Veterinary Medicinal Products (Amendment) Regulations, 2021

L.N. 179 of 2021

VETERINARY SERVICES ACT

(CAP. 437)

Veterinary Medicinal Products (Amendment) Regulations, 2021

IN EXERCISE of the powers conferred by articles 30, 38 and 53

of the Veterinary Services Act, the Minister for Agriculture, Fisheries,

Food and Animal Rights after consultation with the Head of the

National Veterinary Laboratory, has made the following regulations:-

(1) The title of these regulations is Veterinary Medicinal Citation and

Products (Amendment) Regulations, 2021 and these regulations shall scope.

be read and construed as one with the Veterinary Medicinal Products S.L. 437. 47.

Regulations, hereinafter referred to as "the principal regulations".

(2) The scope of these regulations is to add a number of

essential provisions in the "principal regulations" in order to provide a

more adequate and modern legal framework for the regulation and

control of veterinary medicinal products.

Regulation 2 of the principal regulations shall be amended Amends

regulation 2 of

as follows

the principal

regulations.

(a) immediately before the definition "animal" there shall

be added the following new definitions

" "active substance" means any substance or

mixture of substances intended to be used in the

manufacture of a veterinary medicinal product and

that product, when used in its production, becomes an

active ingredient of that product;

"advertising of veterinary medicinal products" means

the making of a representation in any form in connection

with veterinary medicinal products in order to promote the

supply, distribution, sale, prescription or use of veterinary

medicinal products and comprising also the supply of

samples and sponsorships;

"Agency" means the European Medicines Agency

established by Regulation (EC) No 726/2004;";

(b) the definition "the Commission" shall be substituted

by the following new definition

" "Commission" means the Commission in

accordance with Council Decision 1999/468/EC of

28th June, 1999;";

(c)

immediately after the definition "Commission" there

shall be added the following new definition

" "Director for Veterinary Services"

means the Director for Veterinary Services as

defined in the Veterinary Services Act, and

includes, to the extent of the authority given,

to any officer authorised by him, in writing, to

act on his behalf for any of the purposes

mentioned in the Veterinary Services Act.

Whenever in the text the words "Veterinary

Services" are used these should be construed

as referring to the "Director for Veterinary

Services";"; and immediately thereafter there

shall be added the following new definitions

" "dispensing" means the sale or supply of veterinary

medicinal products. The products are sold or supplied from

a veterinary pharmacy or by a veterinary surgeon in

licensed veterinary establishments or during out calls;

"European Union" means the European Union as

referred to in the Treaty;";

(d) immediately after the definition "feeding stuffs" there

shall be added the following new definition

" "food" shall have the same meaning as

assigned to it in the Food Safety Act;";

(e) immediately after the definition "importation" there

shall be added the following new definitions

" "imported veterinary medicinal products"

means veterinary medicinal products obtained from a

source outside the EU;

"licensed veterinary establishment" has

the same meaning as assigned to it in the

S.L. 437. 106.

Private Veterinary Establishments (Licensing)

Regulations;";

(f)

immediately after the definition "lifelong learning"

there shall be added the following new definitions

" "Medicinal products" shall have the

same meaning as is assigned to in the

Medicines Act;

"Member State" means a State which is a member of

the European Union;

"Metaphylactic" means the administration of a

veterinary medicinal product or a medicinal product to a

group of animals after a diagnosis of clinical disease in part

of the group has been established, with the aim of treating

the clinically sick and controlling the spread of the disease

to animals in close contact and at risk and which may

already be sub clinically infected;";

(g) immediately after the definition "Minister" there shall

be added the following new definition

" "Narcotic drugs" means the substances present on

the Yellow List prepared by the International Narcotics

Control Board in accordance with the Single Convention on

Narcotic Drugs, 1961, Protocol of 25 March 1972

amending the Single Convention on Narcotic Drugs,

1961;";

(h) the definition "pharmacist" shall be substituted by the

following new definition

" "Pharmacist" means a person who is

enlisted in the Register of Pharmacists kept by

the Pharmacy Council in terms of article 17 of

the Health Care Professions Act;";

(i) immediately after the definition "placing on the

market" there shall be added the following new definitions

" "placing under official control" means the detaining

of any article by the Director for Veterinary Services in

order to permit the accomplishment of any of its functions;

"prescribing" means the act of preparing a veterinary

prescription by a veterinary surgeon being it on paper or

electronic media;

"preventive use of an antimicrobial agents" means the

administration of antimicrobial agents to healthy animals to

prevent infections to compensate for inadequate good

farming practice;";

(j) immediately after the definition "private veterinary

activity" there shall be added the following new definitions

" "procurement" means the act of acquiring, for profit

or not, a veterinary medicinal product, or part thereof, from

a Member State of the European Union;

"prophylactic administration of antimicrobials"

means the administration of a veterinary medicinal product

or a medicinal product to an animal or group of animal

before clinical signs of a disease, in order to prevent the

occurrence of disease or infection

"psychotropic drugs" means the

substances listed in the Third schedule to the

Medical and Kindred Professions Ordinance

and those substances listed on the Green List

prepared by International Narcotics Control

Board in accordance with the Convention on

Psychotropic Substances of 1971;

"source country" means a Member State of the EU or

a country in the European Economical Area from where the

veterinary medicinal products referred to in regulation 7

can be procured;";

(k) immediately after the definition "State veterinary

activities" there shall be added the following new definition

" "Suitably Qualified Persons" means that person who

has a qualification in a veterinary science and included in

one of the para-veterinary professions mentioned in the

Act;";

(l) immediately after the definition "trading

partner" there shall be added the following new definitions

" "Treaty" shall have the same meaning

as is assigned to it in the European Union Act;

"veterinary pharmacy" means the premises from

where veterinary medicinal products are, dispensed directly

to the public except for licensed veterinary establishments;

"veterinary prescription" means a document issued by

a veterinary surgeon for a veterinary medicinal product or a

medicinal product for human use for its use in animals;";

(m) immediately after the definition "veterinary services"

there shall be added the following new definition

" "veterinary surgeon" means a person as

described and regulated by article 43 of the

Act and whose name is entered in the Register

of Veterinary Surgeons’ Register, or that

person, coming from any other Member State

of the European Union, whose name is entered

in the relevant register kept by the relevant

body of that Member State which regulates the

profession of Veterinary surgeons. In the latter

case the provisions of the Mutual Recognition

of Qualifications Act and the Services

(Internal Market) Act shall apply;"; and

(n) immediately after the definition veterinary medicinal

product" there shall be added the following new definition

" "veterinary wholesale dealer" means that person

authorised to carry out wholesale distribution of veterinary

medicinal products;".

Paragraph (e) of sub-regulation (1) of regulation 3 of the Amends

regulation 3 of

principal regulations shall be deleted.

the principal

regulations.

Immediately after sub-regulation (2) of regulation 4 of the Amends

principal regulations, there shall be added the following new sub- regulation

the principal

regulations

regulations.

"(3) In order to be granted the exemption for the

veterinary medicinal product referred to in this sub-

regulation applicants shall submit an application with the

Veterinary Services.

(4) In order to qualify under the exemption

described in this sub-regulation (2) the product must be

manufactured by

(a) the holder of a manufacturing

authorisation if manufactured in Malta or in another

Member State of the European Union;

(b) the holder of a relevant licence

conferring authorisation to manufacture veterinary

medicinal products if the product is manufactured

in a Third country.

(5) The product must not be classified as

requiring a veterinary prescription.

(6) The manufacturer, importer, wholesale dealer

or retailer of a veterinary medicinal product shall declare

that he will notify the Veterinary Services within fifteen

(15) days of learning of any serious adverse reactions in

accordance with sub-regulations (2) and (3) of regulation

68. A record of each adverse reaction and serious adverse

reaction must be maintained on becoming aware of it.

The records shall be kept for five (5) years.

(7) The Veterinary Services shall prepare and

publish a list of active substances that can be used in

veterinary medicinal products authorised under sub-

regulation (2), specifying the species of non-food

producing animals for which it is approved and may

specify how the active substance or a product containing

the active substances to be administered.

(8) The Veterinary Services may decide not to

apply the provisions of this Regulation to a previously

exempted product if any one or more of the following

occur

(a) serious adverse reactions are reported;

(b) it is demonstrated, at any time after

authorisation, that the substance is carcinogenic,

genotoxic or that it shows developmental toxicity

(including teratogenicity);

(c) the product contain active substances

that are re-classified as narcotic or psychotropic

substances;

(d) any one of the ingredient/s in the

product is/are not included anymore in the list

mentioned in paragraph (d) of sub-regulation (3);

(e) it is reported and is verified by the

Veterinary Services that the product is not being

used on the animals mentioned in sub-regulation

(2);

(9) The product authorised under sub-regulation

(2) shall be clearly labelled as being exempt from the

requirements of regulations 5, 6, 7 and 8 in relation to a

Marketing Authorisation. The information obtainable

from the whole pack must at least show the following

details

(a) the name of the veterinary medicinal

product;

(b) the pharmaceutical dosage form;

(c) the name and strength of each active

substance;

(d) the route of administration;

(e) the batch number;

(f) the expiry date;

(g) a sentence to the effect of "For

administration on non-food producing animals

only" authorised in accordance to regulation 4(2) of

these regulations;

(h) the target species;

(i) storage instructions;

(j) the shelf-life after the immediate

packaging has been opened for the first time;

(k) therapeutic indications;

(l) contra-indications;

(m) interaction with other medicines and

other forms of interaction;

(n) dosage instructions.

(10) If there is sufficient room on the label, the

information may be present only on it without the need of

a package leaflet. The information must be conveyed in a

clear and legible manner.

(11) The provisions of sub-regulation 5 shall come

into force on the 1st November 2021.".

Immediately after regulation 4 of the principal regulations, Adds new

there shall be added the following new regulations

"4A. (1)A veterinary medicinal product may be

obtained from any country and administered to animals

for research purposes in accordance with article 53(3) of

the Veterinary Services Act.

(2) The veterinary medicinal products authorised

according this regulation may be exempt from the

provisions of regulations 5, 6, 7 and 8.

(3) The veterinary medicinal products shall only

be used in authorised research facilities which are in

conformity with the Animal Welfare Act and the

Protection of Animals for Scientific Purposes

Regulations.

(4) (a) In order to be allowed to carry out the

activity mentioned in sub-regulation (1) a person, herein

referred to as the "applicant for a veterinary medicinal

product to be used for research purposes", shall submit an

application with the Veterinary Services.

(b) If the application is positively completed a

licence for Research Purposes shall be issued. The

Veterinary Services shall make, modify, add or remove

any terms and conditions pertaining to the licence that it

may deem fit in light of scientific advancements or new

information that may emerge on particular substances or

ingredients contained in the veterinary medicinal

products used for research purposes.

(c) The holder of the licence for a veterinary

medicinal product to be used for research purposes shall

utilise a product or administer it to a test animal only

under the terms and conditions set out under the Animal

Welfare Act.

(d) The holder of the licence for a veterinary

medicinal product to be used for research purposes who

becomes aware of any serious adverse reactions on the

animal or on the person administering it shall report the

reaction to the Veterinary Services within fifteen (15)

days from the day the serious adverse reaction was

discovered.

(e) Food for human consumption can be taken

from test animals only in accordance with regulation 86

and with the prior approval of the Veterinary Services.

(f) The application submitted by the applicant

shall be granted without prejudice to any licence or

permit that the applicant may need to obtain from other

departments and directorates in order to engage in the

indicated research activity.

(g) The applicant for a veterinary medicinal

product or holder of the licence is subject to official

inspections by the Veterinary Services on the premises

and the activities undertaken within the premises.

(h) The Veterinary Services shall set out the

criteria for veterinary medicinal product which are

obtained in accordance with sub-regulation (1) and make

them public.

4B. (1) Veterinary medicinal products may be

exempted from the provisions in regulations 5 to 8 if it

can be demonstrated that the products are veterinary

samples or demonstration packs distributed to veterinary

surgeons or pharmacists by veterinary wholesale

distributors.

(2) The products referred to in sub-regulation (1)

may be used under the following conditions

(a) they are distributed for free to persons

authorised to receive them or are exhibited during

conferences or similar activities which are held for

intended

for

veterinary

surgeons

and/or

pharmacists;

(b) they bear a label printed "Free sample/

Demonstration pack – Not for sale";

(c) the unit pack should not contain more

than

(i) 50 units for capsules/tablets;

(ii) 10 units for injections and spot-

ons

(iii) 300g for powders

(iv) 3L for liquids

(v) 5 units for intra-mammary tubes

(vi) any other measurement as

established by the Veterinary Services for all

other Pharmaceutical forms

(d) the information provided with the

samples shall not be promotional in nature;

(e) the maximum period of time the

authorised veterinary wholesale dealer can procure

a product from a Member State of the European

Union as a free sample is one (1) year from the first

consignment thereof;

(f) if any product authorised in accordance

with the provisions of sub-regulation (1) is

administered to a food producing animals, that

animal is excluded permanently from the food

chain.

