Veterinary Medicinal Products (Amendment) Regulations, 2006

L.N. 82 of 2006

VETERINARY SERVICES ACT

(CAP. 437)

Veterinary Medicinal Products (Amendment) Regulations, 2006

IN exercise of the powers conferred by articles 30 and 31 of the

Veterinary Services Act, 2001, the Minister for Rural Affairs and the

Environment has made the following regulations>-

(1) The title to these regulations is the Veterinary Medicinal Title and scope.

Products (Amendment) Regulations, 2006 and they shall be read and

construed as one with the Veterinary Medicinal Products Regulations, L.N. 469 of 2004.

2004 hereinafter in these regulations referred to as “the principal

regulations”.

(2) The scope of these rules is to implement the rules found

under European Union Council Directive 2004#28 EC amending

European Council Directive 2001#82#EC on the Community code

relating to veterinary medicinal products.

For sub-regulation (3) of regulation 1 of the principal Amends regulation

1 of the principal

regulations, there shall be substituted the following>

regulations.

“(3) (a) These regulations shall apply to veterinary

medicinal products, including pre-mixes for medicated feedingstuffs,

intended to be placed on the market in Malta and prepared industrially

or by a method involving an industrial process.

(b) In cases of doubt, where, taking into account all its

characteristics, a product may fall within the definition of a “veterinary

medicinal product” and within the definition of a product covered by

other Community legislation, the provisions of these regulations shall

apply.

(c) Notwithstanding paragraph (a) hereof, these

regulations shall also apply to active substances used as starting materials

to the extent set out in regulations 44, 44A, 45 and 72 and additionally

to certain substances that may be used as veterinary medicinal products

that have anabolic, anti-infectious, anti-parasitic, anti-inflammatory,

hormonal or psychotropic properties to the extent set out in regulation

61.”.

Regulation 2 of the principal regulations shall be amended as

(a)

point (1) shall be deleted<

(b) for point (2) there shall be substituted the following>

“(2) “Veterinary medicinal product” means>

(a) any substance or combination of substances

presented as having properties for treating or preventing

disease in animals< or

(b) any substance or combination of substances

which may be used in or administered to animals with a

view either to restoring, correcting or modifying

physiological functions by exerting a pharmacological,

immunological or metabolic action, or to making a

medical diagnosis.”<

(c)

point (3) shall be deleted<

(d) for points (8), (9) and (10) there shall be substituted the

following>

“(8) “Homeopathic veterinary medicinal product”

means any veterinary medicinal product prepared from

substances called homeopathic stocks in accordance with a

homeopathic manufacturing procedure described by the

European Pharmacopoeia or, in the absence thereof, by the

Pharmacopoeias currently used officially in Member States.

A homeopathic veterinary medicinal product may contain a

number of principles.

(9) “Withdrawal period” means the period necessary

between the last administration of the veterinary medicinal

product to animals, under normal conditions of use and in

accordance with the provisions of these regulations, and the

production of foodstuffs from such animals, in order to protect

public health by ensuring that such foodstuffs do not contain

residues in quantities in excess of the maximum residue limits

for active substances laid down pursuant to European Union

Regulation (EEC) No 2377#90.

(10) “Adverse reaction” means a reaction to a

veterinary medicinal product which is harmful and unintended

and which occurs at doses normally used in animals for the

prophylaxis, diagnosis or treatment of disease or to restore,

correct or modify a physiological function.”<

(e) immediately after point 17 there shall be inserted the

following new point>

“(17A) “Representative of the marketing authorisation

holder” means the person, commonly known as local

representative, designated by the marketing authorisation

holder to represent him in Malta.”<

(f)

for point 18 there shall be substituted the following>

“(18) “Agency” means the European Medicines

Agency established by European Regulation (EC) No

726#2004.”<

(g) for point 19 there shall be substituted the following>

“(19) “Risks relating to use of the product” means>

– any risk relating to the quality, safety and efficacy

of the veterinary medicinal products as regards animal

or human health<

– any risk of undesirable effects on the

environment.”<

(h) immediately after point (26) there shall be added the

following points>

“(27) “Risk#benefit balance” means an evaluation of

the positive therapeutic effects of the veterinary medicinal

product in relation to the risks as defined above.

(28) “Veterinary prescription” means any prescription

for a veterinary medicinal product issued by a professional

person qualified to do so in accordance with applicable

national law.

(29) “Name of veterinary medicinal product” means

the name, which may be either an invented name not liable to

confusion with the common name, or a common or scientific

name accompanied by a trademark or the name of the

marketing authorisation holder.

(30) “Common name” means the international non-

proprietary name recommended by the World Health

Organisation, or, if one does not exist, the usual common

name.

(31) “Strength” means the content of active substances,

expressed quantitatively per dosage unit, per unit of volume

or weight according to the dosage form.

(32) “Immediate packaging” means the container or

any other form of packaging that is in direct contact with the

medicinal product.

(33) “Outer packaging” means the packaging into

which is placed the immediate packaging.

(34) “Labelling” means information on the immediate

or outer packaging.

(35) “Package leaflet” means the leaflet containing

information for the user that accompanies the medicinal

product.”.

For regulation 3 of the principal regulations there shall be

substituted the following>

“3.

(1) These regulations shall not apply to>

(a) medicated feedingstuffs as defined in European

Union Council Directive 90#167#EEC laying down the

conditions governing the preparation, placing on the market

and use of medicated feedingstuffs in the European

Community<

(b) inactivated immunological veterinary medicinal

products which are manufactured from pathogens and antigens

obtained from an animal or animals from a holding and used

for the treatment of that animal or the animals of that holding

in the same locality<

(c) veterinary medicinal products based on radio-active

isotopes<

(d) any additives covered by European Union Council

Directive 70#524#EEC concerning additives in feedingstuffs

where they are incorporated in animal feedingstuffs and

supplementary animal feedingstuffs in accordance with that

Directive< and

(e) without prejudice to regulation 86, medicinal

products for veterinary use intended for research and

development trials.

However, medicated feedingstuffs referred to in

paragraph (a) hereof may be prepared only from pre-mixes

that have been authorised under these regulations.

(2) Except for the provisions on the possession, prescription,

dispensing and administration of veterinary medicinal products, these

regulations shall not apply to>

(a) any medicinal product prepared in a pharmacy in

accordance with a veterinary prescription for an individual animal

or a small group of animals, commonly known as the magistral

formula< and

(b) any medicinal product prepared in a pharmacy in

accordance with the prescriptions of a Pharmacopoeia and intended

to be supplied directly to the end-user, commonly known as the

officinal formula.”.

For sub-regulation (2) of regulation 4 of the principal Amends regulation

4 of the principal

regulations there shall be substituted the following>

regulations.

“(2) In the case of veterinary medicinal products intended

solely for aquarium fish, cage birds, homing pigeons, terrarium

animals, small rodents, and ferrets and rabbits kept exclusively as

pets, Malta may permit exemptions from the provisions in

regulations 5 to 8, provided that such products do not contain

substances the use of which requires veterinary control and that

all possible measures are taken to prevent unauthorised use of the

products for other animals.”.

For regulations 5 and 6 of the principal regulations there shall Substitutes

regulations 5 and 6

be substituted the following>

of the principal

regulations.

“5. (1) No veterinary medicinal product may be placed

on the market of Malta unless a marketing authorisation has been

granted by the Veterinary Services in accordance with these

regulations or a marketing authorisation has been granted in

accordance with European Union Regulation (EC) No 726#2004.

When a veterinary medicinal product has been granted an

initial authorisation in accordance with the first paragraph, any

additional species, strengths, pharmaceutical forms, administration

routes, presentations, as well as any variations and extensions, shall

also be granted an authorisation in accordance with the first

paragraph or be included in the initial marketing authorisation.

All these marketing authorisations shall be considered as belonging

to the same global marketing authorisation, in particular for the

purpose of the application of regulation 13(1).

(2) The marketing authorisation holder shall be

responsible for the marketing of the medicinal product. The

designation of a representative shall not relieve the marketing

authorisation holder of his legal responsibility.

6. (1) A veterinary medicinal product may not be the

subject of a marketing authorisation for the purpose of

administering it to one or more food-producing species unless the

pharmacologically active substances which it contains appear in

Annexes I, II or III to European Regulation (EEC) No 2377#90.

(2) If an amendment to the Annexes to Regulation

(EEC) No 2377#90 so warrants, the marketing authorisation holder

or, where appropriate, the Veterinary Services shall take all

necessary measures to amend or revoke the marketing authorisation

within 60 days of the date on which the amendment to the Annexes

to that Regulation was published in the Official Journal of the

European Union.

(3) By way of derogation from subregulation (1)

hereof, a veterinary medicinal product containing pharma-

cologically active substances not included in Annexes I, II or III

to European Regulation (EEC) No 2377#90 may be authorised for

particular animals of the equidae family that have been declared,

in accordance with European Commission Decision 93#623#EEC

establishing the identification document (passport) accompanying

registered equidae and European Commission Decision

2000#68#EC amending Decision 93#623#EEC and establishing the

identification of equidae for breeding and production, as not being

intended for slaughter for human consumption. Such veterinary

medicinal products shall neither include active substances that

appear in Annex IV to European Regulation (EEC) No 2377#90

nor be intended for use in the treatment of conditions, as detailed

in the authorised Summary of Product Characteristics, for which a

veterinary medicinal product is authorized for animals of the

equidae family.”.

For regulation 8 of the principal regulations there shall be Substitutes

regulation 8 of the

substituted the following>

principal

regulations.

