S.L. 437.116 Art. 5Conditions for the granting of a licence.    S.L. 437.106.

The Director shall, in accordance with article 64(1) of the

Act, inspect the premises and shall not issue a licence unless the following conditions are satisfied:

(a) the licence shall be displayed in a prominent position in the premises at all times;

(b) the external appearance shall reflect the professional character of the veterinary pharmacy and makes it clear to the public that the business of a veterinary pharmacy is the primary activity of the establishment;

(c) the premises shall be kept orderly and clean in such manner that every surface present shall be kept with the least amount of clutter, impermeable and easy to wipe;

(d) the premises shall have a clear area set aside for the unpacking of goods, preparation and compounding of veterinary medicinal products and testing activities;

(e) all products present on the premises shall be protected from the adverse effects of extremes of temperature, sunlight and excess humidity in a manner that the maximum and minimum temperature and humidity and any other condition specified on the packaging by the manufacturer are always complied with:

Provided that records shall be kept for daily readings of thermometers indicating the highest and lowest temperatures reached in different parts of the pharmacy, including any refrigerators;

(f) all access points to the premises shall be securely locked when the veterinary pharmacy is closed;

(g) the premises shall be equipped with toilet facilities which shall be kept clean and in good working order:

Provided that the said facilities shall include warm and cold water, soap and nail brushes and a hand drying facility:

Provided further that the said facilities shall not be used as a source of water dispensing or as storage areas;

(h) all waste derived from veterinary medicinal products or other sources, and expired or deteriorated products shall be segregated from veterinary pharmacy stock and placed in a designated quarantine area:

Provided that the safe disposal of all types of waste shall be made in accordance with regulation 7(d);

(i) psychotropic and narcotic drugs shall be kept in a secure non-conspicuous cabinet which shall be locked at all times when not in use:

Provided that access to the cabinet shall be the responsibility of the managing pharmacist;

(j) the premises shall be kept in a good state of repair at all times and no structural alterations shall be carried out without the prior approval of the Director;

(k) a high level of cleanliness shall be observed in all places and regular cleaning schedules shall be kept;

(l) a pest control programme shall be prepared and records thereof shall be kept:

Provided that the said records shall be retained for a period of at least one (1) year and shall be available for inspection upon request by the Director;

(m) the premises shall not form part of a premises used for habitation and no veterinary pharmacy shall be used for sleeping purposes;

(n) every veterinary pharmacy shall have its own separate and independent entrance for the public and any connection with any other premises which is used for any commercial activity shall be kept to a minimum:

Provided that the provisions of this regulation shall not apply in respect of an existing veterinary pharmacy before the coming into force of these regulations and which cannot be structurally altered as to comply with this regulation:

Provided further that if the commercial activity being carried out from the same premises is that of a veterinary consultancy practice licensed in accordance with the Private

Veterinary Establishments (Licensing) Regulations, such consultancy shall be allowed to continue operating only in cases where the veterinary consultancy practice licence holder held such licence prior to the coming into force of these regulations;

(o) a licence holder shall not carry out, cause to permit, or suffer to be carried out on the premises any activity which is not related to:

(i) the storage, the preparation, the dispensing, the sale or supply of veterinary medicinal products; or

(ii) the storage or sale of other articles and all other activities related to veterinary medicinal products and other animal care products or activities as allowed by these regulations; and

(p) the veterinary pharmacy shall have access to reference sources of information and equipment as the managing pharmacist may require in the exercise of good pharmacy practice within the premises.