Veterinary Medicinal Products Regulations, 2024

L.N. 335 of 2024

VETERINARY SERVICES ACT

(CAP. 437)

Veterinary Medicinal Products Regulations, 2024

IN EXERCISE of the powers conferred by articles 30, 32, 70 and

73 of the Veterinary Services Act, the Minister responsible for

veterinary services, after consultation with the Director Veterinary

Services, has made the following regulations:-

(1) The title of these regulations is the Veterinary

Medicinal Products Regulations, 2024.

(2) These regulations implement the requirements of

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

of 11 December 2018 on veterinary medicinal products and repealing

Directive 2001/82/EC and regulate other matters of Regulation (EU)

2019/6.

(3) These regulations shall also be applicable to veterinarians

referred to in Regulation (EU) 2019/6.

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

months from their date of publication in the Gazette.

(5) Regulation 17(2) shall come into force within two (2) years

from the date of publication of these regulations.

(1)

In these regulations, unless the context otherwise

requires

"Act" means the Veterinary Services Act;

"Agency" means the European Medicines Agency

established by Regulation (EC) No 726/2004 of the European

Parliament and of the Council of 31 March 2004 laying down

Community procedures for the authorisation and supervision of

medicinal products for human and veterinary use and

establishing a European Medicines Agency;

"applicant" means the person who applies with the Director

to obtain any kind of authorisation as the case may be;

"broker" means a person who acts as an intermediary in

arranging sale of veterinary medicinal products between two (2)

or more parties who are authorised to distribute veterinary

medicinal products by means of a wholesale distribution

authorization, without the veterinary medicinal products being

transported or stored by him;

"brokering" means the activity of the broker in relation to

the sale or purchase of veterinary medicinal products, except for

wholesale distribution, which do not include physical handling of

the veterinary medicinal product by the broker, and which consist

of negotiating independently and on behalf of another person;

"country of source" means a Member State of the European

Union or a country in the European Economic Area;

"Director" means the Director Veterinary Services who

shall be a warranted veterinary surgeon or an officer nominated

by him;

"electronic veterinary prescription" means a veterinary

prescription making use of the technology framework made

available by the Director that allows veterinary surgeons to issue

veterinary prescriptions through electronic media and that is

available to those persons who are authorized to dispense

veterinary medicinal products;

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

Food Safety Act;

"imported" means the act of acquiring veterinary medicinal

product or part thereof, whether for the purposes of profit or non-

profit, from a third country;

"investigational veterinary medicinal product’" means a

pharmaceutical form of an active substance or placebo being

tested or used as a reference in a clinical trial, including products

already with a marketing authorisation but used or assembled

(formulated or packaged) in a way which is different from the

authorised form, or when used for an unauthorised indication, or

when used to gain further information about the authorised form;

"licensed veterinary establishment" shall have the same

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

Establishments (Licensing) Regulations;

"medicinal products for human use" shall have the same

meaning as that assigned to it in the Medicines Act;

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

European Union;

"narcotic drugs" means the substances present on the

Yellow List established by the International Narcotics Control

Board in accordance with the Protocol of 25 March 1972

amending the Single Convention on Narcotic Drugs, 1961;

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

of Pharmacists kept by the Pharmacy Council in accordance with

article 17 of the Health Care Professions Act;

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

with, any premises authorised or licensed by the Director, as the

case may be;

"prescribing" means the act of preparing a veterinary

prescription by a veterinary surgeon whether on paper or through

electronic media;

"psychotropic drugs" means the substances listed in the

Third Schedule to the Medical and Kindred Professions

Ordinance and those substances listed on the Green List prepared

by the International Narcotics Control Board in accordance with

the Convention on Psychotropic Substances of 1971, as

amended;

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

of the European Parliament and of the Council of 11 December

2018 on veterinary medicinal products and repealing Directive

2001/82/EC;

"responsible person" means the technically competent

person referred to in Article 101 of Regulation (EU) 2019/6;

"Single Convention" means the Single Convention on

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

subsequently amended by the Protocol adopted in Geneva on the

25th March, 1972;

"suitably learned person" means any person included in the

Register of the Professions and Trades Supplementary to the

Veterinary Profession provided for in the Act who may dispense

veterinary medicinal products of category OTC under the

supervision of a veterinary surgeon or pharmacist and dispense

others of category GS without this supervision;

"veterinary pharmacy" means any premises licensed in

accordance with article 62 of the Act in which any veterinary

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

supplied directly to the public by retail, but shall not include

dispensing of treatments from veterinary establishments and

dispensing during out calls by veterinary surgeons;

"veterinary surgeon" means a person who has a warrant

granted in accordance with article 43 of the Act;

"wholesale distributor of veterinary medicinal products"

means the holder of a valid wholesale distribution authorisation

referred to in Article 99(1) of Regulation (EU) 2019/6.

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

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

same meaning assigned to them in the Act

Provided that words and phrases used in these regulations

which are neither defined in these regulations nor in the Act shall have

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

The Director shall determine the language or languages of Languages.

the summary of the product characteristics and the information on the

labelling and on the package leaflet of veterinary medicinal products to

be marketed in the territory of Malta and make this information public.

The package leaflet of a veterinary medicinal product may Package leaflet.

be made available on paper, electronically, or both of them.

(1) For the purposes of Article 5(6) of Regulation (EU) Exemptions

from a

2019/6, the applicant shall submit an application in the form provided marketing

authorisation.

for by the Director and shall pay the established fee

Provided that the veterinary medicinal product shall only be

placed on the market when the authorisation is issued by the Director.

(2) The exemption stipulated under Article 5(6) of Regulation

(EU) 2019/6 shall only be granted at the discretion of the Director.

(3) The holder of an authorisation in accordance with this

regulation shall notify the Director within fifteen (15) days of

becoming aware of any adverse reaction and shall keep records of such

incidents

Provided that the records provided for in this regulation

shall be kept by a holder of an authorisation in accordance with this

regulation for five (5) years and shall be made available to the Director

upon his request.

(4) The Director may publish a list of active substances that

may be used in veterinary medicinal products authorised in accordance

with this regulation. This list shall specify the species of non-food

producing animals for which the active substances are approved. This

list may also specify the manner in which the product containing the

active substances are to be administered.

(5) The Director may reject an application or may suspend and,

or revoke the authorisation granted in accordance with this regulation

if any one (1) or more of the following occur

(a)

adverse reactions are reported and confirmed;

(b) it is demonstrated, at any time after authorisation, that

the risk-benefit is unfavourable;

(c) the product contains active substances that are re-

classified as narcotic or psychotropic drugs;

(d) any one (1) of the ingredients in the product is not

included anymore in the list of active substances mentioned in

sub-regulation (4); and

(e) it is reported and is verified by the Director that the

product is not being used on animals as established in Article

5(6) of Regulation (EU) 2019/6.

(6) The products authorised under this regulation shall be

labelled with the following

(a)

the name of the veterinary medicinal product;

(b)

the pharmaceutical 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 statement to the effect of "For administration on

non-food producing animals only. Veterinary medicinal product

authorised in accordance with Article 5(6) of Regulation (EU)

2019/6";

(h)

the target species;

(i)

storage instructions, if applicable;

(j)

therapeutic indications, if applicable;

(k)

contra-indications, if applicable; and

(l) interaction with other medicines and other forms of

interaction, if applicable.