“8. (1) In the event of serious epizootic diseases, the

Veterinary Services may provisionally allow the use of

immunological veterinary medicinal products without a marketing

authorisation, in the absence of a suitable medicinal product and

after informing the European Commission of the detailed conditions

of use.

(2) If an animal is being imported from, or exported

to, a third country and is thereby subject to specific binding health

rules, the Veterinary Services may permit the use, for the animal

in question, of an immunological veterinary medicinal product that

is not covered by a marketing authorisation in Malta but is

authorized under the legislation of the third country. The Veterinary

Services shall take all appropriate measures concerning the

supervision of the importation and the use of such immunological

products.”.

For regulations 10 to 13 of the principal regulations there shall Substitutes

regulations 10 to 13

be substituted the following>

of the principal

regulations.

“10. (1) The Veterinary Services shall take the necessary

measures to ensure that, if there is no authorised veterinary

medicinal product in Malta for a condition affecting a non food-

producing species, by way of exception, the veterinarian

responsible may, under his#her direct personal responsibility and

in particular to avoid causing unacceptable suffering, treat the

animal concerned with>

(a) a veterinary medicinal product authorised in Malta

under these regulations or under European Regulation (EC)

No 726#2004 for use with another animal species, or for

another condition in the same species< or

(b) if there is no product as referred to in paragraph

(a) –

(i) either a medicinal product authorised for

human use in Malta in accordance with European

Directive 2001#83#EC of the European Parliament and

of the European Council or under European Regulation

(EC) No 726#2004,

(ii) or, in accordance with specific national

measures, a veterinary medicinal product authorised in

another Member State in accordance with these

regulations for use in the same species or in another

species for the condition in question or for another

condition< or

(c) if there is no product as referred to in paragraph

(b), and within the limits of the law of Malta, a veterinary

medicinal product prepared extemporaneously by a person

authorized to do so under national legislation in accordance

with the terms of a veterinary prescription.

The veterinarian may administer the medicinal product

personally or allow another person to do so under the

veterinarian’s responsibility.

(2) By way of derogation from regulation 11, the

provisions of subregulation (1) hereof shall also apply to the

treatment by a veterinarian of an animal belonging to the equidae

family provided that it has been declared, in accordance with

European Commission Decisions 93#623#EEC and 2000#68#EC,

as not being intended for slaughter for human consumption.

(1) The Veterinary Services shall take the necessary

measures to ensure that, if there is no authorised veterinary

medicinal product in Malta for a condition affecting a food-

producing species, by way of exception, the veterinarian

responsible may, under his direct personal responsibility and in

particular to avoid causing unacceptable suffering, treat the animals

concerned on a particular holding with>

(a) a veterinary medicinal product authorised in Malta

under these regulations or under European Regulation (EC)

No 726#2004 for use with another animal species, or for

another condition in the same species< or

(b) if there is no product as referred to in paragraph

(a), either>

(i) a medicinal product for human use authorised

in Malta in accordance with European Directive

2001#83#EC or under European Regulation (EC) No

726#2004, or

(ii) a veterinary medicinal product authorised in

another Member State in accordance with these

regulations for use in the same species or in another food-

producing species for the condition in question or for

another condition< or

(c) if there is no product as referred to in paragraph

(b), and within the limits of the law of Malta, a veterinary

medicinal product prepared extemporaneously by a person

authorized to do so under national legislation in accordance

with the terms of a veterinary prescription.

The veterinarian may administer the medicinal product

personally or allow another person to do so under the

veterinarian’s responsibility.

(2) Subregulation (1) hereof shall apply provided that

pharmacologically active substances included in the medicinal

product are listed in Annex I, II or III to European Regulation

(EEC) No 2377#90, and that the veterinarian specifies an

appropriate withdrawal period.

Unless the medicinal product used indicates a withdrawal

period for the species concerned, the specified withdrawal period

shall not be less than>

– 7 days for eggs,

– 7 days for milk,

– 28 days for meat from poultry and mammals including

fat and offal,

– 500 degree-days for fish meat.

(3) With regard to homeopathic veterinary medicinal

products in which active principles figure in Annex II to European

Regulation (EEC) No 2377#90, the withdrawal period referred to

in the second paragraph of subregulation (2) shall be reduced to

zero.

(4) When a veterinarian has recourse to the provisions

of subregulations (1) and (2) hereof, he shall keep adequate records

of the date of examination of the animals, details of the owner, the

number of animals treated, the diagnosis, the medicinal products

prescribed, the doses administered, the duration of treatment and

the withdrawal periods recommended, and shall make these records

available for inspection by the Veterinary Services for a period of

at least five years.

(5) Without prejudice to the other provisions of these

regulations, Malta shall take all necessary measures concerning

the import, distribution, dispensing of and information on the

medicinal products which they permit for administration to food-

producing animals in accordance with subregulation (1)(b)(ii).

(1) For the purposes of obtaining a marketing

authorisation in respect of a veterinary medicinal product, otherwise

than under the procedure established by European Regulation (EC)

No 726#2004, an application shall be lodged with the Veterinary

Services.

In the case of veterinary medicinal products which are

intended for one or more food-producing species but whose

pharmacologically active substances have not yet been included,

for the species in question, in Annexes I, II or III to European

Regulation (EEC) No 2377#90, a marketing authorisation may not

be applied for until after a valid application has been made for the

establishment of maximum residue limits in accordance with that

Regulation. At least six months shall elapse between a valid

application for the establishment of maximum residue limits and

an application for a marketing authorisation.

However, in the case of veterinary medicinal products referred

to in regulation 6(3), a marketing authorisation may be applied for

without a valid application in accordance with European Regulation

(EEC) No 2377#90. All the scientific documentation necessary for

the demonstration of the quality, safety and efficacy of the

veterinary medicinal product, as provided for in subregulation (3)

hereof, shall be submitted.

(2) A marketing authorisation may only be granted to

an applicant established in the European Community.

(3) The application for marketing authorisation shall

include all the administrative information and scientific

documentation necessary for demonstrating the quality, safety and

efficacy of the veterinary medicinal product in question. The file

shall be submitted in accordance with Schedule I and shall contain,

in particular, the following information>

(a) name or business name and permanent address or

registered place of business of the person responsible for

placing the product on the market and, if different, of the

manufacturer or manufacturers involved and of the sites of

manufacture<

(b) name of veterinary medicinal product<

(c) qualitative and quantitative particulars of all the

constituents of the veterinary medicinal product, including

its international non-proprietary name (INN) recommended

by the WHO, where an INN exists, or its chemical name<

(d) description of the method of manufacture<

(e) therapeutic indications, contra-indications and

adverse reactions<

(f) dosage for the various species of animal for which

the veterinary medicinal product is intended, its

pharmaceutical form, method and route of administration and

proposed shelf life<

(g) reasons for any precautionary and safety measures

to be taken when storing the veterinary medicinal product,

administering it to animals and disposing of waste, together

with an indication of potential risks that the veterinary

medicinal product might pose to the environment, to human

and animal health and to plants<

(h) indication of the withdrawal period in the case of

medicinal products intended for food-producing species<

(i) description of the testing methods employed by the

manufacturer<

(j) results of>

– pharmaceutical (physico-chemical, biological or

microbiological) tests,

– safety tests and residue tests,

– pre-clinical and clinical trials<

– tests assessing the potential risks posed by the

medicinal product for the environment. This impact shall

be studied and consideration shall be given on a case-

by-case basis to specific provisions seeking to limit it.

(k) a detailed description of the pharmacovigilance

system and, where appropriate, the risk management system

that the applicant will put in place<

(l) a summary in accordance with regulation 14 of the

product characteristics, a mock-up of the immediate packaging

and the outer packaging of the veterinary medicinal product,

together with the package leaflet, in accordance with

regulations 53 to 55<

(m) a document showing that the manufacturer is

authorized in his own country to produce veterinary medicinal

products<

(n) copies of any marketing authorisation obtained in

another Member State or in a third country for the relevant

veterinary medicinal product, together with a list of those

Member States in which an application for authorisation

submitted in accordance with these regulations is under

examination. Copies of the summary of the product

characteristics proposed by the applicant in accordance with

regulation 14 or approved by the Veterinary Services in

accordance with regulation 25 and copies of the package insert

proposed, details of any decision to refuse authorisation,

whether in the European Community or a third country and

the reasons for that decision. All this information shall be

updated on a regular basis<

(o) proof that the applicant has the services of a

qualified person responsible for pharmacovigilance and has

the necessary means for the notification of any adverse

reaction suspected of occurring either in the European

Community or in a third country<

(p) in the case of veterinary medicinal products

intended for one or more food-producing species and

containing one or more pharmacologically active substances

not yet included, for the species in question, in Annexes I, II

or III to European Regulation (EEC) No 2377#90, a document

certifying that a valid application for the establishment of

maximum residue limits has been submitted to the Agency in

accordance with the aforementioned Regulation.

The documents and particulars relating to the results of

the tests referred to in point (j) of the first paragraph shall be

accompanied by detailed and critical summaries, drawn up

as specified in regulation 15.

(1) By way of derogation from point (j) of the first

subparagraph of regulation 12(3), and without prejudice to the law

relating to the protection of industrial and commercial property,

the applicant shall not be required to provide the results of the

safety and residue tests or of the pre-clinical and clinical trials if

he can demonstrate that the medicinal product is a generic of a

reference medicinal product which is or has been authorised under

regulation 5 for not less than eight years in a Member State or the

European Community.

A generic veterinary medicinal product authorized pursuant

to this provision shall not be placed on the market until ten years

have elapsed from the initial authorisation of the reference product.

