ACT No. XIV of 2022 AN ACT to amend the Veterinary Services Act, Cap. 437.

I assent.

(L.S.)

GEORGE VELLA

President

28th October, 2022

ACT No. XIV of 2022

AN ACT to amend the Veterinary Services Act, Cap. 437.

BE IT ENACTED by the President, by and with the advice and

consent of the House of Representatives, in this present Parliament

assembled, and by the authority of the same as follows:-

(1) The short title of this Act is the Veterinary Services Short title and

(Amendment) Act, 2022 and this Act shall be read and construed as commencement.

one with the Veterinary Services Act, hereinafter referred to as "the Cap. 437.

principal Act".

(2) This Act shall come into force within two months from its

publication in the Gazette.

Article 2 of the principal Act shall be amended as follows

Amendment of

article 2 of the

principal Act.

(a) immediately before the definition "animal" there

shall be added the following new definition

" "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;";

(b) immediately after the definition "Council" there shall

be added the following new definition

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

(c) the definition "Director" shall be substituted by the

following new definition

" "Director" means the Director Veterinary Services

who shall be a warranted Veterinary Surgeon or an officer

nominated by him;";

(d) the definition "feeding stuffs" shall be substituted by

the following new definition

" "feedingstuffs" means any substance or product

including additives, whether processed, partially processed

or unprocessed, intended to be used for oral feeding to

animals;";

(e) the definition "immunological veterinary medicinal

product" shall be deleted;

(f) in the definition "importation", immediately after the

words "of live animals," there shall be added the words

"veterinary medicinal products,";

(g) immediately after the definition "lifelong learning"

there shall be added the following new definition

" "Medicines Authority" means the Medicines

Authority established under the Medicines Act;";

(h) immediately after the definition "trading partner"

there shall be added the following new definition

" "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;";

(i)

the definition "veterinary medicinal product" shall be

substituted by the following new definition

" "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;"; and

(j) the definition "withdrawal period"

shall

be

substituted by the following new definition

" "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;".

In paragraph (b) of sub-article (1) of article 3 of the principal Amendment of

Act, immediately after the word "products" there shall be added the article

principal Act.

words ", active substances and veterinary medical devices;".

Article 6 of the principal Act shall be amended as follows

Amendment of

article 6 of the

principal Act.

(a) in paragraph (a) of sub-article (1) thereof, the words

"listed in the Second Schedule" shall be substituted by the words

"referred to in the list of notifiable terrestrial and aquatic animal

diseases issued by the World Organization for Animal Health";

and

(b) in sub-article (2) thereof, the words "listed in the

Second Schedule" shall be substituted by the words "referred to

in the list of notifiable terrestrial and aquatic animal diseases

issued by the World Organization for Animal Health".

In sub-article (4) of article 15 of the principal Act, the words Amendment of

"Second Schedule" shall be substituted by the words "list of notifiable article

principal Act.

terrestrial and aquatic animal diseases issued by the World

Organization for Animal Health".

In paragraph (a) of sub-article (3) of article 16 of the principal

Act, the words "listed in the Second Schedule" shall be substituted by

the words "referred to in the list of notifiable terrestrial and aquatic

animal diseases issued by the World Organization for Animal Health".

In article 24 of the principal Act, the words "Head of the

National Veterinary Laboratory" shall be substituted by the word

"Director".

Article 29 of the principal Act shall be substituted by the

following new article

"29. Within the scope of this Act, the requirements in

connection with the inspection, supervision,

authorisation, m anufacture, research, wholesale

d i s t r i b u t i o n , b r o k e r i n g , m a r k e t i n g , pr e s c r i b i n g ,

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.".

Article 30 of the principal Act shall be substituted by the

following new article

" Power of the

The Minister may, after consulting the Director,

prescribe regulations establishing requirements relating

to the manufacture, importation, introduction, research,

regulations on

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.".

10. Article 32 of the principal Act shall be substituted by the

following new article

" Power of the

The Minister may, after consulting the Director,

prescribe regulations regarding the authorisation for, and

the inspections and supervision of, the manufacture,

regulations on

importation, wholesale distribution, research, brokering,

supervision of

marketing, prescribing, dispensing, supply, retail,

advertising, provision of data on sales and use of

veterinary medicinal products, active substances and

veterinary medical devices.".