(7) The authorisation granted in accordance with this regulation

shall be valid for a period of five (5) years.

(1) Veterinary medicinal products, investigational Authorisation

for research and

veterinary medicinal products and active substances shall not be used development

for research and development purposes unless the Director grants such purposes.

authorisation to the applicant.

(2) The applicants requesting authorisation to use veterinary

medicinal products, investigational veterinary medicinal products and,

or active substances for research and development purposes shall

submit an application in the form provided by the Director before the

activity takes place and shall pay the relevant fee.

(3) Veterinary medicinal products authorised in accordance

with this regulation may be exempt from the requirements established

by Articles 5, 88 and 99 of Regulation (EU) 2019/6.

(4) Active substances authorised in accordance with this

regulation may be exempted from the requirements established by

Article 95 of Regulation (EU) 2019/6.

(5) The authorisation granted in accordance with this regulation

shall be valid for a period of three (3) years.

(6)

An authorisation in accordance with this regulation shall be

granted without prejudice to any authorisation, licence or permit that

the applicant may need to obtain from another entity in order to engage

in the research activity involving veterinary medicinal product,

investigational veterinary medicinal products or active substances.

(7) The Director may establish, amend, add or remove any

terms and conditions pertaining to the authorisation that he may deem

fit in light of scientific advancements or new information that may

arise, from time to time.

(8) If applicable, the holder of the authorisation in accordance

with this regulation shall administer the product to the test animal after

obtaining prior authorisation from the relevant entity and only in

accordance with the terms and conditions set out in the Animal

Welfare Act and the Protection of Animals used for Scientific Purposes

Regulations.

(9) Unless a withdrawal period is determined, test animals

administered veterinary medicinal products, investigational veterinary

medicinal products and active substances authorised in accordance

with this regulation shall be excluded permanently from the food

chain.

(10) The holder of an authorisation in accordance with this

regulation shall notify the Director within fifteen (15) days of

becoming aware of any adverse reactions on the animal or on the

person administering the products or substances in terms of this

regulation

Provided that the records provided for in this regulation

shall be kept by the holder of an authorisation in accordance with this

regulation for a period of five (5) years and shall be made available to

the Director upon his request.

(11) The Director may carry out inspections on the premises and

the activities being carried out on the premises by the holder of the

authorisation.

(1) Veterinary medicinal products may be exempted from

the requirements provided for in Articles 5, 88 and 99 of Regulation

(EU) 2019/6 when the products are acquired from a Member State or

imported for personal use provided that all the following conditions are

fulfilled

(a)

the products shall not be sold or re-sold;

(b) the products shall not be transferred to other third

parties unless such transfer is notified to the Director;

(c) the quantity of products obtained shall be proportional

to the dosage regime of the condition it will be used for;

(d) the quantity of products which is allowed entry in the

territory of Malta shall cover the period indicated as the duration

of treatment in the product’s specifications or on the veterinary

prescription. However, products intended to be used for recurrent

or chronic conditions may be allowed entry in the territory of

Malta several times a year, provided that cogent evidence that

demonstrates the benefits obtained by the regular use of the

products can be provided;

(e)

a veterinary prescription shall be provided for

products classified as requiring such a prescription in the country

from where they are obtained, or for similar veterinary medicinal

products in the territory of Malta

Provided that the Director may still require the

veterinary prescription when the products are classified as not

requiring a veterinary prescription in the country from where

they are obtained;

(f) 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, shall be

obtained;

(g) only products that do not contain ingredients which

are classified as illegal in territory of Malta and which do not

have banned indications in the territory of Malta shall be

obtained;

(h) only appropriately labelled products which give clear

indication of the nature of the ingredients thereof shall be

obtained;

(i) food producing animals administered with the

veterinary medicinal products authorised in accordance with this

regulation may only be consumed by the individual getting the

veterinary medicinal products, or by other consenting persons of

the same household. The appropriate withdrawal period shall

apply, where applicable;

(j) 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 Director in a

timely manner; and

(k) the Director’s decision shall be without prejudice to

any license or permit that the individual getting the veterinary

medicinal products may need to obtain under other regulations or

rules.

(2) This regulation shall not be applicable to live or attenuated

immunological veterinary medicinal products, 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 the

Measures to monitor certain Substances and Residues thereof in Live

Animals and Animal Products Rules and the substances listed in Table

2 of Commission Regulation (EU) No 37/2010 of 22 December 2009

on pharmacologically active substances and their classification

regarding maximum residue limits in foodstuffs of animal origin.

(3) The Director may release, retain or destroy any veterinary

medicinal products alone or in feed, active substances or other products

intended to be administered to or on animals or given as feed or with

feed or water if and when these products are intercepted at the various

entry control points throughout the territory of Malta, or in any

establishments under his control.

(4) Any expense incurred for the release, retention or

destruction of veterinary medicinal products alone or in feed, active

substances or other products intended to be administered to, or on

animals or given as feed or with feed or water, shall be payable by the

person getting the products as determined by the Director.

(5) Pursuant to sub-regulation (3), the Director may keep a

record of all instances of release, retention or destruction. These

records shall be kept by the Director for a period of not less than fifteen

(15) years.

(6) The Director may issue a list with the requirements needed

for obtaining veterinary medicinal products in accordance with this

regulation through a notice in the Gazette

Provided that the provisions of this regulation shall also

apply to veterinary medicinal products that are brought in the territory

of Malta as a donation for use on animals kept in approved sanctuaries

subject to the donations

Provided further that the Director shall be notified of such

request with the name, quantity and nature of the products, the names

and addresses of the donor, the recipient and the animal sanctuaries

involved.

(1) Before the placing on the market of any veterinary Registration in

accordance with

medicinal product as established by Article 116 of Regulation (EU) Article 116 of

2019/6, a person shall register every veterinary medicinal product with Regulation

2019/6.

the Director in the manner provided by him and shall pay the relevant

(2)

Before approving the registration, the Director may

(a) request the competent authority in the country of

source to furnish a copy of the current marketing authorisation;

(b) ensure that the entity applying for a registration in

accordance with Article 116 of Regulation (EU) 2019/6 is a

legally established company in the European Union or European

Economic Area;

(c) notify the marketing authorisation holder of his

intention to grant a registration in accordance with Article 116 of

Regulation (EU) 2019/6 when the applicant is not the same entity

as the marketing authorisation holder in the country of source;

(d) request the applicant to furnish a copy of the current

marketing authorisation

Provided that when it is not possible for the applicant

to provide a copy of the current marketing authorisation, he shall

be required to provide alternative evidence that the product is

being marketed in the country of source;

(e) request from the applicant data on the impact of the

product on the environment in the territory of Malta;

(f) request the applicant to furnish a letter of access

issued by the market authorisation holder granting him the use of

the marketing authorisation for the purposes of Article 116 of

Regulation (EU) 2019/6

Provided that when it is not possible for the applicant

to obtain a letter of access from the market authorisation holder,

the applicant may be requested by the Director to provide

evidence that due diligence has been exercised to ensure that the

veterinary medicinal products were obtained from a duly

authorised supplier of veterinary medicinal products in the

country of source; and

(g) ensure that the applicant has a system in place for the

recording and investigation of adverse drug reactions and defects

in a batch or veterinary medicinal product.