4C. Any authorisation issued under regulations

4(2), 4A and 4B, shall be deemed to be a Marketing

Authorisation for the purposes of articles 38, 53 and 57

of the Veterinary Services Act.

4D. (1) Veterinary medicinal products may be

exempted from the provisions in regulations 5 to 8 when

other countries the products are procured from a Member State of the

European Union or imported from a Third country under

the terms and conditions mentioned in sub-regulation (2).

(2) The following terms and conditions shall

apply

(a) the products shall not be re-sold for

monetary gain;

(b) the products shall not be transferred to

other third parties unless such transfer is authorised

by the Veterinary Services;

(c) this provision is not applicable to

psychotropic drugs, narcotic drugs for all animals

and in the case of food producing animals also the

substances listed in Group A in Schedule I of

Measures to monitor certain Substances and

Residues thereof in Live Animals and Animal

Products Rules and Table II of Regulation (EU) 37/

2010;

(d) the quantity of products obtained shall

be proportional to the dosage regime of the

condition it will be used for;

(e) the quantity of products which is

allowed entry in Maltese territory shall cover the

period indicated as the duration of treatment in the

product’s specifications or on the veterinary

surgeons ‘s veterinary prescription. However,

products intended to be used for recurrent or

chronic conditions can be allowed entry in Malta

several times a year, provided that cogent evidence

that demonstrate the benefits obtained by the

regular use of the products can be provided;

(f) the individuals shall be required to

provide a veterinary prescription for products

classified as requiring such a prescription in the

country from where they are obtained or for similar

veterinary medicinal products in Malta

Provided that the Veterinary Services

may still ask for such a veterinary prescription even

if the products are classified as not requiring a

veterinary prescription in the country from where

they are obtained;

(g) only products that do not contain animal

by-products which are derived from high risk areas

where certain diseases may be, or suspected to be,

present or prevalent, can be obtained;

(h) only products that do not contain

ingredients that are classified as illegal in Malta

and do not have banned indications in Malta can be

obtained;

(i) only appropriately labelled products

which give clear indication of the nature of the

ingredient/s within can be obtained;

(j) food producing animals administered

with the veterinary medicinal products authorised

in accordance with this regulation can only be

consumed by the person getting the veterinary

medicinal products, or by consenting members of

the same household. The appropriate withdrawal

period shall apply;

(k) before a decision on antimicrobial

veterinary medicinal products and products that

have a hormonal activity is taken, a risk assessment

shall be prepared by the Veterinary Services in a

timely manner;

(l) the decision by the Veterinary Service is

without prejudice to any license or permit that the

person getting the veterinary medicinal products

may need to obtain under other regulations of the

same or of different department.

(3) The veterinary services shall decide on the

release, placing under official control or destruction of

veterinary medicinal products, or the products presumed

to be veterinary medicinal products, if and when these are

intercepted at the various entry control points throughout

the territory of Malta.

(4) Pursuant to sub-regulation (3), the Veterinary

Services shall keep a record of all the opinions or

decisions taken. These records shall be kept by the

Veterinary Services for a period of not less than ten (10)

years.

(5) The Veterinary Services shall set out the

criteria for veterinary medicinal product which can be

obtained in accordance with sub-regulation (1) and make

them public

Provided that the provisions of this

regulations shall also apply to veterinary medicinal

products that are brought in the territory of Malta as a

bona fide donation for use on animals kept in the

approved sanctuary subject to the donation on condition

that the veterinary services is pre-notified of such a

request with the name, quantity and nature of the

products, and the names and addresses of the donator, the

recipient and the animal sanctuary involved.".

In regulation 7 of the principal regulations, immediately

after the words "Member State", there shall be added the words

"referred to as the "source country".

Immediately after regulation 7 of the principal regulations

there shall be added the following new regulation

(1) In order to be allowed to market the

Registration of

products under regulation 7, a person, herein referred to

as the "applicant for the registration of veterinary

medicinal product" under regulation 7, shall submit an

application to the Veterinary Services.

(2) Upon a reasoned request the Veterinary

Services may decide that regulations 60(10) and 60(11)

on the legal category of Veterinary medicinal products

and regulation 51(4) do not apply to registrations granted

under regulation 7.

(3) Before granting such a registration the

Veterinary Services may

(a) request the competent authority in the

source country to furnish a copy of the Marketing

Authorisation in force;

(b) ensure that the entity applying for a

registration in accordance with regulation 7 is a

legally established company in the European Union

or European Economic Area;

(c) notify the Marketing Authorisation

Holder of its intention to grant a registration

according to regulation 7 when the Registration

Holder is not the same entity as the Marketing

Authorisation Holder in the country of source;

(d) request the applicant for a registration in

accordance with regulation 7 to furnish an

authenticated copy of the Marketing Authorisation

in force

Provided that it is not possible for the

applicant to provide an authenticated copy of the

Marketing Authorisation he shall be requested to

provide other proof of an existing Marketing

Authorisation in the country of source.

(e) request from the applicant data on the

impact of the product on the environment in Malta.

(4) The holder of the registration granted in

accordance with regulation 7 shall ensure that

(a) the veterinary medicinal product is in

accordance

with

the

current

Marketing

Authorisation issued in the source country;

(b) notify the veterinary services of any

variations to the terms of the Marketing

Authorisation approved in the country of source;

(c) there are implemented without any delay

actions relating to issues concerning the veterinary

medicinal product which have resulted in adverse

drug reaction and/or a product or batch recall;

(d)

a person is appointed or be himself

responsible for the requirements in paragraph (c);

(e) when the applicant is not the Market

Authorisation Holder of the product in the source

country he shall furnish to the Veterinary Services a

letter of access issued by the Market Authorisation

Holder granting him the use of the Marketing

Authorisation for the purpose of regulation 7

Provided that it is not possible for the

applicant to receive a ‘letter of access’ from the

Market Authorisation Holder in the country of

source the applicant shall be requested to provide

proof of the agreement between himself and a duly

authorised veterinary wholesale distributor in the

country of source;

(f) have a system in place for recording and

investigation adverse drug reactions and batch or

product defects.".

Regulation 10 of the principal regulations shall be amended

as follows

(a) in paragraph (c) of sub-regulation (1) thereof, the

words "a person authorized to do so under national legislation"

shall be substituted by the words "a pharmacist or a veterinary

surgeon"; and

(b) immediately after sub-regulation (2) thereof there

shall be added the following new sub-regulations

"(3) In the case of a veterinary medicinal product

authorised in another member State, veterinary surgeons

shall obtain an authorisation from the Veterinary Services

before getting the product for the administration to the

animal.

(4) In case the veterinary medicinal products

contain restricted substances resulting from the

implementation of the relevant United Nations conventions

on narcotic and psychotropic substances, consideration

should be given to any special requirement that need to be

satisfied before the products could be used.

(5) A veterinary medicinal product or a medicinal

product supplied for administration under paragraphs (a),

(b) and (c) of sub-regulation (1) may only be supplied in

accordance with a veterinary prescription from a veterinary

surgeon, irrespective of the legal category assigned to the

veterinary medicinal product during the Marketing

Authorisation procedure.

(6) The veterinary prescription issued under the

condition referred to in sub-regulation (5) shall be marked

as such. A statement similar to, or stating the equivalent

meaning of, the following statement: "This Product has

been prescribed in accordance with the Cascade Principle",

shall be included on the veterinary prescription.

(7) Unless the veterinary surgeon who prescribed

the veterinary medicinal product or medicinal product both

supplies the product and administers it to the animal in

person, the person supplying it must label it (or ensure that

it is labelled) with at least the following information

(a) the name of the veterinary surgeon who

has prescribed the product;

(b) the identification (including the species)

of the animal or group of animals;

(c)

dosage and administration instructions.

(8) When a veterinary surgeon has recourse to the

provisions of regulation 10, the veterinary surgeon shall

keep adequate records of the treatment given. The records

shall at least contain the particulars mentioned in sub-

regulation (7) and shall be available for inspection by the

Veterinary Services for a period of not less than three (3)

years.

(9) When a veterinary surgeon has recourse to the

provisions in paragraphs (a), (b) and (c) of sub-regulation

(1), the activity undertaken by the veterinary surgeon is

excluded from the scope of the definition of wholesale

distribution under a decision to be laid down by the

Veterinary Services.".

Immediately after regulation 10 of the principal regulations Adds new

regulation to the

principal

regulations.

there shall be added the following new regulation

"10A.(1)(By way of derogation from regulation

Importation of

10(1), where there is no suitable veterinary medicinal

product available either as an authorised product in Malta

or under the provisions of regulation 10(1), veterinary

surgeons may, under their direct and only personal

responsibility, build up a case and expound it to the

Veterinary Services. Veterinary surgeon shall provide

detailed justifications to their request. The Veterinary

Services may where the disease or condition is such that

the veterinary medicinal product is likely to be needed as

a matter of urgency for the treatment of an animal, allow

the importation of a veterinary medicinal product

authorised for any non-food producing species from any

third country under any conditions it may deem fit. The

Veterinary Services shall base its decision on purely

scientific grounds and shall take all precautions, in

particular for the safety and environmental risks which

may be associated with the use of the veterinary

medicinal product, before granting the approval for the

importation, which importation shall be considered as a

once only grant with the possibility for repeated requests,

with each request considered as sui generis.

(2) The provisions in regulations 10 (3), (4), (5),

(7), and (8) shall apply.".

Regulation 11 of the principal regulations shall be amended

as follows

(a) in paragraph (c) of sub-regulation (1) of regulation

11, the words "a person authorized to do so under national

legislation" shall be substituted by the words "a pharmacist or a

veterinary surgeon"; and

(b) immediately after sub-regulation (5) thereof, there

shall be added the following new sub-regulations

"(6) In the case of a veterinary medicinal product

authorised in another member State, the veterinary

surgeons shall obtain an authorisation from the Veterinary

Services before procuring the product for the

administration to the food producing animal.

(7) In case the veterinary medicinal products

contain restricted substances resulting from the

implementation of the relevant United Nations conventions

on narcotic and psychotropic substances, consideration

shall be given to any special requirement that need to be

satisfied before the products could be used.

(8) A veterinary medicinal product or a medicinal

product supplied for administration under paragraphs (a),

(b) and (c) of sub-regulation (1), may only be supplied in

accordance with a prescription from a veterinary surgeon,

irrespective of the legal category assigned to the veterinary

medicinal product in accordance with regulation 60.

(9) The prescription issued under the condition

referred to in sub-regulation (8) shall be marked as such. A

statement similar to, or stating the equivalent meaning of,

the following statement: "This Product has been prescribed

in accordance with Cascade Principle", shall be included on

the veterinary prescription.

(10) Unless the veterinary surgeon who prescribed

the veterinary medicinal product or the medicinal product

both supplies the product and administers it to the animal in

person, the person supplying it must label it (or ensure that

it is labelled) with at least the following information

(a) the name of the veterinary surgeon who

has prescribed the product;

(b)

the name and address of the animal

owner;

(c) the identification (including the species)

of the animal or group of animals;

(d)

the date of supply;

(e)

dosage and administration instructions;

(f)

the withdrawal period, if relevant.

(11) When a veterinary surgeon has recourse to the

provisions in sub-regulation (1) the activity undertaken by

the veterinary surgeon is excluded from the scope of the

definition of wholesale distribution.".

(1) Permezz ta’ deroga mir-regolament

10(1), fejn m’hemmx prodott mediċinali veterinarju

addattat aċċessibbli kemm bħala prodott awtorizzat

f’Malta jew skont id-dispożizzjonijiet tar-regolament

għall-annimali 10(1), il-kirurgi veterinarji jistgħu, fir-responsabbiltà

diretta u personali tagħhom, jibnu każ u jsostnuh

quddiem is-Servizzi Veterinarji. Il-kirurgu veterinarju

għandu jipprovdi ġustifikazzjonijiet dettaljati għat-talba

tiegħu. Is-Servizzi Veterinarji jista’, fejn il-marda jew il-

kundizzjoni tkun tali li jkun meħtieġ b’urġenza l-prodott

mediċinali veterinarju għat-trattament tal-annimal,

jippermetti l-importazzjoni tal-prodott mediċinali

veterinarju awtorizzat għal kwalunkwe speċi li ma

tipproduċix ikel minn kwalunkwe pajjiż terz skont il-

kundizzjonijiet li jħoss li huma xierqa. Is-Servizzi

Veterinajri għandu jibbaża d-deċiżjonijiet tiegħu

purament fuq bażi xjentifika u għandu jieħu l-

prekawzjonijiet kollha, b’mod partikolari għas-sigurtà u

r-riskji ambjentali li jistgħu jkunu assoċjati mal-użu tal-

prodott mediċinali veterinarju, qabel jiggarantixxi l-

approvazzjoni għall-importazzjoni, liema importazzjoni

għandha tiġi kkonsidrata bħala permess ta’ darba bil-

possibilità għal talbiet repetuti, b’kull talba meqjusa

bħala sui generis.

