VETERINARY SERVICES ACT

CHAPTER 437

VETERINARY SERVICES ACT

To establish and consolidate the requirements in the veterinary field,

veterinary medicinal products, feeding stuffs and zootechnical

requirements and for the regulation of the veterinary profession.

1st February, 2002

ACT XXIII of 2001, as amended by Act XVIII of 2002; Legal Notice 426

of 2007; and Acts XXIII of 2009, XXXIV of 2016, XIV of 2022 and XXXV of

2023, XXXVII of 2024 and XV of 2025.

Preliminary

The short title of this Act is the Veterinary Services Act.

(Articles 3, 16, 35, 36, 37, 38, 44 and 45)

Germinal products, by-products and plant products subject to

veterinary requirements

(a) Germinal products

Semen, ova and embryos of domestic species and other

VETERINARY SERVICES

species according to the requirements of the trading

partners in this matter.

(b) By-products

A detailed list of these products (by-products not listed

in Annex II of the Treaty on the European Union),

shall be drawn up in regulations prescribed by the

Minister, on the advice of the Director, taking into

account the requirements of the trading partners in this

matter.

(c) Plant products

A detailed list of plant products which, particularly on

account of their subsequent destination, may give rise

to the risk of spreading infectious or contagious animal

diseases and, for that reason, are to be subjected to

veterinary inspections, shall be drawn up in

regulations prescribed by the Minister, on the advice

of the Director.

In this Act, unless the context otherwise requires

"active substance" means any substance or mixture of substances

intended to be used in the manufacture of a veterinary medicinal

product that, when used in its production, becomes an active

ingredient of that product;

''animal'' means all living members of the animal kingdom, other

than human beings, including free-living larval and, or reproducing

larval forms, but excluding foetal or embryonic forms;

"Authority" means the Food Safety and Security Authority as

established by article 4 of the Food Safety and Security Authority

Act and shall include, to the extent of the authority given by the

aforementioned Authority, any of its officers authorised in writing to

act on its behalf for the purposes of this Act;

"aptitude test" means a test of the professional knowledge, skills

and competences of the applicant, made by the Council with the

aim of assessing the ability of the applicant to pursue a regulated

profession in Malta;

''border inspection post'' means any inspection post, designated

and approved for the carrying out of veterinary inspections on live

animals and products arriving from third countries at the border of

the territory of Malta or at the border of the territory of any trading

partner;

''Council'' means the Veterinary Surgeons’ Council established

by article 39;

"data on sales" means data on the volume of sales;

''Department'' means the Department of Veterinary Services;

''Director'' means the Director Veterinary Services who shall be a

warranted Veterinary Surgeon or an officer nominated by the Food

Safety and Security Authority as established by article 4 of the Food

Safety and Security Authority Act and shall include, to the extent of

the authority given, any of its officers authorised in writing to act on

its behalf for the purposes of this Act;

''feeding stuffs'' means any substance or product including

additives, whether processed, partially processed or unprocessed,

intended to be used for oral feeding to animals;

''importation'' means importation from third countries, of live

animals, veterinary medicinal products, products of animal origin

and products listed in the First Schedule, into Malta or into the

territory of a trading partner;

"lifelong learning" means all general education, vocational

education and training, non-formal education and informal learning

undertaken throughout life, resulting in an improvement in

knowledge, skills and competences, which may include

professional ethics;

"Medicines Authority" means the Medicines Authority established

under the Medicines Act;

''Minister'' means the Minister responsible for veterinary services

and includes, to the extent of the authority given, any officers

authorised on his behalf in writing

Provided that for food related matters and the Authority, the

Minister responsible shall be the Minister responsible for food;

''official veterinarian'' means a veterinary surgeon who is

authorised to carry out State veterinary activities;

''placing on the market'' means holding or displaying for sale,

offering for sale, selling, delivering, transferring or any other form

of offering for consumption, storage, transport for the purpose of

sale and importation for the purpose of sale;

''private veterinary activity'' has the meaning assigned to it in

article 44;

''State veterinary activities'' has the meaning assigned to it in

article 45;

''third country'' means any country which is not a trading partner;

''trading partner'' means such State, or group of States, or

organisation or institution, as may be designated by the Minister by

notice from time to time, which State, group of States, organisation

or institution may have entered into any treaty or agreement, by

whatever name called, with the Government of Malta relating to the

provisions of this Act;

"veterinary medical device" means an instrument, apparatus,

implement, machine, contrivance, implant, in-vitro reagent, or

other similar or related article, including any component, part, or

accessory, which is intended for use in the diagnosis of disease or

other conditions, or in the cure, mitigation, treatment or prevention

of disease in animals, or which is intended to affect the structure or

any function of the body of animals;";

''veterinary services'' means the authority in Malta, or in a

t r a d i n g p a r t n e r, o r i n a t h i r d c o u n t r y, a s t h e c a s e m a y b e ,

empowered to carry out veterinary inspections and examinations;

"veterinary medicinal product" means any substance or

combination of substances which fulfils at least one of the following

conditions

(a) it is presented as having properties for treating or

preventing disease in animals;

(b) its purpose is to be used in, or administered to, animals

with a view to restoring, correcting or modifying

physiological functions by exerting a pharmacological,

immunological or metabolic action;

(c) its purpose is to be used in animals with a view to

making a medical diagnosis;

(d) its purpose is to be used for euthanasia of animals;

''withdrawal period'' means the minimum period between the last

administration of a veterinary medicinal product to an animal and the

production of foodstuffs from that animal which under normal

conditions of use is necessary to ensure that such foodstuffs do not

contain residues in quantities harmful to public health

(Articles 6, 15, 16, 35 and 37)

Repealed by Act XIV.2022.26.

(1)

The provisions of this Act apply to -

(a) the requirements in the veterinary field -

(i)

in connection with animal health and public

health with regard to live animals including the

germinal products referred to in paragraph (a) of

the First Schedule;

(ii) in connection with animal and public health with

regard to products of animal origin, including

by-products and the plant products referred to in

paragraphs (b) and (c) of the First Schedule;

(b) the requirements in veterinary medicinal products,

active substances and veterinary medical devices;

(c) the requirements relating to feeding stuffs;

(d) the zootechnical requirements in animal breeding.

(2)

The regulation of -

(a) the rights and obligations of natural and legal persons

in the field of veterinary activities, as well as

professional veterinary activities and their execution;

(b) the organisation of the persons exercising private

veterinary activities; and

(c) the organisation, scope of authority and powers of the

bodies exercising state veterinary activities,

shall be governed by the provisions of this Act.

The provisions of this Act and of any subsidiary legislation

made thereunder shall also apply, in accordance with the provisions

of the 1982 United Nations Convention on the Law of the Sea as

ratified by the Law of the Sea (Ratification) Act, to an exclusive

economic zone area or an environment protection area as defined in

the Exclusive Economic Zone Act. Any artificial island,

installation, structure, equipment or device therein shall, solely for

the purposes of this Act and any subsidiary legislation made

thereunder, be treated as if they were situated in Malta itself.

VETERINARY SERVICES

PART I

Veterinary requirements

(Articles 8, 35 and 37)

Bovine diseases

-

Foot-and-mouth disease

-

Rabies

-

Tuberculosis

-

Brucellosis

-

Contagious bovine pleuropneumonia

-

Enzootic bovine leukosis

-

Anthrax

Swine diseases

-

Rabies

-

Brucellosis

-

Classical swine fever

-

African swine fever

-

Foot-and-mouth disease

-

Swine vesicular disease

-

Anthrax

VETERINARY SERVICES

Sheep and goats diseases

-

Foot-and-mouth disease

-

Brucellosis (B. melitensis)

-

Contagious epidydimitis (B. ovis)

-

Anthrax

-

Rabies

-

Scrapie

Equidae diseases

-

Dourine

-

Glanders

-

Equine encephalomyelitis (of all types, including VEE)

-

Infectious anaemia

-

Rabies

-

Anthrax

-

African horse sickness

-

Vesicular stomatitis

Poultry diseases

-

Avian influenza

-

Newcastle disease

Fish diseases

-

Infectious salmon anaemia (ISA)

Atlantic salmon (Salmo salar)

-

VHS (Viral haemorrhagic septicaemia)

Salmonid species

Grayling (Thymallus thymallus)

Whitefish (Coregonus spp.)

Pike (Esox lucius)

Turbot (Scophthalmus maximus)

-

Infectious haematopoietic necrosis (IHN)

Salmonid species

Pike fry (Esox lucius)

Molluscs diseases

-

Bonamia ostreae

Flat oyster (Ostrea edulis)

-

Marteilla refringens

Flat oyster (Ostrea edulis)

Other species diseases

VETERINARY SERVICES

-

Newcastle disease

Birds

-

Avian influenza

Birds

-

Psittacosis

Psittacidae

-

American fowlbrood

Bees

-

Foot-and-mouth disease

Ruminants

-

Brucellosis (Brucella ssp.)

suidae

-

Tuberculosis

suidae

-

Classical swine fever

suidae

-

A frican swine fever

suidae

-

Foot-and-mouth disease

suidae

-

Rabies

All susceptible species

Within the scope of this Act, the veterinary requirements

shall include -

(a) measures, concerning live animals, relating to -

(i)

the control of contagious diseases;

(ii)

the notification of diseases;

(iii)

animal identification and registration;

(iv)

health conditions relating to the movement of

live animals and germinal products; and

(v)

importation conditions relating to live animals

and germinal products imported into Malta from

third countries;

(b) measures, concerning products of animal origin,

relating to -

(i)

the production and placing on the market of

products of animal origin;

(ii) animal health measures for the production and

placing on the market of products of animal

origin; and

(iii) importation conditions relating to products of

animal origin imported into Malta from third

countries;

(c) measures relating to live animals and products of

animal origin concerning -

(i) the prohibition on the use of certain substances;

(ii) the monitoring of certain substances and

residues thereof in live animals and products of

animal origin; and

(iii) animal waste and pathogens;

(d) measures concerning veterinary inspections relating to

the exchange, with trading partners, of live animals

and products of animal origin;

(e) measures concerning veterinary inspections relating to

the importation, from third countries, of live animals

and products of animal origin;

(f)

certification with regard to veterinary matters; and

(g) the relationship with trading partners in veterinary

matters.