The first subregulation shall also apply when the reference

medicinal product was not authorised in the Member State in which

the application for the generic medicinal product is submitted. In

this case, the applicant shall indicate in the application the Member

State in which the reference medicinal product is or has been

authorised. At the request of the Veterinary Services, the competent

authority of the other Member State shall transmit, within a period

of one month, confirmation that the reference medicinal product

is or has been authorized together with the full composition of the

reference product and if necessary other relevant documentation.

However, the ten-year period provided for in the second paragraph

shall be extended to 13 years in the case of veterinary medicinal

products for fish or bees or other species designated in accordance

with the procedure referred to in Article 89(2) of European Union

Council Directive 2004#28 EC.

(2) For the purposes of this regulation>

(a) “reference medicinal product” shall mean a product

authorised within the meaning of regulation 5 in accordance

with the provisions of regulation 12<

(b) “generic medicinal product” shall mean a medicinal

product which has the same qualitative and quantitative

composition in active substances and the same pharmaceutical

form as the reference medicinal product, and whose

bioequivalence with the reference medicinal product has been

demonstrated by appropriate bioavailability studies. The

different salts, esters, ethers, isomers, mixtures of isomers,

complexes or derivatives of an active substance shall be

considered to be the same active substance, unless they differ

significantly in properties with regard to safety and#or efficacy.

In such cases, additional information intended to provide proof

of the safety and#or efficacy of the various salts, esters or

derivatives of an authorised active substance must be supplied

by the applicant. The various immediate-release oral

pharmaceutical forms shall be considered to be one and the

same pharmaceutical form. Bioavailability studies neednot

be required of the applicant if he can demonstrate that the

generic medicinal product meets the relevant criteria as

defined in the appropriate detailed guidelines.

(3) In cases where the veterinary medicinal product

does not fall under the definition of a generic medicinal product

set out in subregulation 2(b) or where bio-equivalence cannot be

demonstrated through bioavailability studies or in the case of

changes to the active substance(s), therapeutic indications, strength,

pharmaceutical form or route of administration vis-‡-vis the

reference medicinal product, the results of the appropriate safety

and residue tests and pre-clinical tests or clinical trials shall be

provided.

(4) Where a biological veterinary medicinal product

which is similar to a reference biological veterinary medicinal

product does not meet the conditions in the definition of generic

medicinal products, owing to, in particular, differences relating to

raw materials or in manufacturing processes of the biological

veterinary medicinal product and the reference biological veterinary

medicinal product, the results of appropriate pre-clinical tests or

clinical trials relating to these conditions must be provided. The

type and quantity of supplementary data to be provided must

comply with the relevant criteria stated in Schedule I and the related

detailed guidelines. The results of other tests and trials from the

reference medicinal product’s dossier shall not be provided.

(5) In the case of veterinary medicinal products

intended for one or more food-producing species and containing a

new active substance that has not been authorised in the European

Community by 30 April 2004 the ten-year period provided for in

the second paragraph of subregulation (1) shall be extended by

one year for each extension of the marketing authorisation to

another food-producing species, if it is authorised within the five

years following the granting of the initial marketing authorisation.

This period shall not, however, exceed a total of 13 years, for

a marketing authorisation for four or more food-producing species.

The extension of the ten-year period to 11, 12, or 13 years for

a veterinary medicinal product intended for food-producing species

shall be granted only if the marketing authorisation holder also

originally applied for determination of the maximum residue limits

established for the species covered by the authorisation.

(6) Conducting the necessary studies, tests and trials

with a view to the application of sub-regulations (1) to (5) and

the consequential practical requirements shall not be regarded as

contrary to patent-related rights or to supplementary-protection

certificates for medicinal products.”.

9. Immediately after regulation 13 of the principal regulations Adds new

regulations 13A to

there shall be added the following new regulations>

13D to the principal

regulations.

(1) By way of derogation from point (j) of

“Derogation.

the first paragraph of regulation 12(3), and without prejudice

to the law on the protection of industrial and commercial

property, the applicant shall not be required to provide the

results of safety and residue tests or of pre-clinical tests or

clinical trials if he can demonstrate that the active substances

of the veterinary medicinal product have been in well-

established veterinary use within the European Community

for at least ten years, with recognised efficacy and an

acceptable level of safety in terms of the conditions set out in

Schedule I. In that event, the applicant shall provide

appropriate scientific literature.

(2) The assessment report published by the

Agency following the evaluation of an application for the

establishment of maximum residue limits in accordance with

European Regulation (EEC) No 2377#90 may be used in an

appropriate manner as literature, particularly for the safety

tests.

(3) If an applicant makes use of scientific

literature to obtain authorisation for a food-producing species,

and submits, in respect of the same medicinal product and

with a view to obtaining authorisation for another

foodproducing species, new residue studies in accordance with

European Regulation (EEC) No 2377#90, together with

further clinical trials, it shall not be permissible for a third

party to use such studies or such trials pursuant to regulation

13, for a period of three years from the grant of the

authorization for which they were carried out.

In the case of veterinary medicinal products

containing active substances used in the composition of

authorized veterinary medicinal products but not hitherto used

in combination for therapeutic purposes, the results of safety

and residue tests, if necessary, and new pre-clinical tests or

new clinical trials relating to that combination shall be

provided in accordance with point (j) of the first paragraph

of regulation 12(3), but it shall not be necessary to provide

scientific references relating to each individual active

substance.

After the marketing authorisation has been

granted, the marketing authorisation holder may allow use to

be made of the pharmaceutical, safety and residues, pre-

clinical and clinical documentation contained in the file for

the veterinary medicinal product with a view to examining a

subsequent application for a veterinary medicinal product

having the same qualitative and quantitative composition in

active substances and the same pharmaceutical form.

By way of derogation from point (j) of the first

paragraph of regulation 12(3), and in exceptional

circumstances with respect to immunological veterinary

medicinal products, the applicant shall not be required to

provide the results of certain field trials on the target species

if these trials cannot be carried out for duly substantiated

reasons, in particular on account of other European

Community provisions.”.

10. For regulations 14 to 16 of the principal regulations there

shall be substituted the following>

“14. The summary of the product characteristics shall

contain, in the order indicated below, the following information>

(1) name of the veterinary medicinal product followed

by the strength and the pharmaceutical form<

(2) qualitative and quantitative composition in terms

of the active substances and constituents of the excipient,

knowledge of which is essential for proper administration of

the medicinal product. The usual common name or chemical

description shall be used<

(3) pharmaceutical form<

(4) clinical particulars>

(i) target species,

(ii)

indications for use, specifying the target

species,

(iii)

contra-indications,

(iv) special warnings for each target species,

(v) special precautions for use, including special

precautions to be taken by the person administering the

medicinal product to the animals,

(vi) adverse

reactions

(frequency

and

seriousness),

(vii) use during pregnancy, lactation or lay,

(viii) interaction with other medicinal products

and other forms of interaction,

(ix) amounts

to

be

administered

and

administration route,

(x) overdose (symptoms, emergency procedures,

antidotes), if necessary,

(xi) withdrawal periods for the various foodstuffs,

including those for which the withdrawal period is zero<

(5) pharmacological properties>

(i) pharmacodynamic properties,

(ii) pharmacokinetic particulars<

(6) pharmaceutical particulars>

(i) list of excipients,

(ii) major incompatibilities,

(iii) shelf life, when necessary after reconstitution

of the medicinal product or when the immediate

packaging is opened for the first time,

(iv) special precautions for storage,

(v) nature and composition of immediate

packaging,

(vi) special precautions for the disposal of unused

veterinary medicinal products or waste materials derived

from the use of such products, if appropriate<

(7) marketing authorisation holder<

(8) marketing authorisation number(s)<

(9) date of the first authorisation or date of renewal of

the authorisation<

(10) date of revision of the text.

For authorisation under regulation 13, those parts of the

summary of product characteristics of the reference medicinal

product referring to indications or dosage forms which were

still covered by patent law at the time when a generic medicine

was marketed need not be included.

(1) Applicants shall ensure that the detailed and critical

summaries referred to in the second paragraph of regulation

12(3) are drafted and signed by persons with the requisite

technical or professional qualifications, set out in a brief curriculum

vitae, before being submitted to the Veterinary Services

(2) Persons with the technical or professional

qualifications referred to in subregulation (1) hereof shall justify

any use made of the scientific literature referred to in regulation

13A(1) in accordance with the conditions set out in Schedule I.

(3) A brief curriculum vitae of the persons referred to

in subregulation (1) shall be appended to the detailed critical

summaries.

(1) The Veterinary Services shall ensure that

homeopathic veterinary medicinal products manufactured and

placed on the market within the European Community are

registered or authorised in accordance with regulations 17, 18 and

19, except where such veterinary medicinal products are covered

by a registration or authorisation granted in accordance with

national legislation on or before 31 December 1993. In the case of

homeopathic medicinal products registered in accordance with

regulation 17, regulation 32 and regulation 33(1) to (3) shall

apply.

(2) The Veterinary Services shall establish a simplified

registration procedure for the homeopathic veterinary medicinal

products referred to in regulation 17.

(3) By way of derogation from regulation 10,

homeopathic veterinary medicinal products may be administered

to non-food producing animals under the responsibility of a

veterinarian.

(4) By way of derogation from regulation 11(1) and

(2), Malta shall permit the administration of homeopathic veterinary

medicinal products intended for food-producing species the active

constituents of which appear in Annex II to European Regulation

(EEC) No 2377#90 under the responsibility of a veterinarian. The

Veterinary Services shall take appropriate measures to control the

use of veterinary homeopathic medicinal products registered or

authorised in another Member State in accordance with these

regulations for use in the same species.”.

