Useful Information

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Frequently asked Questions (FAQ)

The information in this website is intended to increase predictability to all stakeholders and to facilitate communication with them. A number of Frequently Asked Questions have been prepared to help stakeholders understand more the requirements in this area.

European Union Regulations on Veterinary Medicinal Product and on Medicated Feed.

The following Regulations were published in the Official Journal of the European Union on 7th January 2019 and were applied on 28th January 2022.

Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 and repealing Council Directive 90/167/EEC

and

Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC

The purpose of these revisions in the EU Legislation is to increase the availability of veterinary medicinal products and Medicated Feeds , to reduce the administrative burden on enterprises, to improve the functioning of the internal market for veterinary medicinal products and Medicated Feeds and to assess the possibilities to have an improved response to antimicrobial resistance.

A video on some important aspects regarding veterinary medicinal products can be found here.

Information in this website

The information in this website is regularly reviewed and updated in line with the rapidly evolving legislative, regulatory and technical areas.

The Veterinary Medicines Section does not take responsibility of the concepts as understood, or misunderstood, by the reader.

The information present in this website is not to be considered as professional consultancy material. Stakeholders are responsible for their own decisions in accordance with the existent legislation and Department's requirements.

The information and instructions contained in this website has guidelines prepared by the Veterinary Medicines Section for the benefits of its stakeholders. Interested parties are encouraged to refer to the legislation proper, i.e. LN 179/2021, Subsidiary Legislation 437.47, Veterinary Medicinal Products Regulations as amended last by LN 179/2021 on 23rd April 2021, and Subsidiary Legislation 437.73 on Medicated Feed. Both Subsidiary Legislation are under Chapter 437, Veterinary Services Act as amended by ACT No. XIV of 2022 on the 28th December 2022.

The amendments added the necessary vires to the minister to enact important legislation related with anything related with veterinary medicinal products. Amongst other important changes there are those related with enforcement action, collection of data on sales, penalties, the application for licences for veterinary pharmacies, managing pharmacist and alignment with regulation (EU) 2019/6 of the European Parliament and of the Council of 11th December 2018. Amendments have also been carried out in relation to the functions of the National Veterinary Laboratory, the responsibilities of the Director of Veterinary Services and the slaughter of food-producing animals.

Interested parties can read more about the amended CAP 437 by referring to the User Guidelines on ACT No. XIV

All interested parties can find a list of all authorised veterinary products in the EU in the Union Product Database (UPD). More information on this can be found here .

This website was last updated on the: 23/02/2023