(3) After registration in accordance with this regulation, the

registration holder shall ensure that

(a) the veterinary medicinal product is kept in line with

the marketing authorisation issued in the country of source for as

long as the registration remains valid;

(b) the Director is notified of any variation to the terms of

the marketing authorisation approved in the country of source

that affects the summary of the products’ characteristics, the

package leaflet, the packaging, the labelling and any change in

administrative details that may have been made after the original

registration;

(c) any action relating to adverse drug reaction and, or a

product or batch recall shall be implemented without delay; and

(d) he is responsible for the requirements in paragraph

(c), or appoints another person for such purpose.

(4) By way of derogation from Article 2(1) and (2) of the

Regulation (EU) 2019/6, only Articles 57, 94, 117, 119, 123 and 134 of

Regulation (EU) 2019/6 shall apply to veterinary medicinal products

registered in accordance with Article 116 of Regulation (EU) 2019/6.

(5) The registration granted in accordance with this regulation

shall be valid for a period of three (3) years.

(1) A veterinary medicinal product shall not be procured

from another Member State or imported by veterinary surgeons before

the Director grants the necessary authorisation in accordance with

Articles 110 (2) and (3), 112, 113 and, or 114 of Regulation (EU)

2019/6.

(2) Veterinary surgeons shall apply in the manner provided by

the Director to obtain an authorisation for procuring a veterinary

medicinal product from another Member State or for the importation of

veterinary medicinal products in accordance with Articles 110 (2) and

(3), 112, 113 or 114 of Regulation (EU) 2019/6 and shall pay the

relevant fee.

(3) The authorisation granted in accordance with this regulation

shall be valid for a period of one (1) year.

(4) Veterinary surgeons shall keep adequate records of the

treatment given with the veterinary medicinal products authorised in

accordance with this regulation for a period of not less than five (5)

years and shall be made readily available to the Director upon his

request.

(5) The records provided for in this regulation shall include the

identification, including the target species, of the animal or group of

animals, the date of supply, the dosage, the administration instructions

and the withdrawal period assigned, if applicable.

(6) For the purposes of this regulation, the activity undertaken

by the veterinary surgeons shall be excluded from the provisions of

Articles 88 and 99 of Regulation (EU) 2019/6.

(1) For the purposes of Article 86 of Regulation (EU) Registration of

homeopathic

2019/6, a person shall submit a request in the manner indicated by the veterinary

Director for each homeopathic veterinary medicinal product that he medicinal

products.

intends to register and place on the market and shall pay the relevant

fee.

(2) The registration granted in accordance with this regulation

shall be valid for a period of five (5) years.

(1) For the purposes of Article 102 of Regulation (EU) Parallel trade.

2019/6, wholesale distributors shall submit a request in the manner

indicated by the Director for the registration of each veterinary

medicinal product intended for parallel trade and shall pay the relevant

fee.

(2) The registration granted in accordance with this regulation

shall be valid for a period of five (5) years.

(1) For the purposes of these regulations, the manufacture

of active substances shall include both total and partial manufacture or

importation of an active substance, and the various processes of

dividing up, packaging or presentation prior to their incorporation into

a veterinary medicinal product, including repackaging or re-labelling,

as are carried out by a distributor.

(2) For the purposes of Article 89 of Regulation (EU) 2019/6,

the applicants shall submit an application in the manner provided by

the Director to obtain the manufacturing authorisation referred to in

Article 88(1) of Regulation (EU) 2019/6 and shall pay the relevant

fees.

(3) A manufacturing authorisation shall not be required for

preparation, division, changes in packaging or presentation where

these processes are carried out solely for retail directly to the public by

pharmacists in veterinary pharmacies, or by other persons legally

authorised to supply veterinary medicinal products to the public.

(4) The manufacturing authorisation shall only be granted by

the Director when the requirements provided for in Article 89 of

Regulation (EU) 2019/6 are satisfied.

(5) The Director may, upon a request by the holder of

authorisation for a change in the manufacturing authorisation, vary the

condition of the authorisation if he is satisfied that such change will not

adversely affect the standard of good practice in manufacture as may

be prescribed.

(6) For the purposes of Article 133 of Regulation (EU) 2019/6

and when the Director considers that circumstances may exist which

necessitate the consideration of whether the authorisation should be

varied, suspended or revoked, the Director may serve on the holder of a

manufacturing authorisation a notice requiring him, within such period

as may be specified in such notice, to obtain any information specified

in the notice.

(7) The Director may, at his own discretion, suspend, revoke or

vary the conditions of a manufacturing authorisation if

(a) the information stated in the application on which the

authorisation was granted was false or incomplete in an essential

manner;

(b) a material change of circumstances has occurred in

relation to any of such information;

(c) any

condition

of

the

authorisation

has

been

contravened;

(d) the requirements in relation to the authorisation as

established by these regulations and Regulation (EU) 2019/6

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 exists the sale and processing of active

substance and veterinary medicinal products under unsanitary

conditions or leading to adulteration; and

(h)

there occurs any of the other circumstances

established under these regulations.

(8) The Director may 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.

(9) With respect to the manufacture of veterinary medicinal

products and active substance, the Director may

(a) inspect the manufacturing establishment and any

other premises at any reasonable time;

(b)

examine any relevant document;

(c) take any sample deemed necessary and if necessary,

submit it 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 as he 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;

(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; and

(i)

draw up a report of the inspection within thirty (30)

working days of the inspection and forward a copy of such report

to the holder of the authorisation.

(10) Except in urgent cases, an inspection shall be carried out in

the presence of a qualified person responsible for manufacturing and

batch release referred to in Article 97 of Regulation (EU) 2019/6, or

his representative.

(11) Subject to the provisions of these regulations, every

authorisation shall, unless previously renewed or revoked, continue to

be valid until such time as it is renewed by the Director following an

inspection.

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

conclusions of an inspection, the authorisation shall be valid for a

period of three (3) years.

(13) Following an inspection the Director may renew the

authorisation, with or without modifications, for such a further period

as specified.

(14) The holder of the manufacturing authorisation, or the

manufacturer of active substance shall

(a)

verify the authenticity and quality of the excipients;

(b) keep a record of all suspected adverse reactions and

adverse reactions on humans relating to the use of veterinary

medicinal products that are brought to his attention and report

them promptly to the Director in no later than fifteen days (15)

following receipt of the information;

(c) 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;

(d) record and investigate any complaint concerning

quality defects; and

(e) perform other responsibilities as may be established

by the Director from time to time.

(15) Manufacturing authorisation holders shall be regarded as

producers and therefore shall be held liable for damages in cases and

under the conditions set forth in the Consumer Affairs Act.

