Veterinary Pharmacy Regulations, 2024

L.N. 337 of 2024

VETERINARY SERVICES ACT

(CAP. 437)

Veterinary Pharmacy Regulations, 2024

IN EXERCISE of the powers conferred by articles 30 and 70 of

the Veterinary Services Act, the Minister responsible for veterinary

services, after consultation with the Director Veterinary Services, has

made the following regulations:-

(1) The title of these regulations is the Veterinary Citation, scope

and commence-

Pharmacy Regulations, 2024.

ment.

(2) The scope of these regulations is to establish standards to

be complied with by veterinary pharmacies licensed in accordance

with article 62 of the Veterinary Services Act and to further implement Cap. 437.

Article 103 of Regulation (EU) 2019/6 of the European Parliament and

of the Council of 11 December 2018 on veterinary medicinal products

and repealing Directive 2001/82/EC.

(3) These regulations shall come into force within two (2)

months from their publication in the Gazette.

(1)

In these regulations, unless the context otherwise Interpretation.

requires

"Act" means the Veterinary Services Act;

"Director" shall have the same meaning as assigned to it in

the Act;

"licence" means a veterinary pharmacy licence issued in

accordance with article 62 of the Act;

"licensed veterinary establishment" shall have the same

meaning as assigned to it in the Private Veterinary S.L. 437.106.

Establishments (Licensing) Regulations;

"managing pharmacist" means the pharmacist managing

the pharmacy referred to in article 63(1)(d) of the Act;

"narcotic drugs" means the substances present on the

Yellow List established by the International Narcotics Control

Board in accordance with the Protocol of 25 March 1972

amending the Single Convention on Narcotic Drugs, 1961;

"pharmacist" means a person who is enlisted in the Register

of Pharmacists kept by the Pharmacy Council in accordance with

article 17 of the Health Care Professions Act;

"premises" means the premises used for, or in connection

with, any premises licensed by the Director to carry out the

business of a veterinary pharmacy;

"psychotropic drugs" means the substances listed in the

Third Schedule to the Medical and Kindred Professions

Ordinance and those substances listed on the Green List prepared

by the International Narcotics Control Board in accordance with

the Convention on Psychotropic Substances of 1971, as amended

from time to time;

"Regulation (EU) 2019/6" means Regulation (EU) 2019/6

of the European Parliament and of the Council of 11 December

2018 on veterinary medicinal products and repealing Directive

2001/82/EC;

"relocation" means the transfer of a veterinary pharmacy

premises from a physical premises within a locality to another

physical premises within the same or different locality, upon the

approval of the Director;

"Single Convention" means the Single Convention on

Narcotic Drugs adopted at New York on the 30th March 1961, as

subsequently amended by the Protocol adopted in Geneva on the

25th March, 1972;

"suitably learned person" means any person included in the

Register for the Professions and Trades Supplementary to the

Veterinary Profession mentioned in the Act who can dispense

veterinary medicinal products of category OTC under the

supervision of a veterinary surgeon or pharmacist and dispense

others of category GS without this supervision;

"veterinary consultancy practice" shall have the same

meaning as assigned to it in the Private Veterinary

Establishments (Licensing) Regulations;

"veterinary medicinal products" shall have the same

meaning as assigned to it in Regulation (EU) 2019/6 of the

European Parliament and of the Council of 11 December 2018 on

veterinary medicinal products and repealing Directive 2001/82/

EC;

"veterinary pharmacy" means any premises licensed in

accordance with article 62 of the Act in which any veterinary

medicinal product is kept or from where it is sold, dispensed or

supplied directly to the public by retail but shall not include

dispensing of treatments from veterinary establishments and

dispensing during out calls by veterinary surgeons;

"veterinary surgeon" means a person who has a warrant

granted in accordance with article 43 of the Act.

(2) Unless the context otherwise requires, words and phrases

used in these regulations which are not defined herein shall have the

same meaning as assigned to them in the Act

Provided that words and phrases used in these regulations

which are not defined herein nor in the Act shall have the same

meaning as assigned to them in Regulation (EU) 2019/6.