(2) Id-dispożizzjonijiet tas-subregolamenti (3),

(4), (5), (7), u (8) tar-regolament 10 għandhom

japplikaw.".

10. Ir-regolament 11 tar-regolamenti prinċipali għandu jiġi

emendat kif ġej

(a) fil-paragrafu (ċ) tas subregolament (1) tiegħu, il-

kliem "persuna li tkun awtorizzata skont il-liġi nazzjonali"

għandhom jiġi sostitwiti bil-kliem "spiżjar jew kirurgu

veterinarju"; u

(b) minnufih wara s-subregolament (5) tiegħu għandhom

jiżdiedu s-subregolamenti ġodda li ġejjin

"(6) Fil-każ ta’ prodott mediċinali veterinarju

awtorizzat fi Stat Membru ieħor, il-kirurgi veterinarji

għandhom jiksbu awtorizzazzjoni mis-Servizzi Veterinarji

qabel jakkwistaw il-prodott għall-amministrazzjoni fuq

annimal li jipproduċi l-ikel.

(7) Fil-każ li l-prodotti mediċinali veterinarji fihom

sustanzi ristretti li jirriżultaw mill-implimentazzjoni tal-

konvenzjonijiet relevanti tan-Nazzjonijiet Uniti fuq is-

sustanzi -narkotiċi u psikotropiċi, għandha tingħata

kunsiderazzjoni lil kull rekwiżit speċjali li jeħtieġ ikun

sodisfatt qabel ma l-prodotti jkunu jistgħu jintużaw.

(8) Prodott mediċinali veterinarju jew prodott

mediċinali provdut għall-amministrazzjoni skont il-

paragrafi (a), (b) u (ċ) tas-subregolament (1), jista’ jiġi

pprovdut biss skont preskrizzjoni veterinarja minn kirurgu

veterinarju, irrispettivament mill-kategorija legali assenjata

lill-prodott mediċinali veterinarju skont ir-regolament 60.

(9) Il-preskrizzjoni veterinarja maħruġa skont il-

kundizzjoni msemmija fis-subregolament (8) għandha tiġi

mmarkata bħala tali. Dikjarazzjoni simili għal, jew li tagħti

l-istess tifsira lid-dikjarazzjoni li ssegwi: "Dan il-prodott

ġie preskritt skont il-Cascade Principle", għandha tiġi

inkluża fuq il-preskrizzjoni veterinarja.

(10) Sakemm il-kirurgu veterinarju li ppreskriva l-

prodott mediċinali veterinarju jew il-prodott mediċinali ma

jissupplixxix kif ukoll jamministrax il-prodott lill-annimal

hu stess, il-persuna li tissupplixxih għandha timmarkah

(jew tassigura li hu mmarkat) b’minn tal-anqas l-

informazzjoni li ssegwi

(a) l-isem tal-kirurgu veterinarju li ppreskriva

l-prodott;

(b)

l-isem u l-indirizz ta’ sid l-annimal;

(ċ) l-identifikazzjoni (inkluż l-ispeċi) tal-

annimal jew grupp ta’ annimali;

(d)

id-data tal-forniment;

(e) id-doża

u

l-istruzzjonijiet

ta’

amministrazzjoni;

(f)

il-perjodu ta’ irtirar, jekk applikabbli;

(11) Meta kirurgu veterinarju jirrikorri għad-

dispożizzjonijiet tas-subregolament (1), l-attività li ssir

mill-kirurgu veterinarju tkun eskluża mill-iskop ta’

definizzjoni ta’ distributuzzjoni bl-ingrossa.".

Immediately after regulation 11 of the principal regulations Adds new

regulation to the

principal

regulations.

there shall be added the following new regulation

(1) By way of derogation from regulation 11

Importation of

(1) and from Article 16(1) of Regulation (EC) No 470/

2009, where there is no suitable veterinary medicinal

product available either as an authorised product in the

Malta or under the provisions of regulation 11(1),

veterinary surgeon may, under their direct and only

personal responsibility, build up a case and expound it to

the Veterinary Services. Veterinary surgeons shall provide

detailed justifications to their request. The Veterinary

Services shall and where the disease or condition is such

that the veterinary medicinal product is likely to be

needed as a matter of urgency for the treatment of an

animal, allow the importation of a veterinary medicinal

product authorised for any food producing species from

any Third country under any conditions it may deem fit,

including the assignment of an appropriate withdrawal

period, if applicable. The Veterinary Services shall base

its decision on purely scientific grounds and shall take all

precautions, in particular for the safety and environmental

risks which may be associated with the use of the

veterinary medicinal product, before granting the

approval for the importation, which importation shall be

considered as a once only grant with the possibility for

repeated requests, with each request considered as sui

generis.

(2) The provisions of sub-regulations (6), (7), (8)

and (10)of regulations 11 shall apply.".

In regulation 30 of the principal regulations, the word

"Community" shall be deleted wherever it occurs.

Regulations 38 to 50 of the principal regulations shall be

substituted by the following new regulations

(1)

The provisions of this Title shall not

Manufacturing

apply to

(a) magistral formula;

(b) officinal formula;

(c) veterinary

medicinal

products

intended for research and development trials;

(d) intermediate products intended for

further

processing

by

an

authorised

manufacturer;

(e) any radionuclides in the form of sealed

sources;

(f) whole blood, plasma or blood cells of

animal origin, except for plasma which is prepared

by a method involving an industrial process;

(g) veterinary medicinal products supplied in

response to a bona fide unsolicited order, formulated in

accordance with the specifications of a veterinary

surgeon and for use by an individual animal under his

direct personal responsibility.

(2) The provisions of these regulations shall

apply also to the manufacture and assembly of

homeopathic veterinary medicinal products, veterinary

medicinal products derived from animal blood or plasma,

radiopharmaceuticals,

immunological

veterinary

medicinal products and herbal veterinary medicinal

products.

(1) (a)No veterinary medicinal product,

Manufacturing

for veterinary biological active substance, or active substance to be

products and used directly as an investigational veterinary medicinal

product, may be manufactured in Malta unless there is, in

respect of such product or substance, a Manufacturing

Authorisation.

This Manufacturing Authorisation shall also be

required for the processes of sterilisation of active

substances.

(b) The Manufacturing Authorisation shall

also be required for the manufacture of veterinary

medicinal products intended for export.

2. (a) The Manufacturing Authorisation,

which shall remain in force for a period to be

determined by the Veterinary Services, shall be

required for both total and partial manufacture, and

for the various processes of dividing up, packaging

or presentation.

(b) A Manufacturing Authorisation shall not be

required for preparation, dividing up, changes in

packaging or presentation where such processes are

carried out solely for retail supply by pharmacists in

veterinary pharmacies, or by other persons legally

authorised to carry out such processes.

(3) The authorisation referred to in sub-regulation

(1) shall also be required for imports from third countries

into the territory of Malta;

The territory of Malta shall take all appropriate

measures to ensure that veterinary medicinal products

brought into the territory from a third country and

destined for Member States are accompanied by a copy

of the authorisation referred to in sub-regulation (1).

(4) Any application for the grant of a licence to

manufacture, assemble or modify a veterinary medicinal

product shall be made to the Veterinary Services and

shall contain such information, documents, samples and

other material as provided by the provisions of these

regulations.

(5) A Manufacturing Authorisation shall include

a licence to distribute by wholesale the veterinary

medicinal products in respect of which the

Manufacturing Authorisation has been issued.

(6) The Veterinary Services shall forward to the

Agency a copy of the Authorisation referred to in sub-

regulation (1).

(7) The Veterinary Services shall enter the

information relating to the Authorisation referred to in

sub-regulation (1) in the European Union database

referred to in regulation 72(6).

The Veterinary Services, shall only grant

manufacturing

or renew an Authorisation, if the applicant

Authorisation.

(a) specifies the veterinary medicinal

products and pharmaceutical forms which are

to be manufactured or imported and the place

where they are to be manufactured and, or

controlled;

(b) has at his disposal, for the manufacture

or import of veterinary medicinal products, suitable

and sufficient premises, technical equipment and

control facilities complying with requirements set

by the Veterinary Services;

(c) has at his disposal the services of at

least one qualified person within the meaning of

regulation 46; and

(d) provides all necessary documentation in

support of his application.

(1) (a)The Veterinary Services shall issue

manufacturing

the Authorisation after verifying the contents of the

Authorisation.

application but in any case not later than ninety (90) days

from receipt of the application.

(b) This time period shall be suspended when the

Veterinary Services requests additional information from

the applicant.

(c) The Veterinary Services shall, before

determining an application, inspect the premises

indicated in the application and shall not issue an

Authorisation until it is satisfied that such premises

conform with the requirements established by the

provisions of these regulations;

(d) The Veterinary Services may grant a

conditional licence subject to the carrying out of certain

obligations imposed on the applicant.

(2) The Authorisation shall apply only to the

premises,

veterinary

medicinal

products

and

pharmaceutical forms specified in the application.

(3) Where the Veterinary Services considers that

circumstances may exist which would render necessary

the consideration of whether the Authorisation should be

varied, suspended or revoked, the Veterinary Services

may serve on the holder of a manufacturer's

Authorisation a notice requiring him, within such time as

may be specified in the notice, to furnish it with any

information specified in the notice.

(1) When

the

holder

of

the

manufacturing

Authorisation requests a change in the particulars

Authorisation.

specified in regulation 4(a) and 4(b), he shall apply

in writing to the Veterinary Services.

The process of verification of such information

shall not exceed thirty (30) days. However, in

exceptional cases, this period of time may be extended to

ninety (90) days.

(2) The veterinary services may upon such an

application made by the holder of Authorisation in

request thereof, vary the condition of the licence if it

is satisfied that such variation will not adversely

affect standard of good practice in manufacture as

may be prescribed.

(3) Where the Veterinary Services considers

that circumstances may exist which would render

necessary the consideration of whether the

Authorisation should be varied, suspended or

revoked, the Veterinary Services may serve on the

holder of a manufacturing Authorisation a notice

requiring him, within such time as may be specified

in the notice, to furnish it with any information

specified in the notice.

(1) The Veterinary Services may

manufacturing suspend a manufacturing Authorisation for such

Authorisation. period as it may determine, or may refuse, revoke,

or vary the provisions of, any such Authorisation.

(2) The powers vested in sub-regulation (1)

shall only be exercisable in any of the following

circumstances, where

(a) the matters stated in the application on

which the Authorisation was granted were false or

incomplete in an essential manner;

(b) a material change of circumstances

has occurred in relation to any of those

matters;

(c) any of the conditions of the

Authorisation has been contravened;

(d) the requirements in relation to the

licences as established by these regulations

have not been complied with;

(e) the processes of manufacture or

assembly of a veterinary medicinal product are

carried out in a manner that is not in

compliance with the provisions of the

marketing authorisation of that veterinary

medicinal product;

(f) the

conditions

for

good

manufacturing practice are not being complied

with;

(g) there is sale and processing of active

substance and veterinary medicinal products

under unsanitary conditions or leading to

adulteration; and

(h) in any other circumstance as is

established under these regulations.

(3) The Veterinary Services shall carry out

regular inspections to ensure that the requirements

established by these regulations in relation to the

manufacture, assembly or modification of a

veterinary medicinal product or active substance are

complied with.

(4) With respect to the manufacture of veterinary

medicinal products or active substance the Veterinary

Services or any authorised person carrying out an

inspection shall

(a) inspect the manufacturing establishment

and any other location and at any reasonable time

the Director may deem necessary;

(b) examine any relevant documents;

(c) take any samples the Director may

deem necessary and if necessary submit them to

designated laboratories for testing;

(d) open or/and examine or/and seize any

article believed to be in violation of these

regulations or for obtaining evidence;

(e) draw up a report of the findings and

communicate the contents of such report to the

Manufacturing Authorisation holder or the

applicant for a Manufacturing Authorisation and to

the qualified person in relation to such inspection;

(f) carry out any other activity the Director

may deem appropriate for the proper execution of

his duties and responsibilities as provided by these

regulations;

(g) produce, upon request by the inspected

part, the designated document containing

information on the legal basis and scope of the

inspection and the identification of the inspector/s;

(h) at the time of the inspection draw up a

list of deficiencies that may have been identified

and shall sign this list, and such list shall be

countersigned by the holder of the Authorisation or

his legal representative;

(i) shall draw up a report of the inspection

within thirty (30) working days of the inspection

and shall forward a copy of such report to the

holder of the Authorisation.

(5) Except in urgent cases an inspection shall

be carried out in the presence of a qualified person

or his representative.

(6) Subject to the provisions of these regulations,

every licence shall, unless previously renewed or

revoked, continue to be valid until such time as it is

renewed by the Veterinary Services following an

inspection.