11. Regulation 17 of the principal regulations shall be amended Amends regulation

17 of the principal

as follows>-

regulations.

(a) for subregulation (1) thereof, there shall be substituted

the following>

“(1) Without prejudice to the provisions of European

Regulation (EEC) No 2377#90 on the establishment of

maximum residue limits of pharmacologically active

substances intended for food-producing animals, only

homeopathic veterinary medicinal products which satisfy all

of the following conditions may be subject to a special,

simplified registration procedure>

(a) they are administered by a route described in

the European Pharmacopoeia or, in the absence thereof,

by the Pharmacopoeias currently used officially in Malta<

(b) no specific therapeutic indication appears on

the labelling of the veterinary medicinal product or in

any information relating thereto<

(c) there is a sufficient degree of dilution to

guarantee the safety of the medicinal product. In

particular, the medicinal product shall not contain more

than one part per 10 000 of the mother tincture.”< and

(b) subregulation (3) thereof shall be deleted.

12. Regulation 18 of the principal regulations shall be amended

(a) for paragraph (c) thereof, there shall be substituted the

following>

“(c) manufacturing and control file for each

pharmaceutical form and a description of the method of

dilution and potentisation,”<

(b) for paragraph (f) thereof, there shall substituted the

following>

“(f) one or more mock-ups of the outer packaging and

immediate packaging of the medicinal products to be

registered,”< and

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

added the following new paragraph>

“(g) proposed withdrawal period together with all

requisite justification.”.

13. For regulation 19 of the principal regulations there shall be

substituted the following>

“19. (1) Homeopathic veterinary medicinal products other

than those referred to in regulation 17(1) shall be authorized in

accordance with regulations 12, 13A, 13B, 13C, 13D and 14.

(2) Malta may introduce or retain on its territory

specific rules for the safety tests and pre-clinical and clinical trials

of homeopathic veterinary medicinal products intended for pet

species and non-food-producing exotic species other than those

referred to in regulation 17(1), in accordance with the principles

and characteristics of homeopathy as practised in Malta. In this

case, the Veterinary Services shall notify the European Commission

of the specific rules in force.”.

14. For regulations 21, 22 and 23 of the principal regulations Substitutes

regulations 21 to 23

shall be substituted the following>

of the principal

regulations.

“21. (1) The Veterinary Services shall take all appropriate

measures to ensure that the procedure for granting a marketing

authorisation for a veterinary medicinal product is completed within

a maximum of 210 days after the submission of a valid application.

Applications for marketing authorisations for the same

veterinary medicinal product in two or more Member States, shall

be submitted in accordance with regulations 31 to 43.

(2) Where Malta notes that another marketing

authorisation application for the same medicinal product is being

examined in another Member State, Malta shall decline to assess

the application and shall advise the applicant that regulations 31

to 43 apply.

Where the Veterinary Services is informed, in

accordance with paragraph (n) of regulation 12(3), that another

Member State has authorised a veterinary medicinal product which

is the subject of an application for authorisation in Malta, the

Veterinary Services shall reject the application unless it was

submitted in compliance with regulations 31 to 43.

In order to examine the application submitted pursuant

to regulations 12 to 13D, the Veterinary Services>

(1) shall check that the documentation submitted in

support of the application complies with regulations 12 to

13D and ascertain whether the conditions for the issue of the

marketing authorisation have been fulfilled<

(2) may submit the medicinal product, its starting

materials and if necessary intermediate products or other

constituent materials for testing by an Official Medicines

Control Laboratory or a laboratory that has designated for

that purpose by the Veterinary Services, in order to ensure

that the testing methods employed by the manufacturer and

described in the application documents, in accordance with

point (i) of the first paragraph of regulation 12(3), are

satisfactory<

(3) may similarly check, in particular through

consultation of a national or European Community reference

laboratory, that the analytical method used for detecting

residues presented by the applicant for the purposes of

regulation 12(3)(j), second indent is satisfactory<

(4) may, where appropriate, require the applicant to

provide further information as regards the items listed in

regulations 12, 13a, 13b, 13c and 13d. Where the Veterinary

Services take this course of action, the time-limits specified

in regulation 21 shall be suspended until the further data

required have been provided. Similarly, these time-limits shall

be suspended for any period which the applicant may be given

to provide oral or written explanations.”.

15. For regulation 25 of the principal regulations there shall be

substituted the following>

“25. (1) When granting a marketing authorisation, the

Veterinary Services shall inform the holder of the summary of

product characteristics that it has approved.

(2) The Veterinary Services shall take all necessary

measures to ensure that information concerning the veterinary

medicinal product, and in particular the labelling and package

leaflet, is in conformity with the summary of product characteristics

approved when the marketing authorisation was granted or

subsequently.

(3) The Veterinary Services shall make the marketing

authorisation publicly available without delay, together with the

summary of product characteristics for each veterinary medicinal

product that it has authorised.

(4) The Veterinary Services shall draw up an

assessment report and comments on the file as regards the results

of the pharmaceutical, safety and residue tests and the pre-clinical

and clinical trials of the veterinary medicinal product concerned.

The assessment report shall be updated whenever new information

becomes available which is of importance for the evaluation of

the quality, safety or efficacy of the veterinary medicinal product

concerned.

The Veterinary Services shall make the assessment report and

its reasons for the opinion publicly available without delay, after

deleting any information of a commercially confidential nature.”.

16. Regulation 26 of the principal regulations shall be amended Amends

26 of the principal

as follows>

regulations.

(a) for subregulation (1) thereof, there shall be substituted

the following>

“(1) The marketing authorisation may require the

holder to indicate on the immediate packaging and, or the

outer wrapping and the package leaflet, where the latter is

required, other particulars essential for safety or health

protection, including any special precautions relating to use

and any other warnings resulting from the clinical and

pharmacological trials prescribed in regulation 12(3)(j) and

in regulations 13 to 13D or from experience gained during

the use of the veterinary medicinal product once it has been

marketed.”<

(b) subregulation (2) thereof shall be deleted< and

(c) subregulation (3) shall be renumbered as subregulation

(2) thereof and it shall be substituted as follows>

“(2) In exceptional circumstances, and following

consultation with the applicant, the authorization may be

granted subject to a requirement for the applicant to introduce

specific procedures, in particular concerning the safety of the

veterinary medicinal product, notification to the competent

authorities of any incident relating to its use, and action to be

taken. Such authorisations may be granted only for objective,

verifiable reasons. Continuation of the authorization shall be

linked to the annual reassessment of such conditions.”.

Amends regulation

Regulation 27 shall be amended as follows>

17. 27 of the principal

regulations.

(a) for subregulations (2) and (3) thereof, there shall be

substituted the following>

“(2) The Veterinary Services may require the applicant

or the marketing authorisation holder to provide sufficient

quantities of the substances to enable controls to be made on

the identification of the presence of residues of the veterinary

medicinal products in question.

At the Veterinary Services’ request, the marketing

authorisation holder shall provide his technical expertise to

facilitate the implementation of the analytical method for

detecting residues of the veterinary medicinal products in the

national reference laboratory designated under European

Union Council Directive 96#23#EC on measures to monitor

certain substances and residues thereof in live animals and

animal products.

(3) The authorisation holder shall immediately supply

the Veterinary Services with any new information that might

entail the amendment of the particulars or documents referred

to in regulations 12(3), 13, 13A, 13B and 14 or Schedule I.

In particular, he shall immediately inform the Veterinary

Services of any prohibition or restriction imposed by the

competent authorities of any country in which the veterinary

medicinal product is placed on the market and of any other

new information which might influence the assessment of

the benefits and risks of the veterinary medicinal product

concerned.

In order to permit continuous assessment of the risk-

benefit balance, the Veterinary Services may at any time ask

the marketing authorisation holder to forward data

demonstrating that the risk-benefit balance remains

favourable.”<

(b) subregulation (4) thereof shall be deleted<

(c) for subregulation (5) there shall be substituted the

following>

“(5) The marketing authorisation holder shall

immediately inform the Veterinary Services, with a view to

authorisation, of any alteration which he proposes to make to

the particulars or documents referred to in regulations 12 to

13D.”.

18. Immediately after regulation 27 of the principal regulations, Adds new

regulation 27A to

there shall be added the following new regulation>

the principal

regulations.

After a marketing authorisation has been granted,

the holder of the authorisation shall inform the Veterinary

Services of the date of the actual placing on the market of the

veterinary medicinal product in Malta, taking into account

the various presentations authorised.

The holder shall also notify the Veterinary Services if

the product ceases to be placed on the market of Malta, either

temporarily or permanently. Such notification shall, otherwise

than in exceptional circumstances, be made no less than two

months before the interruption in the placing on the market

of the product.

Upon request by the Veterinary Services, particularly in

the context of pharmacovigilance, the marketing authorization

holder shall provide the Veterinary Services with all data

relating to the volume of sales of the veterinary medicinal

product, and any data in his possession relating to the volume

of prescriptions.”.

19. For regulation 28 of the principal regulations there shall be Substitutes

regulation 28 of the

substituted the following>

principal

regulations.

“28. (1) Without prejudice to subregulations (4) and (5),

a marketing authorisation shall be valid for five years.

(2) The authorisation may be renewed after five years

on the basis of a re-evaluation of the risk-benefit balance.