(Articles 8, 19, 35 and 37)

Bovine disease

-

Infectious bovine rhinotracheitis

Swine diseases

-

Aujeszky's disease

-

Brucella suis infection

-

Transmissible gastro-enteritis

Sheep and goats diseases

-

Contagious agalactia

-

Paratuberculosis

-

Caseous lymphadenitis

-

Pulmonary adenomatosis

VETERINARY SERVICES

-

Maedi visna

-

Caprine viral arthritis. encephalitis

Fish diseases

-

Infectious pancreatic necrosis (IPN)

-

Spring viraemia of carp (SVC)

-

Bacterial

kidney

disease

(BKD)

(Renibacterium

salmonidarum)

-

Furunculosis (Aeromonas salmonicida)

-

Enteric redmouth disease (ERM) (Yersinia ruckeri)

-

Gyrodactylus salaris

Crustaceans

Crayfish plague (Aphanomyces astaci)

Other species diseases

-

Viral enteritis

Mink

-

Aleutian disease

Mink

-

European foulbrood

Bees

-

Varroasis and acariasis

Bees

-

Tuberculosis

Apes and felids

-

Tuberculosis

Ruminants

-

Myxomatosis

Lagomorphs

-

Viral haemorrhagic disease

Lagomorphs

-

Tularaemia

Lagomorphs

(1) The Minister may prescribe rules concerning the

prevention and control of diseases and, in particular, may by such

rules -

(a) classify diseases as dangerous contagious diseases and

prescribe veterinary requirements in relation thereto;

(b) impose obligations on the owners of animals and of

products of animal origin, including the obligation to

notify the Department, in such circumstances as may

be prescribed;

(c) prescribe the procedure for the diagnosis of diseases;

(d) impose restrictive measures in case of suspicion or

occurrence of diseases.

(e) Deleted by Act XV.2025.37.

(2) The Minister shall draw up rules concerning contingency

plans relating to diseases referred to in subarticle (1).

(3) For the purposes of this article, control of contagious

diseases shall include measures for protection against specified

zoonoses and specified zoonotic agents in animals and products of

animal origin in order to prevent outbreaks of food-borne infections

and intoxications.

(Article 18)

Foot-and-mouth disease

Rinderpest (cattle plague)

Contagious bovine pleuropneumonia

VETERINARY SERVICES

Bluetongue

Swine vesicular disease

Classical swine fever

African swine fever

Porcine enterovirus encephalomyelitis (was Teschen disease)

Avian influenza (was fowl plague)

African horse sickness

Vesicular stomatitis

Peste des petits ruminants

Rift Valley Fever

Lumpy skin disease

Sheep and goat pox (Capripox)

Hemorrhagic disease of deer

Venezuelan equine viral encephalomyelitis

(1) The Department shall, within twenty-four hours of

each such occurrence, notify trading partners about -

(a) the primary outbreak, confirmed in Malta, of any of

the diseases referred to in the list of notifiable terrestrial

and aquatic animal diseases issued by the World

Organization for Animal Health; and

(b) the removal, after the eradication of the last case in an

outbreak, of restrictions imposed in relation to the

outbreak of the disease.

(2) Without prejudice to the provisions of subarticle (1), the

Department shall notify directly to the trading partners, at least on

the first working day of each week, the secondary outbreaks of any

of the diseases referred to in the list of notifiable terrestrial and

aquatic animal diseases issued by the World Organization for Animal

Health which are confirmed in Malta. The aforesaid notification

shall cover the week ending at midnight between the Sunday and

Monday prior thereto.

(3) The notifications referred to in subarticles (1) and (2) shall

be communicated in such a manner as may be determined by the

Director.

(Article 32)

Repealed by Act XIV.2022.27.

The Minister may prescribe rules establishing systems for

the identification and registration of animals.

The Minister may prescribe rules concerning the health

conditions to be observed in relation to the movement of live

animals and germinal products.

(1) The Minister may prescribe rules concerning the

conditions, and particularly health conditions, under which live

animals and germinal products may be imported from third

countries.

(2)

The Director shall publish in the Gazette -

(a) a list of third countries from which live animals and

germinal products are authorised to be imported into

Malta;

(b) a list of collection centres, approved bodies, institutes

or centres, authorised to export live animals and

germinal products to Malta;

(c) a model certificate, relating to the different kinds of

live animals and germinal products, to be used by the

importers.

(1) The Minister may prescribe rules concerning the

production and, after consultation with the Minister responsible for

public health, may prescribe rules concerning the placing on the

market of products of animal origin.

(2) The Director shall publish in the Gazette the list of

establishments approved for processing and placing on the market

products of animal origin.

The Minister may prescribe rules concerning animal health

measures to be taken for the production, processing and placing on

the market of products of animal origin.

(1) The Minister may, in agreement with the Minister

responsible for public health, prescribe rules concerning the

conditions, and particularly health and sanitary conditions, under

which products of animal origin may be imported from third

countries.

(2)

The Director shall publish in the Gazette -

(a) a list of third countries from which products of animal

origin are authorised to be imported into Malta;

(b) a list of establishments authorised to export products

of animal origin to Malta;

(c) a model certificate relating to the different kinds of

products of animal origin, to be produced by the

importers.

The Minister may, with the concurrence of the Minister

responsible for public health, prescribe rules -

(a) concerning the prohibition of the use, in stock farming,

of substances which have a hormonal or thyreostatic

action and of beta agonists and bovine somatotrophin,

and of other substances which may, in the opinion of

the Minister responsible for public health, be injurious

to public health; and

(b) concerning the measures to be taken to monitor

substances and residues thereof in live animals and

products of animal origin.

The Minister may, in consultation with the Minister

responsible for the environment, prescribe rules concerning the

measures to be taken for the disposal and processing of animal

waste and pathogens, for their placing on the market, and for the

prevention of pathogens in feeding stuffs of animal or fish origin.

(1) The Minister may prescribe rules concerning the

veterinary inspections to be carried out on live animals, germinal

products, animal waste, pathogens and products of animal origin,

which are intended for trade and which are subjected to exchange

with trading partners.

(2) The Minister may prescribe the measures to be taken during

an inspection carried out at the place of origin and destination of a

consignment or during transportation.

(3) The Minister may prescribe the manner in which costs

relating to the measures prescribed in subarticle (2) shall be borne

by the consignor or his representative or by the person responsible

for the animals or products of animal origin.

(4) The Minister may prescribe the measures to be taken in the

case where the veterinary services in Malta establish the presence

of agents responsible for a disease referred to in the list of notifiable

terrestrial and aquatic animal diseases issued by the World

Organization for Animal Health, a zoonosis or disease, or any cause

likely to constitute a serious hazard to animals or humans.

(5) In the cases referred to in subarticles (2) and (4), the

Director may order that immediate emergency measures be taken,

and shall establish direct contacts with the persons, organisations

or administrations concerned in Malta or abroad.

(1) The Customs Department shall not authorise the

release, for free circulation in Malta, of live animals or products of

animal origin, including the products listed in the First Schedule,

imported into Malta, unless it is satisfied that the requirements laid

down in this article have been complied with.

(2) The Minister may, with the concurrence of the Minister

responsible for Customs, prescribe rules concerning the

organisation and the action to be taken following the inspection of

live animals; and the action to be taken following the inspection of

products of animal origin.

(3) The Director may order that immediate emergency

measures be taken, and shall establish direct contact with the

persons, organisations or administrations concerned in Malta or

abroad where -

(a) in a third country, any of the diseases referred to in the

list of notifiable terrestrial and aquatic animal diseases

issued by the World Organization for Animal Health, a

zoonosis or other disease, or any other circumstance

liable to present a serious threat to animal or public

health, manifests itself or spreads; or

(b) any other serious animal health or public health reason

so warrants, in the light of findings of the veterinary

experts of a trading partner or on the basis of the

inspections carried out at a border inspection post of a

trading partner; or

(c) any one of the inspections provided for in this article

indicates that any consignment of live animals or

products of animal origin, including the products listed

in the First Schedule, is likely to constitute a danger to

animal or human health.

(4) The Minister may by regulations prescribe the manner in

which costs relating to the measures prescribed in subarticle (2)

shall be borne by the consignor or his representative or by the

person responsible for the animals or products of animal origin.

(5) The Minister may prescribe the frequency of veterinary

inspections relating to importations, from third countries, of live

animals and products of animal origin, including the products listed

in the First Schedule.

(6) The Minister may prescribe regulations for the approval of

border inspection posts situated in Malta, and for the suspension,

for reasons related to public or animal health, of the said border

inspection posts.

The Minister may prescribe rules concerning the

certification to be established in connection with veterinary

inspections and control of live animals and animal products and

prescribe rules concerning fees to be paid in connection with the

inspectorate activity.

(1) The financial measures which are to be taken for the

purpose of the eradication of diseases shall consist of -

(a) financial contributions and compensatory measures

within the framework of an emergency, as declared by

order of the Minister; and

(b) financial contributions in connection with national

schemes for the eradication of particular diseases.

(2) In the event of an outbreak of any of the diseases listed in

the Fifth Schedule, the veterinary services shall define protection

zones and the owners of animals shall receive such State financial

contribution from the veterinary services for the eradication of the

disease, as the Minister may from time to time establish, subject to

the condition that the measures applied consist of, at least, the

isolation of the holding from the time of a suspicion of the presence

of the disease and following official confirmation of the disease,

and -

(a) the veterinary services demand the slaughter of

animals of susceptible species which have been

affected or contaminated or suspected of having been

affected or contaminated, and their destruction, and, in

the case of avian plague, the destruction of the eggs;

(b) the veterinary services demand the destruction of

contaminated feeding stuffs and contaminated

equipment, in the case where the contaminated items

cannot be disinfected in accordance with paragraph

(c); and

(c) the veterinary services demand the cleaning,

disinsectisation and disinfection of the holdings and of

the equipment on the holdings.

