use of medicated feedingstuffs Rules, 2005

L.N. 225 of 2005

VETERINARY SERVICES ACT, 2001

(ACT NO. XXIII OF 2001)

Conditions governing the preparation, placing on the market and

use of medicated feedingstuffs Rules, 2005

IN exercise of the powers conferred by article 26 of the Veterinary

Services Act, the Minister for Rural Affairs and the Environment has

made the following rules>-

(1) The title of these rules is Conditions governing the Title and scope.

preparation, placing on the market and use of medicated feedingstuffs

Rules, 2005.

(2) These rules lay down, without prejudice to the adoption

of the list laid down in Article 3 point 1, second sub-paragraph to

European Union Directive 2001#82#EC, the conditions other than those

of animal health, governing the preparation, placing on the market and

use of medicated feedingstuffs within the territory of Malta.

(3) These rules shall not affect European Community rules

applicable to additives used in feedingstuffs, or national rules adopted

pursuant to the said rules, and in particular those applicable to the

additives referred to in Article 1 second sub-paragraph to European

Union Council Directive 90#167#EC

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

under the European Union Council Directive of the 26 th March, 1990

laying down the conditions governing the preparation, placing on the

market and use of medicated feedingstuffs in the Community

(1) For the purposes of these rules the definitions appearing Definitions.

in Article 1 of European Union Directive 2001#82#EC of the European

Parliament and of the Council of 6 November 2001 on the Community

code relating to veterinary medicinal products and Article 2 of Council

Directive 79#373#EEC of 2 April 1979 on the marketing of compound

feedingstuffs, as last amended by Directive 2000#16#EC of the European

Parliament and the Council of 10 April 2000 shall apply as necessary.

(2) For the purposes of these rules, the following definitions

shall also apply>

“authorized medicated pre-mix” means any pre-mix for the

manufacture of medicated feedingstuffs as defined in Article 1

point 5 of European Union Directive 2001#82#EC which has been

granted an authorization in accordance with Articles

5,6,7,8,9,10,and 11, of that Directive<

“Member State” means a State which is a Member within the

European Community<

“placing on the market” means the holding in the territory of

the Community for sale or disposal in any other form whatever to

third parties, whether or not for consideration, and actual sale or

disposal<

“the Commission” means the European Union Commission<

“the Community” means the European Community<

“Third Country” means a State which is not a Member within

the European Community<

“Veterinary Services” means the competent authority within

the territory of Malta as established under article 2 of the Veterinary

Services Act.

(1) The Veterinary Services shall prescribe that, as regards

the medicinal component, medicated feedingstuffs may be manufactured

from authorized medicated pre-mixes only.

(2) By way of derogation from the first subparagraph, the

Veterinary Services may, provided they comply with the requirements

of Article 6 of European Union Directive 2001#82#EC>

(a) subject to any specific conditions laid down in

authorizations to place authorized medicated pre-mixes on the

market, authorize intermediate products which are prepared from

such medicated pre-mixes authorized in accordance with Article

6, 7, 8, 9,10, and 11 of Directive European Union Directive

2001#82#EC and from one or more feedingstuffs and which are

intended for the subsequent manufacture of medicated feedingstuffs

ready for use.

(b) The Veterinary Services shall take all necessary steps

to ensure that intermediate products are manufactured only by

establishments authorized in accordance with rule 4 and that they

are the subject of a declaration to the Veterinary Services, authorize

the veterinarian to have manufactured under the conditions laid

down in Article 4 (3) of Directive 81#851#EEC, and under his

responsibility and on prescription, medicated feedingstuffs from

several authorized medicated pre-mixes, provided that there is no

specific authorized therapeutic agent in pre-mix form for the disease

to be treated or for the species concerned.

(c) Until the date on which the Veterinary Services has to

comply with the new rules laid down in Article 9 of European

Union Directive 2001#82#EC, national rules governing the above

conditions shall remain applicable, with due regard for the general

provisions of the Treaty.

(3) Products authorized pursuant to sub-rule (1) shall be

subject to the rules laid down in Articles 44 to 63 of European Union

Directive 2001#82#EC.

(1) The Veterinary Services shall take all necessary measures Conditions for the

manufacture of

to ensure that medicated feedingstuffs are manufactured only under the medicated

conditions set out below>

feedingstuffs.

