MANUFACTURE, PLACING ON THE MARKET AND USE OF MEDICATED FEED RULES

MANUFACTURE, PLACING ON THE MARKET AND USE

OF MEDICATED FEED

SUBSIDIARY LEGISLATION 437.114

MANUFACTURE, PLACING ON THE MARKET AND

USE OF MEDICATED FEED RULES

8th December, 2024

LEGAL NOTICE 266 of 2024.

(1)

The title of these rules is the Manufacture, Placing

on the Market and Use of Medicated Feed Rules.

(2)

These rules implement the requirements of Regulation

(EU) 2019/4 of the European Parliament and of the Council of 11

December 2018 on the manufacture, placing on the market and use of

medicated feed, amending Regulation (EC) No 183/2005 of the

European Parliament and of the Council and repealing Council

Directive 90/167/EEC and also regulate other matters which are

incidential to the subject matter thereof.

In these rules, unless the context otherwise requires

"Act" means the Veterinary Services Act;

"animal keeper" means any natural or legal person

responsible for animals on a permanent or on a temporary basis;

"Director" shall have the same meaning as assigned to in

the Act;

"operators" means feed business operators or on-farm

mixers as defined in Regulation (EU) 2019/4;

"Regulation (EU) 2019/4" means Regulation (EU) 2019/

4 of the European Parliament and of the Council of 11

December 2018 on the manufacture, placing on the market and

use of medicated feed, amending Regulation (EC) No 183/2005

of the European Parliament and of the Council and repealing

Council Directive 90/167/EEC.

The Director may request the operators and animal

keepers to provide any information relating to the importation, export,

intra-trade, sale, use, administration and disposal of any type of

medicated feed or its intermediate products.

(1)

The operators and animal keepers shall dispose of

all the unused or expired medicated feed and, or all unused

intermediate products in accordance with the guidelines as may be

issued by the Director.

(2)

The operators and animal keepers shall keep receipts of

destruction of the medicated feed and intermediate products for a

MANUFACTURE, PLACING ON THE MARKET AND USE

OF MEDICATED FEED

period of five (5) years and such receipts shall be made available to the

Director upon request.

(1)

The quantity of medicated feed referred to in item

9 of Annex V of Regulation (EU) 2019/4 shall be sub-divided in the

veterinary prescription for medicated feed into quantity prescribed for

production and quantity supplied for use.

(2)

The prescribing of medicated feed shall be made only on

prescription for medicated feed provided by the Director in line with

Article 16 of Regulation (EU) 2019/4.

(3)

The veterinary prescription for medicated feed shall

remain valid as a printed copy for a period of time as determined by the

Director who may decide that it shall be substituted by an electronic

version, and in such case Article 16 of Regulation (EU) 2019/4 and

sub-rule (1) shall apply mutatis mutandis.

(4)

An electronic veterinary prescription for medicated feed

shall be established by the Director for the purposes of this rule.

Establishments for the purposes of manufacture, storage,

transport or placing on the market of medicated feed or intermediate

products shall submit an application in the form prescribed by the

Director before the activity takes place.

Operators shall provide a list of medicated feed they

manufacture and, or distribute to the Director in January of each year.

Any changes in the list shall be notified to the Director without delay.

(1)

Decisions of the Director in terms of these rules

shall be subject to a right of appeal before the Administrative Review

Tribunal established by article 5(1) of the Administrative Justice Act.

(2)

An appeal in terms of this rule shall be filed within twenty

(20) days from the service of the Director’s decision

Provided that the Director’s decision shall become

immediately applicable and enforceable and shall remain applicable

throughout the term of appeal until final judgment by the

Administrative Review Tribunal and shall remain applicable unless it is

reversed by the Tribunal or withdrawn by the Director.

Any person who contravenes or acts in violation of the

provisions of Regulation (EU) 2019/4 and these rules, shall be guilty of

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

than one thousand euro (€1,000) and not more than five thousand euro

(€5,000), or to imprisonment for a term not exceeding two (2) months,

or to both such fine and imprisonment

Provided that the Director shall not be precluded from

MANUFACTURE, PLACING ON THE MARKET AND USE

OF MEDICATED FEED

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