(7) The Veterinary Services shall establish the

period of validity of any licence.

(8) Following the inspection mentioned in sub-

regulation (1), the Veterinary Services

(a) may renew the licence, with or without

modifications, for such a further period as

specified; or

(b) if, having regard to the provisions of

these regulations, it considers it necessary or

expedient to do so, may refuse to renew the licence.

(1) The holder of the Authorisation or

manufacturing the manufacturer of active substance shall

(a) comply with the EU principles and

guidelines of good manufacturing practice and any

annexes thereof for veterinary medicinal products

and use only active substances which have been

manufactured in accordance with the EU guidelines

on good manufacturing practice for active

substances and distributed in accordance with good

distribution practices for active substances. To this

end, the holder of the manufacturing authorisation

shall verify compliance by the manufacturer and

distributors of active substances with good

manufacturing practice and good distribution

practices by conducting audits at the manufacturing

and distribution sites of the manufacturer and

distributors of active substances. The holder of the

manufacturing authorisation shall verify such

compliance either by himself or, without prejudice

to his responsibility as provided for in these

regulations and in the Act, through an entity acting

on his behalf under a contract;

(b) inform the competent authority and the

marketing authorisation holder immediately if he

obtains information that veterinary medicinal

products which come under the scope of his

manufacturing authorisation or the active substance

are, or are suspected of being, falsified irrespective

of whether those veterinary medicinal products

were distributed within the legal supply chain or by

illegal means, including illegal sale at a distance by

means of information society services;

(c) verify that the manufacturers, importers

or distributors from whom he obtains active

substances are registered with the competent

authority of the Member State in which they are

established;

(d) verify the authenticity and quality of the

active substances and the excipients.

(e) have at his disposal the services of staff

complying with the legal requirements set by the

Veterinary Services as regards both manufacture

and controls

(f) dispose of the veterinary medicinal

products only in accordance with the legislation of

the territory of Malta;

(g) give prior notice to the Veterinary

Services of any changes which he may wish to

make to any of the particulars supplied pursuant to

regulation 40 or other significant changes or of

conditions which may affect the quality, safety or

efficacy of the veterinary medicinal product.

The Veterinary Services shall, in any event, be

immediately informed if the qualified person

referred to in regulation 46(1) is replaced;

(h) enable the qualified person referred to

in regulation 46(1) to carry out his duties,

particularly by placing at his disposal all the

necessary facilities;

(i) keep detailed records of all veterinary

medicinal products supplied by him, including

samples, in accordance with the laws of the

countries of destination

(i) date;

(ii) name of the veterinary medicinal

product;

(iii) quantity supplied ;

(iv) name and address of the recipient;

(v) batch number;

These records shall be available for inspection

by the Veterinary Services for a period of at least

three (3) years.

(j) the following information at least shall

be recorded in respect of each transaction, whether

or not it is made for payment;

(k) record all suspected serious adverse

reactions and human adverse reactions relating to

the use of veterinary medicinal products that are

brought to his attention and report them promptly

to the Veterinary Services in no later than fifteen

days following receipt of the information;

(l) implement a system for recording and

reviewing complaints together with an effective

system for recalling promptly and at any time the

veterinary medicinal products or the active

substance in the distribution network;

(m) record and investigate any complaint

concerning quality defects;

(n) other responsibilities as may be

established by the Veterinary Services from time to

time;

(2) For the purposes of this regulation,

manufacture of active substances used as starting

materials shall include both total and partial manufacture

or import of an active substance used as a starting

material as defined in the Schedule Part 2. Section C of

these regulations, and the various processes of dividing

up, packaging or presentation prior to its incorporation

into a veterinary medicinal product, including

repackaging or re-labelling, such as are carried out by a

distributor of starting materials.

(3) Manufacturing Authorisation holders shall be

regarded as producers and therefore held liable for

damages in the cases and under the conditions set forth in

the Consumer Affairs Act.

(4) It shall be the duty of the importer to ensure

that

(a) in the case of veterinary medicinal

products and investigational veterinary medicinal

products imported from third countries, these have

been manufactured in accordance with standards

which are at least equivalent to the good

manufacturing practice standards laid down in the

Good Manufacturing Practice for Veterinary

S.L. 437. 108.

Medicinal Products Rules;

(b) in the case of veterinary medicinal

products, such products have been manufactured by

manufacturers duly authorised for the purpose; and

(c) in the case of investigational veterinary

medicinal products, such products have been

manufactured by a manufacturer notified to the

competent authorities and accepted by them for that

purpose.

The Veterinary Services may require from the

pursuant to the applicant further information concerning both the

particulars supplied pursuant to regulation 40 and the

manufacturing qualified person referred to in regulation 46(1). Where

Authorisation. the Veterinary Services exercise this right, application of

the time limits referred to in regulations 41 and 42(1)

shall be suspended until the additional data required have

been supplied.

(1) The holder of the Authorisation shall

have permanently and continuously at his disposal the

services of at least one qualified person, in accordance

with the conditions laid down in regulation 47,

responsible in particular for carrying out the duties

specified in regulation 49

Provided that when more than one qualified

person is nominated, the application will clearly

delineate the specific responsibilities of each person

Provided further that the qualified persons

may nominate another person similarly qualified to act as

his representative.

(2) When the qualified person has nominated a

representative as aforesaid he shall immediately inform

the Veterinary Services of such nomination.

(3) If the manufacturing Authorisation holder

personally has the qualifications laid down in regulation

47, then he may himself assume the responsibility of a

qualified person.

(1) For a person to be designated as

qualified

person, he must possess the following

qualifications

(a) a diploma;

(b) certificate or other evidence of formal

qualifications awarded on completion of a

university course of study; or

(c) a course recognised as equivalent by the

territory of Malta, extending over a period of at

least four (4) years of theoretical and practical

study in one of the following scientific disciplines -

pharmacy, medicine, veterinary science, chemistry,

pharmaceutical chemistry and technology, biology.

(2) However, the minimum duration of the

university course may be three and a half (3.5) years

where the course is followed by a period of theoretical

and practical training of at least one (1) year and includes

a training period of at least six (6) months in a pharmacy

open to the public, corroborated by an examination at

university level.

(3) The course shall include theoretical and

practical tuition bearing upon at least the following basic

subjects

(a) experimental physics;

(b) general and inorganic chemistry;

(c) organic chemistry;

(d) analytical chemistry;

(e) pharmaceutical chemistry, including

analysis of medicinal products;

(f) general and applied biochemistry

(medical);

(g) physiology;

(h) microbiology;

(i) pharmacology,

(j) pharmaceutical technology;

(k) toxicology;

(l) pharmacognosy

(study

of

the

composition and effects of the active principles of

natural substances of plant and animal origin).

(4) Tuition in these subjects should be so

balanced as to enable the person concerned to fulfil the

obligations specified in regulation 49.

(5) Where certain diplomas, certificates or other

evidence of formal qualifications mentioned in this sub-

regulation do not fulfil the criteria laid down above, the

Veterinary Services shall ensure that the person

concerned provides evidence that he has, in the subjects

involved, the knowledge required for the manufacture

and control of veterinary medicinal products.

(6) The qualified person shall have acquired

practical experience over at least two (2) years, in

one or more undertakings which are authorised

manufacturers, in the activities of qualitative

analysis of medicinal products, of quantitative

analysis of active substances and of the testing and

checking necessary to ensure the quality of

veterinary medicinal products.

(7) The duration of practical experience may be

reduced by one year where a university course lasts for at

least five years and by a year and a half where the course

lasts for at least six (6) years.

(1) A person engaging, in Malta, in the

activities of the person referred to in regulation

46(1) on the date on which these regulations

become applicable, without complying with the

provisions of regulation 47, shall be eligible to

continue to engage in those activities within the EU.

(2) The holder of a diploma, certificate or

other evidence of formal qualifications awarded on

completion of a university course or a course

recognised as equivalent by the territory of Malta in

a scientific discipline allowing him to engage in the

activities of the person referred to in regulation

46(1) in accordance with the laws of the territory of

Malta, may, if he began his course prior to the date

on which these regulations became applicable, be

considered as qualified to carry out in the territory

of Malta the duties of the person referred to in

regulation 46(1), provided that he has previously

engaged in the following activities for at least two

(2) years before the date on which these regulations

became applicable in one or more undertakings with

a

manufacturing

authorisation,

production

supervision and, or qualitative and quantitative

analysis of active substances, and the necessary

testing and checking under the direct authority of a

person as referred to in regulation 46(1) to ensure

the quality of veterinary medicinal products.

If the person concerned has acquired the practical

experience referred to in sub-regulation (1) before the

date on which these regulations became applicable, a

further one year’s practical experience in accordance

with the conditions referred to in sub-regulation (1) shall

be completed by him immediately before he engages in

such activities.

(1) The qualified person, without

Responsibilitie

prejudice to his relationship with the holder of the

Authorisation, shall be responsible to ensure that

(a) each batch of veterinary medicinal

products manufactured in Malta has been

manufactured and checked in terms of the laws in

force and is in accordance with the requirements of

the marketing authorisation;

(b) in the case of veterinary medicinal

products coming from third countries, irrespective

of whether the product has been manufactured in

the EU, each production batch has undergone in a

Member State a full qualitative analysis, a

quantitative analysis of at least all the active

substances and all the other tests or checks

necessary to ensure the quality of the veterinary

medicinal product in accordance with the

requirements of the marketing authorisation

Provided that when the batches of medicinal

products have already undergone the controls above

mentioned in a Member State, they shall be exempt from

further controls if they are accompanied by the control

reports signed by the qualified person, and are marketed

within the EU;

(c) standards of good practice in

manufacturing are complied with at all times.

(2) The qualified person need not carry out

the controls above mentioned in the case of

imported veterinary medicinal products, where

arrangements have been made by the EU with the

exporting country to ensure that the manufacturer of

the veterinary medicinal products applies standards

of good manufacturing practice at least equivalent

to those laid down by the EU, and to ensure that the

controls referred to above have been carried out in

the exporting country.

(3) The Veterinary Services, may if it has

reasonable suspicion to believe that any qualified

person is acting in contravention of any of the

provisions of these regulations, suspend the activity

of such qualified person by notice in writing

specifying the reasons for such suspension until

such person has complied with any requirement of

the Veterinary Services to remedy the non-

compliance.

(1) It shall be the duty of the qualified

person to keep a register to document and certify that

each production batch satisfies provisions of these

regulations.

(2) The said register shall be kept up to date

as operations are carried out and must be made

available for inspection by the Veterinary Services

for at least five (5) years.

50A.(1) The obligations of qualified persons

referred to in regulation 46(1) shall be fulfilled either by

means of appropriate administrative measures or by

making such persons subject to a professional code of

conduct.

(2) The Veterinary Services may provide for the

temporary suspension of such a person upon the

commencement of administrative or disciplinary

proceedings against him for failure to fulfil his

obligations.

L-obbligazzjonijiet tal-persuni kwalifikati

msemmija fir-regolament 46(1) għandhom ikunu

sodisfatti jew permezz ta’ mezzi xierqa ta’ miżuri

amministrattivi jew billi t-tali persuni jkunu soġġetti

għall-kodiċi ta’ mġieba professjonali.

(2) Is-Servizzi Veterinarji jista’ jikkonsidra s-

sospensjoni temporanja tat-tali persuna mal-bidu ta’

proċessi amministrattivi jew dixxiplinarji kontriha għal

falliment li twettaq l-obbligi tagħha.

(1) Importers, exporters, distributors

Registration of

and manufacturers of active substances who are

established in Malta shall register their activity with

the Veterinary Services.

manufacturers.

(2) The registration form shall include, at

least, the following information

(a) name or corporate name and permanent

address;

(b) the active substances which are to be

imported, exported, distributed or manufactured;

(c) particulars regarding the premises and

the technical equipment for their activity

Provided that the persons referred to in sub-

regulation (1) shall submit the registration form to the

Veterinary Services at least sixty (60) days prior to the

intended commencement of their activity.

(3) The Veterinary Services may, based on a risk

assessment, decide to carry out an inspection. If the

Veterinary Services notifies the applicant within sixty

(60) days of the receipt of the registration form that an

inspection will be carried out, the activity shall not begin

before the Veterinary Services has notified the applicant

that he may commence the activity. If within sixty (60)

days of the receipt of the registration form the Licensing

Authority has not notified the applicant that an inspection

will be carried out, the applicant may commence the

activity.

(4) The persons referred to in sub-regulation (1)

shall communicate annually to the Veterinary Services an

inventory of the changes which have taken place as

regards the information provided in the registration form.

Any changes that may have an impact on the quality or

safety of the active substances that are manufactured,

exported, distributed or imported shall be notified

immediately.