To this end, the marketing authorisation holder shall submit

a consolidated list of all documents submitted in respect of quality,

safety and efficacy, including all variations introduced since the

marketing authorization was granted, at least six months before

the marketing authorisation ceases to be valid in accordance with

subregulatioon (1) hereof. The Veterinary Services may require

the applicant to submit the listed documents at any time.

(3) Once renewed, the marketing authorisation shall

be valid for an unlimited period, unless the Veterinary Services

decides, on justified grounds relating to pharmacovigilance, to

proceed with one additional five-year renewal in accordance with

subregulation (2).

(4) Any authorisation that is not followed within three

years of its granting by the actual placing on the market of the

authorised veterinary medicinal product in Malta, shall cease to

be valid.

(5) When an authorised veterinary medicinal product

previously placed on the market in Malta is no longer actually

present on Malta for a period of three consecutive years, the

authorisation granted for that veterinary medicinal product shall

cease to be valid.

(6) The Veterinary Services may, in exceptional

circumstances, and on human or animal health grounds, grant

exemptions from subregulations (4) and (5). Such exemptions shall

be duly justified.”.

20. For regulation 30 of the principal regulations, there shall be

substituted the following>

“30. The marketing authorisation shall be refused if the file

submitted to the Veterinary Services does not comply with

regulations 12 to 13D and regulation 15.

The authorisation shall also be refused if, after examination

of the documents and particulars listed in regulations 12 and 13(1),

it is clear that>

(a) the risk-benefit balance of the veterinary medicinal

product is, under the authorised conditions of use,

unfavourable< when the application concerns a veterinary

medicinal product for zootechnical use, particular regard shall

be had to the benefits for animal health and welfare and to

consumer safety< or

(b) the product has no therapeutic effect or the applicant

has not provided sufficient proof of such effect as regards the

species of animal which is to be treated< or

(c) its qualitative or quantitative composition is not as

stated< or

(d) the withdrawal period recommended by the

applicant is not long enough to ensure that foodstuffs obtained

from the treated animal do not contain residues which might

constitute a health hazard to the consumer, or is insufficiently

substantiated< or

(e) the labelling or the package leaflet proposed by the

applicant does not comply with these regulations< or

(f) the veterinary medicinal product is offered for sale

for a use prohibited under other European Union Community

provisions.

However, when a European Union Community

legislative framework is in the course of being adopted, the

Veterinary Services may refuse authorisation for a veterinary

medicinal product where such action is necessary for the

protection of public health, consumer or animal health.

The applicant or marketing authorisation holder shall

be responsible for the accuracy of documents and data

submitted.”.

21. The heading of Chapter 4 of the principal regulations shall Substitutes heading

of Chapter 4 of the

be substituted as follows>

principal

regulations.

“CHAPTER 4

Mutual recognition procedure and decentralized

procedure”.

22. For regulations 31 to 34 of the principal regulations there Substitutes

regulations 31 to 34

shall be substituted the following>

of the principal

regulations.

“31. (1) With a view to the granting of a marketing

authorization for a veterinary medicinal product in more than one

Member State, the applicant shall submit an application based on

an identical dossier in those Member States. The dossier shall

contain all the administrative information and scientific and

technical documentation described in regulations 12 to 14. The

documents submitted shall include a list of Member States

concerned by the application.

The applicant shall request one Member State to act as

reference Member State and to prepare an assessment report in

respect of the veterinary medicinal product in accordance with

subregulation (2) or (3).

Where appropriate, the assessment report shall contain an

evaluation for the purposes of regulation 13(5) or regulation

13A(3).

(2) If the veterinary medicinal product has already

received a marketing authorisation at the time of application, the

concerned Member States shall recognize the marketing

authorisation granted by the reference Member State. To this end,

the marketing authorization holder shall request the reference

Member State either to prepare an assessment report in respect of

the veterinary medicinal product or, if necessary, to update any

existing assessment report. The reference Member State shall

prepare or update the assessment report within 90 days of receipt

of a valid application. The assessment report together with the

approved summary of product characteristics, labelling and

package leaflet shall be forwarded to the concerned Member States

and the applicant.

(3) If the veterinary medicinal product has not received

authorisation by the time of application, the applicant shall request

the reference Member State to prepare a draft assessment report

and drafts of the summary of product characteristics, labelling and

package leaflet. The reference Member State shall prepare these

drafts within 120 days of the receipt of a valid application and

shall send them to the concerned Member States and the applicant.

(4) Within 90 days after receipt of the documents

referred to in sub-regulations (2) and (3), the Member States

concerned shall approve the assessment report, the summary of

product characteristics, the labelling and the package leaflet and

inform the reference Member State accordingly. The reference

Member State shall record the agreement of all parties, close the

procedure and inform the applicant accordingly.

(5) Each Member State in which an application

following paragraph 1 has been submitted shall adopt a decision

in conformity with the approved assessment report, summary of

product characteristics, labelling and package leaflet within 30 days

after acknowledgement of the agreement.

(1) If Malta cannot, within the period allowed in

regulation 31(4), agree with the assessment report, summary of

product characteristics, labelling and package leaflet on grounds

of a potential serious risk to human or animal health or to the

environment, a detailed statement of the reasons shall be provided

to the reference Member State, the other Member States concerned

and the applicant. The points of disagreement shall be referred

without delay to the coordination group.

If a Member State to which an application has been submitted

invokes the reasons referred to in regulation 64(1), it shall no longer

be regarded as a Member State concerned by this Chapter.

(2) Within the coordination group, all Member States

referred to in subregulation (1) shall use their best endeavours to

reach agreement on the action to be taken. They shall provide the

applicant with the opportunity to make his point of view known

orally or in writing. If, within 60 days of the communication of the

reasons for disagreement to the coordination group the Member

States reach an agreement, the reference Member State shall record

the agreement, close the procedure and inform the applicant

accordingly. Regulation 31(5) shall apply in such cases.

(3) If within the period of 60 days the Member States

fail to reach an agreement, the Agency shall be immediately

informed with a view to application of the procedure laid down in

Articles 36, 37 and 38 of European Union Council Directive

2004#28#EC. The Agency shall be provided with a detailed

description of the matters on which agreement could not be reached

and the reasons for the disagreement. The applicant shall be

provided with a copy of such information.

(4) As soon as the applicant has been informed that

the matter has been referred to the Agency, he shall forthwith

forward to the Agency a copy of the information and documents

referred to in the first subparagraph of regulation 31(1).

(5) In the case referred to in subregulation (3), the

Member States that have approved the assessment report, summary

of product characteristics, labelling and package leaflet of the

reference Member State may, on request by the applicant, grant a

marketing authorisation for the veterinary medicinal product

without waiting for the outcome of the procedure laid down in

Article 36 of European Union Council Directive 2004#28#EC. In

that case, the authorisation granted shall be without prejudice to

the outcome of that procedure.

(1) If two or more applications submitted in

accordance with regulations 12 to 14 have been made for marketing

authorisation for a particular veterinary medicinal product and

Member States have adopted divergent decisions concerning the

authorisation of that veterinary medicinal product, or suspension

or revocation of authorisation, a Member State, or the European

Commission, or the marketing-authorisation holder may refer the

matter to the Committee for Medicinal Products for Veterinary

Use, hereinafter referred to as “the Committee”, for the application

of the procedure laid down in Articles 36, 37 and 38 of European

Union Council Directive 2004#28#EC.

(1) Malta or the European Commission or the

applicant or marketing authorisation holder shall, in specific cases

where the interests of the European Community are involved, refer

the matter to the Committee for the application of the procedure

laid down in Articles 36, 37 and 38 of European Union Council

Directive 2004#28#EC before a decision is reached on a request

for a marketing authorization or on the suspension or withdrawal

of an authorisation, or on any other variations to the terms of a

marketing authorisation which appear necessary, so as to take

account in particular of the information collected in accordance

with Title VII.

Malta or the European Commission shall clearly identify the

question which is referred to the Committee for consideration and

shall inform the applicant or the marketing authorisation holder.

Malta and the applicant or the marketing authorisation holder

shall forward to the Committee all available information relating

to the matter in question.”.

23. For regulation 37 of the principal regulations there shall be

substituted the following>

“37. Regulations 32(3), (4) and (5) and 33 to 34 shall not

apply to the homeopathic veterinary medicinal products referred

to in regulation 17.

Regulations 31 to 34 shall not apply to the homeopathic

veterinary medicinal products referred to in regulation 19(2).”.

24. Immediately after subregulation (3) of regulation 38 of the

principal regulations there shall be added the following subregulation>

“(4) Malta shall forward to the Agency a copy of the

manufacturing authorisations referred to in subregulation (1). The

Agency shall enter that information in the Community database

referred to in Article 80(6) of European Union Council Directive

2004#28#EC.”.

25. Paragraph (f) in regulation 44 of the principal regulations Amends

44 of the principal

shall be substituted as follows>

regulations.

“(f) comply with the principles and the guidelines on good

manufacturing practice for medicinal products and use as starting

materials only active substances which have been manufactured

in accordance with the detailed guidelines on good manufacturing

practice for starting materials<”.

26. Immediately after regulation 44 of the principal regulations Adds new

regulation 44A to

there shall be added the following new regulation>

the principal

regulations.

(1) For the purposes of these regulations,

“Starting

materials.

manufacturing active substances for use as starting materials

shall include the complete or partial manufacture or the import

of an active substance used as a starting material, as defined

in Part 2, Section C of Schedule I, and the various processes

of dividing up, packaging or presentation prior to its

incorporation in a veterinary medicinal product, including

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

material distributor.”.

27. Subregulation (1) of regulation 46 of the principal regulations Amends regulation

46 of the principal

shall be substituted as follows>

regulations.

