Vet Products & Fertilisers

The 2023 Act

The Veterinary Medicinal Products, Medicated Feed and Fertilisers Regulation Act 2023  Act provides for the making of regulations on the retailing of veterinary medicinal products including sales at a distance which are a matter for national law and will be regulated for in secondary legislation in accordance with the provisions of this Act.

This Act provides for the making of regulations on the licencing of the importation of certain veterinary medicinal products and medicated feed in circumstances permitted under EU law. The Act provides for the making of regulations on the possession, administration and storage of veterinary medicinal products and medicated feed and the enforcement powers of authorised officers.

Information

The Act provides for the creation of a national database, a digital online system which will facilitate the recording of veterinary prescriptions by veterinarians and the dispensing of the veterinary medicinal product/medicated feed by a registered dispensing outlet, Co- Op (Licenced Merchant), Pharmacy or Feed Mill.

The Act, enables the Minister to capture and process information on the import, manufacture, sale, supply and use of fertiliser in the State. It will enable data related to fertilisers and lime to be collected from the point of import into the country until sale to end user. It will provide for the establishment of a National Fertiliser Database which will encompass the registration of fertiliser economic operators and end users.

The 2023 Act provides for the repeal of the Animal Remedies Act 1993 and certain provisions of the Irish Medicines Board (Miscellaneous Provisions) Act 2006, the Animal Health and Welfare Act 2013 and the Horse Racing Ireland Act 2016 and the dissolution of the Animal Remedies Consultative Committee as well as a provision for expenditure under the Act.

Veterinary Prescription

There are restrictions on those who may issue a veterinary prescription to ensure only registered veterinary practitioners do so and provides that all veterinary prescriptions shall be issued electronically and dispensed and recorded on or transmitted to the national database.

Regulations may be made in relation to the prescription and dispensing of veterinary medicinal products or medicated feed to ensure appropriate prescribing of veterinary medicinal products and medicated feed.

The 2023 Act provides for the establishment, maintenance and operation of a database (“national database”) on which veterinary prescriptions and dispensing of veterinary prescriptions shall be recorded to ensure a competitive market for the supply of veterinary medicinal product and to comply with certain reporting obligations under the VMP Regulation. It provides for persons who the information held on the database may be accessed by, shared with and the reasons for the processing of the data. This Section has a commencement order attached to it.

Sale

The 2023 Act  provides for the prescribing and dispensing of veterinary prescriptions as provided for in the VMP Regulation and the Medicated Feed Regulation. It provides for the rules on retail as delegated to Member States in accordance with the provisions of the VMP Regulation.

The Act  provides for

• the routes of retail of veterinary medicinal products to ensure that veterinary medicinal products are retailed in an appropriate manner. The routes are detailed in the Schedule to this Act.
• the restrictions on the retail of veterinary medicinal products by certain persons to ensure that veterinary medicinal products are retailed in an appropriate manner.
• the labelling requirements of veterinary medicinal products that are subject to a prescription, for retail to ensure the correct information in relation to the supply and use of the veterinary medicinal product is clearly displayed to ensure the safe and appropriate use of product.
• the prohibition on retail of a veterinary medicinal product after its expiry date to ensure the safe and appropriate use of veterinary medicinal products.
• the labelling requirements of veterinary medicinal products for retail when retailed outside their original packaging to ensure the safe and appropriate use of veterinary medicinal

Licence

The 2023 Act  provides for

• the restriction on use of premises storing a veterinary medicinal product for the purpose of retail to ensure the safe storage of veterinary medicinal products and for the protection of animal and human health.
• on application the granting of a licence, to be known as a veterinary medicinal product retailer’s licence when certain criteria are fulfilled for the purpose of retailing veterinary medicinal products to ensure the safe and appropriate retailing of veterinary medicinal products.
• the obligations on the holder of a retailer’s licence to ensure the safe and appropriate retailing of veterinary medicinal
• the training to be undertaken by a person in order to be permitted to retail veterinary medicinal products to ensure the safe and appropriate retailing of veterinary medicinal products by suitably trained individuals.
• the establishment and maintenance of a register of retailers of veterinary medicinal products designated “companion animal medicine” to ensure the safe and appropriate retailing of these products.
• the record-keeping requirements for a veterinarian, pharmacist and retailer’s licence holder in addition to those in the VMP Regulation to ensure the safe and appropriate use of veterinary medicinal products.
• a prohibition on using anything other than a fixed premises to retail a veterinary medicinal product to ensure the safe and appropriate retailing of veterinary medicinal products.
• rules on retailing at a distance. “at a distance” means that the service is provided without the parties being simultaneously present as permitted in the VMP Regulations. This includes retailing on the internet.