(3)

The owners of animals shall be entitled to receive a State

f i n a n c i al c o n t r i b u t i o n o n l y i f t h e m e a s u r e s d ef i n e d b y t h e

veterinary services to prevent the risk of the spread of infection are

respected, and where the waiting period established by the

veterinary services to be observed after the slaughter and before the

re-stocking of the holding is complied with.

(4) Without prejudice to any market support measures that may

be taken, the State financial contribution may, if appropriate, be

divided into tranches; the contribution, which must be adequate and

given without delay, may be in the form of -

(a) the reimbursement of the costs incurred by the owners

in the slaughter, destruction of animals and, where

appropriate, their products, for the cleaning,

disinsectisation and disinfection of holdings and

equipment, and for the destruction of the contaminated

feeding stuffs and contaminated equipment referred to

in subarticle (2)(b); or

(b) where the veterinary services have ordered that

animals, or certain types or species of animals, are to

be vaccinated, the supply of the vaccine and the

administration of the vaccination by the veterinary

services shall be carried out free of charge.

(5) Subject to the provisions of subarticle (6), the provisions of

subarticles (2), (3) and (4) shall apply, notwithstanding the

existence of any eradication programme, in accordance with the

provisions of article 19, in respect of the disease.

(6) In the event of an outbreak of Newcastle disease in Malta,

the provisions of subarticles (2) and (3) shall apply

Provided that the Minister may authorise, under certain

conditions and for a limited period and within a limited area, the

recourse to vaccination, but, in such case, no State financial

contribution shall be granted for the supply of the vaccine or for the

administration of the vaccination.

(7) The Minister may apply the provisions of subarticles (3)

and (4), with the exception of the provisions of subarticle (4)(b), to

a zoonosis.

(8) The Minister may by regulations add to the list of diseases

listed in the Fifth Schedule any disease which is likely to constitute

a danger to public or animal health in Malta.

(9)

For the purposes of this article -

''protection zone'' means any area as may be officially declared

by the Minister, being an area based on a minimum radius of three

kilometres and a surveillance zone based on a minimum radius of

ten kilometres, taking into account natural boundaries, wherein the

presence of a notifiable disease has been diagnosed, and wherein

measures shall be taken, in accordance with the provisions of this

Act, for the control and the eradication of the disease; and

''market support measures'' means such measures as may be

permitted, in agreement with trading partners, to be taken to

support market prices in the case of the outbreak of any of the

diseases listed in the Fifth Schedule.

(1) Subject to the provisions of this Act, the Director may

set up national schemes for the prevention, control and eradication

of diseases listed in the Fourth Schedule.

(2) The Minister may, with the concurrence of the Minister

responsible for finance, prescribe rules to bring into effect the

provisions of this article, and, without prejudice to the generality of

the foregoing, may, in particular, prescribe rules regarding -

(a) the diseases which are to be subject to a national

scheme of eradication;

(b) the conditions under which the owners of animals shall

obtain a State financial contribution from the

veterinary services for the eradication of these

diseases; and

(c) the State financial contribution and other services

provided by the veterinary services within the

framework of the scheme.

The Minister may, with the concurrence of the Minister

responsible for finance, prescribe rules concerning the fees to be

charged by the Director for veterinary inspections and for the

control of live animals and animal products.

The Minister may, with the concurrence of the Minister

responsible for Foreign Affairs, prescribe rules regarding the

assistance and co-operation which the veterinary services are to

provide to trading partners so as to ensure the proper application of

veterinary and zootechnical rules, the prevention and detection of

infringements of such rules and the detection of any activity which

is or may be contrary thereto.

Part II

Requirements with regard to Animal Feeding Stuffs

Within the scope of this Act, the veterinary requirements in

the field of feeding stuffs shall include -

(a) the organisation of inspections and the conditions for

the approval of establishments involved in the animal

nutrition sector;

(b) the additives which may be incorporated in feeding

stuffs, the use of certain products and the prohibition

of undesired substances and products used in animal

nutrition;

(c) the methods of sampling and analysis of feeding stuffs

and the assessment of products and additives used in

animal nutrition;

(d) the circulation of feed materials and the marketing of

compound feeding stuffs;

(e) the conditions governing the preparation, the placing

on the market and the use of medicated feeding stuffs;

and

(f)

the fees payable in connection with any service

provided by the veterinary services in the animal

nutrition sector.

The Minister may prescribe rules relating to the

organisation, the inspection and the conditions for the approval of

establishments in the animal nutrition sector and, without prejudice

to the generality of the foregoing, may, in particular, prescribe rules

regarding -

(a) the organisation of official inspections in the field of

animal nutrition;

(b) the conditions under which establishments and

intermediaries operating in the animal nutrition sector

shall be approved and registered; and

(c) the inspections to be carried out on feeding stuffs

imported from third countries.

The Minister may, after consulting the Director, prescribe

rules regarding the additives which may be incorporated in feeding

stuffs, the use of certain products, the prohibition of undesirable

substances and products used in animal nutrition, and the use and

marketing of enzymes and micro-organisms, and their preparation

in connection with animal nutrition.

The Minister may prescribe rules regarding the methods of

sampling and analysis of feeding stuffs and the assessment of

products and additives used in animal nutrition.

The Minister may prescribe rules regarding the circulation

of feed materials and the marketing of compound feeding stuffs.

The Minister may prescribe rules regarding the conditions

governing the preparation, the placing on the market and the use of

medicated feeding stuffs.

The Minister may, with the concurrence of the Minister

responsible for finance, prescribe rules regarding the fees to be

levied -

(a) for the examination of the documentation relating to

additives; and

(b) in connection with the approval and registration of

establishments and intermediaries.

PART III

Requirements with regard to Veterinary Medicinal Products

Within the scope of this Act, the requirements in connection

with the inspection, supervision, authorisation, manufacture, research,

wholesale distribution, brokering, marketing, prescribing, dispensing,

supply, retail, advertising, provision of data on sales and use of

veterinary medicinal products, active substances and veterinary

medical devices shall include

(a)

procedures to be observed; and

(b)

fees to be levied.

The Minister may, after consulting the Director, prescribe

regulations establishing requirements relating to the manufacture,

importation, introduction, research, wholesale distribution, brokering,

marketing, prescribing, dispensing, supply, retail, advertising,

provision of data on sales and use of veterinary medicinal products,

active substances, and veterinary medical devices.

The Minister may, with the concurrence of the Minister

responsible for Public Health, prescribe rules regarding the

analytical, the pharmaco-toxicological and the clinical standards,

and the protocols in respect of the testing of veterinary medicinal

products.

The Minister may, after consulting the Director, prescribe

regulations regarding the authorisation for, and the inspections and

supervision of, the manufacture, importation, wholesale distribution,

research, brokering, marketing, prescribing, dispensing, supply, retail,

advertising, provision of data on sales and use of veterinary medicinal

products, active substances and veterinary medical devices.

The Minister may, with the concurrence of the Minister

responsible for finance, prescribe rules regarding the fees to be

charged for services rendered by the veterinary services under the

provisions of this Part of this Act.

PART IV

Zootechnical requirements in connection with Animal Breeding

The Minister may prescribe rules regarding zootechnical

requirements in animal breeding and, without prejudice to the

generality of the foregoing, may, in particular, prescribe rules

regarding -

(a) pure-bred breeding animals of the bovine species;

(b) pure-bred breeding animals of the swine species;

(c) pure-bred breeding animals of the ovine and caprine

species;

(d) zootechnical and genealogical conditions governing

trade in equidae;

(e) trade in equidae intended for competition and

conditions for participation in such competitions;

(f)

zootechnical and pedigree requirements for the

marketing of other pure-bred animals; and

(g) zootechnical and genealogical conditions applicable to

the importation, from third countries, of animals, their

semen, ova and embryos.

PART V

Obligations of certain persons and other bodies

(1) The owner, the keeper, the dealer or the importer, the

consignee, the carrier, the retailer or, where applicable any other

p e r s o n a u t h o r i s e d u n d e r t h e p r o v i s i o n s o f t h i s A c t k eep,

manufacture, import, prescribe, wholesale distribute, broker, market,

trade, dispense, advertise, provide data on sales and use of veterinary

medicinal products, or to supply, retail or to dispose of live animals,

products of animal origin, products listed in the First Schedule,

a n i m a l f e e d i n g s t u ff s veterinary medicinal products, active

substances or veterinary medical devices or the representative of

such persons, or any person in charge of a private veterinary

activity subject to the provisions of this Act -

(a) shall declare his activity to the veterinary services, in

accordance with the provisions of this Act, as the

Director may determine;

(b) shall provide the necessary cooperation and assistance

to the Director or any other officer nominated by him, in

the performance of any State veterinary activity;

without prejudice to the generality of the foregoing,

such persons shall allow entry into their premises at any

reasonable time and-

(i)

allow the execution of the veterinary

inspections, examinations or inspections of live

animals, products of animal origin, products

listed in the First Schedule, animal feeding

stuffs , active substances, veterinary medical

devices or veterinary medicinal products;

(ii) restrain and transport animals in accordance

with the provisions of this Act relating to

identification controls, examination of animals,

preventive vaccinations or eradication of

diseases;

(iii) manufacture, collect, transport and show in the

best conditions that meet all the requirements of

the applicable laws products of animal origin,

products listed in the First Schedule, feedingstuffs,

active substances, veterinary medical devices and

veterinary medicinal products in accordance with

the provisions of this Act relating to controls or

inspections of such products, feedingstuffs, active

substances, veterinary medical devices and

veterinary medicinal products;

