S.L. 437.115 Art. 18Distribution categories of veterinary medicinal product.

(1) In the territory of Malta there shall be the following four (4) distribution categories of veterinary medicinal product:

(a) prescription-only-medicine, veterinary surgeon and pharmacist, abbreviated to "POM-VP";

(b) prescription-only-medicine, veterinary surgeon, abbreviated to "POM-V";

(c) over-the-counter-medicine, abbreviated to "OTC"; and

(d) general sales, abbreviated to "GS".

(2) The supply of veterinary medicinal products for each distribution category shall be made as follows:

(a) POM-VP shall only be prescribed and, or dispensed by a veterinary surgeon or dispensed by a pharmacist according to the terms of a veterinary prescription. The premises from where, or through which, these veterinary medicinal products may be supplied to the public shall be licensed veterinary pharmacies and licensed veterinary establishments;

(b) POM-V shall only be prescribed, dispensed and administered by a veterinary surgeon. The premises from where, or through which, these veterinary medicinal products may be supplied shall be licensed veterinary pharmacies and licensed veterinary establishments;

(c) OTC may be dispensed without a veterinary prescription. The persons who may dispense these veterinary medicinal products shall be veterinary surgeons, pharmacists and suitably learned persons under the supervision of a pharmacist or a veterinary surgeon. The premises from where, or through which, these veterinary medicinal products may be supplied to the public shall be licensed veterinary pharmacies and licensed veterinary establishments;

(d) GS may be dispensed without a veterinary prescription. The persons who may dispense these veterinary medicinal products shall be veterinary surgeons, pharmacists and suitably learned persons. Veterinary medicinal products that fall under this category may be supplied to the public from, or through, licensed veterinary pharmacies, licensed veterinary establishments, registered pet shops, registered shops that retail animal care products and approved feed business operators where medicated feeds are manufactured, sold or traded:

Provided that, a person carrying out the activities of the suitably learned person on the date on which his qualifications of a suitably learned person are published shall be eligible to continue to engage in such activities.

(3) The Director shall determine the distribution category of veterinary medicinal products when processing application forms for the authorisation or registration thereof:

Provided that this shall not preclude the Director from changing the distribution category of any veterinary medicinal product at any stage after authorisation or registration has been granted.

(4) The marketing authorisation holders and holders of registration in accordance with Article 116 of Regulation (EU) 2019/6 may request the Director to amend the distribution category previously assigned.

(5) When determining the distribution category of veterinary medicinal products, the Director may seek the advice from suitable expert committees and may take in consideration the guidelines of other national, European and international relevant bodies.

(6) Different pack sizes of the same marketing authorisation may be assigned a different distribution category.

(7) The Director may issue guidelines on the criteria based on Article 34 of Regulation (EU) 2019/6 for the categorisation of a veterinary medicinal product.

(8) The holders of a wholesale distribution authorisation shall distribute veterinary medicinal products only to those premises authorised to retail veterinary medicinal products and shall distribute only the category or categories of veterinary medicinal products that are authorised to be retailed from each type of premises in accordance with these regulations.