Regulation

The 2023 Act provides for regulation for

• the licensing of the import of veterinary medicinal products in relation to their use under Articles 110 to 114 or 116 of VMP Regulation.
• regulations to be made regarding the retail, importation or exportation of veterinary medicinal products, ingredients for such or medicated feed to ensure the safe and appropriate use of veterinary medicinal products and medicated feed.
• regulations to be made regarding prohibiting or restricting the possession or control of specified veterinary medicinal products or ingredients thereof or medicated feed or animals that have been administered or fed such products for the protection of animal and human health.
• regulations to be made regarding prohibiting or restricting the administering to an animal a specified veterinary medicinal product or an ingredient thereof for the protection of animal and human health.
• regulations to be made regarding the secure storage and handling of veterinary medicinal products to ensure the safe and appropriate storage and handling of veterinary medicinal products.
• the making of regulations on the advertising or promoting of veterinary medicinal products or medicated feed as permitted by the VMP Regulation to ensure the safe and appropriate use of veterinary medicinal products and medicated feed.

The 2023 act provides for

• licensing of the manufacture, import or export of autogenous vaccines, import of medicated feed or intermediate products and the collection storage and supply of blood, or the storage and supply of blood constituents from an animal to be used in, or administered to non-food-producing animals to safeguard animal health.
• the exemption from a manufacturing authorisation for persons conducting certain activities in specified circumstances to ensure access to veterinary medicinal products when necessary and appropriate to do so.
• the making of regulations in relation to matters mentioned in the VMP Regulation or the Medicated Feed Regulation that are to be determined by national law or to be put in place by national procedures or that the State is permitted to do.
• the laying of regulations in respect of veterinary medicinal products and medicated feed made under the Act.
• the application, revocation, refusal or varying and appeal processes for all licences in the Act.

Enforcement

The 2023 Act provides for

• the appointing in writing of such persons or class of persons, as the Minister considers appropriate, to be authorised officers for the exercise of the functions conferred on an authorised officer under this Part. Italso provides the powers for an authorised officer and details the specific circumstances that an authorised officer can use their powers.
• for the specific circumstances that a search warrant may be issued
• the specific circumstances that a search of a person or vehicle and the stopping of a vehicle may be
• the specific circumstances that a member of the Garda Síochána can arrest a person without
• the exercise by a member of the Garda Síochána of their lawful powers.
• issuing of a compliance notice in specified circumstances and the operation of such a
• the appeal mechanism against a compliance notice issued.
• the seizure and detention of a product or feed and any means of transport or other thing used in connection with such for non-compliance with compliance notice.

Enforcement

The 2023 Act provides for

• an offence where a person in specified circumstances obstructs an authorised officer, member of the Garda Síochána or officer of customs or any person who accompanies such officer or member.
• an offence for impersonating an authorized officer or unlawfully being in possession of documents that do
• or certain evidentiary rules in the prosecution of an offence under this part.
• the disposal of things seized by an authorised officer, a member of the Garda Síochána or an officer of customs for the purposes of enforcing the Act.
• the authenticity of the contents of a certificate purported to be signed by a person in a
• for offences by body
• circumstances and service of notices and
• the disqualification from keeping animals, veterinary medicinal products, or medicated feed of a person who is convicted on indictment of an offence.
• the forfeiture in specified circumstances of an animal, veterinary medicinal product and ingredients thereof and associated items.
• the recoupment of costs of certain
• an offence for forgery or alteration of a veterinary prescription, licence, record or document.
• the power for the Minister to bring proceedings summarily.
• the circumstances where a fixed notice may be issued and the operation of that
• the issuing of identity cards to authorized officers under this

Fertilisers Feeding Stuffs and Mineral Mixtures Act

Part 3 of the Act provide for the amendment of the Fertilisers Feeding Stuffs and Mineral Mixtures Act 1955.

The Minister may prescribe substances not considered to be fertilisers or feeding stuffs.

The Act provides for

• the application of a licence and the right to appeal if a licence is not granted.
• the establishment of a Fertiliser Economic Operator’s Register and a Fertiliser End User It also provides for a National Fertiliser Database, which will encompass the registration of fertiliser economic operators and end users. Information on the manufacturing, import, placing on the market, making available on the market or sales (whether wholesale or retail) of fertiliser products will be included in the Database. It also provides the procedures for properly processing the information collected.
• The Act provides for the appointing in writing of such persons or class of persons, as the Minister considers appropriate, to be authorised officers for the exercise of the functions conferred on an authorised officer under this Part. This section also provides the powers for an authorised officer and details the specific circumstances that an authorised officer can use their powers.