(a) the manufacturer shall have premises which have been

previously approved by the competent national authority, technical

equipment and suitable and adequate storage and inspection

facilities<

(b) the medicated feedingstuffs manufacturing plant shall

be manned by staff whose knowledge of and qualifications in

mixing technology are adequate<

(c)

the producer shall be responsible for ensuring that>

(i) only feedingstuffs or combinations thereof which

comply with Community provisions on feedingstuffs are used,

(ii) the feedingstuff used produces a homogeneous and

stable mix with the authorized medicated pre-mix,

(iii) the authorized medicated pre-mix is used during

the manufacturing process in accordance with the conditions

laid down when authorization for placing on the market was

given and, in particular, that>

(1) there is no possibility of any undesirable

interaction between veterinary medicinal products,

additives and feedingstuffs<

(2) the medicated feedingstuff will keep for the

stipulated period<

(3) the feedingstuff to be used for producing the

medicated feedingstuff does not contain the same

antibiotic or the same coccidiostat as those used as an

active substance in the medicated pre-mix<

(iv) the daily dose of medicinal product is contained

in a quantity of feedingstuff corresponding to at least half the

daily feed ration of the animals treated or, in the case of

ruminants, corresponding to at least half the daily requirement

of nonmineral supplementary feedingstuffs<

(d) premises, staff and equipment used and participating in

the entire manufacturing process must comply with the

manufacturing hygiene rules and principles of the Member State

in question< the manufacturing process must conform to the rules

of good manufacturing practice<

(e) the medicated feedingstuffs manufactured shall undergo

regular checks, including appropriate laboratory tests of

homogeneity by the manufacturing establishments, under the

supervision and periodic control of the official department, to

ensure that the medicated feedingstuff complies with the

requirements of these rules, especially in respect of its homogeneity,

stability and storability<

(f) manufacturers shall be obliged to keep daily records of

the types and quantities of the authorized medicated pre-mixes

and feedingstuffs used and of the medicated feedingstuffs

manufactured, held or dispatched, together with the names and

addresses of the breeders or holders of the animals, and in the case

provided for in rule 10 (2), the name and address of the authorized

distributor and, where appropriate, the name and address of the

prescribing veterinarian. The records, which must meet the

requirements of Article 12 and Article 13 (1) of European Union

Directive 2001#82#EC, must be kept for at least three years after

the date of the last entry and must be made available at any time to

the competent authorities in case of checking<

(g) pre-mixes and medicated feedingstuffs shall be stored

in suitable separate and secured rooms or hermetic containers which

are specially designed for the storage of such products.

(2) The Veterinary Services may, by way of derogation from

paragraph 1, subject to any additional guarantees appropriate, authorize

the manufacture of medicated feedingstuffs on farms provided that the

said paragraph is complied with.

(1) The Veterinary Services shall prescribe that medicated Placing on the

market of medicated

feedingstuffs may be placed on the market only in packages or containers feedingstuffs.

sealed in such a way that, when the package is opened, the closure or

seal is damaged and they cannot be re-used.

(2) Where road tankers or similar containers are used to

place medicated feedingstuffs on the market, these must be cleaned

before any re-use in order to prevent any subsequent undesirable

interaction or contamination.

(1) The Veterinary Services shall take all necessary measures Labelling of

medicated

to ensure that medicated feedingstuffs are not put into circulation unless feedingstuffs.

the labelling complies with the European Community provisions in force.

Furthermore, the packages or containers referred to in rule 5 (1) shall

be clearly marked “Medicated Feedingstuffs”.

(2) Where road tankers or similar containers are used to

place medicated feedingstuffs on the market, it shall be sufficient for

the information referred to in paragraph 1 to be contained in the

accompanying documents.

(1) The Veterinary Services shall take all necessary measures Further

to ensure that a medicated feedingstuff cannot be held, placed on the requirements.

market or used unless it has been manufactured in accordance with

these rules.

(2) Subject to the requirements of Article 6 of European

Union Directive 2001#82#EC with regard to the tests to be carried out

on veterinary medicinal products, the Veterinary Services may, however,

for scientific purposes, provide for derogations from these rules,

provided there is adequate official control.