(iv) allow access to the veterinary services at any

time, as the case may require, to places where

live animals, products of animal origin, products

referred to in the First Schedule, animal feeding

stuffs, active substances, veterinary medical

devices or veterinary medicinal products are kept

or transported; and

(v) assist the officers of the veterinary services in

any treatment which they may deem necessary to

be carried out on products of animal origin,

VETERINARY SERVICES

products referred to in the First Schedule, animal

feeding stuffs, active substances, veterinary

medical devices or veterinary medicinal

products;

(c) shall observe any obligation imposed under this Act

relating to contagious diseases, and implement the

rules relating thereto; without prejudice to the

generality of the foregoing, such persons shall -

(i)

co-operate and assist in the control of contagious

diseases, and in the declaration and notification

to the veterinary services of any suspicion of

any of the contagious diseases referred to in the

list of notifiable terrestrial and aquatic animal

diseases issued by the World Organization for

Animal Health;

(ii) observe the obligations imposed by the

veterinary services, in the case of a suspected

outbreak of any of the diseases referred to in the

list of notifiable terrestrial and aquatic animal

diseases issued by the World Organization for

Animal Health including any obligation

concerning the restriction of movement of

animals and humans, the slaughtering of

animals, the destruction of animal products,

feeding stuffs, active substances, veterinary

medical devices, veterinary medicinal productsand

equipment, and the cleaning and disinfection of

premises, material and equipment;

(iii) identify and register animals, and declare the

movements of animals for which they are

responsible;

(iv) keep individual registers for each holding for

which they are responsible;

(v) observe the health conditions in connection with

the movements of live animals and germinal

products;

(vi) produce, at the request of any officer of the

veterinary services, the necessary certificates or

documents;

(vii)

declare and notify to the veterinary services any

suspected outbreak of any contagious diseases

listed in the Third Schedule, or any of the

diseases listed in the Fourth Schedule which are

subject to a national programme of eradication;

(viii) observe the obligations imposed by the

veterinary services in the case of a suspected

outbreak of the diseases listed in the Third

Schedule, or any of the diseases listed in the

Fourth Schedule which are subject to a national

programme of eradication, including obligations

concerning the restriction of movement of

animals, the slaughtering of animals, the

destruction of animal products, feeding stuffs,

active substances, veterinary medical devices,

veterinary medicinal products and equipment, and

the cleaning and disinfection of premises,

material and equipment;

(d) shall comply with the conditions relating to the

importation of live animals, germinal products and

products of animal origin, and provide foreign

operators with the appropriate model of certificates,

relating to the different kinds of live animals, germinal

products and products of animal origin, to be used;

(e) shall produce, at the request of the officers of the

veterinary services, the necessary certificates or

documents;

(f)

shall notify the veterinary services of any suspicion of

zoonosis or other disease or any other phenomenon or

circumstance liable to present a serious threat to

animal or public health;

(g) shall abide by the suspension or the withdrawal, by the

officers of the veterinary services, of any

authorisations or official approval, following the

results of inspections carried out by such officers, or

following the use or manufacture of unauthorised

substances or products by such person;

(h) shall observe the obligations, imposed by the

veterinary services, relating to restriction of trade for

products declared unfit for human consumption, or

unauthorised substances or products, or relating to the

destruction of products of animal origin which present

a serious threat to animal or public health;

(i)

shall observe the animal health measures for the

production and placing on the market of live animals

and products of animal origin, and produce, at the

request of the officers of the veterinary services, the

necessary certificates or documents;

(j)

shall observe any withdrawal period, as may be

ordered under the provisions of this Act;

(k) shall assist the veterinary services in the monitoring of

such substances, and residues thereof, in live animals

and products of animal origin as may be provided by

or under this Act;

(l)

shall pay the relevant fees for the inspections and

controls referred to in this article, or in any regulations

as may be prescribed thereunder;

(m) shall generally assist and co-operate with the

veterinary services in any activities, ordered by the

veterinary services, designed to avoid the outbreak of

diseases amongst animals or for the control thereof; and

(n) shall forfeit to the veterinary services any instruments,

animals, products of animal origin, active substances,

veterinary medical devices, veterinary medicinal product,

feedingstuffs, appliances, products, or substances

suspected to be used in the commission of the offence

against this article.

(2) The Minister may make rules providing that any person

who acts in contravention thereof shall be guilty of an offence

against this article and shall, on conviction, be liable to such

penalty as may be prescribed by the Minister, being a penalty of not

more than imprisonment for six months or of a fine (multa) of not

more than twenty-three thousand and two hundred and ninety-three

euro and seventy-three cents (23,293.73), or of both such fine and

imprisonment.

(1) The owner, the keeper, the dealer or the importer, the

consignee, the carrier, the retailer or ,where applicable, any other

person authorised under the provisions of this Act to keep,

manufacture, import, prescribe, wholesale distribute, broker, market,

trade, dispense, advertise, provide data on sales and use of veterinary

medicinal products or to supply, retail or dispose of live animals,

products of animal origin, products listed in the First Schedule,

animal feeding stuffs veterinary medicinal products or active

substances, or the representative of such persons, or any person in

charge of a private veterinary activity subject to the provisions of

this Act -

(a) shall assist the veterinary services in the monitoring of

such substances, and residues thereof, as may be

provided by or under this Act, in live animals and

products of animal origin;

(b) shall place on the market only animals to which no

unauthorised substances or products have been

administered or which have not undergone any illegal

treatment contrary to the provisions of this Act;

(c) shall not place in a holding or on the market animals

which have been treated with veterinary medicinal

products, unless the relevant withdrawal period has

been observed before the animals were so placed or

slaughtered;

(d) shall not accept, whether by direct delivery or through

an intermediary, any animals for which the producer is

not able to guarantee that the withdrawal periods have

been observed;

(e) shall place under official control, when requested to do

so by an officer of the veterinary services, any

unauthorised substances or products, until appropriate

measures are taken by the veterinary services;

(f)

shall comply with any order for the suspension or

withdrawal of any authorisation or approval previously

given by the veterinary services;

(g) shall comply with any order restricting or prohibiting

trade in products declared unfit for human or animal

consumption, or ordering the destruction of products

of animal origin which present a serious threat to

animal or public health;

(h) shall pay the relevant fees for the inspections and

controls referred to in this article, or in any regulations

as may be prescribed;

(i)

shall generally assist and co-operate with the

veterinary services in any activities, ordered by the

veterinary services, designed to avoid the outbreak of

diseases amongst animals or for the control thereof; and

(j)

shall obtain any relevant authorisations from the

veterinary services prior to the slaughtering of animals

for human or animal consumption, unless exempted

from doing so under this Act or any other national or

EU law; and

(k) shall forfeit to the veterinary services any instruments,

animals, products of animal origin, active substances,

veterinary medical devices, veterinary medicinal

products, feeding stuffs, appliances and other products or

substances which are suspected to have been used in the

commission of an offence against this article.

(2) The Minister may make rules providing that any person

who acts in contravention thereof shall be guilty of an offence

against this article and shall, on conviction, be liable to such

penalty as may be prescribed by the Minister, being a penalty of not

more than imprisonment for six months or of a fine (multa) of not

more than twenty-three thousand and two hundred and ninety-three

euro and seventy-three cents (23,293.73), or of both such fine and

imprisonment.

(1) The owner, the keeper, the dealer or the importer, the

consignee, the carrier, the retailer or any other person authorised

under the provisions of this Act to dispose of live animals, products

of animal origin, products listed in the First Schedule, animal

feeding stuffs or veterinary medicinal products, or the

representative of such persons, or any person in charge of a private

veterinary activity subject to the provisions of this Act -

(a) shall place on the market only those animals which

have been correctly identified, and which are not

subject to any restriction of movement because of the

suspicion, outbreak or existence of a disease referred

to in the list of notifiable terrestrial and aquatic animal

diseases issued by the World Organization for Animal

Health or because of the application of safeguard

measures;

(b) shall not place in a holding or on the market,

recognised as being free from any of the diseases listed

in the Third or Fourth Schedules, any animal which is

not covered by the guarantees in accordance with the

provisions of this Act;

(c) shall not accept, whether by direct delivery or through

an intermediary, any animals which have not been

VETERINARY SERVICES

correctly identified, and for which the producer is not

able to guarantee that the animal is not subject to any

restriction of movement because of the suspicion,

outbreak or existence of a disease referred to in the list

of notifiable terrestrial and aquatic animal diseases issued

by World Organization for Animal Health or because of

the application of safeguard measures;

(d) shall not accept in a holding, centre or organisation, or

on the market, recognised as being free from any of the

diseases listed in the Third or Fourth Schedules, any

animal which is not covered by guarantees, required

by the provisions of this Act, to show that such animal

is free from any of those diseases;

(e) shall ensure that all animals intended for trade or

slaughter meet the health requirements specified in

this article or in any regulations made thereunder;

(f)

shall, before the consignment is divided up or

subsequently marketed, check that the identification

marks, certificates or documents are present, and

notify the veterinary services of any irregularity or

anomaly and, in the latter case, isolate the animals in

question until the veterinary services have taken a

decision regarding the said irregularity or anomaly;

(g) shall report in advance the arrival of animals and

germinal products from a trading partner and, in

particular, the nature of the consignment and the

anticipated arrival date;

(h) shall keep for a period of not less than six months, and

not more than five years, as may be specified by the

veterinary services, the health certificates or

documents referred to in article 17, for presentation to

the veterinary services, should the latter so request;

(i)

shall ensure that products of animal origin intended for

trade have been obtained, checked, marked and

labelled in accordance with the provisions of this Act,

and are accompanied to the final consignee by a health

certificate, animal health certificate or by any other

document as may be required;

(j)

shall ensure, by constant self-supervision, that

products of animal origin intended for trade satisfy the

requirements of the provisions of this Act and of any

regulations made thereunder;

(k) shall ensure that products of animal origin intended for

trade comply with all the requirements in veterinary

matters at all stages of the production, storage,

marketing and transport of such products;

(l)

shall ensure that uniform tests are carried out on

products to which this Act applies, whether the

products are intended for a trading partner or for the

national market;

(m)

shall place under official control, when requested to

do so by the veterinary services, any animals or

products of animal origin, until appropriate measures

are taken by the veterinary services;

(n) shall produce, at the request of the veterinary services,

the necessary certificates or documents where

veterinary inspections relating to the importation, from

third countries, of live animals and products of animal

origin, are held;

(o) shall give sufficient prior notice to the veterinary

services of the border inspection post, where the

animals are to be presented, specifying the number,

nature and estimated time of arrival of the animals;

(p) shall convey directly the animals, under official

supervision, to the inspection site or, where applicable,

to a quarantine centre, as may be directed by the

veterinary services;

(q) shall forward advance information to the veterinary

services, by duly completing, where applicable, any

certificate or document delivered by the inspection

service, or by providing a detailed description, in

writing or in computerised form, of any consignment

of products of animal origin, including the products

referred to in the First Schedule;

(r) shall pay the relevant fees for the inspections and

controls referred to in this article, or in any regulations

as may be prescribed thereunder;

(s) shall generally assist and co-operate with the

veterinary services in any activities, ordered by the

veterinary services, related to trading of animal and

animal products, and investigations carried out at

border inspection posts; and

(t)

shall forfeit to the veterinary services any instruments,

animals, products of animal origin, veterinary medicinal

products, feeding stuffs, appliances and other products or

substances which are suspected to have been used in the

commission of an offence against this article.