(5) The Veterinary Services, shall only grant or

renew an Authorisation, if the applicant

(a) specifies the veterinary medicinal

products and pharmaceutical forms which are to be

manufactured or imported and the place where they

are to be manufactured and, or controlled;

(b) has at his disposal, for the manufacture

or import of veterinary medicinal products, suitable

and sufficient premises, technical equipment and

control facilities complying with requirements set

by the Veterinary Services;

(c) has at his disposal the services of at

least one qualified person within the meaning of

regulation 46(1); and

(d) provides all necessary documentation in

support of his application.

(6) The Veterinary Services shall issue the

Authorisation after verifying the contents of the

application but in any case not later than ninety (90) days

from receipt of the application.

(7) The time period mentioned in sub-regulation

6 shall be suspended when the Veterinary Services

requests additional information from the applicant.

(1) When veterinary medicinal products are

brought from a third country into Malta for the sole

purpose of re-export, and without placing them on the

market in Malta, the provisions of regulation 38 still

apply even though the product remains intact and no

manufacturing activities are carried out.

(2) The only exclusion in respect of the

requirement in regulation 38, is when the operations of

import for the sole purpose of re-export are effected

within a freeport, free trade zone or customs warehouse.

However, in such instances a veterinary wholesale

dealer’s licence is still required by the company engaging

in the process.

(3) In those cases involving a manufacturing

activity in relation to imported products that are destined

for re-export only, a manufacturing authorisation is

required, even if the operations are effected within the

freeport, free trade zone or customs (e.g. bonded

warehouse). Operations of re-labelling and/or affixing of

labels to the outer pack also fall within this category.

(4) The Veterinary Services shall establish

procedures to ensure that the requirements of sub-

regulations (2) and (3) are complied with.

(5) The Veterinary medicinal products imported

for the sole purpose of re-export may be exempted from

obtaining a Marketing Authorisation from the Veterinary

Services.

(6) The authorisation to engage in such an

activity is only given to persons in possession of a

veterinary wholesale dealer licence and without

prejudice to other authorisations that the persons may

have to obtain, particularly with respect to the

requirements of the Importation Control Regulations.

A manufacturing authorisation granted under

Other licences

these regulations shall not relieve any person from the

need to obtain any permit, license or authorisation as may

manufacturing

be required by any other law.".

Authorisation.

14. Immediately after the second paragraph of sub-

regulation (1) of regulation 58 of the principal regulations there

shall be added the following new paragraph

"When the market situation in Malta is such that it

gives rise to a temporary supply issues for an authorised

veterinary medicinal product, the procurement of small

quantities of the same authorised veterinary medicinal product,

or an essentially similar veterinary medicinal product, by a

veterinary surgeon is permitted and is excluded from the scope of

the definition of wholesale distribution

Provided that when a veterinary surgeon has recourse

to this regulation he has the appropriate means to be kept

informed by this supplier of any batch or product recall and

adverse drug reactions.".

15. Title VII and Title VIII of the principal regulations shall be Renumbers Title

renumbered as Title X and Title XI respectively.

16. Immediately after regulation 58 of the principal regulations Adds new Title

there shall be added the following new Title and regulation

"TITLE VII

RETAIL SUPPLY OF VETERINARY

MEDICINAL PRODUCTS

In the territory of Malta, the retail supply of

veterinary medicinal products shall be conducted only

from veterinary pharmacies, licensed veterinary

establishments, other establishments mentioned in

regulation 60(4)(d) and by veterinary surgeons during out

call visits.".

17. Immediately after regulation 58A of the principal Adds new Title

regulations there shall be added the following new Title

"TITLE VIII

DISPENSING REGULATIONS".

18. Regulation 59 of the principal regulations shall be Substitutes

substituted by the following new regulation

(1) In the territory of Malta the dispensing

Dispensing by

of veterinary medicinal products shall only be conducted

in accordance with the provisions of this regulation.

(2) Veterinary surgeons may dispense veterinary

medicinal products during an in-call by the animal

owner/carer/keeper

in

the

licensed

veterinary

establishments and during out-call visits to the animals

under their care.

(3) Veterinary surgeons shall dispense a

veterinary medicinal product in such quantities as would

be required for the treatment of the condition, where

delay in the administration of the product may adversely

affect the health of the animal

Provided that the veterinary surgeon shall

supply the quantities of veterinary medicinal product for

treatments or conditions only to animals under his care. If

the type of the packaging is such that the veterinary

surgeon cannot supply lesser quantities thereof, the

veterinary surgeon may supply the animal owner/keeper/

carer with the quantities needed for the full treatment of

the condition.

Provided further that the above may not apply

for veterinary medicinal product that are regulated by

specific instruments

(4) Veterinary medicinal products can only be

dispensed from the premises referred to in regulation 60.

(5) The dispensers shall be required to keep

detailed records for veterinary medicinal products or

treatments that may be supplied only on prescription, the

following information being recorded in respect of each

incoming or outgoing transaction

(a) date of the transaction;

(b) name of the veterinary medicinal

product including, as appropriate, pharmaceutical

form and strength;

(c) batch number;

(d) quantity received or supplied;

(e) name or company name and permanent

address or registered place of business of the

supplier in the event of purchase, or of the recipient

in the event of sale;

(f) name and contact details of the

prescribing veterinary surgeon and, where

appropriate, a copy of the veterinary prescription ;

(g) marketing authorisation number.

At least once a year a detailed audit shall be carried

out, and incoming and outgoing veterinary medicinal

products and other products issued on a veterinary

prescription shall be reconciled with products currently

held in stock, any discrepancies being recorded in an

appropriate register. These records shall be available for

inspection by the Veterinary Services for a period of not

less than five (5) years.

(6) When dispensing a veterinary medicinal

product the dispenser must be satisfied that the person

who will use the product is competent to do so safely, and

intends to use it for a purpose for which it is authorised or

indicated by the veterinary surgeon.

(7) When dispensing veterinary medicinal

product, the dispenser shall advise the receiver of the

product on the dosing, safe administration of the product

and on any warnings or contra-indications on the label or

package leaflet, including information on any applicable

withdrawal period/s.

(8) If the dispenser dispenses an amount of

veterinary medicinal product that is less than the unit

dose of a package, the veterinary surgeons may break

open any package containing a product for the purposes

of supply, other than the immediate packaging of an

injectable product.

(9) When dispensing an antimicrobial agent the

dispenser must be satisfied that all necessary precautions

have been taken to minimise the risks of antimicrobial

resistance and that the prudent use of the antimicrobial

agent have been taken in consideration, in particular to

the use of critically important antimicrobials.

(10) If the dispenser has concerns about the

content of a veterinary prescription he shall resolve them

with the prescribing veterinary surgeon before dispensing

the product.

(11) If a veterinary medicinal product is supplied

in a container other than that specified in the marketing

authorisation, the veterinary surgeon dispensing the

product must ensure that the container is suitably labelled

and shall supply sufficient written information to enable

the product to be used safely.

(12) The veterinary surgeon referred to in

regulation 79(2) shall be responsible for the cabinet

where veterinary medicinal products are kept. In

particular, storage conditions, traceability issues and

record keeping requirements shall be strictly adhered to.

(13) A veterinary surgeon dispensing a veterinary

medicinal product must be present when the product is

handed over unless the veterinary surgeon

(a) authorises each transaction individually

before the product is supplied;

(b) is satisfied that the person handing it

over is competent to do so.

(14) Only veterinary medicinal product that have

not passed their expiry date shall be dispensed.

(15) The provisions of paragraph (e) of sub-

regulation (5) shall come into force on the 1st November

2021.".

19. Immediately after regulation 59 of the principal

regulations there shall be added the following new Title and

regulation

"TITLE IX

PRESCRIBING REGULATIONS

(1) In the territory of Malta veterinary

Prescribing by

surgeons can only prescribe veterinary medicinal

products in accordance with the provisions of this

regulation.

(2) In the territory of Malta, the prescribing of

veterinary medicinal product or medicinal product to

animals shall be conducted only by Veterinary surgeons.

(3) The prescribing of veterinary medicinal

product or medicinal product for animals shall be made

only on the veterinary prescriptions.

(4) Veterinary surgeons may only prescribe a

veterinary medicinal product or medicinal product for

animals which they have examined themselves and shall

accept clinical responsibility for the treatment of the

animal under their care.

(5) Veterinary medicinal product or medicinal

product may not be used for more than one treatment

under the same prescription.

(6) Before prescribing a veterinary medicinal

product or medicinal product which requires a

prescription, veterinary surgeons shall carry out a clinical

assessment of the animal under their care.

(7) The clinical assessment by the veterinary

surgeons shall be carried out recently enough for the

veterinary surgeons to have personal knowledge of the

condition of the animal or current health status of the herd

or flock to make a reliable diagnosis or start empirical

treatment.

(8) Before prescribing a veterinary medicinal

product or medicinal product the veterinary surgeons

must first satisfy themselves that

(a) the use of the veterinary medicinal

product or medicinal product is justified for the

species concerned on veterinary grounds;

(b) the administration of the veterinary

medicinal product or medicinal product is not

incompatible with a previous treatment or use and

that there is no contra-indication or interaction

where several pre-mixes are used;

(c) the veterinary medicinal product or

medicinal product are prescribed only in such

quantities as are necessary for the purpose of the

treatment;

(d) all necessary precautions have been

taken to minimise the risks of antimicrobial

resistance and that the prudent use of the

antimicrobial agent have been taken in

consideration, in particular to the use of critically

important antimicrobials.

(9) When prescribing a veterinary medicinal

product or medicinal product veterinary surgeons must be

satisfied that the person who will use the product is

competent to do so safely and intends to use it for a

purpose for which it is authorised.

(10) When prescribing antimicrobial agents

veterinary surgeons shall consider the latest guidelines

issued by the Veterinary Services, and other relevant

national, European and International organisations with

regard to critically important antimicrobials.

(11) When preparing a veterinary prescription the

prescribing veterinary surgeon shall advise the receiver of

the prescription on the safe administration of the product

and on any warnings or contra-indications associated with

the product.

(12) A veterinary medicinal product classified as

subject to veterinary prescription may be administered

without a veterinary prescription by a veterinary surgeon

personally. This does not preclude veterinary surgeons

from the record keeping obligations referred to in

regulation 59(5).

(13) The veterinary prescriptions shall be in line

with the guidelines that may be issued by the veterinary

Services.".

20. Regulation 60 of the principal regulations shall be amended

as follows

(a) immediately after sub-paragraph (ii) of paragraph (a)

of sub-regulation (1) thereof there shall be added the following

new sub-paragraph

"(iii) veterinary medicinal products that do not fall

within the classification of regulation 6 (1)(a)(i), (b) and (c)

but nonetheless are deemed to require a veterinary

prescription for a temporary period.";

(b) immediately after paragraph (h) of sub-regulation (2)

thereof there shall be added the following new paragraph

"(i) veterinary medicinal product classified as

prescription only medicines may be exempted from being

prescribed and dispensed by a prescription if entirely

administered by the veterinary surgeon responsible for the

non-food producing animal, who himself provides the

veterinary medicinal product, and if the animal owner does

not explicitly request a prescription." and immediately

thereafter there shall be added the following new sub-

regulations

"(3) Pursuant to sub-regulation (1) there shall be the

following four (4) distribution categories of veterinary

medicinal product

(a) Prescription-Only-Medicine, Veterinary

surgeon and Pharmacist- abbreviated to POM-VP.

(b) Prescription-Only-Medicine,

Veterinary

surgeon- abbreviated to POM-V.

(c) Over-

the-

Counter

–Medicine,

abbreviated to OTC

General Sales, abbreviated to GS

(d)

(4) The supply of veterinary medicinal products for

each distribution category shall be made as follows

(a) POM-VP, shall only be prescribed and/or

dispensed by a veterinary surgeon or dispensed by a

pharmacist according the terms of a veterinary

prescription. Premises from where the products can

be supplied are veterinary pharmacies, licensed

veterinary establishments, and by the veterinary

surgeon during an outcall .

(b) POM-V shall only be prescribed,

dispensed and administered by a veterinary surgeon.

Premises from where the products can be supplied are

licensed veterinary establishments, and by the

veterinary surgeon during an outcall.

(c) OTC, may be dispensed without a

veterinary prescription. The persons who can

dispense this category of veterinary medicinal

products are veterinary surgeons, pharmacists and

suitably qualified persons under the direction of a

pharmacist or a veterinary surgeon. Premises from

where the products can be supplied are veterinary

pharmacies, licensed veterinary establishments, and

by the veterinary surgeon during an outcall.

(d) GS, may be dispensed without a

veterinary prescription. The persons who can

dispense this category of veterinary medicinal

products are veterinary surgeons, pharmacists and

suitably qualified persons. Products that fall under

this category can be supplied from veterinary

pharmacies, veterinary establishments, registered pet

shops, registered aquarium fish product retailers and

approved feed traders where animal medicated feeds

are produced, sold or traded

Provided that the veterinary services may make

requirements to allow products classified in this category to

be supplied from premises other those listed above to

alleviate supply shortages and facilitate accessibility to

treatment that otherwise could be detrimental to animal

welfare. Such premises shall not be general retail outlets

and must be under the responsibility of a person with an

experience of not less than two (2) years in the handling of

this category of veterinary medicinal products.