“(1) Malta shall ensure that the qualified person referred to

in regulation 45 fulfils the conditions of qualification referred to

in subregulations (2) and (3).”.

28. Subregulation (1) of regulation 47 of the principal regulations Amends regulation

47 of the principal

shall be substituted as follows>

regulations.

“(1) A person engaging, in Malta, in the activities of the

person referred to in regulation 45(1) on the date on which these

regulations became applicable, without complying with the

provisions of regulation 46, shall be eligible to continue to engage

in those activities within the Community.”.

29. In regulation 48 of the principal regulations, for paragraph Amends regulation

48 of the principal

(b) of subregulation (1) thereof, there shall be substituted the following> regulations.

“(b) in the case of veterinary medicinal products coming

from third countries, even if manufactured in the Community, each

production batch imported has undergone in Malta a full qualitative

analysis, a quantitative analysis of at least all the active substances,

and all the other tests or controls necessary to ensure the quality of

veterinary medicinal products in accordance with the requirements

of the marketing authorisation.”.

30. Regulation 51 of the principal regulations shall be amended

(a)

subregulation (1) shall be amended as follows>

(i) For the words from “(1) The following” to the words

“of medicinal products –” there shall be substituted the

following>

“Except in the case of the medicinal products

referred to in regulation 17(1), the Veterinary Services

shall approve the immediate packaging and outer

packaging of veterinary medicinal products. Packaging

shall bear the following information, which shall

conform with the particulars and documents provided

pursuant to regulations 12 to 13d and the summary of

product characteristics, and shall appear in legible

characters>”<

(ii) for paragraphs (a) and (b) there shall be substituted

the following>

“(a) the name of the medicinal product, followed

by its strength and pharmaceutical form. The common

name shall appear if the medicinal product contains only

one active substance and its name is an invented name<

(b) a statement of the active substances expressed

qualitatively and quantitatively per unit or according to

the form of administration for a particular volume or

weight, using the common names<”<

(iii) for paragraph (e) there shall be substituted the

following>

“(e) name or corporate name and permanent

address or registered place of business of the marketing

authorisation holder and, where appropriate, of the

representative designated by the marketing authorization

holder<”<

(iv) for paragraph (f) there shall be substituted the

following>

“(f) the species of animal for which the veterinary

medicinal product is intended< the method and, if

necessary, the route of administration. Space shall be

provided for the prescribed dose to be indicated<”<

(v) for paragraph (g) there shall be substituted the

following>

“(g) the withdrawal period for veterinary

medicinal products to be administered to food-producing

species, for all the species concerned and for the various

foodstuffs concerned (meat and offal, eggs, milk, honey),

including those for which the withdrawal period is zero<”<

(vi) for paragraph (j) shall be substituted the following>

“(j) specific precautions relating to the disposal

of unused medicinal products or waste derived from

veterinary medicinal products, where appropriate, as well

as a reference to any appropriate collection system in

place<”<

(vii) for paragraph (l) shall be substituted the following>

“(l) the words “For animal treatment only” or, in

the case of the medicinal products referred to in

regulation 60, the words “For animal treatment only —

to be supplied only on veterinary prescription.””< and

(b) immediately after subregulation (4) there shall be added

the following subregulation>

“(5) In the case of medicinal products that have been

granted a marketing authorisation under European Regulation

(EC) No 726#2004, Malta may permit or require that the outer

packaging bear additional information concerning

distribution, possession, sale or any necessary precautions,

provided that such information is not in infringement of

Community law or the terms of the marketing authorisation,

and is not promotional.

This additional information shall appear in a box with a

blue border to separate it clearly from the information referred

to in subregulation (1).”.

31. Regulation 52 of the principal regulations shall be amended

as follows>

(a) for the words from “(1)As regards” to “be necessary –”

in subregulation (1) thereof, there shall be substituted the words>

“(1) As regards ampoules, the particulars listed in the

first paragraph of regulation 51(1) shall be given on the outer

package. On the immediate packaging, however, only the

following particulars shall be necessary>”< and

(b) for subregulations (2) and (3) thereof, there shall be

substituted the following>

“(2) As regards small immediate packaging containing

a single dose, other than ampoules, on which it is impossible

to give the particulars mentioned in subregulation (1), the

requirements of regulation 51(1), (2) and (3) shall apply only

to the outer package.

(3) The particulars mentioned in paragraphs (c) and

(f) of subregulation (1) shall appear on the outer package and

on the immediate packaging of the medicinal products in the

language or languages of the country in which they are placed

on the market.”.

32. For regulation 53 of the principal regulations there shall be

replaced by the following>

“53. Where there is no outer package, all the particulars

which should feature on such a package pursuant to regulations 51

and 52 shall be shown on the immediate packaging.”.

33. Regulation 54 of the principal regulations shall be amended

as follows>

(a) for subregulation (1) thereof, there shall be substituted

the following>

“(1) The inclusion of a package leaflet in the packaging

of veterinary medicinal products shall be obligatory unless

all the information required by this regulation can be conveyed

on the immediate packaging and the outer packaging. Malta

shall take all appropriate measures to ensure that the package

leaflet relates solely to the veterinary medicinal product with

which it is included. The package leaflet shall be written in

terms that are comprehensible to the general public and in

the official language or languages of Malta.

Subregulation (1) shall not prevent the package leaflet

from being written in several languages, provided that the

information given is identical in all the languages.

The Veterinary Services may exempt labels and package

leaflets for specific veterinary medicinal products from the

obligation for certain particulars to appear and for the leaflet

to be in the official language or languages of Malta, when the

product is intended to be administered only by a veterinarian.”<

(b) subregulation (2) shall be amended as follows>

(i) for the words from “(2) The package insert” to the

words “by the Veterinary Services –“ there shall be substituted

the following>

“(2) The Veterinary Services shall approve

package leaflets. Leaflets shall contain at least the

following information, in the order indicated, which shall

conform to the particulars and documents provided

pursuant to regulations 12 to 13D and the approved

summary of product characteristics>”< and

(ii) for paragraphs (a) and (b) there shall be substituted

the following>

“(a) name or corporate name and permanent

address or registered place of business of the marketing

authorisation holder and of the manufacturer and, where

appropriate, of the representative of the marketing

authorization holder<

(b) name of the veterinary medicinal product

followed by its strength and pharmaceutical form. The

common name shall appear if the product contains only

one active substance and its name is an invented name.

Where the medicinal product is authorised according to

the procedure provided for in regulations Articles 31 to

43 of European Union Council Directive 2004#28#EC

under different names in Malta, a list of the names

authorised in Malta<”< and

(c)

subregulation (3) thereof shall be deleted.

34. For regulation 55 of the principal regulations there shall be

substituted the following>

“55. Where the provisions of this Title are not observed

and a formal notice addressed to the person concerned has been

ineffectual, the Veterinary Services may suspend or revoke the

marketing authorisation.”.

35. Subregulation (2) of regulation 57 of the principal regulations

shall be amended as follows>

(a) for the words from “(2) In addition to” to the words “no

other information –“ there shall be substituted the following>

“(2) In addition to the clear mention of the words

“homeopathic veterinary medicinal product without approved

therapeutic indications”, the labelling and, where appropriate,

package leaflet for the homeopathic veterinary medicinal

products referred to in regulation 17(1) shall bear the following

information and no other information>’< and

(b) for paragraph (a) thereof, there shall be substituted the

following>

“(a) the scientific name of the stock or stocks followed

by the degree of dilution, using the symbols of the

Pharmacopoeia used in accordance with paragraph (8) of

regulation 2. If the homeopathic veterinary medicinal product

is composed of more than one stock, the labelling may mention

an invented name in addition to the scientific names of the

stocks,”.

36. For Title VI of the principal regulations, there shall be

substituted the following>

“TITLE VI

POSSESSION, DISTRIBUTION AND DISPENSING OF

VETERINARY MEDICINAL PRODUCTS”.

37. Regulation 58 of the principal regulations shall be amended

as follows>

(a) immediately after subregulation (3) there shall be

inserted the following new subregulation>

“3A. The holder of a distribution authorisation shall

have an emergency plan guaranteeing the effective

implementation of any recall operation ordered by the

competent authorities or undertaken in cooperation with the

manufacturer of the medicinal product in question or the

holder of the marketing authorisation.”<

(b) immediately after subregulation (4) there shall be

inserted the following new subregulation>

“(5) Any distributor, not being the marketing

authorization holder, who imports a product from another

Member State shall notify the marketing authorization holder

and the Veterinary Services to which the product will be

imported of his intention to import it. In the case of products

which have not been granted an authorisation pursuant to

European Regulation (EC) No 726#2004, the notification to

the Veterinary Services shall be without prejudice to additional

procedures provided for in the legislation of Malta.”.

38. Regulation 59 of the principal regulations shall be amended Amends regulation

59 of the principal

as follows>

regulations.

(a)

subregulation (2) shall be amended as follows>

(i) for the words from “(2) Any person permitted” to

the words “or outgoing transaction –” there shall be substituted

the following>

“(2) Any person permitted under subregulation

(1) to supply veterinary medicinal products shall be

required to keep detailed records for veterinary medicinal

products that may be supplied only on prescription, the

following information being recorded in respect of each

incoming or outgoing transaction>”< and

(ii) in the third paragraph thereof, for the words “for a

period of the years” there shall be substituted the words>

“for a period of five years”<

(b) for subregulation (3) there shall be substituted the

following>

“(3) The Veterinary Services may permit the supply

in Malta of veterinary medicinal products for foodproducing

animals for which a veterinary prescription is required by or

under the supervision of a person registered for this purpose

who provides guarantees with respect to qualifications, record-

keeping and reporting in accordance with national law. The

Veterinary Services shall notify the European Commission

of relevant provisions of national law. This provision shall

not apply to the supply of veterinary medicinal products for

the oral or parenteral treatment of bacterial infections.”< and

(c)

subregulation (4) thereof shall be deleted.