(1) Any person not being a medical practitioner, dental Application for

surgeon or a veterinary surgeon may apply to the Director for the a licence.

issuance of a licence in accordance with article 62 of the Act.

(2) The said person shall submit an application with the

Director in the prescribed form as provided by the Director and shall

pay the applicable fee in accordance with the Veterinary Medicinal L.N.

2024. Products and Veterinary Pharmacies (Fees) Regulations.

(3) The Director shall, within ninety (90) days from the date of

receipt of the said application, decide on the application as referred to

in article 63(2) of the Act.

(4) Unless otherwise determined by the Director based on the

conclusions of an inspection, the licence shall be valid for five (5)

years and renewed in accordance with article 66 of the Act.

(5) The licence shall pertain only to the premises and the

address listed on the application for a veterinary pharmacy submitted

to the Director in accordance with article 64(2) of the Act

Provided that if the licence holder intends to relocate the

veterinary pharmacy, he shall apply for a new licence.

(1) No medical practitioner, dental surgeon or veterinary Revocation of a

surgeon shall enter into any agreement with a pharmacist or any other licence.

person for any share in the profits of a veterinary pharmacy, or to have

any direct or indirect interest of whatever nature in any veterinary

pharmacy in accordance with article 68 of the Act.

(2)

Any person who

(a)

carries on the business of a veterinary pharmacy on

account of, or in partnership with a medical practitioner, dental

surgeon or veterinary surgeon;

(b) enters into any agreement with a medical practitioner,

dental surgeon or veterinary surgeon for any share in the profits

of a veterinary pharmacy; or

(c) allows any other person to use his name in order that

the business may be carried out by such person,

shall have his licence revoked.

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.

(1) Without prejudice to the professional responsibility of

the managing pharmacist to maintain records in accordance with the

obligations of Article 103(3) of Regulation (EU) 2019/6, records in

respect of each transaction of veterinary medicinal products requiring a

veterinary prescription shall include

(a) the species of animals to which the veterinary

medicinal products are to be administered;

(b)

the type of veterinary medicinal product;

(c) the broken, damaged or expired veterinary medicinal

products; and

(d) the copies of invoices or receipts given by suppliers

of veterinary medicinal products or issued to clients for

providing veterinary medicinal products, in electronic or hard

copy format. The minimum particulars present on the invoices or

receipts shall be the following

(i) in cases of establishments which are under the

official control of the Director, the identity of the client;

(ii)

date of supply;

(iii) name and pharmaceutical form of the veterinary

medicinal product; and

(iv) quantity supplied.

(2) The detailed audit which shall be carried out in accordance

with Article 103(5) of Regulation (EU) 2019/6, may also include

information obtained from the veterinary prescriptions.

(3) The information mentioned in sub-regulations (1) and (2)

shall be kept for a period of not less than five (5) years and be readily

available for inspection by the Director upon his request.

The managing pharmacist or his temporary substitute being Obligations of

the managing

a locum pharmacist, shall fulfil the following obligations

pharmacist.

(a) be present at all times during the veterinary

pharmacy’s opening hours to the public.

(b) keep written records in a register of any pharmacist

and suitably learned person working at the veterinary pharmacy.

Such records shall be signed by the managing pharmacist, and

countersigned by the other locum pharmacists or suitably learned

persons. The records shall be retained for a period of at least five

(5) years and be available for inspection by the Director upon his

request.

(c) wear a white lab coat while attending to his

professional duties and shall have an identity tag issued by the

Pharmacy Council attached to their coat clearly showing his

name, designation and the Pharmacy Council registration

number.

(d) prepare standard operating procedures for the

effective running of the veterinary pharmacy which shall at least

include procedures to follow in case of batch or product recalls,

management of expired veterinary medicinal products and their

proper disposal, maintenance of proper storage conditions,

collection of data on sales of antimicrobials and procedures for

the unloading and verification of veterinary medicinal products.