11. Sub-article (1) of article 35 of the principal Act shall be

amended as follows

(a) immediately after the words "retailer or" there shall

be added the words ", where applicable" and immediately after

the words "under the provisions of this Act to" there shall be

added the words "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" and the words "or veterinary medicinal

products" shall be substituted by the words "veterinary medicinal

products, active substances or veterinary medical devices";

(b)

paragraph (b) thereof shall be amended as follows

(i) immediately after the word "shall" there shall

be added the words "allow entry into their premises at any

reasonable time and" and the words "officers of the

veterinary services, the official veterinarian or his

authorised staff" shall be substituted by the words

"Director or any other officer nominated by him";

(ii) in sub-paragraph (i) thereof, immediately after

the words "stuffs" there shall be added the words ", active

substances, veterinary medical devices";

(iii) sub-paragraph (iii) thereof shall be substituted

by the following new sub-paragraph

"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) in sub-paragraph (iv) thereof, immediately

after the word "stuffs" there shall be added the words ",

active substances, veterinary medical devices"; and

(v) in sub-paragraph (v) thereof, immediately after

the word "stuffs" there shall be added the words ", active

substances, veterinary medical devices";

(c)

paragraph (c) thereof shall be amended as follows

(i)

in sub-paragraph (i) thereof, the words "listed

in the Second Schedule" shall be substituted by the words

"referred to in the list of notifiable terrestrial and aquatic

animal diseases issued by the World Organization for

Animal Health";

(ii) in sub-paragraph (ii) thereof, the words "listed

in the Second Schedule" shall be substituted by the words

"referred to in the list of notifiable terrestrial and aquatic

animal diseases issued by the World Organization for

Animal Health" and immediately after the word "stuffs"

there shall be added the words ", active substances,

veterinary medical devices, veterinary medicinal

products"; and

(iii) in sub-paragraph (viii) thereof, immediately

after the word "stuffs" there shall be added the words ",

active substances, veterinary medical devices, veterinary

medicinal products";

(d) in the Maltese version, in paragraph (j) thereof, the

word "distakk" shall be substituted by the word "rtirar";

(e) in paragraph (l) thereof, the words "be prescribed

thereunder; and" shall be substituted by the words "be prescribed

thereunder;"; and

(f) in paragraph (m) thereof, the words "for the control

thereof." shall be substituted by the words "for the control

thereof; and" and immediately thereafter there shall be added the

following new paragraph

"(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.".

12. Sub-article (1) of article 36 of the principal Act shall be

amended as follows

(a) immediately after the words "retailer or" there shall

be added the words ", where applicable," and immediately after

the words "under the provisions of this Act to" there shall be

added the words "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" and the words "or veterinary medicinal

products" shall be substituted by the words "veterinary medicinal

products or active substances";

(b) in the Maltese version, in paragraph (c) thereof, the

word "distakk" shall be substituted by the word "rtirar";

(c) in the Maltese version, in paragraph (d) thereof, the

word "distakk" shall be substituted by the word "rtirar";

(d) in paragraph (h) thereof, the words "may be

prescribed; and" shall be substituted by the words "may be

prescribed;"; and

(e) in paragraph (i) thereof, the words "for the control

thereof." shall be substituted by the words "for the control

thereof; and" and immediately thereafter there shall be added the

following new paragraphs

"(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.".

13. Sub-article (1) of article 37 of the principal Act shall be Amendment of

article 37 of the

amended as follows

principal Act.

(a) in paragraph (a) thereof, the words "Second

Schedule" shall be substituted by the words "list of notifiable

terrestrial and aquatic animal diseases issued by the World

Organization for Animal Health";

(b) in paragraph (c) thereof, the words "Second

Schedule" shall be substituted by the words "list of notifiable

terrestrial and aquatic animal diseases issued by World

Organization for Animal Health";

(c) in paragraph (r) thereof, the words "prescribed

thereunder; and" shall be substituted by the words "prescribed

thereunder;"; and

(d) in paragraph (s) thereof, the words "border inspection

posts." shall be substituted by the words "border inspection

posts; and" and immediately thereafter there shall be added the

following new paragraph

"(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.".

14. Sub-article (1) of article 38 of the principal Act shall be

amended as follows

(a) immediately after the words "under the provisions of

this Act to" there shall be added the words "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" and the words "or

veterinary medicinal products" shall be substituted by the words

"veterinary medicinal products, active substances or veterinary

medical devices";

(b) in paragraph (b) thereof, immediately after the words

"veterinary medicinal products" there shall be added the words ",

active substances or veterinary medical devices";

(c) in paragraph (c) thereof, immediately after the word

"suspension" there shall be added the word ", revocation";

(d) in paragraph (d) thereof, the word "ordering" shall be

substituted by the words "comply with any order relating to" and

immediately after the words "veterinary medicinal products"

there shall be added the words ", active substances or veterinary

medical devices" and immediately after the words "threat to

animal or public health" there shall be added the words "or to the

environment;";

(e) in paragraph (e) thereof, the words "as may be

prescribed thereunder; and" shall be substituted by the words "as

may be prescribed thereunder;";

(f) in paragraph (f) thereof, immediately after the word

"assist" there shall be added the words "allow entry into their

premises at any reasonable time," and immediately after

paragraph (f) there shall be added the following new paragraphs

"(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.".

15. Article 49 of the principal Act shall be renumbered as article Amendment of

article 49 of the

49(1) and it shall be amended as follows

principal Act.

(a) in paragraph (e) thereof, the words "his

responsibility; and" shall be substituted by the words "his

responsibility;"; and

(b) in paragraph (f) thereof, the words "of veterinary

activities." shall be substituted by the words "of veterinary

activities;" and immediately thereafter there shall be added the

following new paragraphs

"(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; and

(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

(c) immediately after paragraph (m) thereof there shall

be added the following new sub-articles

"(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.".