(2) The Minister may make rules providing that any person

who acts in contravention thereof shall be guilty of an offence

against this article and shall, on conviction, be liable to such

penalty as may be prescribed by the Minister, being a penalty of not

more than imprisonment for six months or of a fine (multa) of not

more than twenty-three thousand and two hundred and ninety-three

euro and seventy-three cents (23,293.73), or of both such fine and

imprisonment.

(1) The owner, the keeper, the dealer or the importer, the

consignee, the carrier, the retailer or any other person authorised

under the provisions of this Act to keep, manufacture, import,

prescribe, wholesale distribute, broker, market, trade, dispense,

advertise, provide data on sales and use of veterinary medicinal

products, or to supply, retail or dispose of live animals, products of

animal origin, products listed in the First Schedule, animal feeding

stuffs veterinary medicinal products, active substances or veterinary

medical devices, or the representative of such persons, or any

person in charge of a private veterinary activity subject to the

provisions of this Act -

(a) shall obtain all relevant authorisation from the

veterinary services prior to the placing on the market

of animal feeding stuffs and veterinary medicinal

products;

(b) shall provide, at the demand of the veterinary services,

any studies, results or information relating to the

animal feeding stuffs or veterinary medicinal products,

active substances or veterinary medical devices;

(c) shall comply with any order for the suspension,

revocation or withdrawal of any authorisation or

approval previously given by the veterinary services;

(d) shall comply with any order restricting or prohibiting

trade in feeding stuffs or veterinary medicinal

products, or ordering comply with any order relating to

the destruction of feeding stuffs or veterinary

medicinal products, active substances or veterinary

medical devices which present a serious threat to

animal or public health or to the environment;

(e) shall pay the relevant fees for the inspections and

controls referred to in this article or in any regulations

as may be prescribed thereunder;

(f)

shall generally assist allow entry into their premises at

any reasonable time, and co-operate with the veterinary

services in any activities, ordered by the veterinary

services, related to trading of animal and animal

products, and investigations carried out at border

inspection posts.

(g) shall take samples from animals, products of animal

origin, products listed in the First Schedule,

foodstuffs, veterinary medicinal products, active

substances or veterinary medical devices, as may be

demanded by the veterinary services for control

purposes. The cost of these samples may be

reimbursed by the Director at his discretion; and

(h) shall forfeit to the veterinary services any instruments,

animals, products of animal origin, active substances,

veterinary medical devices, veterinary medicinal

products, feedingstuffs, appliances and other products or

substances which are suspected to have been used in the

commission of an offence against this article.

(2) The Minister may make rules providing that any person

who acts in contravention thereof shall be guilty of an offence

against this article and shall, on conviction, be liable to such

penalty as may be prescribed by the Minister, being a penalty of not

more than imprisonment for six months or of a fine (multa) of not

more than twenty-three thousand and two hundred and ninety-three

euro and seventy-three cents (23,293.73), or of both such fine and

imprisonment.

PART VI

Professional Veterinary Activities

(1) There shall be a Council, to be called the Veterinary

Surgeons’ Council, hereinafter referred to as ''the Council'', which

shall exercise and perform the functions assigned to it by this Act.

(2)

The Council shall consist of the following members

(a) a Chairman, to be appointed by the Prime Minister, on

the advice of the Minister;

(b) the Director or his representative;

(c) two members to be appointed by the Prime Minister,

on the advice of the Minister, one of whom shall be a

veterinary officer from the Department; and

(d) four elected members, of whom two shall be veterinary

surgeons with experience in the practice on large

animals, and two with experience in the practice on

small animals, and who shall be elected by secret

ballot by the veterinary surgeons ordinarily resident in

Malta.

(3) The Director shall, after consultation with the Chairman of

the Council, appoint an officer of the Department to act as

Registrar of the Council.

(1) The Chairman shall hold and vacate his office in

accordance with the terms of his appointment, but may at any time

resign his office by notice in writing to the Prime Minister.

(2) The members appointed or elected, as the case may be,

under article 39(2)(c) and (d) shall be so appointed or elected for a

term of three years.

(3) The members appointed under article 39(2)(c) shall hold

office on such terms and conditions, and may at any time have their

appointment terminated, as the Prime Minister, acting on the advice

of the Minister, may deem appropriate.

(4) Any member appointed or elected, as the case may be,

under article 39(2)(c) and (d) may at any time resign his office by

notice in writing to the Chairman of the Council.

(5) When a vacancy occurs in the composition of the Council, a

new appointment shall be made or an election held to fill the

vacancy for the remaining term of the member vacating the post, as

the case may be, within a period of one month from the date of such

vacancy

Provided that, subject to the provisions of article 41(6), the

C o u n c i l m a y a c t n o t wi t h s t a n d i n g a n y v a c a n c y a m o n g s t i t s

members.

(1) In the absence of the Chairman from any meeting of

the Council, the members present shall elect one of them to preside

VETERINARY SERVICES

over the meeting.

(2) The Council shall have the power to appoint sub-

committees, and to allow at its meetings the presence of persons

who are not members of the Council.

(3) The Council shall meet at least once every three months

a n d, s ub j ec t to t h e p r ov i si o n s o f s ub a r ti c l e ( 6 ) , it m a y a ct

notwithstanding any vacancy amongst its members.

(4) The Council shall hold its meetings at such time and place

as shall be stated in the notice calling the meeting.

(5) The decisions of the Council shall be taken by a majority of

votes. The Chairman shall have an original vote, and in case of

equality of votes, also a second or casting vote.

(6) It shall not be lawful for the Council to transact any

business unless there are at least four of its members present

Provided that, if the Council is convened to consider any

matter upon which its advice is certified by the Minister to be

urgently required by Government, the Council may take decisions

by a majority of members present, notwithstanding that less than

four members may be present.

(7) Subject to the provisions of this Act, the Council may

regulate its own procedure.

(1) The Council shall

(a) advise and make recommendations to the President of

Malta concerning the grant of warrants to veterinary

surgeons to practice their profession;

(b) keep a Register in respect of such profession and

professions and trades supplementary to the veterinary

profession;

(c) prescribe and maintain professional and ethical

standards for the veterinary profession and professions

and trades supplementary to the veterinary profession;

(d) advise the Minister on any matter, including

legislation, affecting such profession and professions

and trades supplementary to the veterinary profession;

(e) advise the Minister on the issue of licences for the

running of veterinary practices, veterinary clinics,

veterinary hospitals, veterinary laboratories and other

veterinary establishments;

(f)

advise and make recommendations to the President of

Malta concerning the suspension or withdrawal of

warrants to veterinary surgeons who are found to be in

breach of the obligations or conditions laid down

under this Act;

(g) plan, monitor and organise professional training of

veterinary surgeons and professional proficiency tests

for veterinary surgeons in private veterinary activities;

(h) carry out expert supervision of private veterinary

activities as described in article 44;

(i)

co-operate in the preparation of programmes of

educational and expert training; and

(j)

carry out such other functions as may be assigned to it

by or under this Act or any other law.

(2) The Council, with the concurrence of the Minister, shall

make regulations governing the conditions and procedures for the

grant of veterinary licences.

(1) Professional veterinary activities shall comprise both

State and private veterinary activities.

(2)

No person shall practice as a veterinary surgeon unless -

(a) he holds a warrant to practice from the President of

Malta; and

(b) his name is registered in the Veterinary Surgeons’

Register.

(3) Warrants shall be granted to any applicant who produces a

certificate issued by the Council showing that the Council is

satisfied that the applicant -

(a) Repealed by Act XVIII. 2002.10;

(b) has graduated in veterinary medicine and surgery,

having a degree or formal qualification recognised by

the Council, after consultation with the Malta

Qualifications Council and in terms of the Mutual

Recognition of Qualifications Act and legislation

made thereunder, as being comparable to the degree or

formal qualification, in the subject, in Malta, or in a

Member State, and in trading partners;

(c) Repealed by Act XVIII. 2002.10;

(d) is of good character;

(e) is in a state of good physical and mental health;

(f)

Repealed by Act XVIII. 2002.10;

(g) is a citizen of Malta or of a Member State or is

otherwise legally entitled to work in Malta.

(4)

(a) The Council shall acknowledge receipt of an

application for a warrant as soon as possible and in any

case by not later than one month of receipt of all

relevant documentation submitted in fulfilment of the

requirements listed in the last preceding sub-article.

The acknowledgment shall include the time by which

the Council expects to reach a decision in terms of this

sub-article and the available means of redress from

decisions of the Council

Provided that in the case of incomplete documentation,

the Council shall inform the applicant accordingly

Provided further that where the applicant is already

established in another Member State and, or has

obtained his qualifications in another Member State

and, or is a citizen of another Member State, the

Council may seek to verify any of the documentation

submitted by the applicant with the relevant competent

authority of that Member State in terms of the Services

(Internal Market) Act.