(1) The Veterinary Services shall ensure that medicated Medicated

feedingstuff

feedingstuffs are not supplied to stockfarmers or holders of animals prescriptions.

except on presentation of a prescription from a registered veterinarian

on the following terms>

(a) the veterinarian’s prescription shall be made out on a

form shown on the specimen in Schedule I< the original form shall

be for the manufacturer or, where appropriate, a distributor

approved by the competent authority of the Member State of

destination of the medicated feedingstuffs<

(b) the veterinarian shall fill Part A of the following

prescription and copies of prescription shown in Schedule I>

(i) Manufacturer’s or authorised distributors original,

which shall be retained by the manufacturer or authorised

distributor for a period which is not less than three years from

date when the prescription was filled by the veterinarian. The

veterinarian shall omit the details of the disease for which the

treatment is prescribed in Part A of this original. The

manufacturer or authorised distributor shall fill Part B of this

original. This prescription shall be made available at all times

to the Veterinary Services during official inspections<

(ii) Food and Veterinary Regulation Division copy

which shall be sent by the manufacturer or authorised

distributor to the Veterinary Services within five days of the

presentation of the prescription. The veterinarian shall omit

the disease for which the treatment is prescribed in Part A of

this copy. The manufacturer or authorised distributor shall

fill Part B of this copy<

(iii) The veterinarian’s copy which shall be retained

by the veterinarian for a period of not less than three years

from the date the prescription was made by him. The disease

to be treated shall only be indicated in Part A of this copy.

This prescription copy shall be made available at all times to

the Veterinary Services during official inspections.

(c) medicated feedingstuffs may not be used for more than

one treatment under the same prescription<

(d) the veterinary prescription shall be valid only for a period

determined by the Veterinary Services which shall not exceed three

months from the date on which the prescription is made by the

veterinarian<

(e) the veterinarian’s prescription may be used only for

animals treated by him. The veterinarian must first satisfy himself

that>

(i) the use of this medication is justified for the species

concerned on veterinary grounds<

(ii) administration of the medicinal product is not

incompatible with a previous treatment or use and that there

is no contra-indication or interaction where several pre-mixes

are used<

(f)

the veterinarian must>

(i) prescribe the medicated feedingstuffs only in such

quantities as, within the maximum limits laid down by the

national authorization for placing medicated pre-mixes on the

market, are necessary for the purpose of the treatment<

(ii) satisfy himself that the medicated feedingstuff and

the feedingstuff currently used to feed treated animals do not

contain the same antibiotic or the same coccidiostat as active

substances.

(2) However, in the case of anthelmintic medicinal products

(vermifuges), the Veterinary Services may, pending the review to be

carried out under European Union Directive 2001#82#EC of the risks

associated with the use of these groups of substances, derogate for five

years after the adoption of these rules from the obligation laid down in

sub-rule (1) not to supply medicated feedingstuffs obtained from

authorized medicated pre-mixes except on presentation of a veterinary

prescription, provided that>

(a) the medicated pre-mixes used do not contain active

substances which belong to the chemical groups used, in the

territory of Malta, on medical prescription for human medicine,

(b) the medicated feedingstuffs accorded such authorization

are used in their territory only prophylactically and in the dosages

necessary for the purpose in question.

(3) The Veterinary Services shall inform the European

Union Commission and the other Member States within the Standing

Veterinary Committee of the application of such a derogation, specifying

in particular the nature of the medicinal products and animal species

that it covers.

(4) Where medicated feedingstuffs are administered to

animals whose meat, flesh, offal or products are intended for human

consumption, the stockfarmer or holder of the animals concerned must

ensure that treated animals are not slaughtered in order to be offered for

consumption before the end of the withdrawal period and that products

obtained from a treated animal before the end of such a withdrawal

period are not disposed of with a view to their being offered for human

consumption.

(1) The Veterinary Services shall take all necessary measures

to ensure that medicated feedingstuffs are issued directly to the

stockfarmer or holder of the animals only by the manufacturer or

distributor specially approved by the competent authority of the Member

State of destination.

(2) Furthermore, medicated feedingstuffs for the treatment

of animals whose meat, flesh, offal or products are intended for human

consumption may not be issued unless>

(a) they do not exceed the quantities prescribed for the

treatment, in accordance with the veterinary prescription where

this is provided for,

(b) they are not issued in quantities greater than one month’s

requirements as established in accordance with the stipulations of

the first indent.