(16) The Director may require from the applicant further

information concerning the particulars supplied pursuant to Article

89(2) of Regulation (EU) 2019/6 and the qualified person referred to in

Article 97 of Regulation (EU) 2019/6

Provided that before the applicant provides the requested

information, the manufacturing authorisation shall be suspended.

(1) When more than one (1) qualified person is Qualified

person.

nominated in accordance with Article 97 of Regulation (EU) 2019/6,

the application shall clearly indicate the specific responsibilities of

each person

Provided that the qualified person may nominate another

person similarly qualified to act as his representative and shall notify

the Director of such nomination within one (1) working day.

(2) A person carrying out duties of a qualified person before the

coming into force of these regulations shall continue to carry out his

duties without the requirements of the provisions of Article 97(2)(3) of

Regulation (EU) 2019/6.

(3) If the qualified person started following a course prior to the

date on which these regulations became applicable, he may be

considered as qualified to carry out the duties thereof

Provided that he shall have been previously engaged in one

(1) or more of the following activities for at least two (2) years before

the date on which these regulations became applicable

(a) in one (1) or more undertakings with a manufacturing

authorisation and production supervision; and, or

(b) qualitative and quantitative analysis of active

substances, and the necessary testing and checking to ensure the

quality of veterinary medicinal products

Provided further that if the person concerned has acquired

the practical experience referred to before the date of the coming into

force of these regulations, he shall complete a further one (1) year’s

practical experience in accordance with the conditions referred to in

sub-regulation (1) immediately before he engages in such activities.

(4) The qualified person shall ensure that standards of good

practice in manufacturing are complied with at all times.

(1) When veterinary medicinal products are in transit for

the sole purpose of export and without them being placed on the

European Union market, the provisions of Article 88 of Regulation

(EU) 2019/6 shall apply, even though the product remains intact and

no manufacturing activities are carried out

Provided that such products may be exempted from the

provisions of Article 88 of Regulation (EU) 2019/6 when the transit is

for the sole purpose of re-export, is affected within the freeport, free

trade zones or customs tax warehouses. However, in such instances the

wholesale distribution authorisation provided for in Article 99 of

Regulation (EU) 2019/6 shall nonetheless be required by the company

engaging in the process.

(2) In cases where manufacturing activity in relation to the

products in transit for the sole purpose of export is carried out, the

manufacturing authorisation provided for in Article 88 of Regulation

(EU) 2019/6 shall be required, even if the operations are affected

within the freeport, free trade zones or customs tax warehouses.

(3)

The veterinary medicinal products which are in transit for

the sole purpose of export which qualify for the exemption provided

for in this regulation may be also exempted from the provisions of

Article 5 of Regulation (EU) 2019/6.

(4) The Director shall be notified by the wholesale distributor

in the manner indicated by the Director if such an activity is ever

conducted.

The retail supply of veterinary medicinal products shall be Retail supply of

veterinary

conducted only from or through licensed veterinary pharmacies in the medicinal

territory of Malta, licensed veterinary establishments, the products.

establishments provided for in regulation 18(2) and by veterinary

surgeons in relation to animals under their care, in the course of their

professional visits or visits by clients.

(1) Veterinary medicinal products may only be dispensed Dispensing.

from the premises and persons provided for in regulation 18.

(2) A veterinary surgeon may dispense veterinary medicinal

products during his professional visits or when clients visit him

Provided that the veterinary surgeon shall supply the

quantities of veterinary medicinal products only for treatments 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 and, or the keeper

and, or the carer with the quantities needed for the full treatment of the

condition.

(3) In any doubtful situation and within the limits of his

responsibilities, when dispensing veterinary medicinal products, the

dispenser shall 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.

(4) 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 periods.

(5) The dispenser shall provide to the Director any information

about veterinary medicinal products, including data on sales and use of

veterinary medicinal products upon his request.

(6) When dispensing veterinary medicinal products and

medicinal products for human use containing antimicrobials, the

dispenser shall be satisfied that all necessary precautions have been

taken to minimise the risks of antimicrobial resistance, in particular the

use of critically important antimicrobials.

(7) If the dispenser is not the veterinary surgeon issuing the

veterinary prescription and the dispenser has concerns about the

veterinary prescription presented to him, he shall resolve them with the

prescribing veterinary surgeon before dispensing the product.

(8) If a veterinary medicinal product is supplied in a container

other than that specified in the marketing authorisation, the dispenser

shall ensure that the container is suitably labelled and shall supply

sufficient written information.

(9) The dispenser shall be present when a veterinary medicinal

product is dispensed unless

(a) each transaction is authorised individually before the

product is supplied; and

(b) the dispenser is satisfied that the person dispensing it

over is competent to do so.

(10) The Director may request the dispenser to provide any

samples of the veterinary medicinal products.

(1) No person shall prescribe veterinary medicinal

products or medicinal products for human use unless that person is a

veterinary surgeon.

(2) The prescribing of veterinary medicinal products or

medicinal products for human use shall be made only on the veterinary

prescription provided for in regulation 31.

(3) A veterinary surgeon may only prescribe veterinary

medicinal products or medicinal products for human use if that

veterinary surgeon has examined those particular animals and he shall

accept clinical responsibility for the treatment of the animals under his

care.

(4) Veterinary medicinal products or medicinal products for

human use may not be used for more than one (1) treatment under the

same veterinary prescription.

(5) Before prescribing veterinary medicinal products or

medicinal products to be administered to animals which require a

veterinary prescription, a veterinary surgeon shall carry out a clinical

assessment of the animal under his care.

(6) Before prescribing a veterinary medicinal products or

medicinal products for human use, the veterinary surgeon shall be

satisfied that

(a) the use of the veterinary medicinal products or

medicinal products for human use is justified for the species

concerned on veterinary grounds;

(b) the administration of the veterinary medicinal

products or medicinal products for human use is not incompatible

with a previous treatment or use and that there is no contra-

indication or interaction where several veterinary medicinal

products and medicinal products for human use are used;

(c) the veterinary medicinal products or medicinal

products for human use are prescribed only in such quantities as

are necessary for the purpose of the treatment; and

(d) all necessary precautions shall be taken to minimise

the risks of antimicrobial resistance and that the prudent use of

veterinary medicinal products or medicinal products for human

use containing antimicrobials have been taken in consideration,

in particular where critically important antimicrobials are being

used.

(7) Within the limits of his responsibility, when prescribing

veterinary medicinal products or medicinal products for human use, a

veterinary surgeon shall be satisfied that the person who will

administer the products on the respective animal is competent to do so

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

directed by the veterinary surgeon.

(8) When prescribing veterinary medicinal products or

medicinal products for human use containing antimicrobials, a

veterinary surgeon shall consider the guidelines as issued by the

Director and other relevant national, European and international

organisations with regard to critically important antimicrobials.

(9)

When preparing a veterinary prescription, the prescribing

veterinary surgeon shall advise the receiver of the veterinary

prescription on the safe administration of the veterinary medicinal

product or medicinal product for human use and on any warning or

contra-indication associated with their use.

(1) In the territory of Malta 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";

and

(d)

general sales, abbreviated to "GS".