(b) The Council shall examine all documentation

submitted by the applicant as early as possible and

lead to a duly substantiated decision within three

months. Such period shall commence to run from the

date of receipt of all necessary documentation. Where

duly motivated, this period may be extended by one

month by the Council, provided that the applicant is

notified before the original period set in paragraph (a)

has expired.

(c) Lack of response within the timescales set in

accordance with this sub-article shall not be deemed to

imply the tacit approval of the applicant’s application.

(5) Without prejudice to sub-articles (2) and (3), and in

accordance with the Mutual Recognition of Qualifications Act and

the Recognition of Professional Qualifications Regulations, a

person may provide veterinary services in Malta, on a temporary and

occasional basis, provided that he is legally established in another

Member State for the purpose of pursuing the profession of a

veterinary surgeon in such Member State.

(6)

(a) Persons referred to in sub-article (5) shall inform the

Council in advance of their intention to provide

veterinary services in Malta by means of a written

declaration. Such written declaration shall include

(i) proof of nationality;

(ii) an attestation certifying that the person is legally

established in another Member State for the

purpose of pursuing the profession of a

veterinary surgeon in that Member State;

(iii) evidence of his professional qualifications;

(iv) details of his current insurance cover or of any

other means of collective protection with regard

to professional liability, as it may be applicable.

(v) Repealed by Act XXXVII.2024.6.

(b) (i) Repealed by Act XXXVII.2024.6.

(ii) Repealed by Act XXXVII.2024.6.

(iii) Repealed by Act XXXVII.2024.6.

(iv) Repealed by Act XXXVII.2024.6.

(v) Where there is a substantial difference between

the professional qualifications of the applicant

and the training required in Malta, to the extent

that that difference is such as to be harmful to

public health or safety, and that it cannot be

compensated by the applicant’s professional

experience or by knowledge, skills and

competences acquired through lifelong learning

formally validated to that end by a relevant

body, the Council shall give that applicant the

opportunity to show, by means of an aptitude

test, that he has acquired the knowledge, skills

or competence that were lacking. The Council

shall take a decision on that basis on whether to

allow the provision of services. In any case, it

must be possible to provide the service within

one month of the decision taken in accordance

with sub-paragraph (ii).

(vi)

All aptitude tests shall be provided directly by

the Council or sub-contracted to any other

authority, organisation or institute as chosen by

the Council.

(vii)

All expenses in taking aptitude tests shall be

borne by the applicant.

(c) In making its decision in terms of this and the

preceding subarticle, the Council shall assess and

determine each application based on its individual

merits.

(6A) (a) Veterinary surgeons benefiting from the recognition of

professional qualifications shall have a knowledge of

either the Maltese language or the English language.

(b) The Council shall ensure that any controls carried out

to ensure compliance with the obligation under

paragraph (a) shall be limited to the knowledge of one

official language of Malta.

(c) Controls carried out in accordance with paragraph (b)

may be imposed in cases where there is a serious and

concrete doubt about the sufficiency of the veterinary

surgeon’s language knowledge in respect of the

professional activities which that veterinary surgeon

intends to pursue.

(d) Controls may be carried out only after the recognition

of a professional qualification.

(e) Any language controls shall be proportionate to the

activity to be pursued, and shall be subject to appeal.

(7)

(a) The Veterinary Surgeons’ Council shall keep a list

within the Veterinary Surgeons’ Register of persons

providing ve t e r i n a r y s e r v i c e s o n a t e m p o r a r y o r

occasional basis under this article.

(b) This registration shall be valid for one year and shall

be renewed, in advance, for every year in which the

applicant intends to provide temporary or occasional

services in Malta during that year.

(8)

(a) The Council shall keep a register, to be called the

Veterinary Surgeons’ Register, in which shall be

entered the name of every veterinary surgeon to whom

a warrant has been granted under this article.

(b) Every veterinary surgeon shall be entitled to have

entered against his name in the Veterinary Surgeons’

Register, any degree or diploma which he may hold,

provided that such degree, diploma or comparable

formal qualification relates to the profession of

veterinary surgeon and is recognised by the Council,

after consultation with the Malta Qualifications

Council.

The Minister may, after consultation with the Council,

prescribe regulations regarding the registration of veterinary

surgeons exercising private veterinary activities, the definition of

private veterinary activities, and the execution of private veterinary

activities.

The Minister may, after consultation with the Council,

prescribe regulations regarding the appointment of veterinary

surgeons in charge of State veterinary activities, and the execution

of State veterinary activities.

The Minister may make regulations for bringing into effect

the provisions of the Mutual Recognition of Qualifications Act and

the Services (Internal Market) Act, and subsidiary legislation

i s s u e d t h e r e u nd e r, i n r e l a t io n t o t h e m ut ua l r e c o g ni t io n o f

qualifications of veterinary surgeons.

(1) Where a veterinary surgeon is found to be in breach of

any of the obligations or conditions laid down under this Act, and

without prejudice to any other liability under any other law, the

Council may suspend or cancel the registration of the veterinary

surgeon from the Veterinary Surgeons’ Register.

(2) The Minister may, in consultation with the Council,

prescribe regulations for the implementation of the provisions of

this article.

The Minister may make regulations prescribing the manner

in which the first elections to the Council shall be held, and

generally for regulating the conduct of elections to the Council.

PART VII

State Veterinary Organisation

(1) All State veterinary activities shall be under the

direction and control of the Department of Veterinary Services,

which shall be headed by the Director.

(2) The Department shall exercise its powers and functions in

the entire territory of Malta, including customs warehouses, free

zones or free warehouses.

(1) Without prejudice to any other obligation relating to the

operation of veterinary activities arising out of the provisions of

this Act, the Director shall -

(a) be the chief advisor to the Government on any matter

relating to animal or veterinary public health or

relating to, or in connection with, the veterinary health

services;

(b) submit periodical reports, to the Minister, on the

situation concerning State veterinary activities;

(c) report to the Minister any information concerning any

new scientific evidence or facts, which may directly or

indirectly affect State veterinary activities;

(d) submit to the Minister the documentation or data

required for the making, by the Minister, of rules and,

or, regulations in accordance with the provisions of

this Act, and advise the Minister on any matter

required to be done by the Minister under this Act;

(e) liaise with other departments or bodies on matters

falling under his responsibility;

(f)

perform such duties and functions as are assigned to

him by or under this Act and, generally, to monitor the

running of veterinary activities;

(g) decide upon any request made by the manufacturer, or

by a duly authorized representative, of veterinary

medicinal products, for the purpose of obtaining

authorisation for the marketing of such products in

accordance with the provisions of this Act;

(h) where a request under paragraph (g) has been

favourably decided upon, issue the authorisation for

the marketing of the veterinary medicinal products and

include such products in the list of approved

Veterinary Medicinal Products, which shall, from time

to time, be published by the Veterinary Services;

(i)

decide on the continuation or cessation of the

manufacture, importation or marketing of a veterinary

medicinal product, active substance or veterinary

medical device and, or on the recalling of that product,

in cases where an undesirable effect has been detected

or suspected;

(j)

upon a reference made to him for that purpose,

determine whether particular substances or active

substances have been used in the manufacture of a

veterinary medicinal product;

(k) exercise supervision and conduct inspections on the

manufacture, importation, introduction, wholesale

distribution, brokering, marketing, retail and use of

veterinary medicinal products and active substances;

(l)

decide on the continuation or cessation of the

manufacture, importation or marketing of a veterinary

medicinal product, active substance or veterinary

medical device in cases where a product or batch

defect has been detected or suspected;

(m) decide on the confiscation, sealing, isolation or otherwise

of veterinary medicinal products, active substances or

veterinary medical devices which are found to be in

breach of any of the provisions of this Act or any

Regulations made thereunder; and

(n) decide on the taking of temporary measures which shall

not have effect for more than six (6) months from their

publication by notice in the Government Gazette, unless

these are extended by such other notice, and said

temporary measures prohibit or limit the introduction, sale,

possession or movement of any animal, product of animal

origin or any other thing capable of carrying or

transmitting pests or diseases.

(2)

Without prejudice to the preceding sub-article, the Director

may also

(a)

draw up and update assessment reports on the

results of analytical and pharmaco-toxicological tests, and on

the results of clinical trials of veterinary medicinal products and

assessment of dossiers thereof; and

(b)

test veterinary medicinal products or any of the

ingredients thereof and, where necessary, intermediate products

or other constituent materials, or submit such products for

testing by a trading partner laboratory or by a laboratory

designated for that purpose, with a view to ensuring that the

manufacturing and testing methods employed by the

manufacturer and described in the application are in accordance

with the provisions of this Act or any regulations made

thereunder.

(3)

The Director may exercise any one or more of his functions

either directly or through any of the officers or employees of the

Veterinary Services or through the Medicines Authority or any agency

authorised for that purpose, or through a contractor or other person

with whom an agreement for the performance of any one or more of

such functions has been entered into

Provided that nothing in this sub-article shall authorise the

Director to contract out or delegate any

(a)

of his regulatory functions; or

(b)

of his authorisation functions, unless such

functions are expressly delegated to the Medicines Authority or

to another public authority established by law, in particular

another national competent authority as defined in this Act.

(4)

The Director may approve the entering into contracts and

memoranda of understanding between the Veterinary Services and the

Medicines Authority for any purpose of cooperation which is deemed

beneficial to any of the parties to the contract or memorandum of

understanding in the carrying out of any of their functions.

(5)

For the purpose of performance of any functions under this

Act, the Director or any other such officer or person as may be

authorised by the Director may request the assistance of the Malta Police

Force, any local council, any department of Government, any agency of

Government, any voluntary organisation or private sector entity.

(6)

For the purposes of sub-articles (3), (4) and (5) where

applicable to the Medicines Authority, these are subject to an

agreement between the Medicines Authority and the Director

Veterinary Services, such as in the form of a contract or memorandum

of understanding.

