MANUFACTURE, PLACING ON THE MARKET AND USE OF MEDICATED FEED [ S.L. 437.114 1 SUBSIDIARY LEGISLATION 437.114 MANUFACTURE, PLACING ON THE MARKET AND USE OF MEDICATED FEED RULES 8th December, 2024 LEGAL NOTICE 266 of 2024. 1.
(1)The title of these rules is the Manufacture, Placing on the Market and Use of Medicated Feed Rules. Citation and scope.
(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: Interpretation. "Act" means the Veterinary Services Act; Cap.
- "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. Request for information. 4.
(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. System of disposal of unused or expired medicated feed.
(2)The operators and animal keepers shall keep receipts of destruction of the medicated feed and intermediate products for a 2 [ S.L. 437.114 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. Veterinary prescription for medicated feed. 5.
(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. Applications.
- 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. List of medicated feed.
- 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. Right to appeal. Cap.
- 8.
(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. Offences, punishments and administrative penalties. 9. 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 [ S.L. 437.114 proceeding in accordance with the provisions of article 61 of the Act. 3