39. Regulation 60 of the principal regulations shall be amended

as follows>

(a) for the words from “Without prejudice” to the words

“medicinal products –” there shall be substituted by the following>

“Without prejudice to stricter European Community or

national rules relating to dispensing veterinary medicinal

products and serving to protect human and animal health, a

veterinary prescription shall be required for dispensing to the

public the following veterinary medicinal products>”<

(b) immediately after paragraph (a) thereof there shall be

inserted the following new paragraph>

“(aa) veterinary medicinal products for foodproducing

animals.

However, Malta may grant exemptions from this

requirement according to criteria established in accordance

with the procedure referred to in Article 89(2) of European

Union Council Directive 2004#28#EC<”<

(c) subparagraph (iii) of paragraph (b) shall be deleted and

subparagraph (iv) shall be renumbered as subparagraph (iii) thereof<

(d) for subparagraph (d) there shall be substituted the

following>

“(d) official formula, within the meaning of Article

3(2)(b) of European Union Council Directive 2004#28#EC,

intended for food-producing animals.”< and

(e) for the words from “In addition,” to the words “sub-

regulation (1) apply.” there shall be substituted the following>

“Malta shall take all necessary measures to ensure that,

in the case of medicinal products supplied only on

prescription, the quantity prescribed and supplied shall be

restricted to the minimum amount required for the treatment

or therapy concerned.

In addition, a prescription shall be required for new

veterinary medicinal products containing an active substance

that has been authorised for use in a veterinary medicinal

product for fewer than five years.”.

40. In regulation 62 of the principal regulations, for the words Amends regulation

62 of the principal

“In the territory of Malta,” to the words “in regulation 61.” there shall regulations.

be substituted the following>

“Malta shall ensure that the owners or keepers of food-

producing animals can provide proof of purchase, possession and

administration of veterinary medicinal products to such animals

for five years after their administration, including when the animal

is slaughtered during the five-year period.”.

41. In regulation 63 of the principal regulations, for the words Amends regulation

63 of the principal

from “Notwithstanding regulations 9 and 60,” to the words “are regulations.

satisfied –” there shall be substituted the following>

“By way of derogation from regulation 9 and without

prejudice to regulation 60, Malta shall ensure that veterinarians

providing services in another Member State can take with them

and administer to animals small quantities of veterinary medicinal

products not exceeding daily requirements other than

immunological veterinary medicinal products which are not

authorised for use in the Member State in which the services are

provided, provided that the following conditions are satisfied>”.

42. Immediately at the end of subregulation (1) of regulation 64 Amends regulation

64 of the principal

of the principal regulations, there shall be added the following regulations.

paragraph>-

“Malta may also invoke the provisions of the first paragraph

in order to withhold marketing authorisation in accordance with a

decentralised procedure as provided for in Articles 31 to 43 of

European Union Council Directive 2004#28#EC.”.

43. For subregulation (2) of regulation 65 of the principal Amends regulation

65 of the principal

regulations, there shall be substituted the following>

regulations.

“(2) Malta may impose specific requirements on veterinary

practitioners and other health-care professionals in respect of the

reporting of suspected serious or unexpected adverse reactions and

human adverse reactions.”.

44. Regulation 66 of the principal regulations shall be amended

as follows>

(a) for the words from “In order to ensure” to the words

“such information scientifically.” there shall be substituted the

following>

“In order to ensure the adoption of appropriate and

harmonised regulatory decisions concerning the veterinary

medicinal products authorised within the European

Community, having regard to information obtained about

suspected adverse reactions to veterinary medicinal products

under normal conditions of use, Malta shall administer a

veterinary pharmacovigilance system. This system shall be

used to collect information useful in the surveillance of

veterinary medicinal products, with particular reference to

adverse reactions in animals and in human beings relating to

the use of veterinary medicinal products, and to evaluate such

information scientifically.”< and

(b) immediately after the second paragraph ending with the

words “medicinal products.” there shall be inserted the following

new paragraph>

“Malta shall ensure that suitable information collected

within this system is communicated to other Member States

and the Agency. This information shall be recorded in the

database referred to in point (k) of the second subparagraph

of Article 57(1) of European Regulation (EC) No 726#2004

and shall be permanently accessible to all Member States and

without delay to the public.”.

Immediately after regulation 66 of the principal regulations

there shall be added the following new regulation>

“Management

The management of funds intended for activities

connected with pharmacovigilance, the operation of

communication networks and market surveillance shall be

under the permanent control of the Veterinary Services in

order to guarantee their independence.”.

46. For the words “The qualified person shall be responsible for Amends

67 of the principal

the following -” in regulation 67 of the principal regulations, there shall regulations.

be substituted the following>

“That qualified person shall reside in the European

Community and shall be responsible for the following>”.

47. For regulation 68 of the principal regulations there shall be Substitutes

regulation 68 of the

substituted the following>

principal

regulations.

“68. (1) The marketing authorisation holder shall maintain

detailed records of all suspected adverse reactions occurring within

the European Community or in a third country.

Save in exceptional circumstances, these reactions shall be

communicated electronically in the form of a report in accordance

with the guidelines referred to in regulation 70(1).

(2) The marketing authorisation holder shall 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, and no later than 15 days following receipt of the

information.

The marketing authorisation holder shall also record all

suspected serious adverse reactions and human adverse reactions

related to the use of veterinary medicinal products of which he can

reasonably be expected to have knowledge, and report them

promptly to the Veterinary Services, and no later than 15 days

following receipt of the information.

(3) The marketing authorisation holder shall ensure that

all suspected serious unexpected adverse reactions, human adverse

reactions and any suspected transmission via a veterinary medicinal

product of any infectious agent occurring on the territory of a third

country are reported promptly in accordance with the guidelines

referred to in regulation 70(1), so that they are available to the

Agency and the competent authorities of the Member States in

which the veterinary medicinal product is authorised, and no later

than 15 days following the receipt of the information.

(4) By way of derogation from subregulations (2) and

(3), in the case of veterinary medicinal products which are covered

by European Directive 87#22#EEC, have benefited from the

authorisation procedures under Articles 31 and 32 of European

Union Council Directive 2004#28#EC or have been the subject of

the procedures provided for in Articles 36, 37 and 38 of European

Union Council Directive 2004#28#EC, the marketing authorisation

holder shall additionally ensure that all suspected serious adverse

reactions and human adverse reactions occurring in the Community

are reported in such a way so as to be accessible to the reference

Member State or a competent authority designated as reference

Member State. The reference Member State shall assume

responsibility for the analysis and follow-up of any such adverse

reactions.

(5) Unless other requirements have been laid down as

a condition for the granting of the marketing authorisation or

subsequently as indicated in the guidelines referred to in regulation

70(1), reports of all adverse reactions shall be submitted to the

Veterinary Services in the form of a periodic safety update report,

immediately upon request or at least every six months after

authorisation until the placing on the market. Periodic safety update

reports shall also be submitted immediately upon request or at least

every six months during the first two years following the initial

placing on the market, and once a year for the following two years.

Thereafter, the reports shall be submitted at three-yearly intervals,

or immediately upon request.

The periodic safety update reports shall include a scientific

evaluation of the risk-benefit balance of the veterinary medicinal

product.

(6) Following the granting of a marketing

authorisation, the holder of such authorisation may request the

amendment of the periods referred to in subregulation (5) hereof

in accordance with the procedure laid down by European

Commission Regulation (EC) No 1084#2003.

(7) The holder of a marketing authorisation may not

communicate information relating to pharmacovigilance concerns

to the general public in relation to its authorized veterinary

medicinal product without giving prior or simultaneous notification

to the Veterinary Services.

In any case, the marketing authorisation holder shall ensure

that such information is presented objectively and is not misleading.

Malta shall take the necessary measures to ensure that a

marketing authorisation holder who fails to discharge these

obligations is subject to effective, proportionate and dissuasive

penalties.”.

48. For subregulation (2) of regulation 71 of the principal Amends regulation

71 of the principal

regulations there shall be substituted the following>

regulations.

“(2) If urgent action is necessary for protecting human or

animal health, Malta may suspend the marketing authorisation of

a veterinary medicinal product, provided that the Agency, the

Commission and the other Member States are informed on the

following working day at the latest.”.

49. Regulation 72 of the principal regulations shall be amended Amends regulation

72 of the principal

as follows>

regulations.

(a) For subregulation (1) thereof, there shall be substituted

the following>

“(1) The Veterinary Services shall ensure, by means

of repeated inspections and, if necessary, unannounced

inspections, and where appropriate, by asking an Official

Medicines Control Laboratory or a laboratory designated for

that purpose to conduct tests on samples, that the legal

requirements relating to veterinary medicinal products are

complied with.

The Veterinary Services may also carry out unannounced

inspections at the premises of manufacturers of active

substances used as starting materials for veterinary medicinal

products, and of the premises of the marketing authorisation

holder whenever it considers that there are grounds for

suspecting non-compliance with the provisions of regulation

Article 51 of European Union Council Directive 2004#28#EC.

Such inspections may also be carried out at the request of

another Member State, the Commission or the Agency.

