S.L. 437.47 Art. 59Dispensing by pharmacists, veterinary surgeons and suitably qualified persons.

(1) In the territory of Malta the dispensing of veterinary medicinal products shall only be conducted in accordance with the provisions of this regulation.

(2) Veterinary surgeons may dispense veterinary medicinal products during an in-call by the animal owner/carer/keeper in the licensed veterinary establishments and during out-call visits to the animals under their care.

(3) Veterinary surgeons shall dispense a veterinary medicinal product in such quantities as would be required for the treatment of the condition, where delay in the administration of the product may adversely affect the health of the animal:

Provided that the veterinary surgeon shall supply the quantities of veterinary medicinal product for treatments or conditions only to animals under his care. If the type of the packaging is such that the veterinary surgeon cannot supply lesser quantities thereof, the veterinary surgeon may supply the animal owner/keeper/carer with the quantities needed for the full treatment of the condition.

Provided further that the above may not apply for veterinary medicinal product that are regulated by specific instruments:

(4) Veterinary medicinal products can only be dispensed from the premises referred to in regulation 60.

(5) The dispensers shall be required to keep detailed records for veterinary medicinal products or treatments that may be supplied only on prescription, the following information being recorded in respect of each incoming or outgoing transaction:

(a) date of the transaction;

(b) name of the veterinary medicinal product including, as appropriate, pharmaceutical form and strength;

(c) batch number;

(d) quantity received or supplied;

(e) name or company name and permanent address or registered place of business of the supplier in the event of purchase, or of the recipient in the event of sale;

(f) name and contact details of the prescribing veterinary surgeon and, where appropriate, a copy of the veterinary prescription;

(g) marketing authorisation number.

At least once a year a detailed audit shall be carried out, and incoming and outgoing veterinary medicinal products and other products issued on a veterinary prescription shall be reconciled with products currently held in stock, any discrepancies being recorded in an appropriate register. These records shall be available for inspection by the Veterinary Services for a period of not less than five (5) years.

(6) When dispensing a veterinary medicinal product the dispenser must be satisfied that the person who will use the product is competent to do so safely, and intends to use it for a purpose for which it is authorised or indicated by the veterinary surgeon.

(7) When dispensing veterinary medicinal product, the dispenser shall advise the receiver of the product on the dosing, safe administration of the product and on any warnings or contra-indications on the label or package leaflet, including information on any applicable withdrawal period/s.

(8) If the dispenser dispenses an amount of veterinary medicinal product that is less than the unit dose of a package, the veterinary surgeons may break open any package containing a product for the purposes of supply, other than the immediate packaging of an injectable product.

(9) When dispensing an antimicrobial agent the dispenser must be satisfied that all necessary precautions have been taken to minimise the risks of antimicrobial resistance and that the prudent use of the antimicrobial agent have been taken in consideration, in particular to the use of critically important antimicrobials.

(10) If the dispenser has concerns about the content of a veterinary prescription he shall resolve them with the prescribing veterinary surgeon before dispensing the product.

(11) If a veterinary medicinal product is supplied in a container other than that specified in the marketing authorisation, the veterinary surgeon dispensing the product must ensure that the container is suitably labelled and shall supply sufficient written information to enable the product to be used safely.

(12) The veterinary surgeon referred to in regulation 79(2) shall be responsible for the cabinet where veterinary medicinal products are kept. In particular, storage conditions, traceability issues and record keeping requirements shall be strictly adhered to.

(13) A veterinary surgeon dispensing a veterinary medicinal product must be present when the product is handed over unless the veterinary surgeon:

(a) authorises each transaction individually before the product is supplied;

(b) is satisfied that the person handing it over is competent to do so.

(14) Only veterinary medicinal product that have not passed their expiry date shall be dispensed.

(15) The provisions of paragraph (e) of sub-regulation (5) shall come into force on the 1st November 2021.