PART VIII

Functions and Duties of the National Veterinary Laboratory

Deleted by Act XV.2025.37.

Deleted by Act XV.2025.37.

Deleted by Act XV.2025.37.

Repealed by Act XIV.2022.18.

PART IX

Enforcement, Offences and Penalties

For the purpose of enforcing the provisions of this Act, or

any regulations made thereunder the Director may request the

assistance of the members of the Police Force, the Armed Forces of

Malta, or of Civil Protection units, as the case may require and, for

this purpose, there shall be a committee composed of

representatives from the Police Force, the Armed Forces of Malta

and from Civil Protection units, and which shall meet on a regular

basis so as to update emergency and contingency plans; without

prejudice to the generality of the foregoing, the Director may, in

particular, request such assistance -

(a) where official veterinarians and, or officers are

empowered, by the provisions of this Act or any

regulations made thereunder, to carry out inspections and

supervision in connection with the restriction of trading

of animals or animal products, or the prohibition of the

movement of persons, animals or animal products in a

contaminated area;

(b) in cases of outbreak of major epizootics, for the

prevention of the spreading of the disease and the

suppression of contagious animal diseases; and

(c) where official veterinarians and, or officers are, while

carrying out their duties and functions under this Act,

or any regulations made thereunder confronted with

physical resistance or otherwise obstructed, or when

such resistance or obstruction is reasonably expected.

(1) The Veterinary Surgeons’ Council shall set up a

subcommittee, to be known as the Disciplinary Committee, which

shall be empowered to conduct investigations and give directions

of a disciplinary nature, upon any case in which it is alleged that a

person is liable to have his name removed from the Veterinary

Surgeons’ Register, hereinafter referred to as ''the Register'', or to

have his registration cancelled or suspended, or to be awarded a

pecuniary penalty (recoverable as a civil debt by the Director) of

not more than one thousand and one hundred and sixty-four euro

and sixty-nine cents (1,164.69) and admonished, or be liable to any

other penalty as may be deemed appropriate in the circumstances of

the case, and in accordance with the provisions of this Act.

(2)

The provisions of subarticle (1) shall apply where -

(a) a veterinary surgeon, who is registered in the Register,

is convicted in Malta or abroad of a criminal offence,

which, in the opinion of the Disciplinary Committee,

renders him unfit to practice the veterinary profession;

or

(b) any such veterinary surgeon is found, by the

Disciplinary Committee, to have been guilty of

disgraceful conduct in any professional respect; or

(c) the Disciplinary Committee is satisfied that the name

of any such person has been fraudulently entered in the

Register.

(3) The Disciplinary Committee will report all its findings and

the results of its investigations and enquiries, together with its

direction, to the Council.

(4) The Disciplinary Committee may, in cases of a grave

offence, direct that a veterinary surgeon’s name be removed from

the Register or, except in a case falling under subarticle (2)(b), that

his registration therein shall be suspended for a period to be

specified in the direction.

(5) The Registrar of the Council shall cause a notice of any

direction of the Disciplinary Committee to be served on the person

to whom the direction refers.

(6)

Notwithstanding any other provision of this Act, any person

whose name has been removed or suspended from the Register

shall automatically be deemed to have had his warrant from the

President of Malta, to practice his profession, withdrawn or

suspended for the period specified in the direction.

(7) A person to whom a direction has been notified under the

provisions of this article may, within twenty-eight days from the

date of service on him of the notice of the direction, appeal to the

Veterinary Surgeons’ Council, in accordance with such regulations

as may be prescribed by the Minister for the purpose of this article.

(8) A direction given under the foregoing provisions of this

article shall take effect

(a) where no appeal is made under subarticle (7) against

the direction within the time specified for such an

appeal, on the expiration of that time;

(b) where such an appeal is brought and is subsequently

withdrawn or struck out as abandoned, on the

withdrawal or striking out of the appeal;

(c) where such an appeal is brought and not withdrawn or

struck out as aforesaid, when the decision on the

appeal is given.

(9) Where a person’s name has been removed from the

Register, in pursuance of a decision as aforesaid, the name of that

person shall not be entered again in the Register unless the

Disciplinary Committee, on an application made to it on that

behalf, otherwise directs.

(10) Where the registration of a person in the Register is

suspended in pursuance of a decision as aforesaid, the name of that

person shall not be entered in the Register throughout the period of

the suspension, unless the Disciplinary Committee, on application

made to it in that regard, otherwise directs.

(11) Any application under subarticles (9) and (10) shall not be

made to the Disciplinary Committee before the expiration of ten

months from the date of the removal or the suspension of the

registration or ten months from the date of a previous application

thereunder.

(12) The provisions of subarticles (1) to (11) shall, mutatis

mutandis, also apply to persons registered in the Register for the

P r o f e s s i o n s a n d Tr a d e s S u p p l e m e n t a r y t o t h e Ve t e r i n a r y

Profession.

Any person who -

(a) assaults, resists or wilfully obstructs an official

veterinarian and, or officer in the exercise of his

powers under this Act or any regulations made

thereunder; or

(b) refuses or neglects to comply with any order or

direction lawfully made or given under this Act or any

regulations made thereunder; or

(c) without reasonable cause fails to -

(i)

answer any question asked by an official

veterinarian and, or officer; or

(ii) produce anything required to be produced,

in pursuance of this Act or any regulations made

thereunder; or

(d) fails to allow a search or inspection under this Act or

any regulations made thereunder; or

(e) prevents or attempts to prevent another person from

complying with such orders or directions or from

answering such questions, producing anything or

allowing a search or inspection; or

(f)

for the purposes of obtaining any licence or permit, or

for the purported compliance with any requirement to

provide any information under this Act, or any

regulations made thereunder provides information

which he knows to be false in a material particular or

recklessly provides information which is false in a

material particular,

shall be guilty of an offence and shall be liable, on conviction, to a

fine (multa) of not less than four hundred and sixty-five euro and

eighty-seven cents (465.87) but not exceeding five thousand and

e i g ht h u n dr e d a n d t w e n t y - t hr e e e u r o a n d f or t y - t h r e e c e n t s

(5,823.43).

(1) Any person who contravenes any provision of this Act

or any regulations made thereunder f o r w h i c h n o p e n a l t y i s

specifically provided shall be guilty of an offence and shall be

liable, on conviction, to a fine (multa) of not more than eleven

thousand and six hundred and forty-six euro and eighty-seven cents

(11,646.87).

(2) Where any person is convicted of an offence against this

Act, or any regulations made thereunder the Court may, in addition to

any other penalty that it may impose, order that any

instruments,animals, products of animal origin, active substances,

veterinary m edi cal devices, veterinary m edicinal products,

feedingstuffs, appliances, products or substances used in the

commission of the offence shall be confiscated by the Government

and, if so confiscated, shall be disposed of in such a manner as the

Court may determine on the advice of the Director.

(1) In respect of proceedings for offences charged against

this Act or any regulations made thereunder, the Court may award in

favour of the Government such costs and expenses incurred in

relation to those proceedings as it may deem proper.

(2) Notwithstanding the provisions of article 413(1)(b) of the

Criminal Code, the Attorney General shall always have a right of

appeal from any judgment given by the Court of Magistrates,

sitting as a court of criminal judicature, in respect of proceedings

for an offence against this Act.

The Minister may by order make such provisions as he may

consider appropriate for the enforcement of any restriction or

obligation relating to the carrying out of veterinary activities and to

animal health in general contained in a Convention to which Malta

is a party and may provide in the order that any contravention of

any such restriction or obligation shall constitute an offence against

this Act liable to the punishment of a fine (multa) as laid down in

the order, which fine (multa) shall not exceed the sum of fifty-eight

thousand and two hundred and thirty-four euro and thirty-three

cents (58,234.33). Any such order may be amended, substituted or

revoked by the Minister from time to time.

(1) In the case of a second or subsequent conviction

against this Act, or any regulations made thereunder the person

convicted shall, in addition to any other penalty, forfeit any licence

authorisation or permit, and any relative entry in any register made

under this Act or any regulations made thereunder shall be cancelled.

The person convicted may, at the discretion of the Court and in

addition to any other penalty, also forfeit any fees paid for any

licence authorisation or permit forfeited as aforesaid or for any

entry cancelled as aforesaid, and shall be incapable for a period of

three years from the day of the second or subsequent conviction, as

the case may be, of holding any such licence authorisation or permit

or of being so entered in the register under this Act or any

regulations made thereunder or any regulations made thereunder.

(2) Notwithstanding the provisions of subarticle (1), the

Minister may, in the circumstances of any particular case and upon

application being made to him, direct that the provisions of that

subarticle are not to apply to any particular licence, authorisation

permit or entry in the record of any register under this Act or any

regulations made thereunder otherwise forfeited.

(1) Where the Director has reasonable cause to believe

that -

(a) an offence against this Act or any regulations made

thereunder has been committed by any person; and

(b) having regard to the previous conduct of the person

concerned, it would be appropriate to impose a penalty

under this article,

he may cause a notice in writing in accordance with subarticle (2)

in the appropriate form to be served on that person.

(2)

A notice under subarticle (1) shall specify -

(a) the date and nature of the offence;

(b) a summary of the facts upon which the allegation that

an offence has been committed is based (being a

sufficient summary fully and fairly to inform the

person of the allegation against him);

(c) any other matters (not being previous convictions) that

the Director considers relevant to the imposition of a

penalty;

(d) the amount of the penalty due, and where the penalty

due depends on a previous conviction, the date of such

conviction; and

(e) any necessary remedial steps to be taken by the person to

whom the notice is addressed to be in compliance with

the requirements of this Act or any regulations made

thereunder,

and shall be endorsed on a statement setting out the provisions of

this article.