(5) The Veterinary Services shall categorise the

distribution category of the veterinary medicinal product

when authorising veterinary medicinal products.

(6) When deciding the distribution category of a

veterinary medicinal product the Veterinary Services may

seek the advice from suitable expert committees and may

take in consideration the guidelines of other National,

European and International relevant bodies, as may be

decided by the Veterinary Services.

(7) Notwithstanding what had been decided during

the initial Marketing Authorisation procedure, the

Veterinary Services may change the distribution category

of a veterinary medicinal product either at the request of the

Marketing Authorisation Holder or due to a compulsory

variation.

(8) The Veterinary Services shall set out the criteria

for the categorisation of a Veterinary Medicinal product

and make them public.

(9) Different pack sizes of the same Marketing

Authorisation may be assigned a different distribution

category.

(10) When the distribution category of the veterinary

medicinal product is POM-V or POM-VP this shall be

indicated on the immediate and/or outer packaging of the

product in legible, undeletable characters.

(11) The legible, undeletable characters citing the

distribution category of the veterinary medicinal product

may be printed on the immediate and/or outer packaging or

made noticeable through an appropriate label.

(12) Both the abbreviated form and the full

description of the distribution category of the veterinary

medicinal product present on the immediate and/or outer

packaging shall be acceptable.

(13) The holders of a wholesale distribution

authorisation shall distribute veterinary medicinal products

only to the premises authorised to retailed veterinary

medical according to these regulations.

(14) The holders of a wholesale distribution

authorisation shall distribute to the premises authorised to

retailed veterinary medical only the category/categories of

veterinary medicinal products that are authorised to be

retailed from each type of premises in accordance with

these regulations.".

21. Regulation 62 of the principal regulations shall be amended Amends

regulation 62 of

as follows

the principal

regulations.

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

following new paragraph

"Malta shall ensure that the owners or keepers of

food-producing animals or keeper of animals that are

confined within enclosures, displayed to the public, or kept

for breeding can provide proof of purchase, possession and

administration of veterinary medicinal products or

medicinal products to such animals for five (5) years after

their administration, including when the animal is

slaughtered or culled during the five (5) year period.";

(b) immediately following the words "The territory of

Malta may extend the scope of this obligation to other veterinary

medicinal products or medicinal products," there shall be added

the following new paragraphs

"The records shall be kept electronically or printed

hard copies. Hard copies shall be kept as hard bound

records or in paper binders. Official hard copies or

electronic templates may be provided by the Veterinary

Services. The records shall be kept in a suitable place in the

farm and available immediately for inspection by the

Veterinary Services.

Proof of purchase refers in particular to the invoices

and/or to the receipts or any document existing as hard

copy or in electronic format that provides documentary

evidence of how, when and from whom the veterinary

medicinal product or medicinal product were acquired.";

and

(c) immediately after paragraph (e) thereof there shall be

added the following paragraphs

"(f) scenario under which the veterinary medicinal

product or medicinal products were prescribed, which

could be one or more of the following scenario: treatment,

prophylactic or metaphylactic use.

(g) scientific justification as to why antimicrobial

veterinary medicinal products or medicinal products were

prescribed by the veterinary surgeon in the case of

metaphylactic and/or prophylactic use.".

22. In sub-regulation (1) of regulation 64, the words "in

accordance with its national legislation" shall be deleted.

23. Regulation 72 of the principal regulations shall be amended

as follows

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

words "veterinary medicinal products" there shall be added the

words "in any place where active substances and veterinary

medicinal products are manufactured, distributed, imported,

exported or used";

(b) in the first paragraph to sub-regulation (1) thereof,

immediately after the words "carry out" there shall be added the

words "at any reasonable time" and immediately after the words

"Council Directive 2004/28/EC" there shall be added the words

"or any provisions of these regulations."; and

(c) immediately after sub-regulation (7) thereof there

shall be added the following new sub-regulation

"(8) the persons responsible for the premises

mentioned in this regulation shall allow entry to the

authorised representatives of the veterinary services to

carry out their duties.".

24. Immediately after regulation 77 of the principal regulations

there shall be added the following new regulation

(5) Id-distributuri għandhom jintalbu jżommu

rendikont aġġornat tal-prodotti mediċinali veterinarji jew

it-trattamenti li jistgħu jiġu pprovduti biss permezz tar-

riċetta, bl-informazzjoni li ssegwi tiġi rrekordjata għal

kull tranżazzjoni li tidħol jew li toħroġ

(a) data tat-tranżazzjoni;

(b) isem tal-prodott mediċinali veterinarju

inkluż, skont il-każ, il-forma farmaċewtika u l-

qawwa tiegħu;

(ċ) in-numru tal-lott;

(d) il-kwantità

li

jirċievu

jew

li

jissupplixxu;

(e) isem jew isem il-kumpanija u l-indirizz

permanenti jew il-post tan-negozju rreġistrat tal-

fornitur f’każ ta’ xiri, jew tar-reċipjent f’każ ta’

bejgħ;

(f) isem u dettalji ta’ kuntatt tal-kirurgu

veterinajru li jagħmel ir-riċetta u, skont il-każ,

kopja tar-riċetta veterinarja;

(g) in-numru

tal-awtorizzazzjoni

ta’

kummerċjalizzazzjoni.

Minn tal-anqas darba fis-sena għandu jsir awditjar

dettaljat, u prodotti mediċinali veterinarji li jidħlu kif

ukoll li joħorġu u prodotti oħra li jingħataw bir-riċetta

għandhom jiġu rrikonċiljati mal-prodotti li jkun hemm

attwalment fl-istokk, kull diskrepanza għandha tiġi

mniżżla fir-reġistru appożitu. Dan ir-rendikont għandu

jkun aċċessibbli għal spezzjoni mis-Servizzi Veterinarji

għal perjodu ta’ mhux anqas minn ħames (5) snin.

(6) Meta ssir distribuzzjoni ta’ prodott mediċinali

veterinarju, id-distributur għandu jkun sodisfatt li l-

persuna li tkun ser tuża l-prodott hija kompententi biex

tagħmel dan b’mod sigur, u għandha l-intenzjoni li tużah

għall-iskop li huwa awtorizzat għalih jew kif indikat mill-

kirurgu veterinarju.

(7) Meta ssir distribuzzjoni ta’ prodott mediċinali

veterinajru, id-distributur għandu jinforma lil min jirċievi

l-prodott bid-doża, l-amministrazzjoni sigura tal-prodott

jew xi avviżi jew kontro-indikazzjonijiet fuq it-tabella

jew fuq il-fuljett fil-pakkett, inkluż informazzjoni fuq

kwalunkwe perjodu/i ta’ irtirar applikabbli.

(8) Jekk id-distributur jissupplixxi ammont ta’

prodott mediċinali veterinarju li huwa anqas mid-doża

indikata fuq il-pakkett, il-kirurgu veterinarju jista’ jiftaħ

pakkett li jkun fih prodott għal skopijiet ta’ forniment,

għajr l-ippakkjar immedjat ta’ prodott mediċinali

injettabbli.

(9) Meta

ssir

distribuzzjoni

ta’

aġent

antimikrobiku, id-distributur għandu jkun sodisfatt li

jkunu ttieħdu l-prekawzjonijiet meħtieġa biex ikunu

imnaqqsa r-riskji ta’ reżistenza antimikrobika u li jkun

ġie kkunsidrat l-użu prudenti tal-aġent antimikrobiku,

b’mod partikolari fl-użu ta’ antimikrobiċi kritikalment

importanti.

(10) Jekk id-distributur ikollu xi dubji fuq il-

kontenut ta’ riċetta veterinarja għandu jsolvihom mal-

kirurgu veterinajru li jkun ħareġ ir-riċetta qabel

jissupplixxi l-prodott.

(11) Jekk prodott mediċinali veterinarju huwa

pprovdut f’kontenitur ieħor li mhux dak speċifikat fl-

awtorizzazzjoni tal-kummerċjalizzazzjoni, il-kirurgu

veterinarju li jissupplixxi l-prodott għandu jassigura li l-

kontenitur huwa mmarkat kif xieraq u għandu jipprovdi

biżżejjed informazzjoni bil-miktub bil-għan li l-prodott

ikun jista’ jintuża b’mod sigur.

(12) Il-kirurgu veterinarju msemmi fir-regolament

79(2) għandu jkun responsabbli għall-armarju fejn

jinżammu l-prodotti mediċinali veterinarji. B’mod

partikolari, għandhom jiġu mħarsa l-kundizzjonijiet tal-

ħażna, tat-traċċabilità u r-rekwiżiti ta’ żamma ta’

informazzjoni.

(13) Kirurgu veterinarju li jissupplixxi prodott

mediċinali veterinarju għandu jkun preżenti meta l-

prodott jiġi mogħti lill-klijent, sakemm il-kirurgu

veterinajru

(a) jawtorizza kull tranżazzjoni b’mod

individwali qabel ma jiġi pprovdut il-prodott;

(b) huwa sodisfatt li l-persuna li qed tagħtih

lill-klijent hija kompetenti li tagħmel dan.

(14) Għandhom jingħataw biss prodotti mediċinali

veterinarji li ma skadewx.

(15) Id-dispożizzjonijiet tal-paragrafu (e) tas-

subregolament (5) paragrafu għandhom jidħlu fis-seħħ

mill-1 ta’ Novembru 2021.".

19. Minnufih wara r-regolament 59 tar-regolamenti prinċipali

għandu jiżdied it-Titolu u r-regolament ġdid li ġej

"TITOLU IX

REGOLAMENTI DWAR PRESKRIZZJONIJIET

59A. (1) Fit-territorju

ta’

Malta

kirurgi

maħruga minn

veterinarji jistgħu jippreskrivu biss prodotti mediċinali

veterinarji skont id-dispożizzjonijiet ta’ dan ir-

regolament.

(2) Fir-territorju ta’ Malta, il-preskrizzjoni ta’

prodott mediċinali veterinarju jew prodott mediċinali

għall-annimali għandha ssir biss minn kirurgi veterinarji.

(3) Il-preskrizzjoni ta’ prodott mediċinali

veterinarju jew prodott mediċinali għall-annimali

għandha ssir biss fuq il-preskrizzjonijiet veterinarji.

(4) Kirurgi veterinarji jistgħu jippreskrivu biss

prodott mediċinali veterinarju jew prodott mediċinali

għall-annimali li jkunu eżaminaw huma nfushom u

għandhom jerfgħu responsabbiltà klinika għat-trattament

tal-annimali fil-kura tagħhom.

(5) Prodott mediċinali veterinajru jew prodott

mediċinali jista’ ma jintużax għal trattament wieħed biss

skont l-istess preskrizzjoni.

(6) Qabel il-preskrizzjoni ta’ prodott mediċinali

veterinarju jew prodott mediċinali li jeħtieġ

preskrizzjoni, il-kirurgi veterinarji għandhom jagħmlu

viżta klinika tal-annimal fil-kura tagħhom.

(7) Il-viżta klinika mill-kirurgi veterinarji għandu

jsir riċentament biżżejjed għall-kirurgi veterinajri biex

ikollhom għarfien personali dwar il-kundizzjoni tal-

annimal jew l-istat ta’ saħħa preżenti tal-bhejjem jew

merħla biex tkun tista’ ssir djanjosi ta’ min joqgħod

fuqha jew jibda t-trattament empiriku.

(8) Qabel il-preskrizzjoni ta’ prodott mediċinali

veterjinarju jew prodott mediċinali, il-kirurgi veterinarji

għandhom qabel xejn jissodisfaw lilhom infushom li

(a) l-użu tal-prodott mediċinali veterinarju

jew il-prodtt mediċinali huwa ġustifikat għall-

ispeċi kkonċernati fuq bażi veterinarja;

(b) l-amministrazzjoni

tal-prodott

mediċinali veterinjarju jew il-prodott mediċinali

mhix inkompatibbli ma’ trattament jew użu

preċedenti u li mhemm l-ebda kontro-indikazzjoni

jew interazzjoni meta jintużaw għadd ta’ ikel

imħallat mal-mediċina għal-lest;

(ċ) il-prodott mediċinali veterinarju jew il-

prodott mediċinali huma preskritti biss f’tali

kwantitajiet kif meħtieġ għall-iskop ta’ trattament;

(d) ikunu ttieħdu l-prekawzjonijiet kollha

meħtieġa biex jiġu mnaqqsa r-riskji ta’ reżistenza

antimikrobika u li jkun ġie kkunsidrat l-użu

prudenti tal-aġent antimikrobiku, b’mod partikolari

fl-użu ta’ antimikrobiċi kritikalment importanti.