16. Paragraphs (a) and (b) of sub-article (2) of article 50 of the Amendment of

principal Act shall be substituted by the following new paragraphs

"(a) to prepare reports on veterinary medicinal products

at the request of the Director; and

(b) to support the veterinary services in the control of

food and feed safety in the primary production of food of animal

origin, feed, animal by-products, and in the control of animal

diseases including zoonosis.".

17. Article 51 of the principal Act shall be substituted by the Substitution of

following new article

"51. The National Veterinary Laboratory shall

(a) provide laboratory analyses and tests

and participate in the diagnosis and control of

animal diseases;

(b) support the Veterinary Services, upon

request;

(c) conduct testing activities in the context

of programmes relating to animal disease

surveillance, food health surveillance, zoonotic

disease surveillance, veterinary drug residue

surveillance, and antimicrobial resistance; and

(d) fulfil the role of National Reference

Laboratory.".

18. Article 53 of the principal Act shall be deleted.

19. Article 54 of the principal Act shall be amended as follows

(a) immediately after the word "Act", wherever it

occurs, there shall be added the words "or any regulations made

thereunder";

(b) paragraph (a) thereof shall be substituted by the

following new paragraph

"(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;"; and

(c) in paragraph (c) thereof, immediately after the words

"official veterinarians" there shall be added the words "and, or

officers".

20. Article 56 of the principal Act shall be amended as follows

(a) in paragraph (a) thereof, immediately after the words

"official veterinarian" there shall be added the words "and, or

officer";

(b) in sub-paragraph (i) of paragraph (c) thereof,

immediately after the words "official veterinarian" there shall be

added the words "and, or officer"; and

(c) in paragraphs (a), (b), (c), (d) and (f) thereof,

immediately after the word "Act" there shall be added the words

"or any regulations made thereunder".

21. Article 57 of the principal Act shall be amended as follows

Amendment of

article 57 of the

principal Act.

(a) in sub-article (1) thereof, immediately after the word

"Act" there shall be added the words "or any regulations made

thereunder"; and

(b) in sub-article (2) thereof, immediately after the word

"Act" there shall be added the words "or any regulations made

thereunder" and immediately after the word "instruments," there

shall be added the words "animals, products of animal origin,

active substances, veterinary medical devices, veterinary

medicinal products, feedingstuffs," and the words "forfeited to"

shall be substituted by the words "confiscated by" and the word

"forfeited" shall be substituted by the word "confiscated".

22. In both sub-articles (1) and (2) of article 58 of the principal Amendment of

Act, immediately after the word "Act" there shall be added the words article

principal Act.

"or any regulations made thereunder".

23. Article 60 of the principal Act shall be amended as follows

Amendment of

article 60 of the

principal Act.

(a) in sub-articles (1) and (2) thereof, immediately after

the word "Act", wherever it occurs, there shall be added the

words "or any regulations made thereunder"; and

(b) in sub-articles (1) and (2) thereof, immediately after

the word "licence" wherever it occurs, there shall be added the

word "authorisation".

24. Article 61 of the principal Act shall be amended as follows

Amendment of

article 61 of the

principal Act.

(a) in paragraph (a) of sub-article (1) thereof,

immediately after the word "Act" there shall be added the words

"or any regulations made thereunder";

(b)

sub-article (2) thereof shall be amended as follows

(i) in paragraph (c) thereof, the words "imposition

of a penalty; and" shall be substituted by the words

"imposition of a penalty;";

(ii) in paragraph (d) thereof, the words "of such

conviction," shall be substituted by the words "of such

conviction; and" and immediately thereafter there shall be

added the following new paragraph

"(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,";

(c) in paragraph (b) of sub-article (3) thereof,

immediately after the word "Act", wherever it occurs, there shall

be added the words "or any regulations made thereunder";

(d) paragraphs (a), (b) and (c) of sub-article (4) thereof

shall be substituted by the following new paragraphs

"(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.";

(e) sub-article (5) thereof shall be substituted by the

following new sub-article

"(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."; and

(f) sub-articles (7) and (8) thereof shall be substituted by

the following new sub-articles

"(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.".

25. Immediately after article 61 of the principal Act there shall be Addition of new

added the following new Part

"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

Suspension or

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

relating to the the issuing, suspension and revocation of veterinary

licensing and 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

manufacturing,

as a manufacturer, importer, wholesale distributor or

distribution of 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

manufacturing, 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

relating to the the issuing, suspension and revocation of manufacture,

licensing and import, research, wholesale distributor and broker

manufacturers, licences, the period of validity of such licences, the

distributors of 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.".

26. The Second Schedule to the principal Act shall be deleted.

27. The Sixth Schedule to the principal Act shall be deleted.

Passed by the House of Representatives at Sitting No. 37 of the 25th

October, 2022.

ANĠLU FARRUGIA

Speaker

RAYMOND SCICLUNA

Clerk of the House of Representatives

€1.98