(2) 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

to the terms of a veterinary prescription. The premises from

where, or through which, these veterinary medicinal products

may be supplied to the public shall be licensed veterinary

pharmacies and licensed veterinary establishments;

(b) POM-V shall only be prescribed, dispensed and

administered by a veterinary surgeon. The premises from where,

or through which, these veterinary medicinal products may be

supplied shall be licensed veterinary pharmacies and licensed

veterinary establishments;

(c) OTC may be dispensed without a veterinary

prescription. The persons who may dispense these veterinary

medicinal products shall be veterinary surgeons, pharmacists and

suitably learned persons under the supervision of a pharmacist or

a veterinary surgeon. The premises from where, or through

which, these veterinary medicinal products may be supplied to

the public shall be licensed veterinary pharmacies and licensed

veterinary establishments;

(d)

GS

may

be

dispensed

without

a

veterinary

prescription. The persons who may dispense these veterinary

medicinal products shall be veterinary surgeons, pharmacists and

suitably learned persons. Veterinary medicinal products that fall

under this category may be supplied to the public from, or

through, licensed veterinary pharmacies, licensed veterinary

establishments, registered pet shops, registered shops that retail

animal care products and approved feed business operators where

medicated feeds are manufactured, sold or traded

Provided that, a person carrying out the activities of the

suitably learned person on the date on which his qualifications of a

suitably learned person are published shall be eligible to continue to

engage in such activities.

(3) The Director shall determine the distribution category of

veterinary medicinal products when processing application forms for

the authorisation or registration thereof

Provided that this shall not preclude the Director from

changing the distribution category of any veterinary medicinal product

at any stage after authorisation or registration has been granted.

(4) The marketing authorisation holders and holders of

registration in accordance with Article 116 of Regulation (EU) 2019/6

may request the Director to amend the distribution category previously

assigned.

(5) When determining the distribution category of veterinary

medicinal products, the Director may seek the advice from suitable

expert committees and may take in consideration the guidelines of

other national, European and international relevant bodies.

(6) Different pack sizes of the same marketing authorisation

may be assigned a different distribution category.

(7) The Director may issue guidelines on the criteria based on

Article 34 of Regulation (EU) 2019/6 for the categorisation of a

veterinary medicinal product.

(8) The holders of a wholesale distribution authorisation shall

distribute veterinary medicinal products only to those premises

authorised to retail veterinary medicinal products and shall distribute

only the category or categories of veterinary medicinal products that

are authorised to be retailed from each type of premises in accordance

with these regulations.

(1)

Any advertising of a veterinary medicinal product

shall include

(a)

the trade name;

(b)

a list of active ingredients;

(c)

the pharmaceutical form;

(d)

the major indications for use;

(e)

the dosage and method of use;

(f) side

effects,

warnings,

precautions

and

contraindications;

(g) the name and address of the marketing authorisation

holder; and

(h) any research and, or publications on the use of the

active substance.

(2) All the information contained in the documentation referred

to in this regulation shall be accurate, up-to-date, verifiable and

sufficiently complete to enable the recipient to form his own opinion of

the therapeutic value of the veterinary medicinal product concerned.

(3) Quotations as well as tables and other illustrative matter

taken from scientific works for use in the documentation provided for

in this regulation shall be faithfully reproduced.

(4)

The person who advertises veterinary medicinal products

(a) keep for a period of not less than five (5) years a

sample of all advertisements emanating from his undertaking

together with a statement indicating to whom the advert is

addressed, the method of dissemination and the date of first

dissemination; and

(b) ensure that any decision taken and any conditions

condition imposed by the Director are immediately and fully

complied with.

(5) The Director may request any of the information provided

for in this regulation at any time.

(1) For the purposes of Article 119(1) and (9) of Samples or

demonstration

Regulation (EU) 2019/6, veterinary medicinal products may be packs.

exempted from the requirements established by Article 5 of Regulation

(EU) 2019/6 if these are intended to be used as samples and, or as

demonstration packs that are given directly to veterinary surgeons or

other persons who are allowed to supply veterinary medicinal products

during sponsored events by pharmaceutical companies or during

professional visits to those persons who are authorised to prescribe or

dispense veterinary medicinal products

Provided that this exemption shall be granted by the

Director following a request from the wholesale distributor of

veterinary medicinal products in the manner indicated by the Director

before the activity takes place, and the exemption shall not be used

before the product has been registered.

(2)

The Director shall only register the product when

(a) the veterinary medicinal products are labelled with

the following words "Free sample - Not for sale" or

"Demonstration pack - Not for sale", as the case may be;

(b) each sample or demonstration pack shall not be bigger

than its smallest presentation on the market;

(c) each sample or demonstration pack shall be

accompanied by a copy of the summary of product

characteristics;

(d) veterinary

medicinal

products

containing

psychotropic or narcotic drugs cannot be distributed as samples

or demonstration packs;

(e) starter packs shall not be regarded as samples and

shall not be labelled as such;

(f) 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 reaction;

(g)

the information provided with the samples or

demonstration packs shall not be promotional in nature;

(h) the applicant shall be a holder of a wholesale

distribution authorisation; and

(i) the validity period of the authorisation shall be one

(1) year from the first consignment thereof.

(3) If any veterinary medicinal product registered in accordance

with this regulation is administered on a food producing animal, that

animal shall be excluded permanently from the food chain.

It shall not be lawful for a person authorised to distribute or

retail veterinary medicinal products to enter into any form of

contractual agreement with animal keepers and, or owners and, or

carers in order to supply to them veterinary medicinal products.

(1) Only authorised or registered veterinary medicinal

products shall be wholesale distributed in the territory of Malta.

(2) Persons may only apply for a wholesale distribution

authorisation of veterinary medicinal products if they are established in

the territory of Malta and have a permanent address

Provided that, this regulation shall not be applicable to

small quantities of veterinary medicinal products supplied from one (1)

retailer to another established in the territory of Malta in accordance

with a decision which shall be stipulated by the Director.

(1) An application for the grant of a wholesale

distribution authorisation provided for in Article 99(1) of Regulation

(EU) 2019/6 shall be made in the manner provided by the Director, and

shall include such information, documents and other material as

provided for by these regulations and Regulation (EU) 2019/6.

(2) An application for the grant of a wholesale distribution

authorisation shall include the following

(a)

the name and address of the applicant;

(b) the name of the responsible person provided for in

Article 100(2)(a) of Regulation 2019/6;

(c) the address of the premises that is to be used for the

purpose of wholesale distribution;

(d) other relevant permits for the premises that is to be

used for the purpose of wholesale distribution from other Maltese

regulatory entities;

(e) a licence, permit or equivalent document from the

financial services or an equivalent authority if the applicant is a

limited liability company;

(f) the equipment and control facilities as may be

required in these regulations;

(g) information, documentation or evidence to prove that

the premises is suitable and adequate, and that there are suitable

facilities, installations and equipment so as to ensure proper

conservation and distribution of veterinary medicinal products as

determined by the Director;

(h) the pharmaceutical forms of the products to be

distributed, in particular any sterile product and product requiring

storage below eight Centigrade (8º), if applicable;

(i) the details of narcotic or psychotropic drugs, blood, or

veterinary immunological medicinal products;

(j) the approval from the authority in the territory of

Malta responsible for planning and building permits, if

applicable; and

(k) the activities related with the wholesale distribution

of veterinary medicinal products intended to be carried out by the

applicant

Provided that the Director may request from the applicant

any other relevant information or additional document, which is

deemed necessary for the purpose of these regulations at any time.