(3) However, notwithstanding sub-rule (1), the Veterinary

Services may in special cases authorize distributors specifically approved

for that purpose to issue, on the basis of a veterinary prescription,

medicated feedingstuffs in small quantities, prepacked and ready for

use, and prepared, without prejudice to rule 8 (2) in accordance with

the requirements of these rules, provided that these distributors>

(a) comply with the same conditions as the manufacturer

regarding the keeping of registers and the storage, transport and

issue of the products concerned,

(b) are subject to special checking for the purpose, under

the supervision of the competent veterinary authority,

(c) may supply only prepacked or prepackaged medicated

feedingstuffs ready for use by the holder or stockfarmer that have

on the packaging or containers instructions for the use of the said

medicated feedingstuffs and, in particular, an indication of the

withdrawal period.

(4) The provisions of sub-rule (2) shall not affect national

rules on the legal ownership of the medicated feedingstuffs.

(1) The Veterinary Services shall ensure that, without Intra-Community

Trade of medicated

prejudice to animal-health rules, there are no prohibitions, limitations feedingstuffs.

or obstacles in respect of intra-Community trade>

(a) in medicated feedingstuffs which have been

manufactured in accordance with the requirements of these

regulations, and in particular rule 4 thereof, with authorized pre-

mixes which have the same active substances as pre-mixes

authorized by the Member State of destination, in accordance with

the criteria of European Union Directive 2001#82#EC, and a

quantitative and qualitative composition similar thereto,

(b) subject to the specific provisions of European Union

Council Directive 96#23#EC of 29 April 1996 on measures to

monitor certain substances and residues thereof in live animals

and animal products and repealing Directives 85#358#EEC and

86#469#EEC and Decisions 89#187#EEC and 91#664#EEC and

Council Directive 96#22#EC of 29 April 1996 concerning the

prohibition on the use in stockfarming of certain substances having

a hormonal or thyrostatic action and of b-agonists, and repealing

Directives 81#602#EEC, 88#146#EEC and 88#299#EEC as referred

to in Article 7 (1) of Council Directive 96#22#EC, in animals to

which those medicated feedingstuffs except those produced

pursuant to rule 3 (2), have been administered, or in meat, flesh,

offal or their products from such animals.

(2) Where the application of sub-rule (1) gives rise to

dispute, in particular as concerns recognition of the similar nature of

the pre-mix, the Member States concerned or the Commission may

submit the dispute to assessment by an expert appearing on a list of

Community experts to be drawn up by the Commission on a proposal

from the Member States. If the two Member States so agree beforehand,

the parties shall abide by the opinion of the expert, in compliance with

Community legislation.

(3) The Member State of destination may require that each

consignment of a medicated feedingstuff be accompanied by a certificate

issued by the competent authority, corresponding to the specimen form

in Schedule II.

(1) The safeguard measures laid down by European Union Safeguard

Measures.

Council Directive 89#662#EEC shall apply to trade in authorized

medicated pre-mixes or medicated feedingstuffs.

(2) The rules laid down concerning veterinary control and,

in particular, the requirements laid down in Article 5 (2) and Article 20

of European Union Council Directive 89#662#EEC shall apply to trade

in authorized pre-mixes or medicated feedingstuffs to the extent that

they are subject to veterinary control.

The Veterinary Services shall take all necessary measures to

ensure compliance to these rules>

(a) by making sampling checks at all stages of the

production and marketing of the products referred to by these rules,

to ensure that the provisions of these rules are complied with<

(b) in particular, by making sampling checks on farms and

slaughterhouses, to ensure that medicated feedingstuffs are used

in compliance with the conditions of use, and that withdrawal

periods have been complied with.

Pending the implementation of Community measures relating

to imports of medicated feedingstuffs from third countries, the Veterinary

Services shall apply to those imports measures which are at least

equivalent to those of these rules.

Schedule I

Schedule II

ACCOMPANYING CERTIFICATE IN RESPECT

OF MEDICATED FEEDINGSTUFFS FOR ANIMALS INTENDED FOR TRADE

Name and address of the manufacturer or approved distributor: ………………………………..

………………………………………….................................................................................................

Name of the medicated feedingstuff: ............................................................................................

Type of animal for which the medicated feedingstuff is intended: ............................................

Name and composition of the authorised medicated pre-mix: ..................................................

Dosage of the medicated pre-mix authorised in the medicated feedingstuff: ..........................

Quantity of medicated feedingstuff: .............................................................................................

Name and address of the recipient: ..............................................................................................

It is hereby certified that the medicated feedingstuff as described above has been

manufactured by an authorised person in accordance with Directive 90/167/EEC.

Done at ..................................................................., on ..................................................................

(place)

(date)

(Signature)

(Name and position)

Stamp of the veterinary authority

or other competent authority

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