(9) Meta ssir preskrizzjoni ta’ prodott mediċinali

veterinarju jew prodott mediċinali, il-kirurgi veterinarji

għandhom ikunu sodisfatti li l-persuna li ser tuża l-

prodott hija kompetenti biex tagħmel dan b’mod sigur u

għandha l-intenzjoni li tużah għall-iskop li huwa

awtorizzat għalih.

(10) Meta

ssir

preskrizzjoni

ta’

aġenti

antimikrobiċi,

il-kirurgi

veterinarji

għandhom

jikkonsidraw l-aktar linjigwida riċenti maħruġa mis-

Servizzi Veterinajri, u organizzazzjonijiet oħra

nazzjonali, Ewropej jew Internazzjonali relevanti fir-

rigward ta’ antimikrobiċi kritikalment importanti.

(11) Waqt il-preparazzjoni ta’ preskrizzjoni

veterinarja, il-kirurgu veterinarju għandu jinforma lil min

se jirċievi l-preskrizzjoni fuq l-amministrazzjoni sigura

tal-prodott preskritt u fuq kwalunkwe avviżi jew kontra-

indikazzjonijiet assoċċjati mal-prodott.

(12) Prodott mediċinali veterinarju klassifikat

bħala soġġett għal preskrizzjoni veterinarja jista’ jiġi

amministrat

mingħajr

preskrizzjoni

veterinarja

personalment mill-kirurgu veterinarju. Dan ma

jipprekludix kirurgi mill-obbligazzjonijiet ta’ żamma ta’

informazzjoni msemmija fir-regolament 59(6).

(13) Il-preskrizzjonijiet veterinarji għandhom

ikunu konformi mal-linjigwida li jkunu ħarġu mis-

Servizzi Veterinarji.".

20. Ir-regolament 60 tar-regolamenti prinċipali għandu jiġi

emendat kif ġej

(a)

minnufih wara s-subparagrafu (ii) tal-paragrafu (a)

tas-subregolament (1) tiegħu għandu jiżdied is-subparagrafu

ġdid li ġej

"(iii) prodotti mediċinali veterinarji li ma jaqgħux fi

ħdan il-klassifikazzjoni tar-regolament 60(1)(a)(i), (b) u (ċ)

iżda madanakollu huma meqjusa li jeħtieġu preskrizzjoni

veterinarja għal perjodu temporanju.";

(b) minnufih wara l-paragrafu (h) tas-subregolament (2)

tiegħu għandu jiżdied is-subparagrafu ġdid li ġej

"(i) prodott mediċinali veterinarju klassifikat bħala

mediċina mogħtija biss bi preskrizzjoni jista’ jiġi eżentat

milli jkun preskritt u ddispensat bi preskrizzjoni jekk ikun

amministrat kollu kemm hu mill-kirurgu veterinarju

responsabbli mill-annimal li ma jipproduċix ikel, li hu

nnifsu jipprovdi l-prodott mediċinali veterinarju, u jekk sid

l-annimal ma jitlobx espliċitament preskrizzjoni."u

minnufih wara għandhom jiżdiedu s-subregolamenti ġodda

li ġejjin

"(3) Skont is-subregolament (1) għandu jkun hemm

l- erba’ (4) kategoriji ta’ distribuzzjoni ta’ prodotti

mediċinali veterinarji li ġejjin

(a) mediċina soġġetta għal Preskrizzjoni

Medika, Kirurgu Veterinarju u Spiżjar- imqassra għal

POM-VP;

(b) mediċina soġġetta għal Preskrizzjoni

Medika, Kirurgu Veterinajru- mqassra għal POM-V;

(ċ) prodott Mediċinali mhux bi Preskrizzjoni,

mqassra għal OTC;

bejgħ Ġenerali, mqassra għal GS.

(d)

(4) Il-forniment ta’ prodotti mediċinali veterinarji

għal kull kategorija ta’ distribuzzjoni għandha ssir bil-mod

segwenti

(a) POM-VP, għandha tiġi preskritta biss u/jew

iddispensata minn kirurgu veterinajru jew

iddispensata minn spiżjar skont it-termini tal-

preskrizzjoni veterinarja. Postijiet minn fejn dawn il-

prodotti jistgħu jiġu pprovduti huma spiżeriji

veterinarji, stabbilimenti veterinarji liċenzjati, u minn

kirurgu veterinarju waqt viżti fuq il-post;

(b) POM-V għandha tiġi preskritta biss,

iddispensata u amministrata minn kirurgu veterinarju.

Postijiet minn fejn dawn il-prodotti jistgħu jiġu

pprovduti huma stabbilimenti veterinarji liċenzjati, u

minn kirurgu veterinarju waqt viżti fuq il-post;

(ċ) OTC, tista’ tiġi ddispensata mingħajr

preskrizzjoni veterinarja. Il-persuni li jistgħu

jiddispensaw din il-kategorija ta’ prodotti mediċinali

veterinarji huma kirurgi veterinarji, spiżjara u persuni

kwalifikati kif meħtieġ skont l-ordni ta’ spiżjar jew

kirurgu veterinarju. Postijiet minn fejn dawn il-

prodotti jistgħu jiġu pprovduti huma spiżeriji

veterinarji, stabbilimenti veterinajri liċenzjati, u minn

kirurgu veterinajru waqt viżti fuq il-post;

(d) GS, tista’ tiġi ddispensata mingħajr

preskrizzjoni veterinarja. Il-persuni li jistgħu

jiddispensaw din il-kategorija ta’ prodotti mediċinali

veterinarji huma kirurgi veterinarji, spiżjara jew

persuni kwalifikati kif meħtieġ. Prodotti li jaqgħu

f’din il-kategorija jistgħu jiġu pprovduti minn

spiżeriji veterinarji, stabbilimenti veterinarji, pet

shops irreġistrati, bejjiegħa bl-imnut irreġistrati ta’

ħut tal-akwarju u kummerċjanti approvati fejn jiġi

prodott, mibjugħ jew innegozjat għalf immedikat

għall-annimali

Iżda s-Servizzi Veterinarji jista’ jagħmel

rekwiżiti biex jippermetti li prodotti klassifikati f’din

il-kategorija jiġu provduti minn postijiet oħra

minbarra dawk imniżżla hawn fuq biex jagħmel tajjeb

għal nuqqasijiet fil-forniment u jiffaċilita l-aċċess

għat-trattament biex ma jkunx ta’ detriment għall-

kura tal-annimal. It-tali postijiet ma jistgħux ikunu

ħwienet ġeneriċi u għandhom jaqgħu fir-

responsabbiltà ta’ persuna bl-esperjenza ta’ mhux

anqas minn sentejn (2) fl-immaniġġjar ta’ prodotti

mediċinali veterinarji ta’ din il-kategorija.

(5) Is-Servizzi

Veterinarji

għandu

jikkategorizza l-kategoriji ta’ distribuzzjoni ta’

prodotti mediċinali veterinarji meta jawtorizza

prodotti mediċinali veterinarji.

(6) Meta jiddeċiedi fuq il-kategorija ta’

distribuzzjoni ta’ prodott mediċinali veterinarju, is-

Servizzi Veterinajri jista’ jitlob parir mingħand

kumitati ta’ esperti fil-qasam u jista’ jikkonsidra l-

linjigwida ta’ korpi oħra relevanti kemm mil-lat

Nazzjonali, Ewropew jew Internazzjonali, skont kif

jiġi deċiż mis-Servizzi Veterinarji.

(7) Minkejja dak li jiġi deċiż waqt il-

proċedura inizzjali ta’ Awtorizzazzjoni ta’

Kummerċjalizzazzjoni, is-Servizzi Veterinarji jista’

jibdel il-kategorija ta’ distribuzzjoni ta’ prodott

mediċinali veterinarju kemm fuq talba mad-detentur

tal-Awtorizzazzjoni ta’ Kummerċjalizzazzjoni jew

minħabba varjazzjoni obbligatorja.

(8) Is-Servizzi

Veterinajri

għandu

jistabbilixxi l-kriterji għall-ikkategorizzar ta’ prodott

mediċinali veterinarju u jagħmilhom pubbliċi.

(9) Qisien differenti ta’ pakketti tal-istess

Awtorizzazzjoni ta’ Kummerċjalizzazzjoni jistgħu

jingħataw kategoriji ta’ distribuzzjoni differenti.

(10) Meta l-kategorija ta’ distribuzzjoni tal-

prodott mediċinali veterinarju hija POM-V jew POM-

VP din għandha tkun indikata fuq il-pakkett immedjat

u/jew fuq barra tal-prodott b’mod leġibbli, u mingħajr

karattri mħassra.

(11) Il-kliem li jispeċifika l-kategorija ta’

distribuzzjoni tal-prodott mediċinali veterinarju u li

għandu jkun jinqara u ma jitħassarx, jistgħu jkunu

stampati fuq il-pakkett immedjat u/jew fuq barra tal-

prodott jew fuq tabella addattata li tidher sew.

(12) Kemm il-forma mqassra kif ukoll id-

deskrizzjoni sħiħa tal-kategorija ta’ distribuzzjoni tal-

prodott mediċinali veterinarju preżenti fuq il-pakkett

immedjat u/jew fuq barra tal-prodott għandhom ikunu

aċċettabbli.

(13) Id-detentur tal-awtorizzazzjoni għad-

distribuzzjoni bl-ingrossa għandu jqassam biss il-

prodotti mediċinali veterinarji f’postijiet awtorizzati

għall-bejgħ ta’ prodotti mediċinali veterinarji skont

dawn ir-regolamenti.

(14) Id-detentur tal-awtorizzazzjoni għad-

distribuzzjoni bl-ingrossa għandhom iqassmu biss

f’postijiet awtorizzati li jbigħu biss prodotti

mediċinali veterinarji tal-kategorija/i ta’ prodotti

mediċinali veterinajri li huma awtorizzati li jinbigħu

minn kull tip ta’ post skont dawn ir-regolamenti.".

21. Ir-regolament 62 tar-regolamenti prinċipali għandu jiġi Jemenda r-

regolament 62

emendat kif ġej

tar-regolamenti

prinċipali.

(a) l-ewwel paragrafu tiegħu għandu jiġi sostitwit bil-

paragrafu ġdid li ġej

"Malta għandha tassigura illi s-sidien jew persuni li

jieħdu ħsieb l-annimali li jipproduċu l-ikel jew persuni li

jieħdu ħsieb annimali li huma magħluqa ġewwa postijiet,

murija lin-nies jew miżmuma għat-trobbija, jistgħu

jipprovdu evidenza ta’ xiri, pussess u amministrazzjoni ta’

prodotti mediċinali veterinarji ta’ dawn l-annimali għall-

ħames (5) snin wara l-amministrazzjoni tagħhom, inklużi

wkoll meta l-annimal jiġi maqtul matul il-perjodu ta’

ħames (5) snin.";

(b)

minnufih wara l-kliem "It-territorju ta’ Malta jista’

jestendi l-iskop ta’ dan l-obbligu lil prodotti mediċinali

veterinarji" għandhom jiżdiedu l-paragrafi ġodda li ġejjin

"Ir-rendikont għandu jinżamu b’mod elettroniku jew

stampat. Kopji stampati għandhom jinżammu llegati jew

fil-forma ta’ paper binders. Kopji uffiċjali stampati jew

mudelli elettroniċi jistgħu jingħataw mis-Servizzi

Veterinarji. Ir-rendikont għandu jinżamm f’post addattat

fir-razzett u immedjatament aċċessibbli għal spezzjoni mis-

Servizzi Veterinarji.

Prova tax-xiri tirreferi b’mod partikolari għall-fatturi

u/jew l-irċevuti jew kull tip ta’ dokument ieħor li jeżisti fil-

forma stampata jew fil-forma elettronika li jipprovdi

evidenza dokumentata ta’ kif, meta u mingħand min ġew

miġjuba l-prodotti mediċinali veterinarji jew il-prodotti

mediċinali.";

(ċ)

minnufih wara l-paragrafu (e) tiegħu għandhom

jiżdiedu l-paragrafi ġodda li ġejjin

"(f) f’xenarju fejn il-prodott mediċinali veterinarju

ġie preskritt, jista’ jkun wieħed minn dawn it-tliet xenarji

possibli, trattament, profilattiku jew użu metafilattiku;

(g) Xjentifikament ġustifikat għaliex aġenti

antimikrobiċi ġew rakkomandati mill-kirurgu veterinarju

fil-każ ta’ użu metafilattiku u/jew profilattiku.".

22. Fis-subregolament (1) tar-regolament 64, il-kliem "skont il-

leġislazzjoni nazzjonali" għandhom jiġu mħassra.