(3) The premises used for the wholesale distribution of

veterinary medicinal products shall not be interconnected with other

premises which are used for other commercial activities or for

habitation

Provided that, interconnection with any other premises

which is used for other commercial activities or for habitation may be

allowed when the scale of activities and the commercial turnover of

veterinary medicinal products may be reasonably expected to be below

a certain threshold established by the Director by means of a notice in

the Gazette. In such cases, the physical connection between the

premises shall be kept to a minimum whilst the different areas shall be

clearly demarcated and properly marked so that a visible distinction

can be made clearly and unequivocally

Provided further that, the provisions of this sub-regulation

shall not apply in respect of existing premises before the coming into

force of these regulations and which cannot be structurally altered as to

comply with the said provisions.

(4) The Director may revoke a wholesale distributor

authorisation granted through such an exemption at any time.

(1) No person shall act as a wholesale distributor of

veterinary medicinal products unless a wholesale distribution

authorisation is issued by the Director.

(2) The Director shall carry out inspections at the premises

indicated in the application and shall not issue the authorisation until

he is satisfied that such premises is in conformity with the

requirements established in Regulation (EU) 2019/6 and these

regulations.

(3) The authorisation granted shall include the premises and the

applicable activities.

(4) A person who intends to acquire a wholesale distribution

authorisation shall apply with the Director by means of the application

form issued by the said Director and shall pay the applicable fee.

(5) All the premises, equipment and documents used by the

wholesale distributor shall be readily accessible at all reasonable times

for inspection by the Director.

(1) The wholesale distributor of veterinary medicinal

products shall

(a) comply with the requirements as stipulated by Article

101 of Regulation (EU) 2019/6;

(b) immediately inform the Director of any change in the

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

day of the said change;

(c) provide the Director access to his premises at any

reasonable time to carry out inspections as necessary;

(d) provide any sample of the veterinary medicinal

products which are distributed or were distributed or intended to

be distributed or found in the authorized premises at the request

of the Director;

(e) provide any information and document about

veterinary medicinal products, including data on sales,

distribution and use of veterinary medicinal products as

requested by the Director;

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

premises authorised for the wholesale distribution of veterinary

medicinal products three (3) months prior relocation and shall

apply for a new authorisation in accordance with regulation 23;

and

(g) carry out any other responsibility as may be

established from time to time by the Director.

(2) When the veterinary medicinal product is obtained from the

manufacturer or importer, the wholesale distributor shall verify that the

manufacturer or importer holds a valid manufacturing authorisation.

(3) When the veterinary medicinal product is obtained through

brokering, the wholesale distributor shall verify that the broker

satisfies the requirements set out in these regulations and that he has a

valid registration for the activity of brokering.

(4) When the veterinary medicinal product is obtained from

another wholesale distributor of veterinary medicinal products, the

wholesale distributor shall verify that the other wholesale distributor of

veterinary medicinal products holds a valid wholesale distribution

authorisation.

(5) When distributing veterinary medicinal product to persons

entitled to retail veterinary medicinal products in the territory of Malta

the wholesale distributor shall keep record of at least the name of

veterinary medicinal product, name of recipient, pharmaceutical form,

batch number, expiry date and quantities supplied in respect of each

transaction.

(6) A wholesale distributor shall exercise all necessary

precautions when veterinary medicinal products are received from a

third country but not imported for the sole purpose of export, in order

to ensure that these veterinary medicinal products do not in any way

end up on any Member State market.

(7) The Director may request the wholesale distributor to

provide a letter of access issued by the marketing authorisation holder

granting the wholesale distribution authorisation holder the use of such

marketing authorisation in respect of each veterinary medicinal

product he distributes and which is obtained directly from the

marketing authorisation holder or his legal representative.

(1) Every authorisation granted under these regulations

shall, unless previously renewed or revoked remain valid until such

time as it is renewed by the Director.

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

conclusions of an inspection, the authorisation shall be valid for a

period of three (3) years.

(3) The Director may renew the authorisation with or without

modifications for such a further period as specified by the Director, or

refuse to renew the authorisation

Provided that in the case that the authorisation is not

renewed, the Director shall stipulate corrective measures as necessary,

and he may suspend the authorisation until it is confirmed that the

holder of the authorisation is in compliance with these regulations and

Regulation (EU) 2019/6.

(4) The Director may suspend or revoke the authorisation

granted under these regulations for such period as it may be determined

in any of the following instances

(a) where the information stated in the application on

which the authorisation was issued was false or incomplete in a

particular detail;

(b) where a material change of circumstance has occurred

in relation to any of that information;

(c) where any condition of the authorisation has been

contravened;

(d) where the requirements in relation to the authorisation

as provided for by these regulations and Regulation (EU) 2019/6

have not been complied with; and

(e) where conditions of good practice in wholesale

distribution, particularly those established by the Commission in

the implementation of Regulation (EU) 2021/1248 are not being

complied with

Provided that the Director may revoke or suspend the

authorisation for any other matter that he deems appropriate.

(1) The responsible person shall be a pharmacist enlisted Duties of the

responsible

in the Register of Pharmacists in terms of article 17 of the Health Care person.

Professions Act.

(2)

The responsible person shall

(a) ensure that the wholesale distribution authorisation

conditions are adhered to;

(b) be permanently and continuously at the disposal of

the holder of the wholesale authorisation;

(c) nominate, if necessary, another person to act as his

representative and inform the Director of such nomination within

one (1) working day from date of nomination;

(d) inform the Director within one (1) working day in the

case that another representative be replacing the previous

representative temporarily or permanently;

(e) not abandon his duties without giving prior notice in

writing to the Director and to the wholesale distributor at least

two (2) weeks in advance;

(f) have in place a contact number which is available

twenty-four (24) hours a day and seven (7) days a week in case of

emergencies which shall also be provided to the Director; and

(g) upon request by the Director, provide any data in his

possession relating to the importation, sale, distribution, use and

administration of any type of veterinary medicinal product.

(1) Without prejudice to any provision of these Other medicinal

products.

regulations, the Director may establish additional requirements for the

wholesale distribution of the following veterinary medicinal products

and publish them in the Gazette

(a) veterinary medicinal products containing strong

sedatives, narcotic drugs or psychotropic drugs;

(b)

veterinary medicinal products used for euthanasia;

(c)

veterinary medicinal products derived from blood;

(d)

immunological veterinary medicinal products;

(e) such other veterinary medicinal products or class or

classes of veterinary medicinal products as the Minister may

prescribe; and

(f) veterinary

medicinal

products

containing

antimicrobials, in particular those that are deemed critical for

human health.

(2) Without prejudice to any provision of these regulations, the

Director shall take the necessary measures in order to prevent

veterinary medicinal products that are introduced into the European

Union but which are not intended to be placed on the market of the

European Union from entering into circulation if there are sufficient

grounds to suspect that those products are falsified. These measures

shall include the application of these regulations to warehouses

situated in the free port, free trade zones or customs tax warehouses

authorized to store veterinary medicinal products. These measures may

be issued in the Gazette through a notice.