Veterinary medicinal products can only be retailed from the

veterinary pharmacy under the following conditions

(a) veterinary medicinal products shall be appropriately

kept in their original boxes, fully labelled and with no loose

blister or mixed batches;

(b) unauthorised veterinary medicinal products shall not

be kept at the veterinary pharmacy;

(c) veterinary medicinal products shall be kept at

appropriate temperature, light and humidity levels in accordance

with the summary of products characteristics; and

(d) expired or unused veterinary medicinal products shall

be kept segregated in designated areas.

A veterinary pharmacy shall be kept open on such days and

on such times as the Director may order in accordance with the

provisions of article 70 of the Act.

The provisions of these regulations shall, as far as

applicable, apply also to stores used in connection with any veterinary

pharmacy.

A licence holder of a veterinary pharmacy shall

(a) immediately inform the Director of any changes in

the details given in the original application within one (1)

working day;

(b) provide the Director access to his premises,

documents and equipment at any reasonable time to carry out

inspections as necessary;

(c) enable the Director to carry out his duties established

by the Act and these regulations;

(d) provide any samples of the veterinary medicinal

products which have been retailed or available from the

veterinary pharmacy at the request of the Director;

(e) provide any information about veterinary medicinal

products, including data on sales and use of veterinary medicinal

products, as requested by the Director;

(f) inform the Director of any intention to relocate the

veterinary pharmacy three (3) months prior to relocation and

shall apply for a new licence in accordance with regulation 3;

and

(g) abide by other responsibilities as may be established

from time to time by the Director.

(1) When the Director has valid reason to believe that the Acting in

breach.

licence holder, any pharmacist or suitable learned person working in

the veterinary pharmacy are acting in breach of any of the provisions of

these regulations or article 62 of the Act, he shall notify the said person

in writing through a notice, specifying the type of breach and a time

frame during which a valid justification for his actions is to be

provided

Provided that when the notice is sent to any pharmacist or

suitable learned person working in the veterinary pharmacy, a copy of

the notice shall also be sent to the licence holder.

(2) Where the said person referred to in sub-regulation (1) fails

to provide a valid justification within such time as specified in the

notice, or if the reply is unsatisfactory, the Director may suspend the

activity of the said person through a written notice specifying the

reasons for the said suspension until such person is in compliance.

(3) The Director may report any breach of these regulations to

the relevant national body that regulates the said professional.

(4) Any license issued in accordance with article 62 of the Act

shall not be renewed unless remedial measures as specified in the

notice are taken by the person to whom such notice is addressed.

Any person who contravenes or acts in violation of any of Offences,

these regulations shall on conviction be liable to a fine (multa) of not punishments

and

less than two hundred euro (€200) and not more than four hundred administrative

penalties.

euro (€400), or to imprisonment for a term not exceeding one (1)

month, or both such fine and imprisonment

Provided that the Director shall not be precluded from

proceeding in accordance with the provisions of article 61 of the Act.

Decisions in terms of these regulations shall be subject to a Right of appeal.

right of appeal before the Administrative Review Tribunal established

in terms of article 5(1) of the Administrative Justice Act by not later Cap. 490.

than twenty (20) days from the service of the decision, wherein the

person aggrieved by the said decision shall specify the reasons on the

basis of which the said decision of the Director should be cancelled or

modified

Provided that the decision shall become immediately

applicable and enforceable and shall remain applicable throughout the

term of appeal until final judgement by the Administrative Review

Tribunal, unless such decision is reversed by the said Tribunal and, or

the Court of Appeal or cancelled or modified by the Director

Provided further that any party, who feels aggrieved by a

decision of the Tribunal, may on a point of law, appeal to the Court of

Appeal in accordance with article 22 of the Administrative Justice Act.

Immediately after the last item of the Second Schedule to

the Administrative Justice Act there shall be added the words

"Veterinary Pharmacy Regulations, S.L. 437.116, Superior/Inferior

Competence".

€0.90