23. Regolament 72 tar-regolamenti prinċpali għandu jiġi

emendat kif isegwi

(a)

fis-subregolament (1) tiegħu, minnufih wara l-kliem

"mal-prodotti mediċinali veterinarji" għandhom jiżdiedu l-kliem

"u ta’ kwalunkwe post fejn is-sustanzi attivi u l-prodotti

mediċinali veterinarji huma manifatturati, imqassma, impurtati,

esportati jew użati.";

(b) fl-ewwel paragrafu tas-subregolament (1) tiegħu,

minnufih wara l-kelma "jistgħu jagħmlu wkoll" għandhom

jiżdiedu l-kliem "fi kwalunkwe ħin raġonevoli" u minnufih wara

l-kliem "Direttiva tal-Kusnill 2004/28/KE" għandhom jiżdiedu l-

kliem "jew kwalunkwe dispożizzjoni oħra ta’ dawn ir-

regolamenti."; u

(ċ) minnufih wara s-subregolament (7) tiegħu għandu

jiżdied is-subregolament ġdid li ġej

"(8) Il-persuni

responsabbli

mill-postijiet

imsemmija f’dan ir-regolament għandhom jippermettu d-

dħul tar-rappreżentanti awtorizzati tas-servizzi veterinarji

biex iwettqu d-dmirijiet tagħhom.".

24. Minnufih wara r-regolament 77 tar-regolamenti prinċipali Iżid regolament

għandu jiżdied ir-regolament ġdid li ġej

" Regolamenti

(1) The Veterinary Services shall permit the

Advertising of

advertising of veterinary medicinal products that in

accordance with regulation 60, are available on

veterinary prescription to

(a) veterinary surgeons and pharmacists;

(b) professional keepers of animals,

provided that the veterinary medicinal products are

preventive immunological products or anti-

helmintic therapies.

(2) The Veterinary Services shall permit the

advertising of veterinary medicinal products to the

general public which, by virtue of their composition and

purpose, are intended and designed for use with the

advice of the pharmacist, if necessary, but without the

intervention of a veterinary surgeon for diagnostic

purposes or for the prescription or monitoring of

treatment.

(3) No person may advertise medicinal product

for administration to animals. Scientific informative

material can be sent on request to the veterinary surgeon

when the provisions of regulation 10 and 11 are to be

applied. The information must not be promotional in

nature and must not include a price list.

(4) (a) It shall not be permissible for persons

allowed to supply veterinary medicinal products to

veterinary surgeons or pharmacy owners to induce them

to prescribe or supply veterinary medicinal products by

the gift, offer or promise of any benefit or bonus,

whether in money or in kind.

(b) It shall not be permissible for persons

allowed to supply veterinary medicinal products to make

any form of contractual agreement with animal keepers

that benefits the sale of their products.

(c) It shall not be permissible for persons

allowed to supply veterinary medicinal products to

solicit or accept any inducement prohibited under sub-

regulations 4(a) and 4(b). Provided that existing

measures or trade practices relating to prices, profit

margins and discounts shall not be affected.

(5) The advertising of a veterinary medicinal

product shall

(a) encourage the rational use of the

veterinary medicinal product, by presenting it

objectively and without exaggerating its

properties;

(b) comply with the particulars listed in the

summary of product characteristics;

(c) not be misleading;

(d) be set out in such a way that it is clear

that the message is an advertisement and that the

product is clearly identified as a veterinary

medicinal product;

(e) not give the impression that a veterinary

surgeon is unnecessary, in particular by offering a

diagnosis or by suggesting treatment by mail,

internet or any other means;

(f) not suggests that the effects of

administering the veterinary medicinal product are

guaranteed, are not accompanied by adverse

reactions or are better than, or equivalent to, those

of another treatment or veterinary medicinal

product;

(g) not suggests that the health of the

animal can be enhanced by taking the veterinary

medicinal product;

(h) not suggests that the health of the

animal could be affected by not taking the

veterinary medicinal product provided that this

shall not apply to the vaccination campaigns;

(i) not suggests that the veterinary

medicinal product is a foodstuff, cosmetic or other

consumer product;

(j) not suggests that the safety or efficacy

of the veterinary medicinal product is due to the

fact that it is natural.

(6) (a) Any advertising of a veterinary

medicinal product to persons qualified to prescribe or

supply such products shall include

(i) the trade name;

(ii) a list of active ingredients;

(iii) the pharmaceutical form;

(iv) major indications for use;

(v) the dosage and method of use;

(vi) side effects, warnings, precautions and

contraindications;

(vii) the name and address of the marketing

authorisation holder;

(viii) any research and/or publications on the

use of the active substance.

(b) All the information contained in the

documentation referred to in sub-regulation (6)(a) shall

be accurate, up-to-date, verifiable and sufficiently

complete to enable the recipient to form his or her own

opinion of the therapeutic value of the veterinary

medicinal product concerned.

(c) Quotations as well as tables and other

illustrative matter taken from scientific works for use in

the documentation referred to in sub-regulation (9)(a)

shall be faithfully reproduced.

(7) (a) Free samples shall be provided on an

exceptional basis only to persons qualified to prescribe

them and on the following conditions

(i) each sample shall be no larger than the

smallest presentation on the market;

(ii) each sample shall be marked "free

sample - not for sale";

(iii) each sample shall be accompanied by a

copy of the summary of product characteristics;

(iv) veterinary

medicinal

products

containing psychotropic or narcotic substances as

defined under the First Schedule to the Dangerous

Drugs Ordinance and the Third Schedule to the

Medical and Kindred Professions Ordinance

cannot be distributed as samples;

(b) Starter packs shall not be regarded as samples

and shall not be labelled as such.

(c) During visits by sales representatives the

persons visited should be given information about the

use of the veterinary medicinal products, with particular

reference to any adverse reactions.

(8) The person who advertises the veterinary

medicinal products shall

(a) keep available for, or communicate to,

the Veterinary Services, a sample of all

advertisements emanating from his undertaking

together with a statement indicating the persons to

whom it is addressed, the method of dissemination

and the date of first dissemination;

(b) supply the Veterinary Services with the

information and assistance it requires to carry out

its responsibilities;

(c) ensure that the decisions taken and

conditions imposed by the Veterinary Services are

immediately and fully complied with.

(9) It is not permissible to advertise veterinary

medicinal products which are not registered with the

Veterinary Services.".

25. Regulation 79 of the principal regulations shall be amended Amends

(a)

sub-regulation (2) thereof shall be substituted by the

following new sub-regulation

"(2) For the purposes of these regulations every registered

or licensed establishment where food producing animals are kept

and are not excluded from the provisions of the Official Controls

Regulation (EU) 2017/625 by the veterinary services , and the

establishments where animals are kept for display to the public

or for breeding purposes in the territory of Malta shall have an

appropriate animal health control programme designed and

implemented under the responsibility of a professional registered

with the Veterinary Surgeons Council

Provided that a register of the professionals

responsible for each animal health control programme shall be

kept by the Veterinary Services

Provided further that the Veterinary Services may

from time to time publish requirements related to animal health

control programmes in the Gazette."; and

(b) sub-regulation (3) thereof shall be substituted by the

following new sub-regulation

"(3) The provisions of sub-regulation (2) shall come

into force two (2) years from the date of coming into force

of these regulations.".

26. Title IX and Title X of the principal regulations shall be

renumbered as Title XIII and Title XIV respectively.

27. Immediately after regulation 79 of the principal

regulations, there shall be added the following new Title and

regulation

"TITLE XII

ADMINISTRATION OF VETERINARY MEDICINAL

PRODUCTS AND MEDICINAL PRODUCT TO

ANIMALS

(1) In extreme and/or urgent situation to

Administration

of veterinary

alleviate suffering of the animal or impending spread of

medicinal

products and

disease any person can administer a veterinary medicinal

medicinal

product or medicinal product which requires a veterinary

products to

animals.

prescription without the veterinary prescription or the

instructions to administer the product by the veterinary

surgeon.

(2) No person can administer, or supply for

administration, a veterinary medicinal product to animals

unless the product obtains an authorisation from the

Veterinary Services.

(3) Products whose therapeutic effectiveness is

merely anecdotal should be used with caution in all

animals. The administration of these products to food

producing species is subject to the approval of the

veterinary services. The veterinary services may ask the

animal keeper to provide chemical data, clinical

documentation and studies about the possible

environmental impact before granting its approval.

(4) The keeper/owner/carer of animals must keep

proof of purchase of all products administered or

intended to be administered to the animals for the

treatment or prevention of disease or, if he did not buy

them, documentary evidence of how he acquired them.

(5) Metaphylactic or prophylactic antimicrobial

treatment may be allowed with conditions. Preventive

use of antimicrobials veterinary medicinal products or

medicinal products is not allowed.

(6) Except in emergency situations, before

prescribing a veterinary medicinal product or a medicinal

product that contains an antimicrobial agent classified as

critically important to human health or that is reserved

for treating infections in animals for which no effective

alternative treatments exist, the prescribing veterinary

surgeon shall take into account the results of the

diagnostic laboratory information (pathogen isolation,

identification and antibiogram).

(7) No person shall administer a veterinary

medicinal product or a medicinal product to a food

producing species and place the animal for slaughter to

be consumed unless the relevant withdrawal period has

been observed.

(8) Stockpiling of antimicrobial veterinary

medicinal products or medicinal products in a farm to be

administered at a later stage is not permitted.

(9) Use of combination of antimicrobials should

be scientifically supported.".

28. Sub-regulation (2) of regulation 82 of the principal Amends

regulations shall be renumbered as sub-regulation (2)(a) and the principal

immediately thereafter there shall be added the following new sub- regulation.

regulations

"(b) The marketing authorisation holder shall implement a

system for recording and reviewing complaints together with an

effective system for recalling promptly and at any time the

veterinary medicinal products in the distribution network.

(c) record and investigate any complaint concerning a

quality defect.

(d) The Veterinary Services shall be informed by the

Marketing Authorisation holder of any quality defect that could

result in a recall or abnormal restriction on the supply. In so far

as possible, the countries where the products are marketed shall

also be indicated.".

29. Regulation 87 of the principal regulations shall be

substituted by the following new regulation

(1) Any person who in the course of his

activity generates veterinary medicinal products waste,

shall inform himself of the current procedures regarding

the safe disposal of unused, unsuitable or expired

medicinal products from the entity responsible for waste

management in Malta and shall follow the guidelines

issued by the veterinary services.

(2) Companies,

large

establishments

and

professional bodies shall describe the procedure they

follow for the safe disposal of unused, unsuitable or

expired veterinary medicinal products in writing, and

keep it updated according to the requirements that may

change over-time.

(3) The Veterinary Services shall ensure that

veterinary medicinal product waste producers have

appropriate procedures set in place for the disposal of

unused, unsuitable or expired veterinary medicinal

products in accordance with the law of Malta and any

particular instructions described in the summary of

product characteristics of the product.".

30. Immediately after regulation 87 of the principal regulations

there shall be added the following new regulations

Any person who contravenes regulations

"Offences and

5(1), 27(A), 39(1)(a)(b), 39(2)(a), 39(3), 46(1), 50B,

50C, 58(1), 58A, 59(1), 59A(2), 59A(3), 60(13),

60(14), 62 and 77A(4) shall be guilty of an offence

against Article 38 of the Act and shall be liable, on

conviction, to a fine (multa) of not less than five

thousand euro (€5,000) and not more than ten thousand

euro (€10,000).

Any person who contravenes regulations

39(3), 59A(2) and 59A(3), shall be guilty of an offence

against article 38 of the Act and shall be liable, on

conviction, to a fine (multa) of not less than three

thousand euro (€3,000) and not more than seven thousand

euro (€7,000).

Any person who contravenes regulation

72(8) shall be guilty of an offence against article 35 of

the Act and shall be liable, on conviction, to a fine

(multa) of not less than three thousand euro (€3,000)

and not more than seven thousand euro (€7,000).

Any person who contravenes regulations 27A,

46(1), 50B, 50C, 59(1), 60(13), 60(14), 62 and 77A(4)

shall be guilty of an offence against article 38 of the Act

and shall be liable, on conviction, to a fine (multa) of not

less than five hundred euro (€500) and not more than one

thousand euro (€1,000).

Any person who contravenes any regulation

other than those mentioned in regulations 88,89, 90 and

91 shall be guilty of an offence and shall be liable, on

conviction, to a fine (multa) of not less than two

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

euro (€400).

Where the Director has reasonable cause to

believe that an offence against these regulations has

been committed and that it would be appropriate to

impose an administrative penalty under article 61 of the

Act, the Director shall proceed in accordance with the

provisions of the said article 61 of the Act.".

31. The principal regulations shall be amended as follows

(a)

the word "veterinarian", wherever it occurs, shall be

substituted by the words "veterinary surgeon";

(b

the word "veterinarians", wherever it occurs, there

shall be substituted the words "veterinarian surgeons";

(c) the words "territory of Malta", wherever they occur

with the exception of the same words used in the meaning of the

term "Veterinary Services" in regulation 2 and in regulation 51,

shall be substituted by the word "Director"; and

(d) the word "Community", wherever it occurs with the

exception of the same word used in sub-regulation (2) of

regulation 1 and regulation 30, shall be substituted by the word

"Union".

€4.68