(3) When the Director has valid reason to believe that

circumstances may exist which would render necessary the

consideration of whether the wholesale distribution authorisation

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

holder a notice requiring him, within such period as may be specified

in the notice, to provide any information specified in the notice.

(1) Any person intending to engage in the brokering of

veterinary medicinal products shall have a permanent address in the

territory of Malta and shall register his activity with the Director before

the activity takes place.

(2) The person intending to engage in the brokering of

veterinary medicinal products shall send a request to the Director in the

in the manner indicated by the Director to register his activity, and the

request shall include

(a) the name of the applicant and, if applicable, the

corporate name;

(b)

the permanent address in the territory of Malta;

(c)

the contact details of the applicant; and

(d)

the payment of the relevant fee

Provided that the Director may request, from time to time,

any other relevant information or additional document which he may

deem necessary for the purpose of the registration.

(3) The Director shall process the request for registration of a

broker within ninety (90) days of receipt of the request which shall be

suspended in cases where the applicant is requested to provide

additional data.

(4) The Director may carry out an inspection at the permanent

address of the applicant before registering the activity of the applicant

to ensure accurate identification and location, and that the applicant

has the necessary means to conduct the activity and is in compliance

with these regulations.

(5) Where the Director notifies that an inspection shall be

carried out, the activity shall not begin before the Director has notified

that the activity may start. In such a case, the Director shall carry out

the inspection and communicate to the broker the results of the

inspection within ninety (90) days of the notification of his intention to

carry out the inspection. When within ninety (90) days of receipt of the

request the Director has not notified that an inspection shall be carried

out, the activity may start.

(6)

The broker shall

(a) inform the Director of any change in the details given

in the original registration within one (1) working day;

(b) provide the Director access to his permanent address

at any reasonable time;

(c)

maintain records for any dealings in veterinary

medicinal products as may be provided for by these regulations,

and have such records readily available for inspection by the

Director for a period of not less than five (5) years;

(d) provide any information about the brokering

veterinary medicinal products, including information about the

amounts and identity of veterinary medicinal products brokered;

(e) abide by other responsibilities as may be established

from time to time by the Director; and

(f) informs the Director and, where applicable, other

related parties, of veterinary medicinal products he suspects to be

falsified.

(7) Unless otherwise determined by the Director, the

registration granted in accordance with this regulation shall be valid for

a period of three (3) years.

(1) This regulation shall apply to veterinary medicinal

products which require a veterinary prescription as per Article 34 of

Regulation (EU) 2019/6 and to products or substances that may not be

classified as veterinary medicinal products, but which may be deemed

by the Director to require a veterinary prescription for their

administration to animals

Provided that this regulation shall not apply to veterinary

prescriptions issued for the preparation, placing on the market and use

of medicated feed.

(2) No person shall alter a veterinary prescription unless

authorized to do so by the veterinary surgeon who has issued the

prescription

Provided that the veterinary surgeon who authorised that

the veterinary prescription be altered and the dispenser shall keep a

note to this effect.

(3) Veterinary prescriptions shall be printed or handwritten in

indelible ink, signed in original handwriting and rubber stamped by the

veterinary surgeon who issues the veterinary prescription

Provided that in the event that the veterinary prescription is

printed, the signature and rubber stamp of the veterinary surgeon shall

be made in ink which is different from the printing ink

Provided further that this regulation shall not be applicable

to electronic veterinary prescription.

(4) In addition to the elements listed in Article 105(5) of

Regulation (EU) 2019/6, a veterinary prescription issued in the

territory of Malta shall also include the following

(a) the name of veterinary medicinal products or

medicinal products for human use dispensed, including their

active substances and pharmaceutical form and strength;

(b) the quantity dispensed or the number of packs,

including pack size;

(c)

the disease treated or prevented;

(d) the name, signature and stamp of the dispenser of the

veterinary medicinal products or medicinal products for human

use, including the professional number, if available;

(e) the name and address of premises from where the

veterinary medicinal products or medicinal products for human

use are dispensed; and

(f) the dates when the veterinary medicinal products or

medicinal products for human use were dispensed.

(5) The dispenser shall not accept verbal instructions unless all

the following conditions are satisfied

(a) that the dispenser is satisfied that the verbal

instruction comes from a veterinary surgeon who by reason of an

emergency is unable to furnish a veterinary prescription;

(b) that the veterinary surgeon undertakes to furnish the

dispenser with a veterinary prescription within forty-eight (48)

hours of the verbal instruction; and

(c) that the product is dispensed in accordance with the

directions of the veterinary surgeon.

(6) If not all the products on the veterinary prescription are

dispensed, the dispenser shall make a note on the veterinary

prescription to that effect.

(7) In case more than one (1) product is listed on the veterinary

prescription and not all of them are dispensed from a single (1) place

from where veterinary medicinal products can be retailed in

accordance with the regulation 18, the dispenser shall make a note on

the veterinary prescription to that effect. The dispenser shall note on

the veterinary prescription which product and how many of the

products were dispensed. The dispenser shall keep an accurate account

of the course of action he has taken. The veterinary prescription may

then be given to another dispenser by the customer, whereupon if the

rest of the products are dispensed, it shall be considered as supplied in

its entirety

Provided that this regulation shall apply also to products

which are only partially dispensed from a single (1) place with the

remaining quantities of the same product dispensed from another

place.

(8) A veterinary prescription for veterinary medicinal products

that are not antimicrobials or that do not contain narcotic or

psychotropic drugs shall be valid for a period not exceeding six (6)

months from the date of issue.

(9) A veterinary prescription for veterinary medicinal products

containing narcotic or psychotropic drugs shall be valid for a period

not exceeding one (1) month from the date of issue.

(10) Pursuant to Article 105(12) of Regulation (EU) 2019/6, a

veterinary medicinal product or a medicinal product for human use

classified as subject to a veterinary prescription may be administered

personally by the veterinary surgeon without a veterinary prescription,

provided that they do not contain antimicrobials or narcotic or

psychotropic drugs.

(11) The veterinary surgeon, dispenser and the animal owner or

keeper shall keep the veterinary prescriptions for a period of not less

than five (5) years and shall be made readily available to the Director

upon his request.

(1) The Director shall provide the veterinary

prescriptions on which veterinary surgeons shall prescribe veterinary

medicinal products or medicinal products for human use.

(2) The printed version of a veterinary prescription shall remain

valid until such time as determined by the Director, who may decide

that it shall be substituted by an electronic version where all the

regulations apply mutatis mutandis.

(3) The electronic veterinary prescription shall be established

by the Director and used by the persons authorised to prescribe and

dispense.

(4) An electronic veterinary prescription shall be issued in such

a way as to unequivocally demonstrate the identity of the prescriber

and dispenser of veterinary medicinal products.

(5) The Director shall keep copies of the veterinary

prescriptions, in electronic format or hard copies, for a period of five

(5) years from the date of issue.

