VETERINARY PHARMACY REGULATIONS

SUBSIDIARY LEGISLATION 437.116

VETERINARY PHARMACY REGULATIONS

10th February, 2025

LEGAL NOTICE 337 of 2024.

(1)

The title of these regulations is the Veterinary

Pharmacy Regulations.

(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

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.

(1)

In these regulations, unless the context otherwise

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

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 surgeon or a veterinary surgeon may apply to the Director for

the 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

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 surgeon shall enter into any agreement with a pharmacist or

any other 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 a locum pharmacist, shall fulfil the following obligations

(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 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 these regulations shall on conviction be liable to a fine (multa) of

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

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 before the Administrative Review Tribunal

established in terms of article 5(1) of the Administrative Justice Act by

not later 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.