S.L. 437.115 Art. 29Brokering of veterinary medicinal products.

(1) Any person intending to engage in the brokering of veterinary medicinal products shall have a permanent address in the territory of Malta and shall register his activity with the Director before the activity takes place.

(2) The person intending to engage in the brokering of veterinary medicinal products shall send a request to the Director in the in the manner indicated by the Director to register his activity, and the request shall include:

(a) the name of the applicant and, if applicable, the corporate name;

(b) the permanent address in the territory of Malta;

(c) the contact details of the applicant; and

(d) the payment of the relevant fee:

Provided that the Director may request, from time to time, any other relevant information or additional document which he may deem necessary for the purpose of the registration.

(3) The Director shall process the request for registration of a broker within ninety (90) days of receipt of the request which shall be suspended in cases where the applicant is requested to provide additional data.

(4) The Director may carry out an inspection at the permanent address of the applicant before registering the activity of the applicant to ensure accurate identification and location, and that the applicant has the necessary means to conduct the activity and is in compliance with these regulations.

(5) Where the Director notifies that an inspection shall be carried out, the activity shall not begin before the Director has notified that the activity may start. In such a case, the Director shall carry out the inspection and communicate to the broker the results of the inspection within ninety (90) days of the notification of his intention to carry out the inspection. When within ninety (90) days of receipt of the request the Director has not notified that an inspection shall be carried out, the activity may start.

(6) The broker shall:

(a) inform the Director of any change in the details given in the original registration within one (1) working day;

(b) provide the Director access to his permanent address at any reasonable time;

(c) maintain records for any dealings in veterinary medicinal products as may be provided for by these regulations, and have such records readily available for inspection by the Director for a period of not less than five (5) years;

(d) provide any information about the brokering veterinary medicinal products, including information about the amounts and identity of veterinary medicinal products brokered;

(e) abide by other responsibilities as may be established from time to time by the Director; and

(f) informs the Director and, where applicable, other related parties, of veterinary medicinal products he suspects to be falsified.

(7) Unless otherwise determined by the Director, the registration granted in accordance with this regulation shall be valid for a period of three (3) years.