(3) Any person on whom a notice under subarticle (1) is served

may, within thirty days after such service by notice in writing in the

appropriate form served on the Director, require that proceedings in

respect of the alleged offence shall be dealt with by the Court, in

which case the following provisions shall apply

(a) no further proceedings shall be taken under this article

by the Director; and

(b) nothing in this article shall be construed to prevent the

institution of any proceedings in respect of the alleged

offence or the conviction of the person for the offence

by the Court or the imposition of any penalty or

forfeiture under this Act or any regulations made

thereunder upon such conviction.

(4) Any person on whom a notice under subarticle (1) is served

who does not wish that proceedings in respect of the alleged

offence shall be dealt with by the Court may by notice in writing

served on the Director -

(a) admit the offence;

(b) carry out all the necessary remedial steps which may be

indicated in the notice served in terms of sub-article (1);

and.

(c) pay the amount of the penalty to the Director within

thirty (30) days after the notice of the penalty is served or

after such subsequent period as the Director may

determine."

(5) Where under this article a person admits an offence and carries

out all the necessary remedial steps requested in the notice in

accordance with sub-article (2), the Director shall impose a monetary

penalty on that person in respect of the offence amounting to one third

of the maximum penalty to which the person would be liable if he

were convicted of the offence by the Court.

(6) The penalty imposed under subarticle (5) shall be due as a

civil debt enforceable by the competent Court of civil jurisdiction

in favour of the Government and the declaration by the person on

whom the penalty is imposed that he admits the charge shall

constitute an executive title for the purposes of article 253 of the

Code of Organization and Civil Procedure in the same manner as if

it were a judgement of the competent Court of civil jurisdiction.

(7) Notwithstanding any other provisions of this Act or of any

other enactment, where an offence has been admitted under this

article and all requested necessary remedial steps have been taken

by the person admitting such offence to be in compliance with the

requirements of this Act or any regulations made thereunder no

charge may be laid in respect of the offence against any person by

whom it has been admitted.

(8) Where a person on whom a notice under sub-article (1) is

served does not, within thirty (30) days after the notice is served on

him, admit the offence and take all requested necessary remedial steps

to be in compliance with the requirements of this Act or any

regulations made thereunder, the Director shall institute proceedings

or cause proceedings to be instituted before the Court in respect of the

alleged offence.

PART X

Veterinary Pharmacies and licences for manufacturers, importers,

wholesale distributors and brokers of Veterinary Medicinal

Products

(1)

It shall not be lawful for any person to open or keep a

veterinary pharmacy unless he is in possession of a veterinary

pharmacy licence issued in accordance with the provisions of this Act

or any regulations made thereunder.

(2)

Without prejudice to any exemption that may be granted by

or under this Act, no person shall retail any veterinary medicinal

product unless in accordance with a veterinary pharmacy licence

issued in accordance with the provisions of this Act or any regulations

or rules made thereunder.

(3)

The licensee shall be responsible for complying with the

conditions of the licence as may be established by the Director.

(1)

Any application for the grant of a veterinary

pharmacy licence shall be made to the Director and shall contain such

information, documents, samples and other material as required by or

under this Act, and shall in particular include the following

(a)

the name and address of the applicant;

(b)

the address of the premises that is to be used for

the purpose of the retail of the veterinary medicinal products;

(c)

the equipment and control facilities as may be

required by or under this Act;

(d)

the name of a managing pharmacist who shall be

professionally responsible for all activities;

(e)

any other information, documentation or evidence

as may be requested by the Director in accordance with or

under this Act.

(2)

The Director shall determine the application in such time-

frame as the Minister may establish by regulations under this Act

Provided that such time-frame may be suspended until the

required information is provided by the applicant.

(1)

The Director shall, before determining an application

for a veterinary pharmacy licence, inspect the premises indicated in the

application and shall not issue a licence until he is satisfied that such

premises is suitable and adequate, and that it includes suitable

facilities, installations and equipment so as to ensure the proper

conservation and dispensing of veterinary medicinal products

Provided that a licence may be made conditional upon the

carrying out of such obligations as may be imposed therein, which

conditions may be revoked or varied by the Director at any time, as he

may deem fit.

(2)

A veterinary pharmacy licence shall specify the premises

and the activities to which it applies

Provided that the Director may, upon application, grant an

additional licence for the use of identified premises as a store for the

purpose of a veterinary pharmacy, after he is satisfied that such

premises complies with any requirements established by or under this

Act.

Where the Director considers that circumstances may exist

which would render necessary the consideration of whether the licence

should be varied, suspended or revoked, the Director may serve on the

holder of a veterinary pharmacy licence a notice requiring him, within

such time as may be specified in the notice, to furnish him with any

information specified in the notice.

(1)

Subject to the provisions of this Act, every licence

granted under this Part shall, unless previously revoked in accordance

with the provisions of article 68, continue to be valid until such time as

may be specified in the licence or in regulations adopted by the

Minister under this Act

Provided that the Director shall, prior to the renewal of the

period of validity of a licence, conduct an inspection of the premises

specified in the licence.

(2)

Following an inspection as referred to in the preceding sub-

article, the Director may either

(a)

renew the licence, with any modifications deemed

necessary, for such a further period as may be specified in the

licence or in regulations adopted by the Minister under this Act;

or

(b)

if, having regard to the provisions of this Act, he

considers it necessary or expedient to do so, refuse to renew the

licence.

No person may transfer a licence unless authorised to do so

by the Director which authorisation shall not be issued unless the

Director is satisfied that the new licensee complies with any

requirements established by or under this Act, and upon payment of

the prescribed fee.

The Director may suspend a veterinary pharmacy licence

granted under this Act prior to the expiry of the period referred to in

article 66, for such period of time as he may determine, or may revoke

or vary the provisions of any such licence in any of the following

circumstances

(a)

where any information indicated in the

application on the basis of which the licence was issued is

subsequently found to be false or incomplete;

(b)

where a material change of circumstances has

occurred in relation to any matter indicated in the application;

(c)

where the conditions of the licence have been

breached by the licensee; or

(d)

in any other circumstance as may be established

by or under this Act

Provided that the Director shall notify the licensee of any

decision issued under this Article, giving detailed reasons for such

decision.

(1)

The licensee of a veterinary pharmacy shall not close

such veterinary pharmacy, temporarily or otherwise, unless he has

given at least twenty-four (24) hours notice to, and such closure has

been authorised by, the Director

Provided that, for the purposes of this article, temporary

closure shall not include the closure of a veterinary pharmacy resulting

from the unforeseen or unexpected absence of the managing

pharmacist, force majeure resulting in the inability to open the

premises, or closure outside the business hours for veterinary

pharmacies as may be established by regulations adopted by the

Minister.

(2)

Subject to the provisions of sub-article (1), the licence in

relation to a veterinary pharmacy which has remained closed for a

period of five (5) consecutive working days without the authorisation

of the Director shall be deemed to have been automatically revoked.

(3)

The Director may, upon receipt of a notice as referred to in

sub-article (1), or where it has come to his knowledge that a veterinary

pharmacy has been closed for a period of ten (10) consecutive working

days, seal all the veterinary medicinal products, wherever kept by the

licensee in terms of the provisions of this Act, and take charge of any

register required to be kept by the licensee pursuant to regulations as

may be adopted by the Minister.

The Minister may, after consultation with the Director,

adopt regulations to make provisions relating to the issuing,

suspension and revocation of veterinary pharmacy licenses, the period

of validity of such licences, the obligations of the holders of a

veterinary pharmacy licence, the obligations of managing pharmacists,

the veterinary medicinal products that may exclusively be retailed

from a veterinary pharmacy, standards for prescribing, dispensing,

storage and disposal of veterinary medicinal products, the fees to be

levied for the issuing of licences and the business hours of veterinary

pharmacies.

(1)

It shall not be lawful for any person to act as a

manufacturer, importer, wholesale distributor or broker of veterinary

medicinal products unless he is in possession of a licence issued in

accordance with the provisions of this Act or any regulations made

thereunder.

(2)

A licensee pursuant to this article shall be responsible for

complying with the conditions of the licence as may be established by

the Director.

(1)

Any application for the grant of a licence to act as

manufacturer, importer, wholesale distributor or broker of veterinary

medicinal products shall be made to the Director and shall contain

such information, documents, samples and other material as provided

by or under this Act, and shall include in particular the following

information

(a)

the name and address of the applicant;

(b)

the address of the premises that is to be used for

the purpose of the manufacture, importation, distribution,

storage or brokering of veterinary medicinal products;

(c)

the equipment and control facilities as may be

required by or under this Act;

(d)

any other information, documentation or evidence

as may be requested by the Director in accordance with or

under this Act.

(2)

The Director shall determine the application within such

time-frame as the Minister may establish by regulations under this

Act

Provided that such time-frame may be suspended until the

required information is provided by the applicant.

(3)

The Director shall, before determining an application for

any licence pursuant to this article, inspect the premises indicated in

the application and shall not issue a licence until he is satisfied that

such premises is suitable and adequate, and that it includes suitable

facilities, installations and equipment so as to ensure the proper

manufacture, control and conservation of veterinary medicinal

products

Provided that a licence may be made conditional upon the

carrying out of such obligations as may be imposed therein, which

conditions may be revoked or varied by the Director at any time, as he

may deem fit.

The Minister may, after consultation with the Director, adopt

regulations to make provision relating to the issuing, suspension and

revocation of manufacture, import, research, wholesale distributor and

broker licences, the period of validity of such licences, the obligations

and responsibilities of the holders of such licences and of their

employees, standards in the manufacture, importation, distribution,

brokering and disposal of veterinary medicinal products, and the fees

that may be levied by the Director for the issuing of such licences.

Without prejudice to any provision of this Act granting the

Minister the power to make regulations, the Minister may, subject to

the provisions of the Exclusive Economic Zone Act, from time to

time, make, amend, substitute or repeal regulations for the purpose of

regulating, prescribing or otherwise providing for any matters

regulated by or under this Act or by or under any subsidiary legislation

made thereunder, in respect of an exclusive economic zone area or an

environment protection area as defined in the Exclusive Economic

Zone Act or any activities therein including, but not limited, to the

applicability or otherwise of this Act and, or of any subsidiary

legislation made thereunder.