In order to verify whether the data submitted in order to

obtain a conformity certificate comply with the monographs

of the European Pharmacopoeia, the standardization body for

nomenclatures and quality norms within the meaning of the

Convention relating to the elaboration of a European

Pharmacopoeia (European Directorate for the Quality of

Medicines) may ask the Commission or the Agency to request

such an inspection when the starting material concerned is

the subject of a European Pharmacopoeia monograph.

The Veterinary Services may carry out inspections of

starting material manufacturers at the manufacturer’s own

request.

Such inspections shall be carried out by authorized

representatives of the Veterinary Services who shall be

empowered to>

(a) inspect manufacturing or trading

establishments and any laboratories entrusted by the

holder of the manufacturing authorisation with the task

of carrying out control tests pursuant to regulation 24<

(b) take samples including with a view to an

independent analysis by an Official Medicines Control

Laboratory or by a laboratory designated for that purpose

by Malta<

(c) examine any documents relating to the object

of the inspection, subject to the provisions in force in

Malta placing restrictions on these powers with regard

to the description of the manufacturing method<

(d) inspect the premises, records and documents

of marketing authorisation holders or any firms

performing the activities described in Title VII, and in

particular regulations 67 and 68 thereof, on behalf of a

marketing authorisation holder.”<

(b) subregulation (3) thereof shall be substituted by the

following>

“(3) The authorised representatives of the Veterinary

Services shall report after each of the inspections mentioned

in subregulation (1) on whether the principles and guidelines

on good manufacturing practice referred to in Article 51 of

European Union Council Directive 2004#28#EC or, where

appropriate, the requirements set out in Title VII, are being

complied with. The inspected manufacturer or market

authorization holder shall be informed of the content of such

reports.”< and

(c) immediately at the end of subregulation (3) thereof, there

shall be added the following new subregulations>

“(4) Without prejudice to any arrangements which may

have been concluded between the European Community and

a third country, Malta, the European Commission or the

Agency may require a manufacturer established in a third

country to undergo an inspection as referred to in

subregulation (1).

(5) Within 90 days after an inspection as referred to in

subregulation (1), a certificate of good manufacturing practice

shall be issued to the manufacturer if the inspection established

that the manufacturer in question is complying with the

principles and guidelines on good manufacturing practice as

provided for by Community law.

In the event of an inspection carried out at the request of

the European Pharmacopoeia, a certificate of compliance with

the monograph shall be issued, if appropriate.

(6) Malta shall enter the certificates of good

manufacturing practice which they issue in a Community

database managed by the Agency on behalf of the Community.

(7) If the outcome of the inspection as referred to in

subregulation (1) is that the manufacturer does not comply

with the principles and guidelines of good manufacturing

practice as provided for by Community legislation, the

information shall be entered in the Community database as

referred to in subregulation (6).”.

50. Regulation 74 of the principal regulations shall be substituted Substitutes

regulation 74 of the

as follows>

principal

regulations.

“74. (1) Where it considers it necessary for reasons of

human or animal health, the Veterinary Services may require the

marketing authorisation holder for an immunological veterinary

medicinal product to submit samples of batches of the bulk product

and, or veterinary medicinal product, for control by an Official

Medicines Control Laboratory before the product is put into

circulation.

(2) On request by the Veterinary Services, the

marketing authorisation holder shall promptly supply the samples

referred to in subregulation (1), together with the reports of the

control referred to in regulation 73(2).

The Veterinary Services shall inform all the other Member

States in which the veterinary medicinal product is authorised as

well as the European Directorate for the Quality of Medicines of

its intention to control batches or the batch in question.

(3) After studying the control reports referred to in

regulation 73(2), the laboratory responsible for the control shall

repeat, on the samples provided, all the tests carried out by the

manufacturer on the finished product, in accordance with the

relevant provisions shown in the dossier for marketing

authorisation.

The list of tests to be repeated by the laboratory responsible

for the control shall be restricted to justified tests, provided that all

Member States concerned, and if appropriate the European

Directorate for the Quality of Medicines, agree to this.

For immunological veterinary medicinal products authorized

under European Regulation (EC) No 726#2004, the list of tests to

be repeated by the control laboratory may be reduced only after

agreement by the Agency.

(4) Malta shall recognise the results of the tests.

(5) Unless the European Commission is informed that

a longer period is necessary to conduct the tests, the Veterinary

Services shall ensure that this control is completed within 60 days

of receipt of the samples.

The Veterinary Services shall notify the other Member States

concerned, the European Directorate for the Quality of Medicines,

the marketing authorisation holder and, if appropriate, the

manufacturer, of the results of the tests within the same period of

time.

If the Veterinary Services concludes that a batch of a

veterinary medicinal product is not in conformity with the control

report of the manufacturer or the specifications provided for in the

marketing authorisation, it shall take all the necessary measures

vis-a-vis the marketing authorisation holder and the manufacturer,

where appropriate, and shall inform accordingly the other Member

States in which the veterinary medicinal product is authorised.”<

51. Regulation 75 of the principal regulations shall be amended

as follows>

(a)

subregulation (1) shall be amended as follows>

(i) for the words from “(1) The Veterinary Services”

to the words “is clear that-” there shall be substituted the

words>

“The Veterinary Services shall suspend, revoke,

withdraw or vary marketing authorisations when it is

clear that>”<

(ii) for paragraph (a) there shall be substituted the

following>

“(a) the risk-benefit assessment of the veterinary

medicinal product is, under the authorized conditions of

use, unfavourable, particular regard being had to the

benefits for animal health and welfare and to consumer

safety, when the authorisation concerns a veterinary

medicinal product for zootechnical use<”<

(iii) the words from “However, pending” to the words

“or animal health<” in paragraph (e) shall be deleted<

(iv) for paragraph (f) there shall be substituted the

following>

“(f) information given in the application

documents pursuant to regulations 12 to 13D and 27 is

incorrect<”<

(v) paragraph (h) shall be deleted< and

(vi) immediately at the end of paragraph (h), the

following second paragraph shall be added>

“However, when a Community legislative

framework is in the course of being adopted, the

Veterinary Services may refuse authorisation for a

veterinary medicinal product where such action is

necessary for the protection of public health, consumer

and animal health.”< and

(b) subregulation (2) shall be amended as follows>

(i) for the words from “(2) Authorisation”

to the words “established that-” there shall be

substituted the following words>

“Marketing authorisations may be

suspended, revoked, withdrawn or varied

when it is established that>”< and

(ii) for paragraph (a) there shall be substituted the

following>

“(a) the particulars supporting the application, as

provided for in regulations 12 to 13D, have not been

amended in accordance with regulations 27(1) and (5)<”.

52. In regulation 76 of the principal regulations, for paragraph

(a) of subregulation (1) there shall be substituted the following>

“(a) it is clear that the risk-benefit assessment of the

veterinary medicinal product is, under the authorized conditions

of use, unfavourable, particular regard being had to the benefits

for animal health and welfare and to the safety and health benefits

for the consumer, when the authorisation concerns a veterinary

medicinal product for zootechnical use.”.

53. In regulation 77 of the principal regulations, immediately

after subregulation (2) thereof, there shall be added the following new

subregulation>

“(3) The Veterinary Services shall prohibit the advertising

to the general public of veterinary medicinal products that>

(a) in accordance with regulation 60, are available on

veterinary prescription only< or

(b) contain psychotropic drugs or narcotics, such as

those covered by the United Nations Conventions of 1961

and 1971.”.

54. Regulation 81 of the principal regulations shall be substituted

as follows>

“81. The Veterinary Services shall communicate the

appropriate information to competent authorities in other Member

States, particularly regarding compliance with the requirements

adopted for the authorisations referred to in regulation 38, for the

certificates referred to in regulation 72(5) or for authorization to

place products on the market.

Upon reasoned request, the Veterinary Services shall forthwith

communicate the reports referred to in regulation 72(3) to the

competent authorities of another Member State.

The conclusions reached following an inspection as referred

to in regulation 72(1) carried out by the inspectors of the Veterinary

Services shall be valid for the European Community.

However, by way of exception, if Malta has not been able,

for serious reasons of human or animal health, to accept the

conclusions of an inspection as referred to in regulation 72(1), the

Veterinary Services shall forthwith inform the Commission and

the Agency.

When the European Commission is informed of such serious

reasons, it may, after consulting the Veterinary Services, ask the

inspector of the Veterinary Services to carry out a new inspection<

the inspector may be accompanied by two other inspectors from

Member States that are not parties to the disagreement.”.

55. In regulation 85 of the principal regulations, for the words Amends regulation

from “Marketing authorizations” to the words “Government Gazette” 85

regulations.

there shall be substituted the following>

“Decisions to grant or revoke a marketing authorization shall

be made publicly available.”.

56. Regulation 86 of the principal regulations shall be substituted Substitutes

regulation 86 of the

as follows>

principal

regulations.

“86. The Veterinary Services shall not permit foodstuffs for

human consumption to be taken from test animals unless an

appropriate withdrawal period has been established. The

withdrawal period shall either>

(a) be at least as laid down in regulation 11(2)

including, where appropriate, a safety factor reflecting the

nature of the substance being tested< or

(b) if maximum residue limits have been established

by the Community in accordance with Regulation (EEC) No

2377#90, ensure that this maximum limit will not be exceeded

in foodstuffs.”.

Adds new

57. Immediately after regulation 86 of the principal regulations

regulation 87 to the

there shall be added the following new regulation>

principal

regulations.

The Veterinary Services shall ensure that

“Collection.

appropriate Systems collection systems are in place for

veterinary medicinal products that are unused or expired.”.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press