

(a) a Special Purpose Assurance Report prepared by an independent auditor, duly warranted by the Accountancy Board, and possessing expertise in the pharmaceutical field; and

(b) an audited financial statement relating to the preceding financial year, which shall not, in any case, be more than two (2) years. The financial statements shall include a revenue note that clearly identifies the turnover derived from dispensing services, the online store-front or both.

(3) The Special Purpose Assurance Report shall be submitted not later than the first (1) of July of each year, covering the preceding financial year and shall include the following:

(a) verification of the total annual turnover of the licence holder for the reporting period, commencing on the 1st of July and ending on the 30th June of each calendar year;

(b) verification that all medicinal products handled by the licence holder during the reporting period were sourced and dispensed in accordance with these regulations.

(4) (a) Failure to submit the Special Purpose Assurance Report within the timeframe in sub-regulation (3), or submission of a report found to be materially deficient, shall constitute a breach of these regulations.

(b) In response to any such breach, the Licensing Authority may impose one or more of the following measures:

(i) issuance of a warning or notice of deficiency.

(ii) administrative penalties as referred to in regulation 21.

(iii) suspension or revocation of the licence holder’s licence.

(iv) the institution of criminal proceedings.

(5) (a) The Licensing Authority reserves the right to audit the licence holder’s operations to verify the accuracy of the submitted Special Purpose Assurance Report.

(b) Licence holders shall grant full access to relevant records and documentation upon request by the Licensing Authority or its authorised representatives.