(1) Any person may administer veterinary medicinal Administration

of veterinary

products or medicinal products for human use which require a medicinal

veterinary prescription without the veterinary prescription in urgent products

medicinal

situations to alleviate suffering of the animal or impending spread of product

animals.

disease.

Provided that a visit to the place where the animal is kept by

the veterinary surgeon or a visit to the veterinary surgeon with the

animal, depending on the best practicable circumstance, shall take

place within forty-eight (48) hours of such an administration.

(2) Veterinary surgeons and persons authorised to dispense a

veterinary medicinal shall not supply for administration or administer

themselves, as may be applicable, veterinary medicinal product unless

such product is authorised by the Director.

(3) Products other than authorised veterinary medicinal

products whose therapeutic effectiveness is merely anecdotal shall be

used with caution. The administration of these products to food

producing species shall be subject to the approval of the Director. The

Director may ask the animal keeper to provide chemical data, clinical

documentation and studies about the possible environmental impact as

stipulated in the Gazette before granting his approval.

(4) Before prescribing a veterinary medicinal product or a

medicinal product that contain critically important antimicrobials, the

prescribing veterinary surgeon may take into account the results of

diagnostic laboratory information.

(5) Every registered or licensed establishment where food

producing animals are kept and are not excluded from the provisions of

Regulation (EU) 2017/625 of the European Parliament and of the

Council of 15 March 2017 on official controls and other official

activities performed to ensure the application of food and feed law,

rules on animal health and welfare, plant health and plant protection

products, amending Regulations (EC) No 999/2001, (EC) No 396/

2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012,

(EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the

European Parliament and of the Council, Council Regulations (EC) No

1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC,

1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and

repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the

European Parliament and of the Council, Council Directives 89/608/

EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC

and 97/78/EC and Council Decision 92/438/EEC (Official Controls

Regulation) by the Director, 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 Director

Provided further that the Director may, from time to time,

publish requirements related to animal health control programmes in

the Gazette through a notice.

(6) Veterinary medicinal products and medicinal products for

human use that are used in the registered or licensed establishments

referred to in sub-regulation (5) shall only be kept in such

establishments.

(7) The records referred to in Article 108 of Regulation (EU)

2019/6 shall only be kept in the registered or licensed establishments

where food producing animals are kept in accordance with sub-

regulation (5).

(1) 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.

(2) The marketing authorisation holder shall record and

investigate any complaint concerning a quality defect.

(3) The marketing authorisation holder or his representative

shall inform the Director of any quality defect that may result in a

recall or restriction on the supply. In so far as possible, the countries

where the products are marketed shall also be indicated.

The Director shall issue guidelines for the disposal of waste Safe disposal of

veterinary

derived from the manufacture, wholesale distribution, retail, research, medicinal

diagnosis and use of veterinary medicinal products. These guidelines products.

shall be issued in the Gazette through a notice.

(1) The persons referred to in Article 123(1) of Regulation Access by the

Director.

(EU) 2019/6, the holders of authorisation in accordance with

regulation 6, the holders authorisation in accordance with Article 5(6)

of Regulation (EU) 2019/6, the holders of registration in accordance

with Article 116 of Regulation (EU) 2019/6, the dispensers of

veterinary medicinal products and the brokers of veterinary medicinal

products shall allow the Director to carry out the controls referred to in

the same provisions by making the premises, documents, installations

and any equipment accessible at any reasonable time for inspection by

the Director.

(2) When the Director has valid reason to believe that any of

the persons referred to in sub-regulation (1) is acting in contravention

of any of the provisions of these regulations or Regulation (EU) 2019/

6, he shall notify the person concerned in writing through a notice

specifying the type of contravention and a time frame during which a

valid justification for his actions is to be provided.

(3) When the person concerned fails to provide a valid

justification within such time as specified in the notice, or if the reply

is unsatisfactory, the Director may suspend the activity of the

concerned person by means of a written notice specifying the reasons

for such suspension until such person is in compliance.

(4) The Director may also commence administrative or

disciplinary measures against the person for failure to fulfil his

obligations.

(5) Any authorisation or registration granted under these

regulations or Regulation (EU) 2019/6 shall not be renewed unless

remedial steps by the person to whom the notice is addressed are taken

as specified in the notice.

(1) Any person who contravenes or acts in breach of

Articles 5(1), 88(1)(a) and (b), 93, 99(1) and 134(1) of Regulation

(EU) 2019/6 and regulations 5, 6(2), 8, 11, 12(2), 15 and 16 shall be

guilty of an offence against article 38 of the Act and shall be liable on

conviction, to a fine (multa) exceeding five thousand euro (€5,000) but

not exceeding ten thousand euro (€10,000), or to imprisonment for a

term not exceeding six (6) months, or to both such fine and

imprisonment.

(2) Any person who contravenes or acts in breach of Articles

88(1)(c) and 127(1) of Regulation (EU) 2019/6 and regulations 6(9),

17(1), 22(1) and 29(1) shall be guilty of an offence against article 38 of

the Act and shall be liable on conviction, to a fine (multa) exceeding

thousand euro (€3,000) but not exceeding seven thousand euro

(€7,000), or to imprisonment for a term not exceeding three (3)

months, or to both such fine and imprisonment.

(3) Any person who contravenes or acts in violation of

regulation 35(1) shall be guilty of an offence against article 35 of the

Act and shall be liable on conviction, to a fine (multa) exceeding three

thousand euro (€3,000) but not exceeding seven thousand euro

(€7,000), or to imprisonment for a term not exceeding three (3)

months, or to both such fine and imprisonment.

(4) Any person who contravenes or acts in breach of Articles

58(6), (12) and (13), 95(1), 97(1), 101, 108(1), (2) and (5), and 121(1)

of Regulation (EU) 2019/6 and regulation 18(8) shall be guilty of an

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

to a fine (multa) exceeding five hundred euro (€500) but not exceeding

one thousand euro (€1,000), or to imprisonment for a term not

exceeding two (2) months, or to both such fine and imprisonment.

(5) Any person who contravenes or acts in breach of any other

provision of Regulation (EU) 2019/6 and, or any of these regulations

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

liable on conviction, to a fine (multa) exceeding two hundred euro

(€200) but not exceeding four hundred euro (€400), or to imprisonment

for a term not exceeding one (1) month, or to both such fine and

imprisonment

Provided that the Director shall not be precluded from

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

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

right of appeal before the Administrative Review Tribunal established

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

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

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

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

modified

Provided that the decision shall become immediately

applicable and enforceable and shall remain applicable throughout the

term of appeal until final judgement by the Administrative Review

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

the Court of Appeal or cancelled or modified by the Director

Provided further that any party, who feels aggrieved by a

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

Appeal in accordance with article 22 of the Administrative Justice Act. Cap. 490.

The Veterinary Medicinal Products Regulations are hereby Repeal and

saving.

repealed without prejudice to anything done or omitted to be done S.L. 437.47.

thereunder.

Immediately after the last item of the Second Schedule to Consequential

amendment.

the Administrative Justice Act there shall be added the words

"Veterinary Medicinal Products Regulations, S.L. 437.115, Superior/ Cap. 490.

Inferior Competence".

€3.69